Study title: Determining the feasibility of a trial to determine the impact of a physiotherapist-led primary care model for low back pain: A pilot cluster randomized controlled trial

Study title: Determining the feasibility of a trial to determine the impact of a physiotherapist-led primary care model for low back pain: A pilot cluster randomized controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Study title: Determining the feasibility of a trial to determine the impact of a physiotherapist-led primary care model for low back pain: A pilot cluster randomized controlled trial Jordan Miller, Kevin Varette, Chad McClintock, Catherine Donnelly, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8902753/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Background Low back pain (LBP) is a leading cause of disability worldwide. The first point of contact in the healthcare system for most individuals with LBP is their family physician; however, models incorporating physiotherapists (PTs) as the first point of contact within a primary care team are becoming more common. Research is needed to determine the impact of a PT-led model of care on patient health and health system outcomes. A pilot study was required before proceeding with a fully powered, multisite cluster randomized controlled trial (RCT) to address the following objectives: 1) Determine the feasibility of patient recruitment, assessment procedures, and retention; and 2) Determine the feasibility of PT training and implementation of a new PT-led primary care model for back pain. Methods A pilot cluster RCT was conducted at four primary care sites: two sites randomized to the PT-led and two sites randomized to usual physician-led model of care for LBP. The intervention arm involved a PT-led model of care in which the PT was integrated in the primary care team and available as the first point of contact. The control arm involved usual physician (or nurse practitioner)-led care. Adults seeking a primary care appointment for LBP were considered eligible to participate. Primary outcomes for the full trial were captured at baseline, six weeks, and three, six, nine and twelve months. Process outcomes were collected from the participant’s electronic medical record. Feasibility measures were assessed using patient recruitment and retention numbers, percentage completeness of assessment procedures, and feasibility indicators for PT training and treatment fidelity. Results 58 participants were recruited to the PT-led and 42 to the usual care arm (> 1.5 patients per week) over a 16-week recruitment period; 89% remained at the 12-month follow-up. Completion of > 99% of assessment procedures was achieved and remained within acceptable times to complete (< 60 minutes). The PT reported confidence (8/10) with their training and chart audits indicated high treatment fidelity. Conclusions The results suggest that implementing this model of care and utilizing the described trial methods are feasible. These findings support proceeding with the fully powered trial. Trial registration: ClinicalTrials.gov, NCT03320148. Submitted for registration on 17 September 2017. Low back pain Primary care Physiotherapy Cluster randomized trial Pilot study Figures Figure 1 Figure 2 Key message Prior to this pilot study, uncertainty existed as to the feasibility of successfully integrating a physiotherapist into a primary care setting for low back pain management in the Canadian context. The ability to recruit and retain participants and to administer assessments over a one-year follow-up period was undetermined. Our results suggest that a fully powered cluster randomized controlled trial to determine the impact of a new physiotherapist-led primary care model for low back pain is feasible. Key findings from the pilot study will have the following implications on the design of the full study: (1) additional efforts are required to achieve balanced recruitment across trial arms; (2) adjustments were made to the full trial sample size; (3) estimates of the hours required for physiotherapy coverage are now more accurate; (4) participants at high risk for ongoing disability will be offered physiotherapy in the PT-led primary care sites, rather than through referral; (5) formal physiotherapy orientation to the primary care sites will be conducted; and (6) improvements to the outcome assessment process have been incorporated. BACKGROUND Low back pain (LBP) is one of the leading causes of disability around the world 1 , 2 . It is one of the largest contributors to time off work 3 , 4 , inappropriate diagnostic testing 4 , 5 , emergency department (ED) visits 6 , and specialist consultations. Research has indicated that people with LBP utilize health care services at a rate approximately 60% higher than those without LBP 7 . Given the burden posed by LBP as a result of systemic inefficiencies, low-value interventions, and poor patient outcomes, research into innovative and evidence-based models of care is needed 8 – 10 . In Canada, people with LBP often present to their primary care physician as the first point of contact for the management of their condition 11 . Primary care physicians often express limited confidence with the management of LBP 12 , 13 , a situation commonly linked to insufficient education on the management of musculoskeletal conditions 14 , 15 . Additionally, primary care teams are overburdened with the challenges posed by an aging population 16 , the growing prevalence of multiple chronic health conditions 17 , and increasingly complex patient encounters 18 , 19 . Both federal and provincial government agencies, as well as several health organizations, have recommended the development of interprofessional teams with complementary skillsets to optimize the efficacy and sustainability of the primary healthcare system 20 . Research related to other health conditions has indicated that interprofessional team-based approaches can result in more appropriate referrals, better coordination of care, and improved patient outcomes 2 , 21 , 22 . One interprofessional model of care involves the integration of physiotherapists (PTs) into the primary care team for people with musculoskeletal conditions. Observational research performed in a variety of settings has shown that PTs can effectively assume a primary care role with successful patient outcomes and contribute to increased efficiency of healthcare delivery. A US Military study found that integrating PTs as the first point of contact for service members with work related injuries resulted in shorter wait times, decreased illness-related workdays lost, improved satisfaction with care, and more appropriate specialist referrals 23 – 28 . Research performed by the UK National Health Service on adopting a PT-led model of care, demonstrated reduced wait times, increased patient and provider satisfaction, decreased lost work, a reduced need for diagnostic imaging, and less use of prescription medications 29 – 31 . Guideline-adherent management of LBP has been shown to significantly reduce disability and improve function 32 , 33 and evidence suggests that PTs can collaboratively and successfully implement recommendations from established primary care guidelines for LBP 34 – 42 . These include effective screening for red flags (signs or symptoms of serious pathology such as cancer or neurodegenerative disease) and the need for diagnostic tests 23 , 43 , 44 ; identifying risk factors for poor recovery 45 – 47 ; offering advice and strategies around physical activity, return to work, and therapeutic exercise 48 ; and providing psychosocially informed interventions for patients identified as being at higher risk for delayed recovery 45 . Evidence from outside of Canada suggests early guideline-adherent PT care for LBP improves function and disability 32 , decreases the use of diagnostic imaging and opioid prescriptions, and reduces inappropriate specialist referrals 33 , 49 , 50 , while lowering per person healthcare costs 51 , 52 . These results are encouraging, but more rigorous evaluation specific to LBP in the Canadian primary care system is needed. A systematic search of major databases (Medline, CINAHL, Embase) revealed no randomized controlled trials (RCTs) on the impact of integrating PTs at the first point of contact in primary care for any condition 53 . This absence of rigorous evidence from clinical trials leaves important gaps in our knowledge about the process and impact of integrating PTs into primary care teams for people with LBP. Specifically, there is a dearth of high quality evidence on the impact of PT-led primary care on patient outcomes (e.g., pain, function, quality of life), health system outcomes (e.g., healthcare access, physician workload, ED visits, specialist referrals, medication use, diagnostic imaging), and societal outcomes (e.g., missed work, cost-effectiveness). Additionally, there are specific procedural questions that need to be answered, such as how PTs will navigate the challenges of providing care for people presenting with multiple health concerns and requests for opioid medications, diagnostic imaging, or notes for work absences. Our objective is to address these gaps by conducting a cluster RCT to assess the impact of a PT-led primary care model for LBP. This pilot study was conducted with the following objectives: Determine the feasibility of patient recruitment, assessment procedures, and retention. Determine the feasibility of physiotherapist training and implementation of a new PT-led primary care model for back pain. METHODS Design This pilot study was a cluster RCT. There were four participating primary care sites in Kingston, Ontario, Canada; two sites were randomized to the PT-led primary care model for LBP and two sites randomized to the usual physician-led primary care model. Randomizing individual patients within the same clinic would have created a high risk of contamination, as the PT would be integrated into the care team and routine clinic processes, making it difficult to prevent elements of the intervention from influencing patients receiving usual care. To address this issue, a cluster RCT was used, with randomization occurring at the primary care clinic level. Qualitative interviews by a member of the research team were embedded within the trial with the goal of exploring the perspectives of patients and primary care team members related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. Detailed methods and results have been presented in a companion paper 54 . The study was registered prior to commencing recruitment (ClinicalTrials.gov Identifier: NCT03320148). The methods described below were detailed in a previously published study protocol 55 . See Supplementary file 1 for the completed CONSORT Extension to Pilot and Feasibility Trials checklist 56 . Enrollment and randomization of sites : Four primary care sites in Kingston, Ontario were purposefully selected based on the following criteria: a) they were associated with either family health teams or community health centres (at least one of each, to evaluate the feasibility of the protocol in both settings), b) they had at least two physicians and 2500 registered patients, and c) they did not have a PT integrated within their primary care team at the time of enrollment. Given the range in the number of patients at each of the primary care sites (from 3,000 to 16,000), the largest and smallest sites were grouped together, while the two sites of intermediate size were grouped into the second cluster. Random allocation of the two groups into the intervention or control arms was then carried out using computer-generated random numbers. The randomization was performed by an independent statistician who was blinded to the site names by using anonymized codes for each site. We planned to use covariate-constrained randomization 57 for the full trial. Blinding Because the study is comparing two models of care, blinding of patient participants or health care providers (HCPs) delivering the care was not feasible. Patient participants were made aware that the study they were participating in involved a comparison between these two different models of care; however, it was not disclosed to participants which arm their primary care site had been randomized to until after consent and baseline data collection. The primary outcomes were self-report measures (completed by the patient) and, therefore, outcome assessment was also not blinded. Patient enrollment Enrollment occurred over a 4-month period, from September 2017 to January 2018. When a patient contacted one of the participating sites to book a visit for LBP, the medical secretary screened the patient for consent to be invited to participate in the study. Those patients who consented were scheduled to come in 30 minutes prior to their appointment time to meet with the RA, at which time the RA provided detailed information about the study and obtained written informed consent to enroll the patient. Inclusion/exclusion of patients During the recruitment period, all adult (18 years or older) patients who contacted the participating clinics to book an initial or follow-up visit for LBP were invited to participate in the study, regardless of the duration of symptoms. Patients were excluded if they reported that their LBP was known to be due to cancer or a diagnosed neurodegenerative disease prior to the primary care visit, or if they were not able to understand, read, and write English. Interventions: PT-led primary care arm The intervention integrated a PT within two primary care teams, allowing the PT to be available as the first point of contact for patients presenting with LBP. For this pilot study, we had the same PT at both primary care teams, but for the full study, we plan to use a minimum of three PTs for the 10 sites. Patient participants enrolled in this arm were provided the opportunity to book their initial visit with the PT but were given the option of seeing their physician or NP (for example, if the visit was only requested to discuss medications or if the patient had multiple concerns other than LBP). The PT-led primary care intervention had four components: Assessment and screening : The assessment and screening involved taking a detailed history, including screening for potential pathology (e.g., signs or symptoms of widespread neurological involvement, fractures, or cauda equina syndrome); a thorough physical and neurological assessment; the use of evidence-based measures to screen for comorbid health conditions (e.g., depression/anxiety) that may negatively impact recovery and warrant additional care from another team member 58 , 59 ; and the implementation of a validated tool (STarT Back 46 , 47 ) to identify physical and psychosocial risk factors associated with prolonged pain and disability. Brief individualized intervention : During the initial visit, the PT delivered a brief, personalized intervention to each patient participant, guided by primary care guidelines for LBP 42 . The intervention involved discussion regarding the patient’s experiences with pain with the goal of validating their experiences and the impact of LBP on their lives 60 – 62 . It also involved providing cognitive support 63 , customized exercises based on physical assessment findings 64 , 65 , and encouragement and strategies to stay active 66 . Guidance and instruction were supported with written information to reinforce the recommendations 67 . Health services navigation: Following the assessment, the PT supported patients with LBP in accessing appropriate healthcare services tailored to their needs. Identification of any red flags suggestive of serious underlying conditions prompted immediate communication with the physician or NP for urgent evaluation. Comorbidities uncovered during the assessment, such as a positive depression screen in patients not currently receiving treatment, were also relayed to the family physician or mental health team members for further management. Risk stratification utilizing the STarT Back tool 46 , 47 guided subsequent PT care recommendations. This validated instrument categorizes LBP patients into low, medium, or high risk for persistent pain and ongoing disability by evaluating physical and psychosocial factors 46 . Patients at low risk typically received only the brief individualized intervention during the initial visit. Patients classified as medium risk were referred to conventional community-based PT, while high risk patients were directed to PTs trained in integrated physical and psychological approaches designed to mitigate factors contributing to chronic pain and disability 68 , 69 . For those patients identified as medium or high risk who lacked private insurance or eligibility for government-funded care through the Ontario Health Insurance Plan (OHIP), ongoing treatment was provided by the PT within the primary care setting. Evidence from the UK supports that this stratified care model improves functional outcomes, enhances quality of life, and provides cost advantages when compared to standard care models 47 . Unfortunately, barriers to effective implementation of this approach in Canada have arisen largely due to funding models for physiotherapy services. For instance, patients classified as low risk often decide to pursue additional PT services using private insurance despite a high likelihood of recovery without further intervention. To address this inefficiency, the PT-led primary care model for LBP in this study incorporated educational components to empower low risk patients in making more informed choices about their continued care. Additionally, the barriers (most commonly financial) that often prevent medium and high risk patients from accessing appropriate PT care were mitigated by delivering ongoing PT at no cost to those demonstrating unmet clinical needs. 4. Providing additional physiotherapy care to patients with unmet needs : To overcome financial barriers faced by patients categorized as medium or high risk who lacked private or government-funded physiotherapy coverage, ongoing care was delivered by the PT directly within the primary care setting. This care comprised evidence-based interventions aligned with clinical guidelines, including tailored patient education 70 , customized therapeutic individualized exercise programs 64 , 65 , and cognitive-behavioural techniques 69 . Although all participants in the PT-led intervention had the option to schedule follow-up appointments with the primary care PT, the goal was to minimize unnecessary duplication of accessible PT services. Consequently, follow-up visits at the primary care site were reserved for those patients with identified needs and who were without alternative financial access to physiotherapy services. Physiotherapist training The PT integrated into the primary care teams for this pilot study completed approximately four days of training tailored to their new role. Training was conducted by the principal investigator, who has expertise in the management of LBP in interprofessional team-based primary care settings. In addition to the clinical training, the PT underwent orientation to each of the specific primary care sites where they would be practicing. It is planned that the PTs in the PT-led primary care arm of the fully powered RCT will undergo the same training, which includes A review of screening for potential serious underlying conditions (pathology). Assessment of comorbidities and awareness of available services for these conditions within the family health teams and community health centres participating in the study. Clinical evaluation of LBP based on established clinical practice guidelines, including subjective assessment and objective physical examination. Application and interpretation of patient-reported outcome measures and screening tools for people with LBP. Appropriate use of diagnostic imaging and integration of radiologist findings into clinical decision making. Utilization of the STarT Back tool to stratify patients into low, medium, or high risk of ongoing pain and disability, and determine appropriate physiotherapy referral pathways. Overview of physiotherapy resources in the Kingston, Ontario area based on patient health care resources, including private and OHIP-funded clinics. Delivery of a brief targeted primary care intervention for patients with LBP, incorporating reassurance, education on prognosis, promotion of continued engagement in daily activities, and prescriptions for brief amounts of physical activity and exercise. Implementation of activity-based physiotherapy for medium risk patients, featuring education, graded activity, and exercise prescription. Additional strategies for patients classified as high risk, aimed at addressing psychosocial contributors to pain and disability. These include communication techniques to encourage personal disclosure, pain neurophysiology education; interventions to reduce catastrophizing, graded exposure to reduce activity-related fear; pacing strategies; cognitive-behavioural approaches to enhance self-efficacy and promote behaviour change, and methods to improve sleep, manage stress, and manage flare-ups of symptoms. See Fig. 1 for a depiction of the decisions and care provided through the PT-led primary care model Caption for Fig. 1: Decisions and care provided through the PT-led primary care model. This figure was originally published in the protocol for this trial 55 . Usual physician-led care model The physician-led primary care intervention was intentionally left unstandardized to most accurately represent typical management of LBP within Canadian primary care settings. Generally, patients would consult with a primary care physician or NP, who would conduct a history and physical examination, provide education regarding LBP, and manage care through medication prescription, ordering diagnostic testing, or making referrals based on clinical judgment and patient preferences. Information on all healthcare utilization, including interventions received in the primary care setting, and visits to specialists, PTs, or pain clinics beyond the primary care encounter, was systematically collected throughout the follow-up period, supplemented by audit of the electronic health record (EHR). Evaluation and outcomes The main focus of this pilot study was on feasibility outcomes designed to guide the planning of a full-scale cluster RCT. These included metrics related to participant recruitment, retention, assessment procedures, and effectiveness of PT training to implement the PT-led primary care model. Secondary outcomes comprised clinical, health system, and process measures intended for the full trial. The objective was to assess the feasibility of collecting these secondary data, and the results are presented descriptively in aggregate. As per the study protocol, no between-group comparisons were conducted. 55 Data collection instruments used in the study are available upon request from the authors. 1. Feasibility outcomes : i. Recruitment of primary care teams : Successful recruitment and retention of four primary care sites -- comprising family health teams and/or community health centres (at least one of each) was identified as a key indicator of feasibility to proceed with the full trial. ii. Recruitment of patients : The feasibility of enrolling patients was assessed by the recruitment rate across all sites. Targets were based on the ability to recruit approximately 1.6 participants weekly across the four sites (equivalent to 21 patients over 13 weeks 55 ) or 0.4 patients per week per site. Achieving this rate would support the recruitment projections necessary for enrolling a sample of 640 people across 16 sites (40 patients/site) over a 2.5-year period 55 . iii. Assessment procedures : Completeness of survey responses and completion time were collected. Predefined criteria were established for acceptable data completeness 71 . Feasibility was deemed to be achieved if > 80% of all survey items were completed and the mean completion time was < 60 minutes. iv. Retention : Retention feasibility was gauged by participant attrition at 12-month follow-up, with a threshold of 20% threaten trial validity 72 and would necessitate enhanced retention strategies to be identified and implemented for the full trial. v. PT Training : This pilot study assessed the feasibility of the planned PT training for the new primary care role through attendance records, ratings of self-efficacy (0–10) for delivering each of the four intervention components, and qualitative feedback. Training success was defined as 100% attendance and self-efficacy ratings of at least 8/10 across all intervention components. Qualitative insights gathered will inform improvements to the PT training program for the full trial. vi. PT treatment fidelity : Fidelity to the intervention protocol was monitored through provided PT treatment checklists and audits of the participant EHRs 73 . A fidelity rate of > 80% in key areas – including red flag screening, reassurance, advice to remain active, exercise prescription, and referrals aligned with the STarT Back stratification – was considered sufficient to support protocol adherence. 2. Baseline factors used to describe the population : To characterize the population at baseline, we gathered the following information: age, gender, household income, duration of back pain, occurrence of previous episodes of back pain, presence of pain in other areas of the body, comorbidities (using the Charlson comorbidity index score) 74 , current medications, employment status before the present episode of back pain, and employment status at the time of responding to the survey. 3. Clinical outcomes : We piloted the collection for the clinical outcomes at baseline; six weeks; three, six, nine and twelve months. The RA collected all outcome measures electronically for those with access to a computer or device or on paper for those unable to complete them electronically. The following clinical outcome measures were piloted in this study: i. Self-reported disability was measured using the Roland-Morris Disability Questionnaire (RMDQ). This tool is widely accepted as a valid outcome measure in individuals with back pain 75 , 76 . ii. Pain intensity was assessed through a Numeric Pain Rating Scale (NPRS). Drawing on research indicating that pain experienced during movement can respond differently to treatment compared to pain at rest 77 – 79 , participants reported their pain levels at rest and while walking and lifting a bag of groceries. iii. Health-related quality of life was measured using the EuroQOL-5D (EQ-5D-5L) 80 , with scores converted to quality-adjusted life years (QALYs) using a value set developed for the Canadian setting 81 . This tool has been shown to be appropriate for economic evaluation 82 . iv. Global rating of change was measured using an 11-point Global Rating of Change scale (GROC) [(very much worse (-5) to completely recovered (+ 5)] 83,84 . v. Patient satisfaction was measured using an 11-point scale [very dissatisfied (-5) to very satisfied (+ 5)]. vi. Catastrophic thinking was measured using the Pain Catastrophizing Scale (PCS) 85 , a 13-item scale designed to assess catastrophizing thoughts related to pain. vii. Depressive symptoms were evaluated using the 9-item Patient Health Questionnaire (PHQ-9) 86 . Adverse events were recorded through a questionnaire that was informed by reporting guidelines 56 , 87 . The participants were asked if they encountered any adverse events related to the intervention (yes/no); what adverse event(s) were experienced; the duration of the adverse event(s) (hours or days); and the severity of the adverse event(s) (using a 0–10 scale). No serious adverse events occurred during this pilot study; however, if any arise during the full trial, they will be promptly managed by referring the participant to the most suitable member of the primary healthcare team. 4. Health system outcomes : We piloted data collection related to the health system outcomes listed below: i. Accessibility was evaluated by measuring the proportion of individuals with LBP who were able to book an encounter with their primary care provider within 48 hours of requesting an appointment. Accessibility was further defined, and informed by clinical guidelines, as and the number of participants identified as medium or high risk for ongoing pain (according to the STart Back tool) who received physiotherapy services 88 . ii. Health service utilization was captured using a self-report questionnaire at all follow-up timepoints (see Supplementary file 2). The following utilization measures were collected: number of primary care encounters, ED visits, overnight hospitalizations, surgeries/procedures, physician specialist encounters, visits to other HCPs (e.g., community PTs), diagnostic tests undergone (e.g., MRI), and medications taken. 5. Cost outcomes : A cost utility analysis is planned for the full trail; the following data were collected to achieve that goal: i. Direct healthcare costs : Direct costs included the PT training and salary, training of personnel at the primary care sites, equipment and materials, and clinic space required to integrate the PT. The Ontario Ministry of Health and Long-term Care Schedule of Benefits 89 was used to calculate costs for government-funded healthcare services. For private healthcare services, we surveyed providers in the community to determine the mean cost for services. The Ontario Drug Benefit formulary was referenced to calculate medication costs. ii. Indirect costs : Indirect costs (i.e., costs associated with LBP, but not healthcare-related) were estimated by loss of productivity using a human capital approach. The monetary value of time lost from paid work or caregiving duties, as reported by participants during each follow-up assessment, was calculated using the average wage data provided by Statistics Canada. The cost for time lost from volunteer activities was calculated using the minimum wage value in Ontario. 6. Process outcomes : Process outcomes are meant to help describe differences in the care provided between groups. These data were collected from the EHR and included: medication prescriptions, requisitions for diagnostic testing, referrals made to other internal and external HCPs, encounters within the primary care clinic, and notes provided for employers or insurers. Rates were determined as the number of events per person per year. Data collection and management: Data were collected using electronic (Qualtrics, Provo, Utah) 90 or paper data collection forms (based on the participant’s choice). The initial assessment data were collected with the RA present at the initial visit, and participants were instructed on how to complete the follow-up outcome measures. All data was entered into an encrypted and secure study database. Personal identifying information (name, date of birth, and contact information) were collected for the purpose of linking data from the EHR and for communicating with participants for follow-up appointments. All personal information was saved in a file separate from participant outcomes and was encrypted and password protected. Upon completion of the trial, all de-identified data were permanently anonymized, and the file containing personal identifiers was subsequently destroyed. Access to the data was restricted to study investigators and research personnel. As a data quality assurance check, 10% of data from the database was cross-referenced with the original data collection forms. RESULTS 1. Feasibility Outcomes i. Recruitment of primary care teams: Four primary care sites (three associated with family health teams and one community health centre) were recruited, meeting the established feasibility target for proceeding with the full trial. ii. Recruitment of patient participants : We recruited 100 patient participants over a 16-week recruitment period, which reflects an average recruitment rate of 6.25 patient participants per week across all sites (1.6 patient participants per week per site). 58 participants were in the PT-led arm and 42 were in the usual care arm. This recruitment rate exceeded our a priori stated progression criteria of 1.6 patient participants per week across all sites or > 0.4 patient participants per site per week 55 . iii. Assessment procedures : Using the data collection processes described above, a completion rate of > 99% of all items on our included measures was achieved, with an average completion time of < 60 minutes at all assessment points. These meet the a priori criteria set for feasibility of the assessment procedures for the full trial 55 . iv. Retention : All four primary care sites (clusters) were retained throughout the 12-month follow-up. We retained 89% of patient participants at the 12-month follow-up period, representing 11% attrition, which meets the < 20% attrition criterion we stated a priori as a feasibility criterion for progression to the full trial with the existing retention strategies. The retention rate was 87.9% in the PT-led primary care model arm and 90.5% in the usual care arm. Attrition was due to two patient participants withdrawing, both in the PT-led primary care model arm (reasons: no longer wishing to participate), and nine participants lost to follow-up with no reason obtained. A CONSORT flow diagram 56 is provided in Fig. 2. [INSERT FIGURE 2 APPROXIMATELY HERE] Caption for Fig. 2: Study flow diagram. v. PT Training : The PT who was integrated into the PT-led primary care sites reported 9/10 or 10/10 confidence in delivering all four components of the PT-led intervention being proposed for the full study (exceeding the 8/10 confidence progression criteria). These confidence ratings indicate feasibility of proceeding to the full trial by incorporating the PT training. Qualitative feedback on the training was obtained from the PT. The PT reported the experience of having to orient to site processes and interprofessional team members along-side provision of care at participating sites. Therefore, strategies to enhance training and orientation for the PT will include providing the PT with a more formal orientation to the primary care site prior to initiation of patient recruitment for the fully powered trial. vi. PT treatment fidelity : To determine consistency of the intervention with the protocol, we performed audits of the fidelity checklist completed by the PT throughout the study period, the EHRs of all patients in the PT-led arm, and self-report measures collected from the patient participants at the six-week assessment. These audits indicated that the intervention was carried out with high fidelity (> 95% of participants received a recommendation aligned with the STarT Back classification, and 100% received all other planned intervention components). 2. Baseline factors used to describe the population Participants in this pilot study were a mean 51.7 years of age (SD 17.0) and the majority were men (67%). Differences in participants characteristics between arms, including those that are expected to be prognostic indicators, were intentionally not tested statistically or set as a progression criteria because of the small number of clusters in this pilot study and expected differences between clusters (e.g., Community Health Centers in Ontario serve populations with a higher proportion of chronic conditions and lower income than Family Health Teams). The Community Health Center was allocated to the usual care arm and there were baseline differences between groups in the direction expected. For example, the Charlson Comorbidity Index Score was 1.83 (SD 1.80) in the PT-led arm and 2.83 (SD 2.57) in the usual care arm, and the proportion of people categorized as high risk on the STarT Back tool was 5.2% in the PT-led arm and 33.3% in the usual care arm. Table 1 provides a description of the patient participant characteristics in this pilot study at baseline. Table 1 – Participant Characteristics Age – years [mean (SD)] Total PT-led primary care group (n = 58) Usual care group (n = 42) 51.7 (17.0) 50.1 (18.4) 53.8 (14.7) Gender [n (%)] Men Women 67 (67%) 33 (33%) 39 (67.2%) 19 (32.8%) 28 (66.7%) 14 (33.3%) Household income [n (%)] $100,000 13 (13.3%) 26 (26.5%) 14 (14.3%) 17 (17.3%) 10 (10.2%) 18 (18.4%) 4 (7.0%) 17 (29.8%) 10 (17.5%) 9 (15.8%) 7 (12.3%) 10 (17.5%) 9 (22.0%) 9 (22.0%) 4 (9.8%) 8 (19.5%) 3 (7.3%) 8 (19.5%) Work status prior to pain [n (%)] Working full-time Working part-time Student Volunteer Retired Not working Short-term sick leave On disability insurance Other 41 (41.0%) 7 (7.0%) 2 (2.0%) 2 (2.0%) 0 (0.0%) 46 (46.0%) 0 (0.0%) 1 (1.0%) 1 (1.0%) 21 (36.2%) 5 (8.6%) 1 (1.7%) 1 (1.7%) 0 (0.0%) 30 (51.7%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 20 (47.6%) 2 (4.8%) 1 (2.4%) 1 (2.4%) 0 (0.0%) 16 (38.1%) 0 (0.0%) 1 (2.4%) 1 (2.4%) Current work status [n(%)] Working F/T Full duties Modified duties Full Hours Modified Hours Working P/T Full duties Modified duties Full Hours Modified Hours Student Volunteer Retired Not working Short-Term Sick Leave On disability insurance Other 26 (26.0%) 25 (25.0%) 1 (1.0%) 26 (26.0%) 0 (0.0%) 8 (8.0%) 5 (5.0%) 3 (3.0%) 5 (5.0%) 3 (3.0%) 3 (3.0%) 3 (3.0%) 8 (8.0%) 32 (32.0%) 8 (8.0%) 9 (9.0%) 3 (3.0%) 18 (31.0%) 18 (31.0%) 0 (0.0%) 18 (31.0%) 0 (0.0%) 6 (10.3%) 4 (6.9%) 2 (3.4%) 5 (8.6%) 1 (1.7%) 2 (3.4%) 1 (1.7%) 3 (5.2%) 21 (36.2%) 5 (8.6%) 2 (3.4%) 0 (0.0%) 8 (19.0%) 7 (16.7%) 1 (2.4%) 8 (19.0%) 0 (0.0%) 2 (4.8%) 1 (2.4%) 1 (2.4%) 0 (0.0%) 2 (4.8%) 1 (2.4%) 2 (4.8%) 5 (11.9%) 11 (26.2%) 3 (7.1%) 7 (16.7%) 3 (71%) Charlson comorbidity index [mean (SD)] 2.25 (2.20) 1.83 (1.80) 2.83 (2.57) Duration of back pain – months [median (Q1, Q2)] 3.9 (0.9, 26.2) 2.7 (0.8, 6.1) 8.93 (1.0, 166.2) Number of pain locations [mean (SD)] 4.1 (4.2) 3.6 (4.1) 4.7 (4.8) First episode of back pain [n (%)] Yes No 28 (28.0%) 72 (72.0%) 10 (17.2%) 48 (82.8%) 18 (42.9%) 24 (57.1%) STaRT Back Category [n (%)] Low risk Medium risk High risk 24 (24.0%) 59 (59.0%) 17 (17.0%) 16 (27.6%) 39 (67.2%) 3 (5.2%) 8 (19.1%) 20 (47.6%) 14 (33.3%) Medications for back pain [n (%)] NSAIDS Pain killers Other medications 58 (58.0%) 65 (65.0%) 79 (79.0%) 35 (60.3%) 36 (62.1%) 44 (75.9%) 23 (54.8%) 29 (69.0%) 35 (83.3%) 3. Clinical outcomes The aggregate mean for the primary outcome, RMDQ score, was 11.0 (SD 6.2) at baseline and 6.7 (SD 6.5) at 12-month follow-up. Table 2 presents the aggregate (both arms) mean scores and standard deviations or frequencies and percentages for the outcome measures planned for the full trial. As planned a priori, no statistical comparisons were conducted between arms. Table 2 – Aggregate Clinical Outcomes Measure Baseline (n = 100) Week 6 (n = 91) Week 12 (n = 90) 6 months (n = 91) 9 months (n = 91) 12 months (n = 89) RMDQ 11.03 (6.23) 8.11 (6.53) 8.09 (6.92) 5.35 (4.40) 6.69 (6.47) 6.71 (6.52) Pain at rest 4.08 (2.58) 3.38 (2.66) 4.07 (2.41) 4.02 (2.56) 3.96 (2.58) 3.73 (2.34) Pain walking 5.26 (2.59) 4.33 (2.85) 5.09 (2.82) 5.00 (2.97) 4.78 (3.07) 4.56 (2.87) Pain lifting 6.07 (2.68) 4.62 (3.10) 5.53 (2.96) 5.22 (2.89) 4.70 (2.90) 4.53 (2.70) EQ5D-5L Index Score Global Rating 0.462 (0.267) 64.47 (19.00) 0.591 (0.243) 68.49 (19.66) 0.614 (0.228) 68.30 (19.19) 0.628 (0.205) 70.22 (18.15) 0.637 (0.207) 68.09 (21.96) 0.652 (0.205) 69.00 (20.63) PHQ-9 8.13 (7.11) 7.19 (6.60) 6.60 (6.89) 5.63 (5.05) 5.56 (5.84) 5.53 (6.18) PCS 28.76 (12.40) 28.48 (12.11) 26.11 (12.89) 26.09 (12.12) 24.75 (11.54 24.15 (11.39) GROC [n (%)] -5 -4 -3 -2 -1 0 +1 +2 +3 +4 +5 1 (1.1%) 2 (2.2%) 7 (7.7%) 5 (5.5%) 3 (3.3%) 25 (27.5%) 7 (7.7%) 17 (18.7%) 13 (14.3%) 7 (7.7%) 4 (4.4%) 1 (1.1%) 1 (1.1%) 5 (5.6%) 5 (5.6%) 3 (3.3%) 20 (22.2%) 11 (12.2%) 16 (17.8%) 16 (17.8%) 7 (7.8%) 5 (5.6%) 0 (0.0%) 4 (4.4%) 3 (3.3%) 3 (3.3%) 10 (11.1%) 24 (26.4%) 5 (5.5%) 8 (8.8%) 18 (19.8%) 11 (12.1%) 5 (5.5%) 1 (1.1%) 2 (2.2%) 6 (6.6%) 6 (6.6%) 3 (3.3%) 17 (18.7%) 6 (6.6%) 11 (12.2%) 17 (18.7%) 12 (13.2%) 10 (11.1%) 5 (5.6%) 0 (0.0%) 5 (5.6%) 5 (5.6%) 4 (4.5%) 17 (19.1%) 3 (3.4%) 14 (15.7%) 16 (18.0%) 12 (13.5%) 8 (9.0%) Satisfaction [n (%)] -5 -4 -3 -2 -1 0 +1 +2 +3 +4 + 5 5 (5.5%) 4 (4.4%) 5 (5.5%) 1 (1.1%) 2 (2.2%) 14 (15.4%) 4 (4.4%) 3 (3.3%) 13 (14.3%) 13 (14.3%) 27 (29.7%) 1 (1.1%) 2 (2.2%) 1 (1.1%) 2 (2.2%) 5 (5.6%) 20 (22.2%) 2 (2.2%) 7 (7.8%) 15 (16.7%) 9 (10.0%) 26 (28.9%) 1 (1.1%) 1 (1.1%) 2 (2.2%) 3 (3.3%) 5 (5.5%) 20 (22.0%) 3 (3.3%) 5 (5.5%) 13 (14.3%) 11 (12.1%) 27 (29.7%) 3 (3.3%) 3 (3.3%) 1 (1.1%) 4 (4.4%) 3 (3.3%) 19 (20.9%) 1 (1.1%) 6 (6.6%) 15 (16.5%) 7 (7.7%) 29 (31.9%) 3 (3.4%) 2 (2.2%) 5 (5.6%) 1 (1.1%) 2 (2.2%) 15 (16.9%) 2 (2.2%) 9 (10.1%) 10 (11.2%) 14 (15.7%) 26 (32.6%) * For all measures other than GROC and Satisfaction, values represent Mean (SD). GROC and satisfaction are presented as frequency (percentage) of participants. Health service utilization (4) and cost (5) outcomes Cost outcomes were calculated using health service utilization counts and cost per unit. Health service utilization and costs necessary for the planned health service utilization and cost utility analyses for the full trial were collected and reported descriptively in Table 3 . Table 3 describes the aggregate (both arms) health service utilization counts and cost per person. As planned, no statistical analysis was conducted to compare between groups. Other direct costs that will be included in the cost utility analysis will include the PT training and salary, training materials for orienting the PT and team members at the primary care sites, equipment and materials for care delivery, and clinic space require to integrate the PT. Among the 76 subjects identified as medium or high risk by the STart Back tool, 41 (53.9%) accessed physiotherapy services for their LBP; 31 (73.8%) and 10 (29.4%) participants accessed physiotherapy services in the PT-led and usual care groups, respectively. Indirect costs associated with time lost from occupational activities (paid work, caregiving, volunteer activities) are reported in Table 4 . These will be included in the full trial as part of the cost utility analysis conducted using a societal perspective for the primary analysis. Table 3 – Aggregate health service utilization counts and direct costs (count, cost per person) ED visits 0–6 weeks 6–12 weeks 3–6 months 6–9 months 9–12 months 2, $2.15 1, $1.08 4, $4.29 1, $1.07 2, $2.19 Overnight hospital stays 2, $32.44 1, $16.40 0, $0.00 18, $292.00 0, $0.00 Specialist visits Orthopaedic 0, $0.00 1, $0.92 0, $0.00 1, $0.91 2, $1.51 Neurosurgery 1, $1.33 2, $2.69 0, $0.00 3, $3.99 3, $1.96 Physiatrist 1, $1.90 0, $0.00 0, $0.00 0, $0.00 0, $0.00 Pain specialist 7, $7.01 13, $11.18 18, $11.52 22, $13.81 7, $4.10 Other * 1, $0.88 1, $1.69 2, $2.53 1, $1.09 0, $0.00 Clinic visits Pain management clinic 3, $2.75 4, $3.85 4, $3.40 5, $4.04 2, $1.32 Other ** 0, $0.00 0, $0.00 4, $4.94 12, $14.24 0, $0.00 Visits to other healthcare providers Physiotherapist 72, $43.19 36, $28.94 52, $39.45 60, $45.77 35, $29.83 Chiropractor 5, $2.31 16, $7.72 12, $4.23 21, $9.78 16, $8.48 Massage therapist 15, $11.65 10, $10.50 21, $20.27 6, $7.91 9, $10.17 Other † 7, $7.80 1, $0.83 3, $5.27 7, $7.03 3, $5.28 Diagnostic imaging Xray 7, $5.36 4, $3.10 5, $3.83 6, $4.59 3, $2.35 CT scan 1, $2.71 0, $0.00 2, $5.41 1, $2.71 2, $5.53 MRI 5, $21.28 3, $12.91 5, $21.28 0, $0.00 2, $8.70 Other § 0, $0.00 0, $0.00 1, $1.18 1, $1.38 0, $0.00 Surgeries 2, $26.73 0, $0.00 0, $0.00 0, $0.00 1, $13.58 Medications for back pain NSAIDS $3.87 $2.32 $5.71 $6.43 $2.89 Other analgesics $19.09 $18.74 $41.37 $25.01 $33.78 Other $11.04 $15.17 $20.63 $14.60 $16.21 * Includes: neurology, gastroenterology, respirology, cardiology, oncology, and free-text option ** Includes: addiction clinics, sleep clinics, acupuncture, psychotherapy † Includes: osteopathy, naturopathy, social work, psychology, and free-text option § Includes: bone mineral density scan, ultrasound Table 4 – Aggregate Indirect Costs (cost per person) Time off work total 0–6 weeks 6–12 weeks 3–6 months 6–9 months 9–12 months $849.37 $805.76 $1,426.23 $1,289.67 $1,149.90 Time off work/week $141.56 $134.29 $118.85 $107.47 $95.83 Time off caregiving $15.87 $22.46 $6.15 $51.85 $27.69 Time off volunteer $35.47 $4.92 $42.46 $12.31 $6.29 6. Process outcomes We were able to successfully determine the feasibility of collecting the following process outcomes, related to the management of LBP, from the EHR: medications prescribed, diagnostic imaging ordered, referrals made to other HCPs (both internal and external to the primary health care team), the number of visits to members of the primary care team, and notes provided to employers or insurers. Table 5 (below) shows the crude counts and rates of these process outcome measures. Table 5 – Process outcomes by intervention group (count, rate) Primary care visits for LBP † PT-led Usual care Total 183, 3.31 249, 5.93 432, 4.44 Physician/Resident 66, 1.17 120, 2.86 186, 1.89 NP 1, 0.02 5, 0.12 6, 0.06 PT 104, 1.85 19, 0.45 123, 1.25 OT 1, 0.02 2, 0.05 3, 0.03 Registered Nurse 11, 0.20 91, 2.17 102, 1.04 Social Worker 0, 0 12, 0.29 12, 0.12 Dietitian 0, 0 0, 0 0, 0 Number of referrals for LBP † 30, 0.54 30, 0.71 60, 0.61 PT 11, 0.20 15, 0.36 26, 0.26 Chiropractor 1, 0.02 0, 0 1, 0.01 Neurology 0, 0 0, 0 0, 0 Neurosurgery 4, 0.07 1, 0.02 5, 0.05 Orthopaedics 4, 0.07 4, 0.10 8, 0.08 OT 1, 0.02 1, 0.02 2, 0.02 Physiatry 0, 0 0, 0 0, 0 Massage Therapy 1, 0.02 2, 0.05 3, 0.03 Bariatrics 0, 0 1, 0.02 1, 0.01 Community Care Access Centre 1, 0.02 0, 0 1, 0.01 Pain Clinic 4, 0.07 3, 0.07 7, 0.07 General surgery 1, 0.02 0, 0 1, 0.01 Psychology 0, 0 1, 0.02 1, 0.01 Rheumatology 2, 0.04 0, 0 2, 0.02 Social Work 0, 0 2, 0.05 2, 0.02 Total images ordered for LBP † 17, 0.30 8, 0.19 25, 0.25 Xray 9, 0.16 4, 0.10 13, 0.13 CT scan 0, 0 0, 0 0, 0 Bone Mineral Density 1, 0.02 1, 0.02 2, 0.02 MRI 7, 0.12 3, 0.07 10, 0.10 Total medications prescribed for LBP † 41, 0.72 78, 1.86 119, 1.20 NSAIDS 6, 0.11 4, 0.10 10, 0.10 Opioids 13, 0.23 29, 0.69 42, 0.43 Acetaminophen 0, 0 2, 0.05 2, 0.02 Antidepressants 4, 0.07 7, 0.17 11, 0.11 Benzodiazepines 2, 0.04 7, 0.17 9, 0.09 Cannabinoids 3, 0.05 6, 0.14 9, 0.09 Gabapentinoids 6, 0.11 10, 0.24 16, 0.16 Muscle relaxants 6, 0.11 8, 0.19 14, 0.14 Tricyclics 1, 0.02 5, 0.12 6, 0.06 Notes provided for LBP 8, 0.14 6, 0.14 14, 0.14 Note: rates presented as events per 1 person year. DISCUSSION The progression criteria for each of our primary feasibility outcomes (recruitment, retention, outcome measure completion, and treatment fidelity) were met, indicating feasibility of proceeding with the fully powered cluster randomized trial. Through the pilot study, we were able to identify several additional important learning opportunities to optimize the processes for the full trial. One important learning was the need to overcome challenges related to identification and recruitment bias. Selection bias, i.e., differential identification and recruitment of participants between arms, represents a risk of bias common in cluster trials 91 . While our recruitment rate met the progression criteria throughout the study period, we experienced early concerns with imbalance between arms. In the first four weeks of recruitment, 18 participants were recruited from PT-led primary care sites and seven were recruited from the usual physician-led care sites. Our strategy to mitigate against selection bias was to provide the same information to potential participants across both arms at the time of screening: "Our primary care team is taking part in a study on physiotherapy and primary care for low back pain with Queen's University. The goal of the study is to compare two models of care where you would see either a physiotherapist or your family doctor/nurse practitioner for your upcoming visit. Is this something you would hearing more about and consider participating in?” By providing this same information, we aimed to not reveal the site allocation until after patient participant consent and baseline data collection. However, by cross-referencing the number of patients screened with the number of visits for LBP in the EHRs, we were able to identify a higher rate of screening at the intervention arm sites in the first four weeks, i.e., more participants were receiving the screening question above in the PT-led arm than in the usual care arm. To mitigate the risk of ongoing bias, we increased the time that research assistants were present at the usual care sites. This permitted them to visit more frequently with the reception staff and primary care providers who were performing the screening to encourage adherence to the screening protocol. Subsequent to implementing this strategy, we witnessed a balancing of recruitment rates between the two arms for the remainder of the recruitment period (39 at PT-led and 36 at physician-led care sites). This learning experience will be carried over into the full trial as a successful approach to minimizing the risk of recruitment bias. While it was not the intention of this pilot trial to conduct a statistical analysis to compare baseline differences in characteristics between groups, we did observe differences in prognostic indicators such as number of comorbidities and STarT Back risk category at one site (a Community Health Center) in comparison to the other three sites (Family Health Teams or Family Health Organizations). This finding was not entirely unexpected. Community Health Centres in Ontario each have a unique focus based on their mandate to serve the health needs of priority populations identified in their communities. This leads them to serve patient populations who have faced barriers to accessing health services, such as people with low income, new immigrants, and people with complex mental health needs. Based on our pilot data, we perceive that the unique focus of each community health center may make it more challenging to balance key prognostic indicators between arms, even when using a covariate constrained randomization procedure for the full trial as planned. Additionally, family health organizations, family health groups, and family health groups serve a greater proportion of the population in Ontario, making these models the more predominant place where the PT-led model of care would be implemented if effective. So, the findings from this pilot trial have also led us to make the decision to recruit only family health organizations, family health groups, or family health teams (or their equivalent) for our fully powered trial. We also learned about the strengths and areas of improvement of our PT orientation and training. During our pilot study, the core components of the model of care were carried out with high fidelity - we achieved > 95% compliance for all aspects of the PT-led model of care, measured with a fidelity checklist and EHR chart audit. This aligns with research that shows PTs in primary care roles can provide guideline adherent care 34 – 42 . However, qualitative feedback from the PT indicated that a more formal or structured orientation for the PT to the primary care practice in which they will be integrated would be beneficial. By familiarizing the PT with the clinical site, physicians, and staff, the PT will be better prepared to integrate within the primary care team and collaborate as a primary care team member. Another important learning was the use of our healthcare utilization and fidelity data to inform the human resource and space requirements for the full trial. In our pilot study, all patient participants received a one hour initial assessment and 28 (48%) participated in follow-up visits with the physiotherapist. These data will be used to estimate the hours required for the PT to meet the needs of each of our participating sites for the full trial. Finally, through our healthcare utilization and fidelity data, we learned that very few participants classified as high risk of ongoing LBP-related disability were able to access psychosocial risk-factor targeted treatment. We learned about access barriers, such as funding and/or transportation barriers to the community-based physiotherapists who had received the high risk training, even though they were located in the same city as the primary care team. Given these access limitations as well as challenges in training enough community-based PTs to offer the high-risk intervention in the communities served by 20 different primary care sites in the full trial, we now intend to offer the high-risk intervention for patients classified as high risk for ongoing disability by the PT in the primary care sites during the full trial. We think this will overcome some of the access and fidelity challenges, and therefore we would be testing a more scalable model of care. Limitations There are a few important limitations of this pilot trial. First, when patients requested support to complete the self-report outcome measures, the study PT met with some of the patients to support them to complete the outcome measures due to a lack of research staff support onsite. We do not perceive this had an important impact on our feasibility outcomes (e.g. outcome measure completion). It was not a goal of this pilot study to estimate the effectiveness of the PT-led model of care; however, it is important for readers to recognize the potential for observer bias present in our descriptive data, especially if they are incorporated into a future meta-analysis. To mitigate against this risk of bias in the full trial 92 , the PT will not be collecting these data and we will plan research staff such that we are adequately prepared to support all participants who request support for outcome measure completion. Another limitation is our recruitment from just four sites (all non-rural) and one region, which may limit the generalizability of our recruitment and retention rate to the other centers planned for the full trial (20 sites). We will monitor these rates closely during the full trial and create plans to mitigate any new challenges with recruitment and retention. For example, transportation barriers amongst people requesting support for completing the outcome measures in person may be more common in rural settings. Finally, a third limitation of our study is the use of a single PT to carry out the intervention across all three sites in this pilot trial. This may have made achieving high fidelity rates easier in this pilot study. A potential challenge for the full trial will be to achieve similar adherence to the protocol with multiple PTs carrying out the model of care across a larger number of sites. During the pilot, the principal investigator and PT met regularly to problem solve implementation barriers. We will employ a similar strategy with all study PTs, principal investigator, and research coordinators meeting frequently throughout the one year intervention period to encourage fidelity and ensure compliance with study protocols. Conclusions Our results suggest that implementing this model of care and utilizing our described cluster trial methods are feasible. These findings support proceeding with the fully powered trial. Abbreviations CT Computerized tomography ED Emergency department EHR Electronic health medical record GROC Global Rating of Change IC/ES Institute for Clinical Evaluative Sciences LBP Low back pain MRI Magnetic resonance imaging NP Nurse practitioner NPRS Numeric Pain Rating Scale NSAID Non-steroidal anti-inflammatory drug OHIP Ontario Health Insurance Plan PCS Pain Catastrophizing Scale PHQ-9 9-item Patient Health Questionnaire PT Physiotherapist QALY Quality-adjusted life year RA Research assistant RCT Randomized controlled trial RMDQ Roland-Morris Disability Questionnaire SD Standard deviation Declarations Ethics approval and consent to participate Ethics approval for this pilot study was obtained from the Queen’s University Health Science and Affiliated Teaching Hospitals Research Ethics Board (HSREB #6021536). Written consent was obtained from all participants willing to participate. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. Funding This pilot study has been funded through the Canadian Institutes of Health Research Catalyst Grant: Musculoskeletal Health and Arthritis (#384307). The study sponsor contributed to the peer review of this protocol, but did not play any role in the design, management, analysis, interpretation, writing, or publication. Author Contribution JMi is the principal investigator who has led the team in all aspects of the development of this pilot study. DB, MG, CD, JMacD, JH, SF, KN, JR, and TW all contributed expertise to the study design and implementation and contributions to manuscript writing. JMar provided expertise and leadership for the collections of healthcare utilization and costs in preparation for the full trial. MT provided expertise in cluster trial design and statistical analysis. LC provided experiences as a person living with pain who seeks primary care to inform the outcomes, data collection mechanisms, engagement of patients, and writing of results. KV was responsible data collection and cleaning, contributing to manuscript writing, and presentation of results. CM contributed to data analysis, presentation of results, and manuscript writing. All authors have reviewed and approved the manuscript and to the interpretation of the results in planning for the fully powered cluster trial. Acknowledgements Not applicable Data Availability Access to the study data may be made available with appropriate data sharing agreements and ethical approval by requesting the data from the corresponding author. References Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. 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Norman","email":"","orcid":"","institution":"Queen's University","correspondingAuthor":false,"prefix":"","firstName":"Kathleen","middleName":"E.","lastName":"Norman","suffix":""},{"id":623811675,"identity":"0a15aa4c-1e0c-4e51-a32f-ffb072499e4d","order_by":13,"name":"Julie Richardson","email":"","orcid":"","institution":"McMaster University","correspondingAuthor":false,"prefix":"","firstName":"Julie","middleName":"","lastName":"Richardson","suffix":""},{"id":623811676,"identity":"a710d730-2731-491c-b562-2332611d7242","order_by":14,"name":"Timothy Wideman","email":"","orcid":"","institution":"McGill University","correspondingAuthor":false,"prefix":"","firstName":"Timothy","middleName":"","lastName":"Wideman","suffix":""}],"badges":[],"createdAt":"2026-02-17 16:10:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8902753/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8902753/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":107482327,"identity":"cf4d7c23-e878-41fc-bf0c-e76d3f22f29b","added_by":"auto","created_at":"2026-04-22 02:23:12","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":137827,"visible":true,"origin":"","legend":"\u003cp\u003eDecisions and care provided through the PT-led primary care model. This figure was originally published in the protocol for this trial\u003csup\u003e55\u003c/sup\u003e.\u003c/p\u003e","description":"","filename":"PTinprimarycareforlowbackpainFigure1Jan102017.png","url":"https://assets-eu.researchsquare.com/files/rs-8902753/v1/7f17b2bef4d5d16fca984393.png"},{"id":107245621,"identity":"8879cfbb-3b8a-470c-a93a-a74c05454d3f","added_by":"auto","created_at":"2026-04-19 08:06:04","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":183168,"visible":true,"origin":"","legend":"\u003cp\u003eStudy flow diagram.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8902753/v1/843b57a4e13c5bc0ebbc319e.png"},{"id":108005863,"identity":"c69dbeb7-95ee-48f5-9bd2-4dd5b8e70d4b","added_by":"auto","created_at":"2026-04-28 12:49:41","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1051745,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8902753/v1/15d338a9-a030-4a0f-81e4-78c8b7b82720.pdf"},{"id":107245620,"identity":"40033f2e-1c68-4f10-af31-06e66e2de9a0","added_by":"auto","created_at":"2026-04-19 08:06:04","extension":"doc","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":233472,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORTextensionforPilotandFeasibilityTrialsChecklist.doc","url":"https://assets-eu.researchsquare.com/files/rs-8902753/v1/1b058bc1c1d7904d7dc68f48.doc"},{"id":107484267,"identity":"f5b21a6d-9dfe-48a1-b53d-8305500645f3","added_by":"auto","created_at":"2026-04-22 02:31:18","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":92771,"visible":true,"origin":"","legend":"","description":"","filename":"HealthServiceUtilizationQuestionnaire.docx","url":"https://assets-eu.researchsquare.com/files/rs-8902753/v1/88403909a4aee6de3da615a0.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Study title: Determining the feasibility of a trial to determine the impact of a physiotherapist-led primary care model for low back pain: A pilot cluster randomized controlled trial","fulltext":[{"header":"Key message","content":"\u003cul\u003e\n \u003cli\u003ePrior to this pilot study, uncertainty existed as to the feasibility of successfully integrating a physiotherapist into a primary care setting for low back pain management in the Canadian context. The ability to recruit and retain participants and to administer assessments over a one-year follow-up period was undetermined.\u003c/li\u003e\n \u003cli\u003eOur results suggest that a fully powered cluster randomized controlled trial to\u0026nbsp;determine the impact of a new physiotherapist-led primary care model for low back pain\u0026nbsp;is feasible.\u003c/li\u003e\n \u003cli\u003eKey findings from the pilot study will have the following implications on the design of the full study: (1) additional efforts are required to achieve balanced recruitment across trial arms; (2) adjustments were made to the full trial sample size; (3) estimates of the hours required for physiotherapy coverage are now more accurate; (4) participants at high risk for ongoing disability will be offered physiotherapy in the PT-led primary care sites, rather than through referral; (5) formal physiotherapy orientation to the primary care sites will be conducted; and (6) improvements to the outcome assessment process have been incorporated.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"BACKGROUND","content":"\u003cp\u003eLow back pain (LBP) is one of the leading causes of disability around the world\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. It is one of the largest contributors to time off work\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e,\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e, inappropriate diagnostic testing\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e,\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e, emergency department (ED) visits\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e, and specialist consultations. Research has indicated that people with LBP utilize health care services at a rate approximately 60% higher than those without LBP\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. Given the burden posed by LBP as a result of systemic inefficiencies, low-value interventions, and poor patient outcomes, research into innovative and evidence-based models of care is needed\u003csup\u003e\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn Canada, people with LBP often present to their primary care physician as the first point of contact for the management of their condition\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. Primary care physicians often express limited confidence with the management of LBP\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e, a situation commonly linked to insufficient education on the management of musculoskeletal conditions\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e,\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. Additionally, primary care teams are overburdened with the challenges posed by an aging population\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e, the growing prevalence of multiple chronic health conditions\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e, and increasingly complex patient encounters\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e,\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. Both federal and provincial government agencies, as well as several health organizations, have recommended the development of interprofessional teams with complementary skillsets to optimize the efficacy and sustainability of the primary healthcare system\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e. Research related to other health conditions has indicated that interprofessional team-based approaches can result in more appropriate referrals, better coordination of care, and improved patient outcomes\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eOne interprofessional model of care involves the integration of physiotherapists (PTs) into the primary care team for people with musculoskeletal conditions. Observational research performed in a variety of settings has shown that PTs can effectively assume a primary care role with successful patient outcomes and contribute to increased efficiency of healthcare delivery. A US Military study found that integrating PTs as the first point of contact for service members with work related injuries resulted in shorter wait times, decreased illness-related workdays lost, improved satisfaction with care, and more appropriate specialist referrals\u003csup\u003e\u003cspan additionalcitationids=\"CR24 CR25 CR26 CR27\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e. Research performed by the UK National Health Service on adopting a PT-led model of care, demonstrated reduced wait times, increased patient and provider satisfaction, decreased lost work, a reduced need for diagnostic imaging, and less use of prescription medications\u003csup\u003e\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eGuideline-adherent management of LBP has been shown to significantly reduce disability and improve function\u003csup\u003e\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e,\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e and evidence suggests that PTs can collaboratively and successfully implement recommendations from established primary care guidelines for LBP\u003csup\u003e\u003cspan additionalcitationids=\"CR35 CR36 CR37 CR38 CR39 CR40 CR41\" citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e. These include effective screening for red flags (signs or symptoms of serious pathology such as cancer or neurodegenerative disease) and the need for diagnostic tests\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e,\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e,\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e; identifying risk factors for poor recovery\u003csup\u003e\u003cspan additionalcitationids=\"CR46\" citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e; offering advice and strategies around physical activity, return to work, and therapeutic exercise\u003csup\u003e\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e\u003c/sup\u003e; and providing psychosocially informed interventions for patients identified as being at higher risk for delayed recovery\u003csup\u003e\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e\u003c/sup\u003e. Evidence from outside of Canada suggests early guideline-adherent PT care for LBP improves function and disability\u003csup\u003e\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e, decreases the use of diagnostic imaging and opioid prescriptions, and reduces inappropriate specialist referrals\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e,\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e,\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e\u003c/sup\u003e, while lowering per person healthcare costs \u003csup\u003e\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e,\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThese results are encouraging, but more rigorous evaluation specific to LBP in the Canadian primary care system is needed. A systematic search of major databases (Medline, CINAHL, Embase) revealed no randomized controlled trials (RCTs) on the impact of integrating PTs at the first point of contact in primary care for any condition\u003csup\u003e\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e\u003c/sup\u003e. This absence of rigorous evidence from clinical trials leaves important gaps in our knowledge about the process and impact of integrating PTs into primary care teams for people with LBP. Specifically, there is a dearth of high quality evidence on the impact of PT-led primary care on patient outcomes (e.g., pain, function, quality of life), health system outcomes (e.g., healthcare access, physician workload, ED visits, specialist referrals, medication use, diagnostic imaging), and societal outcomes (e.g., missed work, cost-effectiveness). Additionally, there are specific procedural questions that need to be answered, such as how PTs will navigate the challenges of providing care for people presenting with multiple health concerns and requests for opioid medications, diagnostic imaging, or notes for work absences. Our objective is to address these gaps by conducting a cluster RCT to assess the impact of a PT-led primary care model for LBP.\u003c/p\u003e \u003cp\u003eThis pilot study was conducted with the following objectives:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eDetermine the feasibility of patient recruitment, assessment procedures, and retention.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eDetermine the feasibility of physiotherapist training and implementation of a new PT-led primary care model for back pain.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cstrong\u003eDesign\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis pilot study was a cluster RCT. There were four participating primary care sites in Kingston, Ontario, Canada; two sites were randomized to the PT-led primary care model for LBP and two sites randomized to the usual physician-led primary care model. Randomizing individual patients within the same clinic would have created a high risk of contamination, as the PT would be integrated into the care team and routine clinic processes, making it difficult to prevent elements of the intervention from influencing patients receiving usual care. To address this issue, a cluster RCT was used, with randomization occurring at the primary care clinic level.\u003c/p\u003e\n\u003cp\u003eQualitative interviews by a member of the research team were embedded within the trial with the goal of exploring the perspectives of patients and primary care team members related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. Detailed methods and results have been presented in a companion paper\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e54\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe study was registered prior to commencing recruitment (ClinicalTrials.gov Identifier: NCT03320148). The methods described below were detailed in a previously published study protocol\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e. See Supplementary file 1 for the completed CONSORT Extension to Pilot and Feasibility Trials checklist\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e56\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEnrollment and randomization of sites\u003c/strong\u003e: Four primary care sites in Kingston, Ontario were purposefully selected based on the following criteria: a) they were associated with either family health teams or community health centres (at least one of each, to evaluate the feasibility of the protocol in both settings), b) they had at least two physicians and 2500 registered patients, and c) they did not have a PT integrated within their primary care team at the time of enrollment. Given the range in the number of patients at each of the primary care sites (from 3,000 to 16,000), the largest and smallest sites were grouped together, while the two sites of intermediate size were grouped into the second cluster. Random allocation of the two groups into the intervention or control arms was then carried out using computer-generated random numbers. The randomization was performed by an independent statistician who was blinded to the site names by using anonymized codes for each site. We planned to use covariate-constrained randomization\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e57\u003c/span\u003e\u003c/sup\u003e for the full trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBlinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBecause the study is comparing two models of care, blinding of patient participants or health care providers (HCPs) delivering the care was not feasible. Patient participants were made aware that the study they were participating in involved a comparison between these two different models of care; however, it was not disclosed to participants which arm their primary care site had been randomized to until after consent and baseline data collection. The primary outcomes were self-report measures (completed by the patient) and, therefore, outcome assessment was also not blinded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient enrollment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEnrollment occurred over a 4-month period, from September 2017 to January 2018. When a patient contacted one of the participating sites to book a visit for LBP, the medical secretary screened the patient for consent to be invited to participate in the study. Those patients who consented were scheduled to come in 30 minutes prior to their appointment time to meet with the RA, at which time the RA provided detailed information about the study and obtained written informed consent to enroll the patient.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion/exclusion of patients\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring the recruitment period, all adult (18 years or older) patients who contacted the participating clinics to book an initial or follow-up visit for LBP were invited to participate in the study, regardless of the duration of symptoms. Patients were excluded if they reported that their LBP was known to be due to cancer or a diagnosed neurodegenerative disease prior to the primary care visit, or if they were not able to understand, read, and write English.\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n\u003ch2\u003eInterventions:\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003ePT-led primary care arm\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention integrated a PT within two primary care teams, allowing the PT to be available as the first point of contact for patients presenting with LBP. For this pilot study, we had the same PT at both primary care teams, but for the full study, we plan to use a minimum of three PTs for the 10 sites. Patient participants enrolled in this arm were provided the opportunity to book their initial visit with the PT but were given the option of seeing their physician or NP (for example, if the visit was only requested to discuss medications or if the patient had multiple concerns other than LBP).\u003c/p\u003e\n\u003cp\u003eThe PT-led primary care intervention had four components:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cem\u003eAssessment and screening\u003c/em\u003e: The assessment and screening involved taking a detailed history, including screening for potential pathology (e.g., signs or symptoms of widespread neurological involvement, fractures, or cauda equina syndrome); a thorough physical and neurological assessment; the use of evidence-based measures to screen for comorbid health conditions (e.g., depression/anxiety) that may negatively impact recovery and warrant additional care from another team member\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e58\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e; and the implementation of a validated tool (STarT Back\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e) to identify physical and psychosocial risk factors associated with prolonged pain and disability.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cem\u003eBrief individualized intervention\u003c/em\u003e: During the initial visit, the PT delivered a brief, personalized intervention to each patient participant, guided by primary care guidelines for LBP\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e. The intervention involved discussion regarding the patient\u0026rsquo;s experiences with pain with the goal of validating their experiences and the impact of LBP on their lives\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e60\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e62\u003c/span\u003e\u003c/sup\u003e. It also involved providing cognitive support\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e63\u003c/span\u003e\u003c/sup\u003e, customized exercises based on physical assessment findings\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e64\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e65\u003c/span\u003e\u003c/sup\u003e, and encouragement and strategies to stay active\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e66\u003c/span\u003e\u003c/sup\u003e. Guidance and instruction were supported with written information to reinforce the recommendations\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e67\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cem\u003eHealth services navigation: Following the assessment, the PT supported patients with LBP in accessing appropriate healthcare services tailored to their needs.\u003c/em\u003e Identification of any red flags suggestive of serious underlying conditions prompted immediate communication with the physician or NP for urgent evaluation. Comorbidities uncovered during the assessment, such as a positive depression screen in patients not currently receiving treatment, were also relayed to the family physician or mental health team members for further management.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eRisk stratification utilizing the STarT Back tool\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e guided subsequent PT care recommendations. This validated instrument categorizes LBP patients into low, medium, or high risk for persistent pain and ongoing disability by evaluating physical and psychosocial factors\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e\u003c/sup\u003e. Patients at low risk typically received only the brief individualized intervention during the initial visit. Patients classified as medium risk were referred to conventional community-based PT, while high risk patients were directed to PTs trained in integrated physical and psychological approaches designed to mitigate factors contributing to chronic pain and disability\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e68\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e69\u003c/span\u003e\u003c/sup\u003e. For those patients identified as medium or high risk who lacked private insurance or eligibility for government-funded care through the Ontario Health Insurance Plan (OHIP), ongoing treatment was provided by the PT within the primary care setting.\u003c/p\u003e\n\u003cp\u003eEvidence from the UK supports that this stratified care model improves functional outcomes, enhances quality of life, and provides cost advantages when compared to standard care models\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e. Unfortunately, barriers to effective implementation of this approach in Canada have arisen largely due to funding models for physiotherapy services. For instance, patients classified as low risk often decide to pursue additional PT services using private insurance despite a high likelihood of recovery without further intervention. To address this inefficiency, the PT-led primary care model for LBP in this study incorporated educational components to empower low risk patients in making more informed choices about their continued care. Additionally, the barriers (most commonly financial) that often prevent medium and high risk patients from accessing appropriate PT care were mitigated by delivering ongoing PT at no cost to those demonstrating unmet clinical needs.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e4. Providing additional physiotherapy care to patients with unmet needs\u003c/em\u003e: To overcome financial barriers faced by patients categorized as medium or high risk who lacked private or government-funded physiotherapy coverage, ongoing care was delivered by the PT directly within the primary care setting. This care comprised evidence-based interventions aligned with clinical guidelines, including tailored patient education\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e70\u003c/span\u003e\u003c/sup\u003e, customized therapeutic individualized exercise programs\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e64\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e65\u003c/span\u003e\u003c/sup\u003e, and cognitive-behavioural techniques\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e69\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eAlthough all participants in the PT-led intervention had the option to schedule follow-up appointments with the primary care PT, the goal was to minimize unnecessary duplication of accessible PT services. Consequently, follow-up visits at the primary care site were reserved for those patients with identified needs and who were without alternative financial access to physiotherapy services.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePhysiotherapist training\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe PT integrated into the primary care teams for this pilot study completed approximately four days of training tailored to their new role. Training was conducted by the principal investigator, who has expertise in the management of LBP in interprofessional team-based primary care settings. In addition to the clinical training, the PT underwent orientation to each of the specific primary care sites where they would be practicing. It is planned that the PTs in the PT-led primary care arm of the fully powered RCT will undergo the same training, which includes\u003c/p\u003e\n\u003col style=\"list-style-type: lower-roman;\"\u003e\n\u003cli\u003e\n\u003cp\u003eA review of screening for potential serious underlying conditions (pathology).\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAssessment of comorbidities and awareness of available services for these conditions within the family health teams and community health centres participating in the study.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eClinical evaluation of LBP based on established clinical practice guidelines, including subjective assessment and objective physical examination.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eApplication and interpretation of patient-reported outcome measures and screening tools for people with LBP.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAppropriate use of diagnostic imaging and integration of radiologist findings into clinical decision making.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eUtilization of the STarT Back tool to stratify patients into low, medium, or high risk of ongoing pain and disability, and determine appropriate physiotherapy referral pathways.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eOverview of physiotherapy resources in the Kingston, Ontario area based on patient health care resources, including private and OHIP-funded clinics.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eDelivery of a brief targeted primary care intervention for patients with LBP, incorporating reassurance, education on prognosis, promotion of continued engagement in daily activities, and prescriptions for brief amounts of physical activity and exercise.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eImplementation of activity-based physiotherapy for medium risk patients, featuring education, graded activity, and exercise prescription.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAdditional strategies for patients classified as high risk, aimed at addressing psychosocial contributors to pain and disability. These include communication techniques to encourage personal disclosure, pain neurophysiology education; interventions to reduce catastrophizing, graded exposure to reduce activity-related fear; pacing strategies; cognitive-behavioural approaches to enhance self-efficacy and promote behaviour change, and methods to improve sleep, manage stress, and manage flare-ups of symptoms.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eSee Fig.\u0026nbsp;1 for a depiction of the decisions and care provided through the PT-led primary care model\u003c/p\u003e\n\u003cp\u003eCaption for Fig.\u0026nbsp;1: Decisions and care provided through the PT-led primary care model. This figure was originally published in the protocol for this trial\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eUsual physician-led care model\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe physician-led primary care intervention was intentionally left unstandardized to most accurately represent typical management of LBP within Canadian primary care settings. Generally, patients would consult with a primary care physician or NP, who would conduct a history and physical examination, provide education regarding LBP, and manage care through medication prescription, ordering diagnostic testing, or making referrals based on clinical judgment and patient preferences. Information on all healthcare utilization, including interventions received in the primary care setting, and visits to specialists, PTs, or pain clinics beyond the primary care encounter, was systematically collected throughout the follow-up period, supplemented by audit of the electronic health record (EHR).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEvaluation and outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe main focus of this pilot study was on feasibility outcomes designed to guide the planning of a full-scale cluster RCT. These included metrics related to participant recruitment, retention, assessment procedures, and effectiveness of PT training to implement the PT-led primary care model.\u003c/p\u003e\n\u003cp\u003eSecondary outcomes comprised clinical, health system, and process measures intended for the full trial. The objective was to assess the feasibility of collecting these secondary data, and the results are presented descriptively in aggregate. As per the study protocol, no between-group comparisons were conducted.\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e Data collection instruments used in the study are available upon request from the authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1. Feasibility outcomes\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ei. Recruitment of primary care teams\u003c/em\u003e: Successful recruitment and retention of four primary care sites -- comprising family health teams and/or community health centres (at least one of each) was identified as a key indicator of feasibility to proceed with the full trial.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eii. Recruitment of patients\u003c/em\u003e: The feasibility of enrolling patients was assessed by the recruitment rate across all sites. Targets were based on the ability to recruit approximately 1.6 participants weekly across the four sites (equivalent to 21 patients over 13 weeks\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e) or 0.4 patients per week per site. Achieving this rate would support the recruitment projections necessary for enrolling a sample of 640 people across 16 sites (40 patients/site) over a 2.5-year period\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eiii. Assessment procedures\u003c/em\u003e: Completeness of survey responses and completion time were collected. Predefined criteria were established for acceptable data completeness\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e71\u003c/span\u003e\u003c/sup\u003e. Feasibility was deemed to be achieved if\u0026thinsp;\u0026gt;\u0026thinsp;80% of all survey items were completed and the mean completion time was \u0026lt;\u0026thinsp;60 minutes.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eiv. Retention\u003c/em\u003e: Retention feasibility was gauged by participant attrition at 12-month follow-up, with a threshold of \u0026lt;\u0026thinsp;20% considered to be indicative of successful retention strategies used in this pilot for the full trial. Attrition rates\u0026thinsp;\u0026gt;\u0026thinsp;20% threaten trial validity\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e72\u003c/span\u003e\u003c/sup\u003e and would necessitate enhanced retention strategies to be identified and implemented for the full trial.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ev. PT Training\u003c/em\u003e: This pilot study assessed the feasibility of the planned PT training for the new primary care role through attendance records, ratings of self-efficacy (0\u0026ndash;10) for delivering each of the four intervention components, and qualitative feedback. Training success was defined as 100% attendance and self-efficacy ratings of at least 8/10 across all intervention components. Qualitative insights gathered will inform improvements to the PT training program for the full trial.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003evi. PT treatment fidelity\u003c/em\u003e: Fidelity to the intervention protocol was monitored through provided PT treatment checklists and audits of the participant EHRs\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e73\u003c/span\u003e\u003c/sup\u003e. A fidelity rate of \u0026gt;\u0026thinsp;80% in key areas \u0026ndash; including red flag screening, reassurance, advice to remain active, exercise prescription, and referrals aligned with the STarT Back stratification \u0026ndash; was considered sufficient to support protocol adherence.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2. Baseline factors used to describe the population\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eTo characterize the population at baseline, we gathered the following information: age, gender, household income, duration of back pain, occurrence of previous episodes of back pain, presence of pain in other areas of the body, comorbidities (using the Charlson comorbidity index score)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e74\u003c/span\u003e\u003c/sup\u003e, current medications, employment status before the present episode of back pain, and employment status at the time of responding to the survey.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3. Clinical outcomes\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eWe piloted the collection for the clinical outcomes at baseline; six weeks; three, six, nine and twelve months. The RA collected all outcome measures electronically for those with access to a computer or device or on paper for those unable to complete them electronically. The following clinical outcome measures were piloted in this study:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ei. Self-reported disability\u003c/em\u003e was measured using the Roland-Morris Disability Questionnaire (RMDQ). This tool is widely accepted as a valid outcome measure in individuals with back pain\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e75\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e76\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eii. Pain intensity\u003c/em\u003e was assessed through a Numeric Pain Rating Scale (NPRS). Drawing on research indicating that pain experienced during movement can respond differently to treatment compared to pain at rest\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e77\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e79\u003c/span\u003e\u003c/sup\u003e, participants reported their pain levels at rest and while walking and lifting a bag of groceries.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eiii. Health-related quality of life\u003c/em\u003e was measured using the EuroQOL-5D (EQ-5D-5L)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e80\u003c/span\u003e\u003c/sup\u003e, with scores converted to quality-adjusted life years (QALYs) using a value set developed for the Canadian setting\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e81\u003c/span\u003e\u003c/sup\u003e. This tool has been shown to be appropriate for economic evaluation\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e82\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eiv. Global rating of change\u003c/em\u003e was measured using an 11-point Global Rating of Change scale (GROC) [(very much worse (-5) to completely recovered (+\u0026thinsp;5)]\u003csup\u003e83,84\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ev. Patient satisfaction\u003c/em\u003e was measured using an 11-point scale [very dissatisfied (-5) to very satisfied (+\u0026thinsp;5)].\u003c/p\u003e\n\u003cp\u003e\u003cem\u003evi. Catastrophic thinking\u003c/em\u003e was measured using the Pain Catastrophizing Scale (PCS)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e85\u003c/span\u003e\u003c/sup\u003e, a 13-item scale designed to assess catastrophizing thoughts related to pain.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003evii. Depressive symptoms\u003c/em\u003e were evaluated using the 9-item Patient Health Questionnaire (PHQ-9)\u003csup\u003e86\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAdverse events\u003c/em\u003e were recorded through a questionnaire that was informed by reporting guidelines\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e56\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e. The participants were asked if they encountered any adverse events related to the intervention (yes/no); what adverse event(s) were experienced; the duration of the adverse event(s) (hours or days); and the severity of the adverse event(s) (using a 0\u0026ndash;10 scale). No serious adverse events occurred during this pilot study; however, if any arise during the full trial, they will be promptly managed by referring the participant to the most suitable member of the primary healthcare team.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4. Health system outcomes\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eWe piloted data collection related to the health system outcomes listed below:\u003c/p\u003e\n\u003cp\u003ei. \u003cem\u003eAccessibility\u003c/em\u003e was evaluated by measuring the proportion of individuals with LBP who were able to book an encounter with their primary care provider within 48 hours of requesting an appointment. Accessibility was further defined, and informed by clinical guidelines, as and the number of participants identified as medium or high risk for ongoing pain (according to the STart Back tool) who received physiotherapy services \u003csup\u003e\u003cspan class=\"CitationRef\"\u003e88\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eii. \u003cem\u003eHealth service utilization\u003c/em\u003e was captured using a self-report questionnaire at all follow-up timepoints (see Supplementary file 2). The following utilization measures were collected: number of primary care encounters, ED visits, overnight hospitalizations, surgeries/procedures, physician specialist encounters, visits to other HCPs (e.g., community PTs), diagnostic tests undergone (e.g., MRI), and medications taken.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e5. Cost outcomes\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eA cost utility analysis is planned for the full trail; the following data were collected to achieve that goal:\u003c/p\u003e\n\u003cp\u003ei. \u003cem\u003eDirect healthcare costs\u003c/em\u003e: Direct costs included the PT training and salary, training of personnel at the primary care sites, equipment and materials, and clinic space required to integrate the PT. The Ontario Ministry of Health and Long-term Care Schedule of Benefits\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e89\u003c/span\u003e\u003c/sup\u003e was used to calculate costs for government-funded healthcare services. For private healthcare services, we surveyed providers in the community to determine the mean cost for services. The Ontario Drug Benefit formulary was referenced to calculate medication costs.\u003c/p\u003e\n\u003cp\u003eii. \u003cem\u003eIndirect costs\u003c/em\u003e: Indirect costs (i.e., costs associated with LBP, but not healthcare-related) were estimated by loss of productivity using a human capital approach. The monetary value of time lost from paid work or caregiving duties, as reported by participants during each follow-up assessment, was calculated using the average wage data provided by Statistics Canada. The cost for time lost from volunteer activities was calculated using the minimum wage value in Ontario.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e6. Process outcomes\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eProcess outcomes are meant to help describe differences in the care provided between groups. These data were collected from the EHR and included: medication prescriptions, requisitions for diagnostic testing, referrals made to other internal and external HCPs, encounters within the primary care clinic, and notes provided for employers or insurers. Rates were determined as the number of events per person per year.\u003c/p\u003e\n\u003ch3\u003eData collection and management:\u003c/h3\u003e\n\u003cp\u003eData were collected using electronic (Qualtrics, Provo, Utah)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e90\u003c/span\u003e\u003c/sup\u003e or paper data collection forms (based on the participant\u0026rsquo;s choice). The initial assessment data were collected with the RA present at the initial visit, and participants were instructed on how to complete the follow-up outcome measures. All data was entered into an encrypted and secure study database. Personal identifying information (name, date of birth, and contact information) were collected for the purpose of linking data from the EHR and for communicating with participants for follow-up appointments. All personal information was saved in a file separate from participant outcomes and was encrypted and password protected. Upon completion of the trial, all de-identified data were permanently anonymized, and the file containing personal identifiers was subsequently destroyed. Access to the data was restricted to study investigators and research personnel. As a data quality assurance check, 10% of data from the database was cross-referenced with the original data collection forms.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003e1. Feasibility Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ei. Recruitment of primary care teams: Four\u003c/em\u003e primary care sites (three associated with family health teams and one community health centre) were recruited, meeting the established feasibility target for proceeding with the full trial.\u003c/p\u003e\n\u003cp\u003eii. \u003cem\u003eRecruitment of patient participants\u003c/em\u003e: We recruited 100 patient participants over a 16-week recruitment period, which reflects an average recruitment rate of 6.25 patient participants per week across all sites (1.6 patient participants per week per site). 58 participants were in the PT-led arm and 42 were in the usual care arm. This recruitment rate exceeded our a priori stated progression criteria of 1.6 patient participants per week across all sites or \u0026gt;\u0026thinsp;0.4 patient participants per site per week\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eiii. Assessment procedures\u003c/em\u003e: Using the data collection processes described above, a completion rate of \u0026gt;\u0026thinsp;99% of all items on our included measures was achieved, with an average completion time of \u0026lt;\u0026thinsp;60 minutes at all assessment points. These meet the \u003cem\u003ea priori\u003c/em\u003e criteria set for feasibility of the assessment procedures for the full trial\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eiv. Retention\u003c/em\u003e: All four primary care sites (clusters) were retained throughout the 12-month follow-up. We retained 89% of patient participants at the 12-month follow-up period, representing 11% attrition, which meets the \u0026lt;\u0026thinsp;20% attrition criterion we stated a priori as a feasibility criterion for progression to the full trial with the existing retention strategies. The retention rate was 87.9% in the PT-led primary care model arm and 90.5% in the usual care arm. Attrition was due to two patient participants withdrawing, both in the PT-led primary care model arm (reasons: no longer wishing to participate), and nine participants lost to follow-up with no reason obtained. A CONSORT flow diagram\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e56\u003c/span\u003e\u003c/sup\u003e is provided in Fig.\u0026nbsp;2.\u003c/p\u003e\n\u003ch3\u003e[INSERT FIGURE 2 APPROXIMATELY HERE]\u003c/h3\u003e\n\u003cp\u003eCaption for Fig.\u0026nbsp;2: Study flow diagram.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ev. PT Training\u003c/em\u003e: The PT who was integrated into the PT-led primary care sites reported 9/10 or 10/10 confidence in delivering all four components of the PT-led intervention being proposed for the full study (exceeding the 8/10 confidence progression criteria). These confidence ratings indicate feasibility of proceeding to the full trial by incorporating the PT training. Qualitative feedback on the training was obtained from the PT. The PT reported the experience of having to orient to site processes and interprofessional team members along-side provision of care at participating sites. Therefore, strategies to enhance training and orientation for the PT will include providing the PT with a more formal orientation to the primary care site prior to initiation of patient recruitment for the fully powered trial.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003evi. PT treatment fidelity\u003c/em\u003e: To determine consistency of the intervention with the protocol, we performed audits of the fidelity checklist completed by the PT throughout the study period, the EHRs of all patients in the PT-led arm, and self-report measures collected from the patient participants at the six-week assessment. These audits indicated that the intervention was carried out with high fidelity (\u0026gt;\u0026thinsp;95% of participants received a recommendation aligned with the STarT Back classification, and 100% received all other planned intervention components).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2. Baseline factors used to describe the population\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants in this pilot study were a mean 51.7 years of age (SD 17.0) and the majority were men (67%). Differences in participants characteristics between arms, including those that are expected to be prognostic indicators, were intentionally not tested statistically or set as a progression criteria because of the small number of clusters in this pilot study and expected differences between clusters (e.g., Community Health Centers in Ontario serve populations with a higher proportion of chronic conditions and lower income than Family Health Teams). The Community Health Center was allocated to the usual care arm and there were baseline differences between groups in the direction expected. For example, the Charlson Comorbidity Index Score was 1.83 (SD 1.80) in the PT-led arm and 2.83 (SD 2.57) in the usual care arm, and the proportion of people categorized as high risk on the STarT Back tool was 5.2% in the PT-led arm and 33.3% in the usual care arm. Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e provides a description of the patient participant characteristics in this pilot study at baseline.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003e\u0026ndash; Participant Characteristics\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eAge \u0026ndash; years [mean (SD)]\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eTotal\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ePT-led primary care group (n\u0026thinsp;=\u0026thinsp;58)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eUsual care group\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;42)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e51.7 (17.0)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e50.1 (18.4)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e53.8 (14.7)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGender [n (%)]\u003c/p\u003e\n\u003cp\u003eMen\u003c/p\u003e\n\u003cp\u003eWomen\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e67 (67%)\u003c/p\u003e\n\u003cp\u003e33 (33%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e39 (67.2%)\u003c/p\u003e\n\u003cp\u003e19 (32.8%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e28 (66.7%)\u003c/p\u003e\n\u003cp\u003e14 (33.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHousehold income [n (%)]\u003c/p\u003e\n\u003cp\u003e\u0026lt;$20,00\u003c/p\u003e\n\u003cp\u003e$20,000 to $40,000\u003c/p\u003e\n\u003cp\u003e$40,000 to $60,000\u003c/p\u003e\n\u003cp\u003e$60,000 to $80,000\u003c/p\u003e\n\u003cp\u003e$80,000 to $100,000\u003c/p\u003e\n\u003cp\u003e\u0026gt;$100,000\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e13 (13.3%)\u003c/p\u003e\n\u003cp\u003e26 (26.5%)\u003c/p\u003e\n\u003cp\u003e14 (14.3%)\u003c/p\u003e\n\u003cp\u003e17 (17.3%)\u003c/p\u003e\n\u003cp\u003e10 (10.2%)\u003c/p\u003e\n\u003cp\u003e18 (18.4%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e4 (7.0%)\u003c/p\u003e\n\u003cp\u003e17 (29.8%)\u003c/p\u003e\n\u003cp\u003e10 (17.5%)\u003c/p\u003e\n\u003cp\u003e9 (15.8%)\u003c/p\u003e\n\u003cp\u003e7 (12.3%)\u003c/p\u003e\n\u003cp\u003e10 (17.5%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e9 (22.0%)\u003c/p\u003e\n\u003cp\u003e9 (22.0%)\u003c/p\u003e\n\u003cp\u003e4 (9.8%)\u003c/p\u003e\n\u003cp\u003e8 (19.5%)\u003c/p\u003e\n\u003cp\u003e3 (7.3%)\u003c/p\u003e\n\u003cp\u003e8 (19.5%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWork status prior to pain [n (%)]\u003c/p\u003e\n\u003cp\u003eWorking full-time\u003c/p\u003e\n\u003cp\u003eWorking part-time\u003c/p\u003e\n\u003cp\u003eStudent\u003c/p\u003e\n\u003cp\u003eVolunteer\u003c/p\u003e\n\u003cp\u003eRetired\u003c/p\u003e\n\u003cp\u003eNot working\u003c/p\u003e\n\u003cp\u003eShort-term sick leave\u003c/p\u003e\n\u003cp\u003eOn disability insurance\u003c/p\u003e\n\u003cp\u003eOther\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e41 (41.0%)\u003c/p\u003e\n\u003cp\u003e7 (7.0%)\u003c/p\u003e\n\u003cp\u003e2 (2.0%)\u003c/p\u003e\n\u003cp\u003e2 (2.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e46 (46.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e1 (1.0%)\u003c/p\u003e\n\u003cp\u003e1 (1.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e21 (36.2%)\u003c/p\u003e\n\u003cp\u003e5 (8.6%)\u003c/p\u003e\n\u003cp\u003e1 (1.7%)\u003c/p\u003e\n\u003cp\u003e1 (1.7%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e30 (51.7%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e20 (47.6%)\u003c/p\u003e\n\u003cp\u003e2 (4.8%)\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e16 (38.1%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCurrent work status [n(%)]\u003c/p\u003e\n\u003cp\u003eWorking F/T\u003c/p\u003e\n\u003cp\u003eFull duties\u003c/p\u003e\n\u003cp\u003eModified duties\u003c/p\u003e\n\u003cp\u003eFull Hours\u003c/p\u003e\n\u003cp\u003eModified Hours\u003c/p\u003e\n\u003cp\u003eWorking P/T\u003c/p\u003e\n\u003cp\u003eFull duties\u003c/p\u003e\n\u003cp\u003eModified duties\u003c/p\u003e\n\u003cp\u003eFull Hours\u003c/p\u003e\n\u003cp\u003eModified Hours\u003c/p\u003e\n\u003cp\u003eStudent\u003c/p\u003e\n\u003cp\u003eVolunteer\u003c/p\u003e\n\u003cp\u003eRetired\u003c/p\u003e\n\u003cp\u003eNot working\u003c/p\u003e\n\u003cp\u003eShort-Term Sick Leave\u003c/p\u003e\n\u003cp\u003eOn disability insurance\u003c/p\u003e\n\u003cp\u003eOther\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e26 (26.0%)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e25 (25.0%)\u003c/p\u003e\n\u003cp\u003e1 (1.0%)\u003c/p\u003e\n\u003cp\u003e26 (26.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e8 (8.0%)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e5 (5.0%)\u003c/p\u003e\n\u003cp\u003e3 (3.0%)\u003c/p\u003e\n\u003cp\u003e5 (5.0%)\u003c/p\u003e\n\u003cp\u003e3 (3.0%)\u003c/p\u003e\n\u003cp\u003e3 (3.0%)\u003c/p\u003e\n\u003cp\u003e3 (3.0%)\u003c/p\u003e\n\u003cp\u003e8 (8.0%)\u003c/p\u003e\n\u003cp\u003e32 (32.0%)\u003c/p\u003e\n\u003cp\u003e8 (8.0%)\u003c/p\u003e\n\u003cp\u003e9 (9.0%)\u003c/p\u003e\n\u003cp\u003e3 (3.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e18 (31.0%)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e18 (31.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e18 (31.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e6 (10.3%)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e4 (6.9%)\u003c/p\u003e\n\u003cp\u003e2 (3.4%)\u003c/p\u003e\n\u003cp\u003e5 (8.6%)\u003c/p\u003e\n\u003cp\u003e1 (1.7%)\u003c/p\u003e\n\u003cp\u003e2 (3.4%)\u003c/p\u003e\n\u003cp\u003e1 (1.7%)\u003c/p\u003e\n\u003cp\u003e3 (5.2%)\u003c/p\u003e\n\u003cp\u003e21 (36.2%)\u003c/p\u003e\n\u003cp\u003e5 (8.6%)\u003c/p\u003e\n\u003cp\u003e2 (3.4%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e8 (19.0%)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e7 (16.7%)\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003cp\u003e8 (19.0%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2 (4.8%)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e2 (4.8%)\u003c/p\u003e\n\u003cp\u003e1 (2.4%)\u003c/p\u003e\n\u003cp\u003e2 (4.8%)\u003c/p\u003e\n\u003cp\u003e5 (11.9%)\u003c/p\u003e\n\u003cp\u003e11 (26.2%)\u003c/p\u003e\n\u003cp\u003e3 (7.1%)\u003c/p\u003e\n\u003cp\u003e7 (16.7%)\u003c/p\u003e\n\u003cp\u003e3 (71%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCharlson comorbidity index [mean (SD)]\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2.25 (2.20)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1.83 (1.80)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2.83 (2.57)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDuration of back pain \u0026ndash; months [median (Q1, Q2)]\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3.9 (0.9, 26.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2.7 (0.8, 6.1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e8.93 (1.0, 166.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNumber of pain locations [mean (SD)]\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.1 (4.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3.6 (4.1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.7 (4.8)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFirst episode of back pain [n (%)]\u003c/p\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003cp\u003eNo\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e28 (28.0%)\u003c/p\u003e\n\u003cp\u003e72 (72.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e10 (17.2%)\u003c/p\u003e\n\u003cp\u003e48 (82.8%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e18 (42.9%)\u003c/p\u003e\n\u003cp\u003e24 (57.1%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSTaRT Back Category [n (%)]\u003c/p\u003e\n\u003cp\u003eLow risk\u003c/p\u003e\n\u003cp\u003eMedium risk\u003c/p\u003e\n\u003cp\u003eHigh risk\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e24 (24.0%)\u003c/p\u003e\n\u003cp\u003e59 (59.0%)\u003c/p\u003e\n\u003cp\u003e17 (17.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e16 (27.6%)\u003c/p\u003e\n\u003cp\u003e39 (67.2%)\u003c/p\u003e\n\u003cp\u003e3 (5.2%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e8 (19.1%)\u003c/p\u003e\n\u003cp\u003e20 (47.6%)\u003c/p\u003e\n\u003cp\u003e14 (33.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedications for back pain [n (%)]\u003c/p\u003e\n\u003cp\u003eNSAIDS\u003c/p\u003e\n\u003cp\u003ePain killers\u003c/p\u003e\n\u003cp\u003eOther medications\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e58 (58.0%)\u003c/p\u003e\n\u003cp\u003e65 (65.0%)\u003c/p\u003e\n\u003cp\u003e79 (79.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e35 (60.3%)\u003c/p\u003e\n\u003cp\u003e36 (62.1%)\u003c/p\u003e\n\u003cp\u003e44 (75.9%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e23 (54.8%)\u003c/p\u003e\n\u003cp\u003e29 (69.0%)\u003c/p\u003e\n\u003cp\u003e35 (83.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003e3. Clinical outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe aggregate mean for the primary outcome, RMDQ score, was 11.0 (SD 6.2) at baseline and 6.7 (SD 6.5) at 12-month follow-up.\u003c/p\u003e\n\u003cp\u003eTable\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e presents the aggregate (both arms) mean scores and standard deviations or frequencies and percentages for the outcome measures planned for the full trial. As planned a priori, no statistical comparisons were conducted between arms.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003e\u0026ndash; Aggregate Clinical Outcomes\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eMeasure\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eBaseline\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;100)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eWeek 6\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;91)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eWeek 12\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;90)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e6 months\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;91)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e9 months\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;91)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e12 months\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;89)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRMDQ\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e11.03 (6.23)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e8.11 (6.53)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e8.09 (6.92)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.35 (4.40)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e6.69 (6.47)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e6.71 (6.52)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePain at rest\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.08 (2.58)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3.38 (2.66)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.07 (2.41)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.02 (2.56)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3.96 (2.58)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3.73 (2.34)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePain walking\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.26 (2.59)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.33 (2.85)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.09 (2.82)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.00 (2.97)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.78 (3.07)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.56 (2.87)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePain lifting\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e6.07 (2.68)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.62 (3.10)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.53 (2.96)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.22 (2.89)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.70 (2.90)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4.53 (2.70)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEQ5D-5L\u003c/p\u003e\n\u003cp\u003eIndex Score\u003c/p\u003e\n\u003cp\u003eGlobal Rating\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.462 (0.267)\u003c/p\u003e\n\u003cp\u003e64.47 (19.00)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.591 (0.243)\u003c/p\u003e\n\u003cp\u003e68.49 (19.66)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.614 (0.228)\u003c/p\u003e\n\u003cp\u003e68.30 (19.19)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.628 (0.205)\u003c/p\u003e\n\u003cp\u003e70.22 (18.15)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.637 (0.207)\u003c/p\u003e\n\u003cp\u003e68.09 (21.96)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.652 (0.205)\u003c/p\u003e\n\u003cp\u003e69.00 (20.63)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePHQ-9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e8.13 (7.11)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e7.19 (6.60)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e6.60 (6.89)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.63 (5.05)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.56 (5.84)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5.53 (6.18)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePCS\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e28.76 (12.40)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e28.48 (12.11)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e26.11 (12.89)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e26.09 (12.12)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e24.75 (11.54\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e24.15 (11.39)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGROC [n (%)]\u003c/p\u003e\n\u003cp\u003e-5\u003c/p\u003e\n\u003cp\u003e-4\u003c/p\u003e\n\u003cp\u003e-3\u003c/p\u003e\n\u003cp\u003e-2\u003c/p\u003e\n\u003cp\u003e-1\u003c/p\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003cp\u003e+1\u003c/p\u003e\n\u003cp\u003e+2\u003c/p\u003e\n\u003cp\u003e+3\u003c/p\u003e\n\u003cp\u003e+4\u003c/p\u003e\n\u003cp\u003e+5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e7 (7.7%)\u003c/p\u003e\n\u003cp\u003e5 (5.5%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e25 (27.5%)\u003c/p\u003e\n\u003cp\u003e7 (7.7%)\u003c/p\u003e\n\u003cp\u003e17 (18.7%)\u003c/p\u003e\n\u003cp\u003e13 (14.3%)\u003c/p\u003e\n\u003cp\u003e7 (7.7%)\u003c/p\u003e\n\u003cp\u003e4 (4.4%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e20 (22.2%)\u003c/p\u003e\n\u003cp\u003e11 (12.2%)\u003c/p\u003e\n\u003cp\u003e16 (17.8%)\u003c/p\u003e\n\u003cp\u003e16 (17.8%)\u003c/p\u003e\n\u003cp\u003e7 (7.8%)\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e4 (4.4%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e10 (11.1%)\u003c/p\u003e\n\u003cp\u003e24 (26.4%)\u003c/p\u003e\n\u003cp\u003e5 (5.5%)\u003c/p\u003e\n\u003cp\u003e8 (8.8%)\u003c/p\u003e\n\u003cp\u003e18 (19.8%)\u003c/p\u003e\n\u003cp\u003e11 (12.1%)\u003c/p\u003e\n\u003cp\u003e5 (5.5%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e6 (6.6%)\u003c/p\u003e\n\u003cp\u003e6 (6.6%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e17 (18.7%)\u003c/p\u003e\n\u003cp\u003e6 (6.6%)\u003c/p\u003e\n\u003cp\u003e11 (12.2%)\u003c/p\u003e\n\u003cp\u003e17 (18.7%)\u003c/p\u003e\n\u003cp\u003e12 (13.2%)\u003c/p\u003e\n\u003cp\u003e10 (11.1%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003cp\u003e0 (0.0%)\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003cp\u003e4 (4.5%)\u003c/p\u003e\n\u003cp\u003e17 (19.1%)\u003c/p\u003e\n\u003cp\u003e3 (3.4%)\u003c/p\u003e\n\u003cp\u003e14 (15.7%)\u003c/p\u003e\n\u003cp\u003e16 (18.0%)\u003c/p\u003e\n\u003cp\u003e12 (13.5%)\u003c/p\u003e\n\u003cp\u003e8 (9.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSatisfaction [n (%)]\u003c/p\u003e\n\u003cp\u003e-5\u003c/p\u003e\n\u003cp\u003e-4\u003c/p\u003e\n\u003cp\u003e-3\u003c/p\u003e\n\u003cp\u003e-2\u003c/p\u003e\n\u003cp\u003e-1\u003c/p\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003cp\u003e+1\u003c/p\u003e\n\u003cp\u003e+2\u003c/p\u003e\n\u003cp\u003e+3\u003c/p\u003e\n\u003cp\u003e+4\u003c/p\u003e\n\u003cp\u003e+ 5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e5 (5.5%)\u003c/p\u003e\n\u003cp\u003e4 (4.4%)\u003c/p\u003e\n\u003cp\u003e5 (5.5%)\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e14 (15.4%)\u003c/p\u003e\n\u003cp\u003e4 (4.4%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e13 (14.3%)\u003c/p\u003e\n\u003cp\u003e13 (14.3%)\u003c/p\u003e\n\u003cp\u003e27 (29.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003cp\u003e20 (22.2%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e7 (7.8%)\u003c/p\u003e\n\u003cp\u003e15 (16.7%)\u003c/p\u003e\n\u003cp\u003e9 (10.0%)\u003c/p\u003e\n\u003cp\u003e26 (28.9%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e5 (5.5%)\u003c/p\u003e\n\u003cp\u003e20 (22.0%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e5 (5.5%)\u003c/p\u003e\n\u003cp\u003e13 (14.3%)\u003c/p\u003e\n\u003cp\u003e11 (12.1%)\u003c/p\u003e\n\u003cp\u003e27 (29.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e4 (4.4%)\u003c/p\u003e\n\u003cp\u003e3 (3.3%)\u003c/p\u003e\n\u003cp\u003e19 (20.9%)\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e6 (6.6%)\u003c/p\u003e\n\u003cp\u003e15 (16.5%)\u003c/p\u003e\n\u003cp\u003e7 (7.7%)\u003c/p\u003e\n\u003cp\u003e29 (31.9%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3 (3.4%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e5 (5.6%)\u003c/p\u003e\n\u003cp\u003e1 (1.1%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e15 (16.9%)\u003c/p\u003e\n\u003cp\u003e2 (2.2%)\u003c/p\u003e\n\u003cp\u003e9 (10.1%)\u003c/p\u003e\n\u003cp\u003e10 (11.2%)\u003c/p\u003e\n\u003cp\u003e14 (15.7%)\u003c/p\u003e\n\u003cp\u003e26 (32.6%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e* For all measures other than GROC and Satisfaction, values represent Mean (SD). GROC and satisfaction are presented as frequency (percentage) of participants.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eHealth service utilization (4) and cost (5) outcomes\u003c/h2\u003e\n\u003cp\u003eCost outcomes were calculated using health service utilization counts and cost per unit. Health service utilization and costs necessary for the planned health service utilization and cost utility analyses for the full trial were collected and reported descriptively in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e. Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e describes the aggregate (both arms) health service utilization counts and cost per person. As planned, no statistical analysis was conducted to compare between groups. Other direct costs that will be included in the cost utility analysis will include the PT training and salary, training materials for orienting the PT and team members at the primary care sites, equipment and materials for care delivery, and clinic space require to integrate the PT. Among the 76 subjects identified as medium or high risk by the STart Back tool, 41 (53.9%) accessed physiotherapy services for their LBP; 31 (73.8%) and 10 (29.4%) participants accessed physiotherapy services in the PT-led and usual care groups, respectively.\u003c/p\u003e\n\u003cp\u003eIndirect costs associated with time lost from occupational activities (paid work, caregiving, volunteer activities) are reported in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e. These will be included in the full trial as part of the cost utility analysis conducted using a societal perspective for the primary analysis.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003e\u0026ndash; Aggregate health service utilization counts and direct costs (count, cost per person)\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eED visits\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e0\u0026ndash;6 weeks\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e6\u0026ndash;12 weeks\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e3\u0026ndash;6 months\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e6\u0026ndash;9 months\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e9\u0026ndash;12 months\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e2, $2.15\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e1, $1.08\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e4, $4.29\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e1, $1.07\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e2, $2.19\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOvernight hospital stays\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $32.44\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $16.40\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e18, $292.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSpecialist visits\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOrthopaedic\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $0.92\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $0.91\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $1.51\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNeurosurgery\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $1.33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $2.69\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3, $3.99\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3, $1.96\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePhysiatrist\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $1.90\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePain specialist\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e7, $7.01\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e13, $11.18\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e18, $11.52\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e22, $13.81\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e7, $4.10\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOther\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $0.88\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $1.69\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $2.53\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $1.09\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eClinic visits\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePain management clinic\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3, $2.75\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4, $3.85\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4, $3.40\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5, $4.04\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $1.32\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOther\u003csup\u003e**\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4, $4.94\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e12, $14.24\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eVisits to other healthcare providers\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePhysiotherapist\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e72, $43.19\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e36, $28.94\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e52, $39.45\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e60, $45.77\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e35, $29.83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eChiropractor\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5, $2.31\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e16, $7.72\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e12, $4.23\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e21, $9.78\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e16, $8.48\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMassage therapist\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e15, $11.65\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e10, $10.50\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e21, $20.27\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e6, $7.91\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e9, $10.17\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOther\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e7, $7.80\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $0.83\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3, $5.27\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e7, $7.03\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3, $5.28\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDiagnostic imaging\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eXray\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e7, $5.36\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4, $3.10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5, $3.83\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e6, $4.59\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3, $2.35\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCT scan\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $2.71\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $5.41\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $2.71\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $5.53\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMRI\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5, $21.28\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3, $12.91\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5, $21.28\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $8.70\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOther\u003csup\u003e\u0026sect;\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $1.18\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $1.38\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSurgeries\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2, $26.73\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0, $0.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1, $13.58\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedications for back pain\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNSAIDS\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$3.87\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$2.32\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$5.71\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$6.43\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$2.89\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOther analgesics\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$19.09\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$18.74\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$41.37\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$25.01\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$33.78\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOther\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$11.04\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$15.17\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$20.63\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$14.60\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$16.21\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"6\"\u003e\u003csup\u003e*\u003c/sup\u003e Includes: neurology, gastroenterology, respirology, cardiology, oncology, and free-text option\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"6\"\u003e\u003csup\u003e**\u003c/sup\u003e Includes: addiction clinics, sleep clinics, acupuncture, psychotherapy\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"6\"\u003e\u003csup\u003e\u0026dagger;\u003c/sup\u003e Includes: osteopathy, naturopathy, social work, psychology, and free-text option\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"6\"\u003e\u003csup\u003e\u0026sect;\u003c/sup\u003e Includes: bone mineral density scan, ultrasound\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab4\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003e\u0026ndash; Aggregate Indirect Costs (cost per person)\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eTime off work total\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e0\u0026ndash;6 weeks\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e6\u0026ndash;12 weeks\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e3\u0026ndash;6 months\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e6\u0026ndash;9 months\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e9\u0026ndash;12 months\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e$849.37\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e$805.76\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e$1,426.23\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e$1,289.67\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e$1,149.90\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTime off work/week\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$141.56\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$134.29\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$118.85\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$107.47\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$95.83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTime off caregiving\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$15.87\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$22.46\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$6.15\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$51.85\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$27.69\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTime off volunteer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$35.47\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$4.92\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$42.46\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$12.31\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e$6.29\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003e6. Process outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe were able to successfully determine the feasibility of collecting the following process outcomes, related to the management of LBP, from the EHR: medications prescribed, diagnostic imaging ordered, referrals made to other HCPs (both internal and external to the primary health care team), the number of visits to members of the primary care team, and notes provided to employers or insurers. Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e (below) shows the crude counts and rates of these process outcome measures.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab5\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003e\u0026ndash; Process outcomes by intervention group (count, rate)\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003ePrimary care visits for LBP\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ePT-led\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eUsual care\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eTotal\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e183, 3.31\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e249, 5.93\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e432, 4.44\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePhysician/Resident\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e66, 1.17\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e120, 2.86\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e186, 1.89\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNP\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5, 0.12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 0.06\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePT\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e104, 1.85\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e19, 0.45\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e123, 1.25\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOT\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3, 0.03\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRegistered Nurse\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11, 0.20\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e91, 2.17\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e102, 1.04\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSocial Worker\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e12, 0.29\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e12, 0.12\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDietitian\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNumber of referrals for LBP\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e30, 0.54\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e30, 0.71\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e60, 0.61\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePT\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11, 0.20\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e15, 0.36\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e26, 0.26\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eChiropractor\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.01\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNeurology\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNeurosurgery\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 0.07\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5, 0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOrthopaedics\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 0.07\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 0.10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 0.08\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOT\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePhysiatry\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMassage Therapy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3, 0.03\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBariatrics\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.01\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCommunity Care Access Centre\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.01\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePain Clinic\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 0.07\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3, 0.07\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7, 0.07\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGeneral surgery\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.01\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePsychology\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.01\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRheumatology\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.04\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSocial Work\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTotal images ordered for LBP\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e17, 0.30\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 0.19\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e25, 0.25\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eXray\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9, 0.16\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 0.10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e13, 0.13\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCT scan\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBone Mineral Density\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMRI\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7, 0.12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3, 0.07\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e10, 0.10\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTotal medications prescribed for LBP\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e41, 0.72\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e78, 1.86\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e119, 1.20\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNSAIDS\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 0.11\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 0.10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e10, 0.10\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOpioids\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e13, 0.23\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e29, 0.69\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e42, 0.43\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAcetaminophen\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAntidepressants\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 0.07\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7, 0.17\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11, 0.11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBenzodiazepines\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 0.04\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7, 0.17\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9, 0.09\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCannabinoids\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3, 0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 0.14\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9, 0.09\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGabapentinoids\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 0.11\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e10, 0.24\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e16, 0.16\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMuscle relaxants\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 0.11\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 0.19\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e14, 0.14\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTricyclics\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1, 0.02\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5, 0.12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 0.06\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNotes provided for LBP\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 0.14\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 0.14\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e14, 0.14\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003eNote: rates presented as events per 1 person year.\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe progression criteria for each of our primary feasibility outcomes (recruitment, retention, outcome measure completion, and treatment fidelity) were met, indicating feasibility of proceeding with the fully powered cluster randomized trial. Through the pilot study, we were able to identify several additional important learning opportunities to optimize the processes for the full trial.\u003c/p\u003e \u003cp\u003eOne important learning was the need to overcome challenges related to identification and recruitment bias. Selection bias, i.e., differential identification and recruitment of participants between arms, represents a risk of bias common in cluster trials\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e91\u003c/span\u003e\u003c/sup\u003e. While our recruitment rate met the progression criteria throughout the study period, we experienced early concerns with imbalance between arms. In the first four weeks of recruitment, 18 participants were recruited from PT-led primary care sites and seven were recruited from the usual physician-led care sites. Our strategy to mitigate against selection bias was to provide the same information to potential participants across both arms at the time of screening: \"Our primary care team is taking part in a study on physiotherapy and primary care for low back pain with Queen's University. The goal of the study is to compare two models of care where you would see either a physiotherapist or your family doctor/nurse practitioner for your upcoming visit. Is this something you would hearing more about and consider participating in?” By providing this same information, we aimed to not reveal the site allocation until after patient participant consent and baseline data collection. However, by cross-referencing the number of patients screened with the number of visits for LBP in the EHRs, we were able to identify a higher rate of screening at the intervention arm sites in the first four weeks, i.e., more participants were receiving the screening question above in the PT-led arm than in the usual care arm. To mitigate the risk of ongoing bias, we increased the time that research assistants were present at the usual care sites. This permitted them to visit more frequently with the reception staff and primary care providers who were performing the screening to encourage adherence to the screening protocol. Subsequent to implementing this strategy, we witnessed a balancing of recruitment rates between the two arms for the remainder of the recruitment period (39 at PT-led and 36 at physician-led care sites). This learning experience will be carried over into the full trial as a successful approach to minimizing the risk of recruitment bias.\u003c/p\u003e \u003cp\u003eWhile it was not the intention of this pilot trial to conduct a statistical analysis to compare baseline differences in characteristics between groups, we did observe differences in prognostic indicators such as number of comorbidities and STarT Back risk category at one site (a Community Health Center) in comparison to the other three sites (Family Health Teams or Family Health Organizations). This finding was not entirely unexpected. Community Health Centres in Ontario each have a unique focus based on their mandate to serve the health needs of priority populations identified in their communities. This leads them to serve patient populations who have faced barriers to accessing health services, such as people with low income, new immigrants, and people with complex mental health needs. Based on our pilot data, we perceive that the unique focus of each community health center may make it more challenging to balance key prognostic indicators between arms, even when using a covariate constrained randomization procedure for the full trial as planned. Additionally, family health organizations, family health groups, and family health groups serve a greater proportion of the population in Ontario, making these models the more predominant place where the PT-led model of care would be implemented if effective. So, the findings from this pilot trial have also led us to make the decision to recruit only family health organizations, family health groups, or family health teams (or their equivalent) for our fully powered trial.\u003c/p\u003e \u003cp\u003eWe also learned about the strengths and areas of improvement of our PT orientation and training. During our pilot study, the core components of the model of care were carried out with high fidelity - we achieved \u0026gt; 95% compliance for all aspects of the PT-led model of care, measured with a fidelity checklist and EHR chart audit. This aligns with research that shows PTs in primary care roles can provide guideline adherent care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e–\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e. However, qualitative feedback from the PT indicated that a more formal or structured orientation for the PT to the primary care practice in which they will be integrated would be beneficial. By familiarizing the PT with the clinical site, physicians, and staff, the PT will be better prepared to integrate within the primary care team and collaborate as a primary care team member.\u003c/p\u003e \u003cp\u003eAnother important learning was the use of our healthcare utilization and fidelity data to inform the human resource and space requirements for the full trial. In our pilot study, all patient participants received a one hour initial assessment and 28 (48%) participated in follow-up visits with the physiotherapist. These data will be used to estimate the hours required for the PT to meet the needs of each of our participating sites for the full trial.\u003c/p\u003e \u003cp\u003eFinally, through our healthcare utilization and fidelity data, we learned that very few participants classified as high risk of ongoing LBP-related disability were able to access psychosocial risk-factor targeted treatment. We learned about access barriers, such as funding and/or transportation barriers to the community-based physiotherapists who had received the high risk training, even though they were located in the same city as the primary care team. Given these access limitations as well as challenges in training enough community-based PTs to offer the high-risk intervention in the communities served by 20 different primary care sites in the full trial, we now intend to offer the high-risk intervention for patients classified as high risk for ongoing disability by the PT in the primary care sites during the full trial. We think this will overcome some of the access and fidelity challenges, and therefore we would be testing a more scalable model of care.\u003c/p\u003e\n\n "},{"header":"Limitations","content":"\u003cp\u003eThere are a few important limitations of this pilot trial. First, when patients requested support to complete the self-report outcome measures, the study PT met with some of the patients to support them to complete the outcome measures due to a lack of research staff support onsite. We do not perceive this had an important impact on our feasibility outcomes (e.g. outcome measure completion). It was not a goal of this pilot study to estimate the effectiveness of the PT-led model of care; however, it is important for readers to recognize the potential for observer bias present in our descriptive data, especially if they are incorporated into a future meta-analysis. To mitigate against this risk of bias in the full trial\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e92\u003c/span\u003e\u003c/sup\u003e, the PT will not be collecting these data and we will plan research staff such that we are adequately prepared to support all participants who request support for outcome measure completion.\u003c/p\u003e\u003cp\u003eAnother limitation is our recruitment from just four sites (all non-rural) and one region, which may limit the generalizability of our recruitment and retention rate to the other centers planned for the full trial (20 sites). We will monitor these rates closely during the full trial and create plans to mitigate any new challenges with recruitment and retention. For example, transportation barriers amongst people requesting support for completing the outcome measures in person may be more common in rural settings.\u003c/p\u003e\u003cp\u003eFinally, a third limitation of our study is the use of a single PT to carry out the intervention across all three sites in this pilot trial. This may have made achieving high fidelity rates easier in this pilot study. A potential challenge for the full trial will be to achieve similar adherence to the protocol with multiple PTs carrying out the model of care across a larger number of sites. During the pilot, the principal investigator and PT met regularly to problem solve implementation barriers. We will employ a similar strategy with all study PTs, principal investigator, and research coordinators meeting frequently throughout the one year intervention period to encourage fidelity and ensure compliance with study protocols.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eOur results suggest that implementing this model of care and utilizing our described cluster trial methods are feasible. These findings support proceeding with the fully powered trial.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eComputerized tomography\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eED\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eEmergency department\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eEHR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eElectronic health medical record\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eGROC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eGlobal Rating of Change\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIC/ES\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInstitute for Clinical Evaluative Sciences\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eLBP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eLow back pain\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMRI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMagnetic resonance imaging\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNurse practitioner\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNPRS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNumeric Pain Rating Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNSAID\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNon-steroidal anti-inflammatory drug\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eOHIP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eOntario Health Insurance Plan\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePCS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePain Catastrophizing Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePHQ-9\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003e9-item Patient Health Questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePhysiotherapist\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eQALY\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eQuality-adjusted life year\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eResearch assistant\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRandomized controlled trial\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRMDQ\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRoland-Morris Disability Questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSD\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":" \u003cp\u003e \u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e \u003cp\u003e Ethics approval for this pilot study was obtained from the Queen\u0026rsquo;s University Health Science and Affiliated Teaching Hospitals Research Ethics Board (HSREB #6021536). Written consent was obtained from all participants willing to participate.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent for publication\u003c/strong\u003e \u003cp\u003eNot applicable.\u003c/p\u003e \u003c/p\u003e\u003cp\u003e \u003ch2\u003eCompeting interests\u003c/h2\u003e \u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis pilot study has been funded through the Canadian Institutes of Health Research Catalyst Grant: Musculoskeletal Health and Arthritis (#384307). The study sponsor contributed to the peer review of this protocol, but did not play any role in the design, management, analysis, interpretation, writing, or\u003c/p\u003e \u003cp\u003epublication.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eJMi is the principal investigator who has led the team in all aspects of the development of this pilot study. DB, MG, CD, JMacD, JH, SF, KN, JR, and TW all contributed expertise to the study design and implementation and contributions to manuscript writing. JMar provided expertise and leadership for the collections of healthcare utilization and costs in preparation for the full trial. MT provided expertise in cluster trial design and statistical analysis. LC provided experiences as a person living with pain who seeks primary care to inform the outcomes, data collection mechanisms, engagement of patients, and writing of results. KV was responsible data collection and cleaning, contributing to manuscript writing, and presentation of results. CM contributed to data analysis, presentation of results, and manuscript writing. All authors have reviewed and approved the manuscript and to the interpretation of the results in planning for the fully powered cluster trial.\u003c/p\u003e\u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003eNot applicable\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eAccess to the study data may be made available with appropriate data sharing agreements and ethical approval by requesting the data from the corresponding author.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eVos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990\u0026ndash;2010: a systematic analysis for the Global Burden of Disease Study 2010. 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Available at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u003c/span\u003e\u003cspan address=\"http://www.training.cochrane.org/handbook\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-primary-care","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"famp","sideBox":"Learn more about [BMC Primary Care](https://bmcprimcare.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12875","title":"BMC Primary Care","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Low back pain, Primary care, Physiotherapy, Cluster randomized trial, Pilot study","lastPublishedDoi":"10.21203/rs.3.rs-8902753/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8902753/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eLow back pain (LBP) is a leading cause of disability worldwide. The first point of contact in the healthcare system for most individuals with LBP is their family physician; however, models incorporating physiotherapists (PTs) as the first point of contact within a primary care team are becoming more common. Research is needed to determine the impact of a PT-led model of care on patient health and health system outcomes. A pilot study was required before proceeding with a fully powered, multisite cluster randomized controlled trial (RCT) to address the following objectives: 1) Determine the feasibility of patient recruitment, assessment procedures, and retention; and 2) Determine the feasibility of PT training and implementation of a new PT-led primary care model for back pain.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA pilot cluster RCT was conducted at four primary care sites: two sites randomized to the PT-led and two sites randomized to usual physician-led model of care for LBP. The intervention arm involved a PT-led model of care in which the PT was integrated in the primary care team and available as the first point of contact. The control arm involved usual physician (or nurse practitioner)-led care. Adults seeking a primary care appointment for LBP were considered eligible to participate. Primary outcomes for the full trial were captured at baseline, six weeks, and three, six, nine and twelve months. Process outcomes were collected from the participant\u0026rsquo;s electronic medical record. Feasibility measures were assessed using patient recruitment and retention numbers, percentage completeness of assessment procedures, and feasibility indicators for PT training and treatment fidelity.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003e58 participants were recruited to the PT-led and 42 to the usual care arm (\u0026gt;\u0026thinsp;1.5 patients per week) over a 16-week recruitment period; 89% remained at the 12-month follow-up. Completion of \u0026gt;\u0026thinsp;99% of assessment procedures was achieved and remained within acceptable times to complete (\u0026lt;\u0026thinsp;60 minutes). The PT reported confidence (8/10) with their training and chart audits indicated high treatment fidelity.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe results suggest that implementing this model of care and utilizing the described trial methods are feasible. These findings support proceeding with the fully powered trial.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eClinicalTrials.gov, NCT03320148. Submitted for registration on 17 September 2017.\u003c/p\u003e","manuscriptTitle":"Study title: Determining the feasibility of a trial to determine the impact of a physiotherapist-led primary care model for low back pain: A pilot cluster randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-19 08:06:00","doi":"10.21203/rs.3.rs-8902753/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-04-27T16:19:02+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-21T11:55:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"327212078531469363751790140285010580185","date":"2026-04-15T11:28:45+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"141271689705440068087644427506613984532","date":"2026-04-13T10:29:04+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-08T17:43:22+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-06T11:57:23+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-03-18T14:42:05+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-03-18T01:49:12+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Primary Care","date":"2026-03-17T18:49:39+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-primary-care","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"famp","sideBox":"Learn more about [BMC Primary Care](https://bmcprimcare.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12875","title":"BMC Primary Care","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"da6c195e-f1fd-4dba-ae5e-d3290188fe51","owner":[],"postedDate":"April 19th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-04-19T08:06:00+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-19 08:06:00","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8902753","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8902753","identity":"rs-8902753","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}