Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS)

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A hospital-led follow-up service designed to address ongoing health problems may avoid unplanned readmissions and improve quality of life. Methods This paper outlines the protocol for a registry-based, single-blind, randomised controlled trial. Based on an intention-to-treat analysis, we will evaluate the feasibility, acceptability, potential effectiveness, and cost implications of a new tailored, co-designed, hospital-led follow-up service for people within 6–12 months of stroke. Participants (n = 100) from the Australian Stroke Clinical Registry who report extreme health problems on the EQ5D-3L between 90–180 days after stroke will be randomly assigned (1:1) to intervention (follow-up service) or control (usual care) groups. All participants will be independently assessed at baseline and 12–14 weeks post-randomisation. Primary outcomes are the proportion of participants: receiving follow-up services; complete ng the trial; and reporting satisfaction (clinicians and participants). Secondary outcomes include: extreme health problems (EuroQoL 5 Dimensions 3 Level Version), unmet needs (Longer-term Unmet Needs questionnaire), unplanned presentations and hospital readmission, functional independence (modified Rankin scale), and health service utilisation. To inform future research or implementation, the design contains a process evaluation including clinical protocol fidelity and an economic evaluation. Discussion The results of this study will provide improved knowledge of service design and implementation barriers and facilitators, and associated costs and resource implications and inform a future fully powered effectiveness trial of the intervention. Trial registration ACTRN12622001015730pr Stroke Clinical Trial Protocol Follow-up Service Figures Figure 1 Figure 2 Background Stroke is a leading cause of global disease burden ( 1 ). In addition to the immediate physical, cognitive and emotional injury impacts post-stroke, the long-term effects can be significant and life-altering. Approximately 25% of people with stroke report their quality of life as equivalent to, or worse than, death ( 2 ). Physical disability, loss of employment, social isolation, cognitive impairment, communication difficulties, anxiety and depression make resuming home and community activities difficult ( 3 ). Furthermore, compared with hospital discharges to rehabilitation or aged care, people discharged directly home are at an increased risk of an unplanned readmission within 90 days (sub-hazard ratio, 1.44 [95% CI, 1.33–1.55]). ( 4 ) Further, one in five people living with stroke have no support services in place after discharge from hospital ( 4 ). Data from the Australian Stroke Clinical Registry (AuSCR) describe significant impacts on people with stroke or transient ischaemic attack (TIA) between 90–180 days after hospital admission ( 5 , 6 ). For example, health-related quality of life data (EQ-5D-3L EuroQoL 5 Dimensions 3 Level Version) ( 7 ) demonstrated that patients reported some or extreme problems with mobility (50%), performing self-care (30%), completing usual activities (58%), pain/discomfort (49%) and anxiety or depression (49%) ( 7 ). To help mitigate these reported problems, efforts to better integrate care across hospital and primary care settings for chronic diseases such as stroke are required. Evaluation from follow-up services in other countries is promising ( 8 – 10 ). For example, a stroke nurse navigator program in the United States reduced 30-day unplanned readmissions by 67.6% ( 10 ). In addition, several authors of different studies have reported positive findings for follow-up services delivered from 30–90 days ( 11 , 12 ). Although these studies suggested that 60% of people living with stroke still had a least one health problem at three-months follow-up ( 12 ), no studies have focused on providing follow-up support after three months. More efficient and targeted approaches that include better communication between hospital specialist services and primary care providers are required for people living with stroke in Australia ( 13 ). Furthermore, some stroke impacts may only become apparent post-discharge, and community-based services may lack the expertise to address stroke-related problems. To address this important gap in stroke care, we co-designed a registry-based, hospital-led tailored follow-up service with key stakeholders and people with lived experience as part of the A uSCR LI fe after S troke T ailored S upport (A-LISTS) study ( 14 ). The follow-up service includes an intervention package that comprises a clinical protocol and procedure manual to be used by the site service coordinators (hereafter service coordinator(s)) to tailor the support provided to the individuals identified un-met need(s) ( 14 ). The service coordinator is a nominated stroke clinician - nurse or allied health staff- who is trained in the procedures. The newly developed follow-up service intervention package was pilot tested in one urban hospital in Australia with six participants, and then refined based on feedback from the service coordinator and participants to ensure it was ready to be used in a feasibility randomised controlled trial (RCT). Methods Research aims The aim of the study is to assess the feasibility (i.e. acceptability and satisfaction of service coordinators and participants), potential clinical effectiveness, participant resource utilisation and cost implications of the tailored hospital-led follow-up service for chronic stroke compared with usual care (control). Study design Multicentre, registry-based, trial with a prospective, parallel, randomised controlled, two group, single blinded design (Figure 1) with an intention-to-treat analysis. The RCT has been prospectively registered with Australian New Zealand Clinical Trials Registry (ACTRN12622001015730p, 20 th July 2022). Methods and results will be reported in compliance with the CONSORT 2010 Statement, including the extension for randomised pilot and feasibility trials (15). A process evaluation and an economic evaluation will be conducted concurrently to the main trial, and will be reported using the relevant reporting guidelines (e.g. CHEERS checklist) (16). The study database will be created via REDCap (Research Electronic Data Capture; a secure web based data management system)(17) and will be hosted on the Florey Institute of Neuroscience and Mental Health servers under the security and information technology infrastructure of the University of Melbourne and will be protected as per industry standards. [Figure 1] Study setting Up to six eligible and interested hospitals from a variety of settings will be identified from the network of hospitals that participate in the AuSCR (n=63 hospitals). Commencement dates will be staggered due to the timing of receiving hospital governance approvals, onboarding and training procedures. The AuSCR is a national clinical quality registry that collects prospective data on all patients from participating hospitals with a clinical diagnosis of stroke or TIA with the purpose of monitoring and improving stroke care in Australia (18). The diagnosis is confirmed by the registrant when they complete a follow-up survey at 90-180 days. Within the AuSCR, data on demographics, clinical characteristics and evidence-based therapies provided to patients during the acute admission are collected by hospital staff. Registrants are then contacted by the AuSCR Office, initially by mail to complete a follow-up health outcome survey. Where there is no response a short message service (SMS) and/or mail to the nominated next-of-kin is sent between 90-180 days post admission. The AuSCR office attempts to obtain health outcomes from all registrants unless they request no follow-up, opt out of having their personal details stored on the registry, were registered on the AuSCR over 180 days post-discharge or were known to be deceased. At the 90-180 day follow-up, registrants provide information about their living situation, and provide Health-Related Quality of Life (HRQoL) details using the EQ-5D-3L survey including the Visual Analogue Scale (VAS) (19). Functional independence is collected using the modified Rankin Scale (mRS) (20), and participants are also asked to indicate their willingness to be contacted for further research opportunities. Study Population Inclusion criteria Participants are selected from the AuSCR registrants if they: Have indicated a willingness to be contacted for future research at 90-180 day follow-up; Are aged ≥18 years with a confirmed diagnosis of stroke; Are living in the community in a private residence; Have reported an extreme problem in at least one dimension of the EQ-5D-3L or have a score on the VAS ≤ 60 at 90-180 day follow-up (19); and Are able to participate in English and provide informed consent (self-report or appropriate proxy can assist). Exclusion criteria AuSCR registrants with a TIA diagnosis will be excluded. Registrants in palliative care and/or a residential aged care facility will be excluded as they may be unlikely to survive to the end of study follow-up period (i.e. 12-14 weeks post randomisation). Trial Procedures Registry-based participant recruitment procedure Identification of eligible AuSCR registrants and recruitment will be undertaken by the Data Manager located at AuSCR Office in Melbourne, Victoria. Trained AuSCR team members will call potential participants to confirm eligibility. Consent will be obtained via mail (paper-form) or email (e-Consent; purpose-designed in the REDCap database). Baseline assessments (including demographic and clinical data) will be completed by an AuSCR team member via telephone post consent. Figure 2 outlines the recruitment pathway. A screening log will be used to capture demographic information on consenting eligible registrants and those who are not, to enable reporting of response and participation rates. [Figure 2] Randomisation, allocation concealment and blinding procedure Once consented, the trial participants will be randomly allocated 1:1 to the intervention group or control (usual care) group. Online randomisation will occur using REDCap (17), stratified by age (<65, 65+ years) and sex (male, female) to ensure balance of age and sex between the two groups as these factors are associated with differences in HRQoL (21). Participants and outcome assessors (AuSCR staff) will be blinded to the group allocation. Service coordinators delivering the intervention will be unaware of participants from their hospital randomised to the control group. To avoid unblinding to group allocation, the control group will not know which group they are in. As part of the study, some participants may be contacted by a member of staff from the hospital or service that treated them for their stroke. Outcome measures The primary and secondary outcomes are listed in Table 1 for each study aim. Data collection tools and relevant timepoints of measurement for the clinical, process and economic evaluation are outlined in Table 2. [Table 1] [Table 2] Description of secondary outcome clinical effectiveness measures Secondary outcome measures relating to the measurement of HRQoL, unmet needs and disability are described below. HRQoL measured by EQ-5D-3L and VAS The EQ-5D-3L (19) is a standardised instrument developed by the EuroQol group to measure health related quality of life and is widely used internationally and by the AuSCR. It comprises five dimensions: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. The EQ-5D-3L also includes a Visual Analogue Scale (VAS). Each dimension is self-reported by participants to indicate no problems, some problems or extreme problems. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The median VAS for reported by patients post-stroke in Australia is 70 (7) and in six European populations the normative median score is 80 (22). Longer-Term Unmet Needs after Stroke (LUNS) questionnaire The LUNS questionnaire is a 22-item tool that reports the longer-term problems affecting the physical, psychological and social facets of people living with stroke (23). It can also be used as a tool to evaluate community service usage and whether those community services are meeting the person’s needs (22). Most studies have used the LUNS between 3-6 months post-stroke, however, it has been used up to 5-8 years following stroke (24). The LUNS is acceptable to people living with stroke and has satisfactory validity and test-retest reliability (23). Modified Rankin Scale (mRS) scale The mRS is a single item, global disability rating scale often used in stroke trials for assessment of patient outcomes (25). The categorical scale is as follows: 0 = No symptoms at all; 1= No significant disability despite stroke-related symptoms; 2= Stroke-related disability but remains functionally independent; 3= Functionally dependent but independently mobile; 4= Requires assistance to mobilise; 5 = Requires constant care and is bed-bound (26). For this study, the mRS outcome will be dichotomised into two groups (0 to 2 [independent] vs dependent/dead [mRS 3 to 6]). Sample size Up to 100 people with stroke will be recruited (50 for intervention and 50 for control), which is consistent with recommendations for pilot and feasibility studies (27, 28). It is anticipated that each participating hospital will provide the intervention to approximately 10-15 people, with a capacity of providing the follow-up service to 1-2 intervention participants per week. Ethics Ethics approval for this project has been obtained by the Austin Health Human Research Ethics Committee (HREC/89487/Austin-2022). Hospital specific governance approval will also be obtained from participating hospitals. Approval for the use of the existing AuSCR data has been obtained from the AuSCR Steering Committee, the governing body of AuSCR. Treatment groups Intervention Participants in the intervention group will receive the tailored follow-up service implemented over 12-weeks. The service coordinator will be provided with a tailored patient referral report (including demographic and clinical data collected from the baseline assessment). The intervention follow-up service utilises clinicians’ clinical reasoning and experience to help participants navigate the hospital, community and primary care systems. This support may include linking participants to appropriate locally available services. All service coordinators will have a clinical background in stroke (e.g., stroke nurse, stroke allied health) and will receive 4-8 hours training tailored to the hospital setup. The service coordinator will conduct an initial assessment with the participant (either in-person or via telehealth; participant’s choice) to ascertain existing service usage, and how to assist the participant with their unmet needs. Through a collaborative and shared decision-making approach with the participant, the level of input required will be tailored to the participants needs. The service coordinator will then organise referrals as required and provide advice and education as necessary. Following the initial consultation, there are six possible scenarios (Figure 2). Only existing and available services or treatments will be offered in the trial. The intervention follow-up service will be tailored to the individual participant. It does not dictate how often, or which clinicians or services will have ongoing engagement with participants over the 12-week intervention period. Participants will be asked for their permission to share information with their GP including the purposively designed A-LISTS GP letter. Depending on the participant’s age, location, needs, priorities and healthcare network we envisage that some participants may be referred to services such as allied health services (e.g., physiotherapy, occupational therapy), community rehabilitation programs and state funded community health programs (e.g., chronic disease management plan (29)). The service coordinator may also liaise with the National Disability Insurance Scheme (30), My Aged Care (31) and other stroke resources (e.g., Stroke Foundation services and information) to help participants navigate the system and provide education. There will be no charges to participants for accessing the follow-up service, although some private services participants are referred to may incur fees. As this is an embedded real-world health services trial, we are utilising existing private, public, free and online services. Research funding will not be used to cover other out-of-pocket expenses (i.e., allied health services, specialist visits). Participants will be provided with an electronic or paper diary, to record health and community care contacts and referrals including dates and reasons for health and community care visits, to assist with completing the trial outcome assessment conducted at 12-14 weeks. Control group Participants in the control group will receive their usual care (e.g., existing services or supports) in the community. They will also be provided with an electronic/paper diary to record health and community care contacts and referrals used to complete the outcome assessment conducted 12-14 weeks post randomisation. At the end of the trial, information about participants in the control group who are assessed as having ongoing high levels of unmet needs, will be passed to the hospital team, who may choose to offer follow-up within current services available to them. Safety Monitoring Occurrence of serious adverse events (SAEs) will be documented throughout the feasibility RCT by the service coordinator and blinded outcome assessor. Relevant information will be obtained from the participant and/or proxy and hospital medical records (where possible by the service coordinator accessing the medical records). SAEs are defined as any untoward or serious medical occurrence that results in death; life-threatening incidents; hospitalisations; an event that results in new disability/incapacity; or other important medical events (32). SAEs will be sent to a neurologist who will act as the Medical Monitor (author VT) for adjudication. If they are deemed to be related to the study intervention, then a report will be submitted to the ethics committee and the local research governance office. Process Evaluation The process evaluation draws on implementation evaluation theory and models including the Medical Research Council guidance for complex interventions (33) and Normalization Process Theory (34). The process evaluation includes mixed methods since qualitative data in feasibility studies helps to refine the understanding of how the intervention works, and facilitate ongoing adaptation of the intervention and evaluation design in preparation for a larger trial.(35) Data will be collected using project documentation, field notes, surveys, and interviews/focus groups as outlined below. Satisfaction Survey: All participants will be invited to complete an electronic/paper satisfaction survey (including open and closed questions) at the 12-14 weeks post-randomisation outcome assessment. Information on satisfaction and experience with the care received in the community will be obtained, with specific questions related to the service coordinator and follow-up service also included for those in the intervention group. The service coordinator (and any other clinicians involved in the initial consultation) will also be invited to complete a survey exploring their experience of implementing and delivering the follow-up service. Interviews/focus groups: At the conclusion of the RCT, semi-structured focus groups/interviews (n=3, 6-10 in each group, with up to 30 people in total) will be undertaken with groups of: i) clinicians involved in delivery of the service (all service coordinators, and up to two other purposively selected clinicians per hospital if they were involved); and ii) purposively selected participants, based on satisfaction variation from survey results, to further explore the facilitators and barriers to service implementation and delivery. Interviews/focus groups will be conducted remotely (e.g., telephone, video conference), recorded with participant consent, and transcribed for analysis. Project documentation will be collected, and researcher field notes will also be taken throughout the trial. Economic Evaluation A cost consequences analysis will be undertaken to present disaggregated costs and outcomes of implementing the follow-up service.(36) This will clarify which costs and outcomes are most relevant to further refine the design of the service and a future effectiveness trial. Costs of providing the intervention will be estimated based on interviews with clinical leads at participating hospitals and from finance departments, where possible. The impacts of the intervention on resources used by participants will be estimated from a health sector (e.g., hospital presentations, general practitioner visits, specialist visits, outpatient visits) and societal perspective (e.g., employment, household productivity, informal care). Unit prices for resources used and productivity will be obtained from the most contemporary Australian sources. Data from participants will be self-reported, with a diary provided for the duration of the study to assist with collection of data related to health care resources utilised. This information will be supplemented by data from the follow-up service records of all referrals and service contacts for intervention participants. Medical records may also be audited to verify the data collected. Statistical and Data Analyses An independent statistician will conduct the analysis blinded to group allocation. Intention-to-treat and per protocol analyses ( participants who did not ‘drop out’ of service/withdraw or failed to attend service coordinator appointments ) will be described. Descriptive statistics will be reported for the participants’ characteristics, retention and completion of outcome measures by group allocation (intervention or control). The difference between groups for the primary outcome (completion of the feasibility trial) will be described as a difference in proportions. Other feasibility outcomes, including the proportion of intervention participants that attended the follow-up service, will be reported descriptively. We acknowledge the limitations of between and within group comparisons of effectiveness in feasibility trials and the imprecision that small samples can create (37). We will also assess within group changes to assess for minimum clinically important effects The EQ-5D-3L domains at pre-trial/baseline determined entry into the trial as people experiencing extreme health problems. We will describe the change in the proportion of participants with extreme health problems at 12 weeks between groups using the original criteria for entry into the trial. The EQ-5D-3L dimension responses will also be converted into a utility score using previously published algorithm for Australia (38). Due to the anticipated skewed distribution of continuous health outcomes measures (e.g., utility values), between-group differences will be reported as median difference. Imputation of missing data will be undertaken as necessary. Multivariable median, logistic and ordinal logistic regression models adjusted for baseline values to assess differences in health outcomes (e.g. VAS, EQ-5D-3L, LUNS, mRS) between groups. Confidence intervals will be reported for secondary health outcomes to inform discussion of the likely treatment effects of the intervention (39). Open interview/focus group transcripts, open-ended responses from the satisfaction surveys, and project documentation/field notes will be analysed using thematic and/or content analysis techniques. Both e both inductive and deductive methods may be incorporated as appropriate, within a Framework Analysis approach(40). Ongoing discussions with the research team will be used to ensure the data are being interpreted and summarised to best reflect the intended meaning. Closed questions will be summarised descriptively. Use of triangulation, involving the combination of multiple data sources, methodological approaches and analysis methods (41), will be used to ensure comprehensiveness and encourage a more reflective analysis of the trial. Discussion The multicentre, hospital-led follow-up service (A-LISTS), is to be evaluated in this feasibility trial. The aim of the intervention is to support people experiencing stroke who report extreme health problems that have been identified using routinely collected national registry data within 3–6 months of a new stroke. The proposed intervention package was co-designed ( 14 ), and should support greater engagement of hospital clinicians, primary care and community-based services. This trial will enable insights into the various contextual factors that exist in the adoption of this type of registry-based, hospital-led service for stroke. Findings will provide improved knowledge of service design and implementation barriers and facilitators, and associated costs and resource implications. The clinical health outcome data will support the calculation of potential effect sizes to inform planning a future fully powered effectiveness trial of the intervention. Trial status The trial has started but not finished recruiting when submitted to the journal. Abbreviations A-LISTS A uSCR LI fe after S troke T ailored S upport AuSCR Australian Stroke Clinical Registry EQ-5D-3L EuroQoL 5 Dimensions 3 Level Version GP General Practitioner HRQoL Health Related Quality of Life mRS Modified Rankin Scale REDCap Research Electronic Data Capture SAE Serious Adverse Events TIA Transient ischaemic attack LUNS Longer-Term Unmet Needs after Stroke Declarations Ethics approval and consent to participate The study is being conducted in accordance with the Declaration of Helsinki, and has been approved by the Austin Health Human Research Ethics Committee (HREC/89487/Austin-2022). Informed consent will be obtained from all subjects involved in the study. Consent for publication N/A. Availability of data and materials N/A. Competing Interests: DAC declares being the Data Custodian for the AuSCR. DAC, RG and MFK are members of the AuSCR Management Committee. No other authors declare any competing interests. Funding: This research was funded by the Medical Research Future Fund 2020 Cardiovascular Health Mission (Australian Government), grant number 2008668. Author Contributions: DC contributed to the study conceptualisation, methodology and study design. DC, AR and JMB contributed to the intervention design. KLB, JK, MFK, TP, KB contributed to the study design, analytic methods and writing of the first draft. All other authors contributed to the study methods or the intervention design, and review and editing of the manuscript. All authors have read and agreed to the published version of the manuscript. Acknowledgments: The authors would like to acknowledge the A-LISTS working group members and people with lived experience of stroke that helped co-design the intervention package that will be used as described in this protocol. References Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, et al. 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The statistical interpretation of pilot trials: should significance thresholds be reconsidered? BMC Med Res Methodol. 2014;14:41. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. Thurmond VA. The point of triangulation. J Nurs Scholarsh. 2001;33(3):253-8. Pagoto S, Bennett GG. How behavioral science can advance digital health. Translational Behavioral Medicine. 2013;3(3):271-6. May CR, Cummings A, Girling M, Bracher M, Mair FS, May CM, et al. Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. Implementation Science. 2018;13(1). May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, et al. Development of a theory of implementation and integration: Normalization Process Theory. Implementation Science. 2009. Tables Table 1: Primary and secondary aims and trial outcome measures Primary aims Primary Outcomes Trial feasibility Acceptability The proportion of participants that: attend the follow-up service complete the feasibility trial Participant, service coordinator and clinician satisfaction^ Satisfaction and experiences of participants and service coordinators (+/- other clinicians at participating health services) with the hospital-led follow-up service, assessed through project documentation, field notes surveys and/or interviews/focus groups Secondary aims Secondary Outcomes Potential clinical effectiveness i.e. health status Health related quality of life (EQ-5D-3L survey (19)) including change in the proportion with extreme health problems at 12-14 weeks post randomisation Also composite outcome: Extreme health problems reported on EQ-5D-3L (19) or Visual Analogue scale score 60 points or less. Unmet needs: Longer-term Unmet Needs Survey (23) Unplanned emergency department presentations and/or admissions to hospital (self-reported) Disability (modified Rankin scale (20)) Healthcare service utilisation# Use of health and community services (self-reported) Change in medications (self-reported) Cost implications of the program# Costs of intervention delivery (self-reported) Cost or cost offsets from health and community services used (self-reported) ^will be included in the process evaluation #will be included in the economic evaluation Table 2: Data collection tools for clinical, process and economic evaluation across trial timepoints Project stage Measure Measurement tool Completed by Pre-trial, Eligibility Baseline During 12-week intervention 12-14 weeks Outcome assessment Post-trial Identifying eligible participants Ongoing health problems impacting quality of life, disability/dependence, living situation* AuSCR follow-up survey including EQ-5D-3L (19), modified Rankin scale (mRs) (20) and current residence AuSCR registrant 90-180 days post-stroke X Clinical Evaluation # Quality of Life EQ-5D-3L (baseline: to verify responses from pre-trial are still current and eligibility is still met for the service) All participants in conjunction with blinded AuSCR follow-up team member X X # Disability /dependence mRS (baseline: to verify responses from pre-trial are still current and eligibility is still met for the service) Communication and fatigue (yes/no and 5-point Likert scale, respectively) X X Unmet Needs Longer-Term Unmet Needs for Stroke questionnaire (42) X X # Unplanned hospital readmissions, ED visits Survey tailored for A-LISTS trial X X # Serious Adverse Events Serious Adverse Events form specific for A-LISTS X X Health service use diary for participants Developed for trial to support recall; used as memory aid at the outcome assessment to respond to questions about current health services used All participants X Process evaluation Satisfaction & experiences with service and study participation Theory informed survey and/or semi-structured interview/focus groups Intervention participants X Satisfaction with service, including implementation features, & intervention fidelity Theory informed survey and semi-structured focus groups (43, 44) Service coordinator and clinicians X Participation numbers, recommended actions, uptake of service coordinator recommendations Template tailored for A-LISTS study; patient-level data will be aggregated Service coordinator X Project documentation Standard Operating Procedures, Minutes, Training documents, Project notes Project team, investigators X X X X X Economic Evaluation # Current health services used, medications, costs Program delivery costs Resource use questionnaire developed for trial Research (financial) documents, invoices. X X Note: *standard 90-180 days after admission Australian Stroke Clinical Registry follow-up survey; # indicates data will also be used for Economic Evaluation Abbreviations: AuSCR – Australian Stroke Clinical Registry, EQ-5D-3L – EuroQol 5 dimension 3 level survey; mRS: modified Rankin Scale Supplementary Files SPIRITCHECKLISTalists.pdf Cite Share Download PDF Status: Published Journal Publication published 30 Jul, 2024 Read the published version in Pilot and Feasibility Studies → Version 1 posted Reviewers agreed at journal 12 Mar, 2024 Reviewers invited by journal 08 Feb, 2024 Editor assigned by journal 04 Feb, 2024 First submitted to journal 05 Dec, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3708649","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":272035423,"identity":"adb4f80d-32f6-4275-a144-ef10f9acf019","order_by":0,"name":"Dominique A Cadilhac","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0001-8162-682X","institution":"Monash University","correspondingAuthor":true,"prefix":"","firstName":"Dominique","middleName":"A","lastName":"Cadilhac","suffix":""},{"id":272035424,"identity":"bd2cc2cf-7795-4d33-aed4-103249189891","order_by":1,"name":"Andrew G Ross","email":"","orcid":"","institution":"Florey Institute of Neuroscience and Mental Health - 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Bundoora Campus: La Trobe University","correspondingAuthor":false,"prefix":"","firstName":"Dana","middleName":"","lastName":"Wong","suffix":""},{"id":272035438,"identity":"0ffd6a76-76c4-4a85-a603-0af485b695ed","order_by":15,"name":"Lisa Murphy","email":"","orcid":"","institution":"Stroke Foundation Australia","correspondingAuthor":false,"prefix":"","firstName":"Lisa","middleName":"","lastName":"Murphy","suffix":""},{"id":272035439,"identity":"329976c1-4a1b-40f0-b7b1-528e4ba057e6","order_by":16,"name":"Grant Russell","email":"","orcid":"","institution":"Monash University Department of General Practice","correspondingAuthor":false,"prefix":"","firstName":"Grant","middleName":"","lastName":"Russell","suffix":""},{"id":272035440,"identity":"4bf75741-d677-446f-bf28-623ae7f1a55e","order_by":17,"name":"Mark Nelson","email":"","orcid":"","institution":"University of Tasmania Menzies Research Institute: University of Tasmania Menzies Institute for Medical Research","correspondingAuthor":false,"prefix":"","firstName":"Mark","middleName":"","lastName":"Nelson","suffix":""},{"id":272035441,"identity":"48ae4b89-131c-4610-b54e-751858977c38","order_by":18,"name":"Vincent Thijs","email":"","orcid":"","institution":"Florey Institute of Neuroscience and Mental Health - Austin Campus","correspondingAuthor":false,"prefix":"","firstName":"Vincent","middleName":"","lastName":"Thijs","suffix":""},{"id":272035442,"identity":"163ff558-e960-47ef-9b03-87c7688d76d2","order_by":19,"name":"Colin Scott","email":"","orcid":"","institution":"Stroke Association","correspondingAuthor":false,"prefix":"","firstName":"Colin","middleName":"","lastName":"Scott","suffix":""},{"id":272035443,"identity":"1d02c219-267f-42ad-9064-c5df1354b981","order_by":20,"name":"Sandy Middleton","email":"","orcid":"","institution":"St Vincent's Hospital Sydney","correspondingAuthor":false,"prefix":"","firstName":"Sandy","middleName":"","lastName":"Middleton","suffix":""}],"badges":[],"createdAt":"2023-12-05 08:24:59","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3708649/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3708649/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s40814-024-01527-y","type":"published","date":"2024-07-30T15:57:19+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":51077836,"identity":"4287a764-552f-4088-a74d-571fb2f9efac","added_by":"auto","created_at":"2024-02-13 18:51:37","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":205120,"visible":true,"origin":"","legend":"\u003cp\u003eOverview of study design\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-3708649/v1/a27771487f6f5dde172f16d5.png"},{"id":51077853,"identity":"8544ce39-1d48-428e-9bf2-826767e7f134","added_by":"auto","created_at":"2024-02-13 18:51:39","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":600283,"visible":true,"origin":"","legend":"\u003cp\u003eSummary of the recruitment and intervention pathway\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3708649/v1/2edc945d53f97575226b56be.jpeg"},{"id":61793446,"identity":"b9f49c6b-6328-46f0-a941-b76df59cfe05","added_by":"auto","created_at":"2024-08-05 16:12:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1415559,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3708649/v1/d2a3623a-afbb-4d15-a769-e7843f8a816e.pdf"},{"id":51077861,"identity":"2e78f968-208c-49f1-8e97-3268de767036","added_by":"auto","created_at":"2024-02-13 18:51:43","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":3024182,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITCHECKLISTalists.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3708649/v1/48aa8111b2a0f8d78e8cef2d.pdf"}],"financialInterests":"","formattedTitle":"Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS)","fulltext":[{"header":"Background","content":"\u003cp\u003eStroke is a leading cause of global disease burden (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). In addition to the immediate physical, cognitive and emotional injury impacts post-stroke, the long-term effects can be significant and life-altering. Approximately 25% of people with stroke report their quality of life as equivalent to, or worse than, death (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Physical disability, loss of employment, social isolation, cognitive impairment, communication difficulties, anxiety and depression make resuming home and community activities difficult (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Furthermore, compared with hospital discharges to rehabilitation or aged care, people discharged directly home are at an increased risk of an unplanned readmission within 90 days (sub-hazard ratio, 1.44 [95% CI, 1.33\u0026ndash;1.55]). (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) Further, one in five people living with stroke have no support services in place after discharge from hospital (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eData from the Australian Stroke Clinical Registry (AuSCR) describe significant impacts on people with stroke or transient ischaemic attack (TIA) between 90\u0026ndash;180 days after hospital admission (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). For example, health-related quality of life data (EQ-5D-3L EuroQoL 5 Dimensions 3 Level Version) (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) demonstrated that patients reported some or extreme problems with mobility (50%), performing self-care (30%), completing usual activities (58%), pain/discomfort (49%) and anxiety or depression (49%) (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). To help mitigate these reported problems, efforts to better integrate care across hospital and primary care settings for chronic diseases such as stroke are required.\u003c/p\u003e \u003cp\u003eEvaluation from follow-up services in other countries is promising (\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). For example, a stroke nurse navigator program in the United States reduced 30-day unplanned readmissions by 67.6% (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). In addition, several authors of different studies have reported positive findings for follow-up services delivered from 30\u0026ndash;90 days (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Although these studies suggested that 60% of people living with stroke still had a least one health problem at three-months follow-up (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e), no studies have focused on providing follow-up support after three months.\u003c/p\u003e \u003cp\u003eMore efficient and targeted approaches that include better communication between hospital specialist services and primary care providers are required for people living with stroke in Australia (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Furthermore, some stroke impacts may only become apparent post-discharge, and community-based services may lack the expertise to address stroke-related problems. To address this important gap in stroke care, we co-designed a registry-based, hospital-led tailored follow-up service with key stakeholders and people with lived experience as part of the \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eA\u003c/span\u003euSCR \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eLI\u003c/span\u003efe after \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eS\u003c/span\u003etroke \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eT\u003c/span\u003eailored \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eS\u003c/span\u003eupport (A-LISTS) study (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). The follow-up service includes an intervention package that comprises a clinical protocol and procedure manual to be used by the site service coordinators (hereafter service coordinator(s)) to tailor the support provided to the individuals identified un-met need(s) (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). The service coordinator is a nominated stroke clinician - nurse or allied health staff- who is trained in the procedures. The newly developed follow-up service intervention package was pilot tested in one urban hospital in Australia with six participants, and then refined based on feedback from the service coordinator and participants to ensure it was ready to be used in a feasibility randomised controlled trial (RCT).\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eResearch aims\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe aim of the study is to assess the feasibility (i.e. acceptability and satisfaction of service coordinators and participants), potential clinical effectiveness, participant resource utilisation and cost implications of the tailored hospital-led follow-up service for chronic stroke compared with usual care (control). \u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eStudy design \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMulticentre, registry-based, trial with a prospective, parallel, randomised controlled, two group, single blinded design (Figure 1) with an intention-to-treat analysis. The RCT has been prospectively registered with Australian New Zealand Clinical Trials Registry (ACTRN12622001015730p, 20\u003csup\u003eth\u003c/sup\u003e July 2022). \u003c/p\u003e\n\n\u003cp\u003eMethods and results will be reported in compliance with the CONSORT 2010 Statement, including the extension for randomised pilot and feasibility trials (15). A process evaluation and an economic evaluation will be conducted concurrently to the main trial, and will be reported using the relevant reporting guidelines (e.g. CHEERS checklist) (16). The study database will be created via REDCap (Research Electronic Data Capture; a secure web based data management system)(17) and will be hosted on the Florey Institute of Neuroscience and Mental Health servers under the security and information technology infrastructure of the University of Melbourne and will be protected as per industry standards. \u003c/p\u003e\n\n\u003cp\u003e[Figure 1]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy setting\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUp to six eligible and interested hospitals from a variety of settings will be identified from the network of hospitals that participate in the AuSCR (n=63 hospitals). Commencement dates will be staggered due to the timing of receiving hospital governance approvals, onboarding and training procedures. The AuSCR is a national clinical quality registry that collects prospective data on all patients from participating hospitals with a clinical diagnosis of stroke or TIA with the purpose of monitoring and improving stroke care in Australia (18). The diagnosis is confirmed by the registrant when they complete a follow-up survey at 90-180 days. Within the AuSCR, data on demographics, clinical characteristics and evidence-based therapies provided to patients during the acute admission are collected by hospital staff. Registrants are then contacted by the AuSCR Office, initially by mail to complete a follow-up health outcome survey. Where there is no response a short message service (SMS) and/or mail to the nominated next-of-kin is sent between 90-180 days post admission. The AuSCR office attempts to obtain health outcomes from all registrants unless they request no follow-up, opt out of having their personal details stored on the registry, were registered on the AuSCR over 180 days post-discharge or were known to be deceased. At the 90-180 day follow-up, registrants provide information about their living situation, and provide Health-Related Quality of Life (HRQoL) details using the EQ-5D-3L survey including the Visual Analogue Scale (VAS) (19). Functional independence is collected using the modified Rankin Scale (mRS) (20), and participants are also asked to indicate their willingness to be contacted for further research opportunities.\u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eStudy Population \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eInclusion criteria \u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants are selected from the AuSCR registrants if they:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eHave indicated a willingness to be contacted for future research at 90-180 day follow-up;\u003c/li\u003e\n\u003cli\u003eAre aged \u0026ge;18 years with a confirmed diagnosis of stroke;\u003c/li\u003e\n\u003cli\u003eAre living in the community in a private residence;\u003c/li\u003e\n\u003cli\u003eHave reported an extreme problem in at least one dimension of the EQ-5D-3L or have a score on the VAS \u0026le; 60 at 90-180 day follow-up (19); and\u003c/li\u003e\n\u003cli\u003eAre able to participate in English and provide informed consent (self-report or appropriate proxy can assist). \u003c/li\u003e\n\u003c/ul\u003e\n\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eExclusion criteria\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuSCR registrants with a TIA diagnosis will be excluded. Registrants in palliative care and/or a residential aged care facility will be excluded as they may be unlikely to survive to the end of study follow-up period (i.e. 12-14 weeks post randomisation).\u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrial Procedures\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRegistry-based participant recruitment procedure\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIdentification of eligible AuSCR registrants and recruitment will be undertaken by the Data Manager located at AuSCR Office in Melbourne, Victoria. Trained AuSCR team members will call potential participants to confirm eligibility. Consent will be obtained via mail (paper-form) or email (e-Consent; purpose-designed in the REDCap database). Baseline assessments (including demographic and clinical data) will be completed by an AuSCR team member via telephone post consent. Figure 2 outlines the recruitment pathway. A screening log will be used to capture demographic information on consenting eligible registrants and those who are not, to enable reporting of response and participation rates.\u003c/p\u003e\n\u003cp\u003e[Figure 2]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRandomisation, allocation concealment and blinding procedure\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOnce consented, the trial participants will be randomly allocated 1:1 to the intervention group or control (usual care) group. Online randomisation will occur using REDCap (17), stratified by age (\u0026lt;65, 65+ years) and sex (male, female) to ensure balance of age and sex between the two groups as these factors are associated with differences in HRQoL (21). Participants and outcome assessors (AuSCR staff) will be blinded to the group allocation. Service coordinators delivering the intervention will be unaware of participants from their hospital randomised to the control group. To avoid unblinding to group allocation, the control group will not know which group they are in. As part of the study, some participants may be contacted by a member of staff from the hospital or service that treated them for their stroke. \u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eOutcome measures\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary and secondary outcomes are listed in Table 1 for each study aim. Data collection tools and relevant timepoints of measurement for the clinical, process and economic evaluation are outlined in Table 2. \u003c/p\u003e\n\u003cp\u003e[Table 1]\u003c/p\u003e\n\u003cp\u003e[Table 2]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDescription of secondary outcome clinical effectiveness measures \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSecondary outcome measures relating to the measurement of HRQoL, unmet needs and disability are described below. \u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eHRQoL measured by EQ-5D-3L and VAS \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe EQ-5D-3L (19) is a standardised instrument developed by the EuroQol group to measure health related quality of life and is widely used internationally and by the AuSCR. It comprises five dimensions: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. The EQ-5D-3L also includes a Visual Analogue Scale (VAS). Each dimension is self-reported by participants to indicate no problems, some problems or extreme problems. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The median VAS for reported by patients post-stroke in Australia is 70 (7) and in six European populations the normative median score is 80 (22).\u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eLonger-Term Unmet Needs after Stroke (LUNS) questionnaire\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe LUNS questionnaire is a 22-item tool that reports the longer-term problems affecting the physical, psychological and social facets of people living with stroke (23). It can also be used as a tool to evaluate community service usage and whether those community services are meeting the person\u0026rsquo;s needs (22). Most studies have used the LUNS between 3-6 months post-stroke, however, it has been used up to 5-8 years following stroke (24). The LUNS is acceptable to people living with stroke and has satisfactory validity and test-retest reliability (23). \u003c/p\u003e\n\n\u003ch4\u003eModified Rankin Scale (mRS) scale\u003c/h4\u003e\n\u003cp\u003eThe mRS is a single item, global disability rating scale often used in stroke trials for assessment of patient outcomes (25). The categorical scale is as follows: 0 = No symptoms at all; 1= No significant disability despite stroke-related symptoms; 2= Stroke-related disability but remains functionally independent; 3= Functionally dependent but independently mobile; 4= Requires assistance to mobilise; 5 = Requires constant care and is bed-bound (26). For this study, the mRS outcome will be dichotomised into two groups (0 to 2 [independent] vs dependent/dead [mRS 3 to 6]).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSample size \u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUp to 100 people with stroke will be recruited (50 for intervention and 50 for control), which is consistent with recommendations for pilot and feasibility studies (27, 28). It is anticipated that each participating hospital will provide the intervention to approximately 10-15 people, with a capacity of providing the follow-up service to 1-2 intervention participants per week. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e \u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthics approval for this project has been obtained by the Austin Health Human Research Ethics Committee (HREC/89487/Austin-2022). Hospital specific governance approval will also be obtained from participating hospitals. Approval for the use of the existing AuSCR data has been obtained from the AuSCR Steering Committee, the governing body of AuSCR. \u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTreatment groups\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eIntervention\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eParticipants in the intervention group will receive the tailored follow-up service implemented over 12-weeks. The service coordinator will be provided with a tailored patient referral report (including demographic and clinical data collected from the baseline assessment). The intervention follow-up service utilises clinicians\u0026rsquo; clinical reasoning and experience to help participants navigate the hospital, community and primary care systems. This support may include linking participants to appropriate locally available services. All service coordinators will have a clinical background in stroke (e.g., stroke nurse, stroke allied health) and will receive 4-8 hours training tailored to the hospital setup. The service coordinator will conduct an initial assessment with the participant (either in-person or via telehealth; participant\u0026rsquo;s choice) to ascertain existing service usage, and how to assist the participant with their unmet needs. Through a collaborative and shared decision-making approach with the participant, the level of input required will be tailored to the participants needs. The service coordinator will then organise referrals as required and provide advice and education as necessary.\u003c/p\u003e\n\n\u003cp\u003eFollowing the initial consultation, there are six possible scenarios (Figure 2). Only existing and available services or treatments will be offered in the trial. The intervention follow-up service will be tailored to the individual participant. It does not dictate how often, or which clinicians or services will have ongoing engagement with participants over the 12-week intervention period. Participants will be asked for their permission to share information with their GP including the purposively designed A-LISTS GP letter. Depending on the participant\u0026rsquo;s age, location, needs, priorities and healthcare network we envisage that some participants may be referred to services such as allied health services (e.g., physiotherapy, occupational therapy), community rehabilitation programs and state funded community health programs (e.g., chronic disease management plan (29)). The service coordinator may also liaise with the National Disability Insurance Scheme (30), My Aged Care (31) and other stroke resources (e.g., Stroke Foundation services and information) to help participants navigate the system and provide education.\u003c/p\u003e\n\n\u003cp\u003eThere will be no charges to participants for accessing the follow-up service, although some private services participants are referred to may incur fees. As this is an embedded real-world health services trial, we are utilising existing private, public, free and online services. Research funding will not be used to cover other out-of-pocket expenses (i.e., allied health services, specialist visits). Participants will be provided with an electronic or paper diary, to record health and community care contacts and referrals including dates and reasons for health and community care visits, to assist with completing the trial outcome assessment conducted at 12-14 weeks. \u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eControl group\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eParticipants in the control group will receive their usual care (e.g., existing services or supports) in the community. They will also be provided with an electronic/paper diary to record health and community care contacts and referrals used to complete the outcome assessment conducted 12-14 weeks post randomisation. At the end of the trial, information about participants in the control group who are assessed as having ongoing high levels of unmet needs, will be passed to the hospital team, who may choose to offer follow-up within current services available to them. \u003c/p\u003e\n\n\u003ch2\u003e\u003cstrong\u003e\u003cem\u003eSafety Monitoring\u003c/em\u003e\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eOccurrence of serious adverse events (SAEs) will be documented throughout the feasibility RCT by the service coordinator and blinded outcome assessor. Relevant information will be obtained from the participant and/or proxy and hospital medical records (where possible by the service coordinator accessing the medical records). SAEs are defined as any untoward or serious medical occurrence that results in death; life-threatening incidents; hospitalisations; an event that results in new disability/incapacity; or other important medical events (32). SAEs will be sent to a neurologist who will act as the Medical Monitor (author VT) for adjudication. If they are deemed to be related to the study intervention, then a report will be submitted to the ethics committee and the local research governance office.\u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eProcess Evaluation \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe process evaluation draws on implementation evaluation theory and models including the Medical Research Council guidance for complex interventions (33) and Normalization Process Theory (34). The process evaluation includes mixed methods since qualitative data in feasibility studies helps to refine the understanding of how the intervention works, and facilitate ongoing adaptation of the intervention and evaluation design in preparation for a larger trial.(35) Data will be collected using project documentation, field notes, surveys, and interviews/focus groups as outlined below.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSatisfaction Survey:\u003c/em\u003e\u003c/strong\u003e All participants will be invited to complete an electronic/paper satisfaction survey (including open and closed questions) at the 12-14 weeks post-randomisation outcome assessment. Information on satisfaction and experience with the care received in the community will be obtained, with specific questions related to the service coordinator and follow-up service also included for those in the intervention group. The service coordinator (and any other clinicians involved in the initial consultation) will also be invited to complete a survey exploring their experience of implementing and delivering the follow-up service. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eInterviews/focus groups:\u003c/em\u003e\u003c/strong\u003e At the conclusion of the RCT, semi-structured focus groups/interviews (n=3, 6-10 in each group, with up to 30 people in total) will be undertaken with groups of: i) clinicians involved in delivery of the service (all service coordinators, and up to two other purposively selected clinicians per hospital if they were involved); and ii) purposively selected participants, based on satisfaction variation from survey results, to further explore the facilitators and barriers to service implementation and delivery. \u003c/p\u003e\n\u003cp\u003eInterviews/focus groups will be conducted remotely (e.g., telephone, video conference), recorded with participant consent, and transcribed for analysis. Project documentation will be collected, and researcher field notes will also be taken throughout the trial.\u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eEconomic Evaluation \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA cost consequences analysis will be undertaken to present disaggregated costs and outcomes of implementing the follow-up service.(36) This will clarify which costs and outcomes are most relevant to further refine the design of the service and a future effectiveness trial. Costs of providing the intervention will be estimated based on interviews with clinical leads at participating hospitals and from finance departments, where possible. The impacts of the intervention on resources used by participants will be estimated from a health sector (e.g., hospital presentations, general practitioner visits, specialist visits, outpatient visits) and societal perspective (e.g., employment, household productivity, informal care). Unit prices for resources used and productivity will be obtained from the most contemporary Australian sources. Data from participants will be self-reported, with a diary provided for the duration of the study to assist with collection of data related to health care resources utilised. This information will be supplemented by data from the follow-up service records of all referrals and service contacts for intervention participants. Medical records may also be audited to verify the data collected.\u003c/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eStatistical and Data Analyses \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAn independent statistician will conduct the analysis blinded to group allocation. Intention-to-treat and per protocol analyses (\u003cem\u003eparticipants who did not \u0026lsquo;drop out\u0026rsquo; of service/withdraw or failed to attend service coordinator appointments\u003c/em\u003e) will be described. Descriptive statistics will be reported for the participants\u0026rsquo; characteristics, retention and completion of outcome measures by group allocation (intervention or control). The difference between groups for the primary outcome (completion of the feasibility trial) will be described as a difference in proportions. Other feasibility outcomes, including the proportion of intervention participants that attended the follow-up service, will be reported descriptively.\u003c/p\u003e\n\n\u003cp\u003eWe acknowledge the limitations of between and within group comparisons of effectiveness in feasibility trials and the imprecision that small samples can create (37). We will also assess within group changes to assess for minimum clinically important effects\u003c/p\u003e\n\n\u003cp\u003eThe EQ-5D-3L domains at pre-trial/baseline determined entry into the trial as people experiencing extreme health problems. We will describe the change in the proportion of participants with extreme health problems at 12 weeks between groups using the original criteria for entry into the trial. The EQ-5D-3L dimension responses will also be converted into a utility score using previously published algorithm for Australia (38). Due to the anticipated skewed distribution of continuous health outcomes measures (e.g., utility values), between-group differences will be reported as median difference. Imputation of missing data will be undertaken as necessary. Multivariable median, logistic and ordinal logistic regression models adjusted for baseline values to assess differences in health outcomes (e.g. VAS, EQ-5D-3L, LUNS, mRS) between groups. Confidence intervals will be reported for secondary health outcomes to inform discussion of the likely treatment effects of the intervention (39). \u003c/p\u003e\n\n\u003cp\u003eOpen interview/focus group transcripts, open-ended responses from the satisfaction surveys, and project documentation/field notes will be analysed using thematic and/or content analysis techniques. Both e both inductive and deductive methods may be incorporated as appropriate, within a Framework Analysis approach(40). Ongoing discussions with the research team will be used to ensure the data are being interpreted and summarised to best reflect the intended meaning. Closed questions will be summarised descriptively. Use of triangulation, involving the combination of multiple data sources, methodological approaches and analysis methods (41), will be used to ensure comprehensiveness and encourage a more reflective analysis of the trial. \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe multicentre, hospital-led follow-up service (A-LISTS), is to be evaluated in this feasibility trial. The aim of the intervention is to support people experiencing stroke who report extreme health problems that have been identified using routinely collected national registry data within 3\u0026ndash;6 months of a new stroke. The proposed intervention package was co-designed (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), and should support greater engagement of hospital clinicians, primary care and community-based services. This trial will enable insights into the various contextual factors that exist in the adoption of this type of registry-based, hospital-led service for stroke. Findings will provide improved knowledge of service design and implementation barriers and facilitators, and associated costs and resource implications. The clinical health outcome data will support the calculation of potential effect sizes to inform planning a future fully powered effectiveness trial of the intervention.\u003c/p\u003e \u003cdiv id=\"Sec27\" class=\"Section2\"\u003e \u003ch2\u003eTrial status\u003c/h2\u003e \u003cp\u003eThe trial has started but not finished recruiting when submitted to the journal.\u003c/p\u003e \u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eA-LISTS \u003cu\u003eA\u003c/u\u003euSCR \u003cu\u003eLI\u003c/u\u003efe after \u003cu\u003eS\u003c/u\u003etroke \u003cu\u003eT\u003c/u\u003eailored \u003cu\u003eS\u003c/u\u003eupport\u003c/p\u003e\n\u003cp\u003eAuSCR Australian Stroke Clinical Registry\u003c/p\u003e\n\u003cp\u003eEQ-5D-3L EuroQoL 5 Dimensions 3 Level Version\u003c/p\u003e\n\u003cp\u003eGP General Practitioner \u003c/p\u003e\n\u003cp\u003eHRQoL Health Related Quality of Life\u003c/p\u003e\n\u003cp\u003emRS Modified Rankin Scale\u003c/p\u003e\n\u003cp\u003eREDCap Research Electronic Data Capture\u003c/p\u003e\n\u003cp\u003eSAE Serious Adverse Events\u003c/p\u003e\n\u003cp\u003eTIA Transient ischaemic attack\u003c/p\u003e\n\u003cp\u003eLUNS Longer-Term Unmet Needs after Stroke\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study is being conducted in accordance with the Declaration of Helsinki, and has been approved by the Austin Health Human Research Ethics Committee (HREC/89487/Austin-2022). Informed consent will be obtained from all subjects involved in the study.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eN/A.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eN/A.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests:\u003c/strong\u003e DAC declares being the Data Custodian for the AuSCR. DAC, RG and MFK are members of the AuSCR Management Committee. No other authors declare any competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e This research was funded by the Medical Research Future Fund 2020 Cardiovascular Health Mission (Australian Government), grant number 2008668.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u003c/strong\u003e DC contributed to the study conceptualisation, methodology and study design. DC, AR and JMB contributed to the intervention design. KLB, JK, MFK, TP, KB contributed to the study design, analytic methods and writing of the first draft. All other authors contributed to the study methods or the intervention design, and review and editing of the manuscript. All authors have read and agreed to the published version of the manuscript. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u003c/strong\u003e The authors would like to acknowledge the A-LISTS working group members and people with lived experience of stroke that helped co-design the intervention package that will be used as described in this protocol.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eFeigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, et al. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76.\u003c/li\u003e\n\u003cli\u003eSturm JW, Donnan GA, Dewey HM, Macdonell RA, Gilligan AK, Srikanth V, et al. Quality of life after stroke: the North East Melbourne Stroke Incidence Study (NEMESIS). Stroke. 2004;35(10):2340-5.\u003c/li\u003e\n\u003cli\u003eAndrew N, Kilkenny M, Naylor R, Purvis T, Lalor E, Moloczij N, et al. Understanding long-term unmet needs in Australian survivors of stroke. Int J Stroke. 2014;DOI: 10.1111/ijs.12325.\u003c/li\u003e\n\u003cli\u003eKilkenny MF, Dalli LL, Kim J, Sundararajan V, Andrew NE, Dewey HM, et al. Factors Associated With 90-Day Readmission After Stroke or Transient Ischemic Attack: Linked Data From the Australian Stroke Clinical Registry. Stroke. 2020;51(2):571-8.\u003c/li\u003e\n\u003cli\u003eKilkenny MF, Kim J, Andrew NE, Sundararajan V, Thrift AG, Katzenellenbogen JM, et al. Maximising data value and avoiding data waste: a validation study in stroke research. Med J Aust. 2019;210(1):27-31.\u003c/li\u003e\n\u003cli\u003eAndrew NE, Kim J, Cadilhac DA, Sundararajan V, Thrift AG, Churilov L, et al. Protocol for evaluation of enhanced models of primary care in the management of stroke and other chronic disease (PRECISE): A data linkage healthcare evaluation study. International Journal of Population Data Science,. 2019;4(1):1-14 \u003c/li\u003e\n\u003cli\u003eCadilhac DA, Dalli LL, Morrison JL, Lester M, Paice K, Moss K, et al. The Australian Stroke Clinical Registry Annual Report 2020. 2021.\u003c/li\u003e\n\u003cli\u003eBridgwood B, Lager KE, Mistri AK, Khunti K, Wilson AD, Modi P. Interventions for improving modifiable risk factor control in the secondary prevention of stroke. Cochrane Database Syst Rev. 2018;5:CD009103.\u003c/li\u003e\n\u003cli\u003eLawn S, Zabeen S, Smith D, Wilson E, Miller C, Battersby M, et al. Managing chronic conditions care across primary care and hospital systems: lessons from an Australian Hospital Avoidance Risk Program using the Flinders Chronic Condition Management Program. Aust Health Rev. 2018;42(5):542-9.\u003c/li\u003e\n\u003cli\u003eJun-O\u0026apos;Connell AH, Grigoriciuc E, Gulati A, Silver B, Kobayashi KJ, Moonis M, et al. Stroke nurse navigator utilization reduces unplanned 30-day readmission in stroke patients treated with thrombolysis. Front Neurol. 2023;14:1205487.\u003c/li\u003e\n\u003cli\u003eAmatya B, Elmalik A, Lee SY, Song K, Galea M, Khan F. A process evaluation of patient care needs using the Post-Stroke Checklist: A prospective study. J Rehabil Med. 2022;54:jrm00259.\u003c/li\u003e\n\u003cli\u003ePugh JD, McCoy K, Needham M, Jiang L, Giles M, McKinnon E, et al. Evaluation of an Australian neurological nurse-led model of postdischarge care. Health \u0026amp; social care in the community. 2022;30(4):e962-e73.\u003c/li\u003e\n\u003cli\u003eWissel J, Olver J, Sunnerhagen KS. Navigating the poststroke continuum of care. J Stroke Cerebrovasc Dis. 2013;22(1):1-8.\u003c/li\u003e\n\u003cli\u003eRoss A BJ, Barclay-Moss K, Purvis T, Frost T, Wong D, Hillier S, Kim J, Cranefield J, Jaques K, Nelson M R, Russell G, Grindon-Ekins K, Scott C, Murphy L, Bagot K, Kilkenny M F, Kleinig T J, Grimley R, Middleton S, Thijs V, Cadilhac D. Co-design of a tailored follow-up intervention package for people living with stroke who report extreme unmet needs: a two stage, four-round modified Delphi study. Int J Stroke. 2023;Vol. 18(2S) Abstract 29:19.\u003c/li\u003e\n\u003cli\u003eEldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016;2:64.\u003c/li\u003e\n\u003cli\u003eHusereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Bmj. 2022;376:e067975.\u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-81.\u003c/li\u003e\n\u003cli\u003eCadilhac DA, Lannin NA, Anderson CS, Levi CR, Faux S, Price C, et al. Protocol and pilot data for establishing the Australian Stroke Clinical Registry. Int J Stroke. 2010;5(3):217-26.\u003c/li\u003e\n\u003cli\u003eEuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199-208.\u003c/li\u003e\n\u003cli\u003evan Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19(5):604-7.\u003c/li\u003e\n\u003cli\u003ePhan HT, Gall SL, Blizzard CL, Lannin NA, Thrift AG, Anderson CS, et al. Sex differences in quality of life after stroke were explained by patient factors, not clinical care: evidence from the Australian Stroke Clinical Registry. Eur J Neurol. 2021;28(2):469-78.\u003c/li\u003e\n\u003cli\u003eJanssen MF, Pickard AS, Shaw JW. General population normative data for the EQ-5D-3L in the five largest European economies. Eur J Health Econ. 2021;22(9):1467-75.\u003c/li\u003e\n\u003cli\u003eLoTS care LUNS study team. Validation of the longer-term unmet needs after stroke (LUNS) monitoring tool: a multicentre study. Clin Rehabil. 2013;27(11):1020-8.\u003c/li\u003e\n\u003cli\u003eChen T, Zhang B, Deng Y, Fan J-C, Zhang L, Song F. Long-Term unmet needs after stroke: Systematic review of evidence from survey studies. BMJ Open. 2019;9:e028137.\u003c/li\u003e\n\u003cli\u003eWilson A, Bath PM, Berge E, Cadilhac DA, Cuche M, Ford GA, et al. Understanding the relationship between costs and the modified Rankin Scale: a systematic review, multidisciplinary consensus and recommendations for future studies. Eur Stroke J. 2017;2(1):3-12.\u003c/li\u003e\n\u003cli\u003eSaver JL, Chaisinanunkul N, Campbell BCV, Grotta JC, Hill MD, Khatri P, et al. Standardized Nomenclature for Modified Rankin Scale Global Disability Outcomes: Consensus Recommendations From Stroke Therapy Academic Industry Roundtable XI. Stroke. 2021;52(9):3054-62.\u003c/li\u003e\n\u003cli\u003eJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4:287-91.\u003c/li\u003e\n\u003cli\u003eWhitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25(3):1057-73.\u003c/li\u003e\n\u003cli\u003eThe Department of Health and Aged Care. Chronic Disease Management Patient Information 2023 [Available from: https://www1.health.gov.au/internet/main/publishing.nsf/Content/mbsprimarycare-chronicdisease-pdf-infosheet.\u003c/li\u003e\n\u003cli\u003eNational Disability Insurance Scheme 2023 [Available from: https://www.ndis.gov.au/.\u003c/li\u003e\n\u003cli\u003eMy Aged Care 2023 [Available from: https://www.myagedcare.gov.au/].\u003c/li\u003e\n\u003cli\u003eCook D, Lauzier F, Rocha MG, Sayles MJ, Finfer S. Serious adverse events in academic critical care research. Cmaj. 2008;178(9):1181-4.\u003c/li\u003e\n\u003cli\u003eMoore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258.\u003c/li\u003e\n\u003cli\u003eMurray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC medicine. 2010;8:1-11.\u003c/li\u003e\n\u003cli\u003eO\u0026apos;Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015;1:32.\u003c/li\u003e\n\u003cli\u003eMauskopf JA, Paul JE, Grant DM, Stergachis A. The role of cost-consequence analysis in healthcare decision-making. Pharmacoeconomics. 1998;13(3):277-88.\u003c/li\u003e\n\u003cli\u003eSim J. Should treatment effects be estimated in pilot and feasibility studies? Pilot Feasibility Stud. 2019;5:107.\u003c/li\u003e\n\u003cli\u003ePhan HT, Gall SL, Blizzard CL, Lannin NA, Thrift AG, Anderson CS, et al. Sex differences in quality of life after stroke were explained by patient factors, not clinical care: evidence from the Australian Stroke Clinical Registry. Eur J Neurol. 2021;28(2):469-78.\u003c/li\u003e\n\u003cli\u003eLee EC, Whitehead AL, Jacques RM, Julious SA. The statistical interpretation of pilot trials: should significance thresholds be reconsidered? BMC Med Res Methodol. 2014;14:41.\u003c/li\u003e\n\u003cli\u003eGale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117.\u003c/li\u003e\n\u003cli\u003eThurmond VA. The point of triangulation. J Nurs Scholarsh. 2001;33(3):253-8.\u003c/li\u003e\n\u003cli\u003ePagoto S, Bennett GG. How behavioral science can advance digital health. Translational Behavioral Medicine. 2013;3(3):271-6.\u003c/li\u003e\n\u003cli\u003eMay CR, Cummings A, Girling M, Bracher M, Mair FS, May CM, et al. Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. Implementation Science. 2018;13(1).\u003c/li\u003e\n\u003cli\u003eMay CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, et al. Development of a theory of implementation and integration: Normalization Process Theory. Implementation Science. 2009.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable 1:\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ePrimary and secondary aims and trial outcome measures\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"41.506410256410255%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary aims\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"58.493589743589745%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary Outcomes\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eTrial feasibility\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"41.506410256410255%\" valign=\"top\"\u003e\n \u003cp\u003eAcceptability\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"58.493589743589745%\" valign=\"top\"\u003e\n \u003cp\u003eThe proportion of participants that:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eattend the follow-up service\u003c/li\u003e\n \u003cli\u003ecomplete the feasibility trial\u0026nbsp;\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"41.506410256410255%\" valign=\"top\"\u003e\n \u003cp\u003eParticipant, service coordinator and clinician satisfaction^\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"58.493589743589745%\" valign=\"top\"\u003e\n \u003cp\u003eSatisfaction and experiences of participants and service coordinators (+/- other clinicians at participating health services) with the hospital-led follow-up service, assessed through project documentation, field notes surveys and/or interviews/focus groups\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"41.506410256410255%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecondary aims\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"58.493589743589745%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecondary Outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"41.506410256410255%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003ePotential clinical effectiveness i.e. health status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"58.493589743589745%\" valign=\"top\"\u003e\n \u003cp\u003eHealth related quality of life (EQ-5D-3L survey\u0026nbsp;(19)) including change in the proportion with extreme health problems at 12-14 weeks post randomisation Also composite outcome: Extreme health problems reported on EQ-5D-3L\u0026nbsp;(19)\u0026nbsp;or Visual Analogue scale score 60 points or less.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" valign=\"top\"\u003e\n \u003cp\u003eUnmet needs: Longer-term Unmet Needs Survey (23)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" valign=\"top\"\u003e\n \u003cp\u003eUnplanned emergency department presentations and/or admissions to hospital (self-reported)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" valign=\"top\"\u003e\n \u003cp\u003eDisability (modified Rankin scale\u0026nbsp;(20))\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"41.506410256410255%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eHealthcare service utilisation#\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"58.493589743589745%\" valign=\"top\"\u003e\n \u003cp\u003eUse of health and community services (self-reported)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" valign=\"top\"\u003e\n \u003cp\u003eChange in medications (self-reported)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"41.506410256410255%\" valign=\"top\"\u003e\n \u003cp\u003eCost implications of the program#\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"58.493589743589745%\" valign=\"top\"\u003e\n \u003cp\u003eCosts of intervention delivery (self-reported)\u003c/p\u003e\n \u003cp\u003eCost or cost offsets from health and community services used (self-reported)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e^will be included in the process evaluation\u003c/p\u003e\n\u003cp\u003e#will be included in the economic evaluation\u003cstrong\u003e\u003cbr\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2:\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eData collection tools for clinical, process and economic evaluation across trial timepoints\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"935\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.081196581196581%\"\u003e\n \u003cp\u003e\u003cstrong\u003eProject stage\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.316239316239317%\"\u003e\n \u003cp\u003e\u003cstrong\u003eMeasure\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.94017094017094%\"\u003e\n \u003cp\u003e\u003cstrong\u003eMeasurement tool\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCompleted by\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.081196581196581%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePre-trial, Eligibility\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.11965811965812%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBaseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.683760683760683%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDuring 12-week intervention\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003e12-14 weeks Outcome assessment\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePost-trial\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.081196581196581%\"\u003e\n \u003cp\u003eIdentifying eligible participants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.316239316239317%\" valign=\"top\"\u003e\n \u003cp\u003eOngoing health problems impacting quality of life, disability/dependence, living situation*\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.94017094017094%\" valign=\"top\"\u003e\n \u003cp\u003eAuSCR follow-up survey including\u0026nbsp;EQ-5D-3L\u0026nbsp;(19), modified Rankin scale (mRs)\u0026nbsp;(20)\u0026nbsp;and current residence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003eAuSCR registrant 90-180 days post-stroke\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.081196581196581%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.11965811965812%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.683760683760683%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.081196581196581%\" rowspan=\"6\"\u003e\n \u003cp\u003eClinical Evaluation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.316239316239317%\" valign=\"top\"\u003e\n \u003cp\u003e# Quality of Life\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.94017094017094%\" valign=\"top\"\u003e\n \u003cp\u003eEQ-5D-3L (baseline:\u0026nbsp;to verify responses from pre-trial are still current and eligibility is still met for the service)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" rowspan=\"5\"\u003e\n \u003cp\u003eAll participants in conjunction with blinded AuSCR follow-up team member\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.081196581196581%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.11965811965812%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.683760683760683%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.9384203480589%\" valign=\"top\"\u003e\n \u003cp\u003e# Disability /dependence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.238286479250334%\" valign=\"top\"\u003e\n \u003cp\u003emRS (baseline:\u0026nbsp;to verify responses from pre-trial are still current and eligibility is still met for the service)\u003c/p\u003e\n \u003cp\u003eCommunication and fatigue (yes/no and 5-point Likert scale, respectively)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.378848728246318%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.174029451137885%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.386880856760374%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.9384203480589%\" valign=\"top\"\u003e\n \u003cp\u003eUnmet Needs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.238286479250334%\" valign=\"top\"\u003e\n \u003cp\u003eLonger-Term Unmet Needs for Stroke questionnaire\u0026nbsp;(42)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.378848728246318%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.174029451137885%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.386880856760374%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.9384203480589%\" valign=\"top\"\u003e\n \u003cp\u003e# Unplanned hospital readmissions, ED visits\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.238286479250334%\" valign=\"top\"\u003e\n \u003cp\u003eSurvey tailored for A-LISTS trial\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.378848728246318%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.174029451137885%\"\u003e\n \u003cp\u003e\u0026nbsp;X\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.386880856760374%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.9384203480589%\" valign=\"top\"\u003e\n \u003cp\u003e# Serious Adverse Events\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.238286479250334%\" valign=\"top\"\u003e\n \u003cp\u003eSerious Adverse Events form specific for A-LISTS\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.378848728246318%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.174029451137885%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.386880856760374%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.441767068273093%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.746180963572268%\" valign=\"top\"\u003e\n \u003cp\u003eHealth service use diary for participants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.031727379553466%\" valign=\"top\"\u003e\n \u003cp\u003eDeveloped for trial to support recall; used as memory aid at the outcome assessment to respond to questions about current health services used\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.220916568742656%\" valign=\"top\"\u003e\n \u003cp\u003eAll participants\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.988249118683902%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.930669800235018%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.750881316098708%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.081196581196581%\" rowspan=\"4\"\u003e\n \u003cp\u003eProcess evaluation\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.316239316239317%\" valign=\"top\"\u003e\n \u003cp\u003eSatisfaction \u0026amp; experiences with service and study participation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.94017094017094%\" valign=\"top\"\u003e\n \u003cp\u003eTheory informed survey and/or semi-structured interview/focus groups\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003eIntervention participants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.081196581196581%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.11965811965812%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.683760683760683%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.746180963572268%\" valign=\"top\"\u003e\n \u003cp\u003eSatisfaction with service, including implementation features, \u0026amp; intervention fidelity\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.031727379553466%\" valign=\"top\"\u003e\n \u003cp\u003eTheory informed survey and semi-structured focus groups\u0026nbsp;(43, 44)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.220916568742656%\" valign=\"top\"\u003e\n \u003cp\u003eService coordinator and clinicians\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.988249118683902%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.930669800235018%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.750881316098708%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.746180963572268%\" valign=\"top\"\u003e\n \u003cp\u003eParticipation numbers, recommended actions, uptake of service coordinator recommendations\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.031727379553466%\" valign=\"top\"\u003e\n \u003cp\u003eTemplate tailored for A-LISTS study; patient-level data will be aggregated\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.220916568742656%\" valign=\"top\"\u003e\n \u003cp\u003eService coordinator\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.988249118683902%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.930669800235018%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.750881316098708%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.746180963572268%\" valign=\"top\"\u003e\n \u003cp\u003eProject documentation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.031727379553466%\" valign=\"top\"\u003e\n \u003cp\u003eStandard Operating Procedures, Minutes, Training documents, Project notes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.220916568742656%\" valign=\"top\"\u003e\n \u003cp\u003eProject team, investigators\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.988249118683902%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.930669800235018%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.750881316098708%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.165687426556993%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.081196581196581%\" valign=\"top\"\u003e\n \u003cp\u003eEconomic Evaluation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.316239316239317%\" valign=\"top\"\u003e\n \u003cp\u003e# Current health services used, medications, costs\u003c/p\u003e\n \u003cp\u003eProgram delivery costs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.94017094017094%\" valign=\"top\"\u003e\n \u003cp\u003eResource use questionnaire developed for trial\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eResearch (financial) documents, invoices.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.081196581196581%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.11965811965812%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.683760683760683%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eNote: *standard 90-180 days after admission Australian Stroke Clinical Registry follow-up survey; # indicates data will also be used for Economic Evaluation\u003c/p\u003e\n\u003cp\u003eAbbreviations: AuSCR \u0026ndash; Australian Stroke Clinical Registry, EQ-5D-3L \u0026ndash; EuroQol 5 dimension 3 level survey; mRS: modified Rankin Scale\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Stroke, Clinical Trial Protocol, Follow-up Service","lastPublishedDoi":"10.21203/rs.3.rs-3708649/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3708649/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eStroke affects long-term physical and cognitive function; many survivors report unmet health needs, such as pain or depression. A hospital-led follow-up service designed to address ongoing health problems may avoid unplanned readmissions and improve quality of life.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis paper outlines the protocol for a registry-based, single-blind, randomised controlled trial. Based on an intention-to-treat analysis, we will evaluate the feasibility, acceptability, potential effectiveness, and cost implications of a new tailored, co-designed, hospital-led follow-up service for people within 6\u0026ndash;12 months of stroke. Participants (n\u0026thinsp;=\u0026thinsp;100) from the Australian Stroke Clinical Registry who report extreme health problems on the EQ5D-3L between 90\u0026ndash;180 days after stroke will be randomly assigned (1:1) to intervention (follow-up service) or control (usual care) groups. All participants will be independently assessed at baseline and 12\u0026ndash;14 weeks post-randomisation. Primary outcomes are the proportion of participants: receiving follow-up services; complete ng the trial; and reporting satisfaction (clinicians and participants). Secondary outcomes include: extreme health problems (EuroQoL 5 Dimensions 3 Level Version), unmet needs (Longer-term Unmet Needs questionnaire), unplanned presentations and hospital readmission, functional independence (modified Rankin scale), and health service utilisation. To inform future research or implementation, the design contains a process evaluation including clinical protocol fidelity and an economic evaluation.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThe results of this study will provide improved knowledge of service design and implementation barriers and facilitators, and associated costs and resource implications and inform a future fully powered effectiveness trial of the intervention.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eACTRN12622001015730pr\u003c/p\u003e","manuscriptTitle":"Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-13 18:51:20","doi":"10.21203/rs.3.rs-3708649/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2024-03-12T22:09:13+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-02-08T14:43:16+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-02-05T03:47:59+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2023-12-05T17:25:23+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"93805c31-19ed-474d-add5-cd4be38b3cc2","owner":[],"postedDate":"February 13th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-08-05T16:01:43+00:00","versionOfRecord":{"articleIdentity":"rs-3708649","link":"https://doi.org/10.1186/s40814-024-01527-y","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2024-07-30 15:57:19","publishedOnDateReadable":"July 30th, 2024"},"versionCreatedAt":"2024-02-13 18:51:20","video":"","vorDoi":"10.1186/s40814-024-01527-y","vorDoiUrl":"https://doi.org/10.1186/s40814-024-01527-y","workflowStages":[]},"version":"v1","identity":"rs-3708649","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3708649","identity":"rs-3708649","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}