Development of a survey instrument to measure patient experiences of care transitions from hospital to home with a focus on primary care’s role

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Care transitions (CTs) from acute care to primary care are an important focus for improvement. Primary care plays a significant role in supporting successful CTs. However, there are few validated patient-reported experience measures (PREMs) on this topic. The purpose of this study is to develop a PREM to capture patients’ experiences of care while transitioning from acute to primary care. Methods. A preliminary instrument was developed through a literature review and concept mapping, followed by content validity testing with content experts (n = 6) by calculating item content validity index (I-CVI) scores and with patients (n = 6) by conducting cognitive interviews. The instrument was modified based on triangulation of results, then underwent a participant validation exercise (patients, n = 6) and formal health literacy review. Results. The literature review identified 13 potentially relevant PREM instruments, of which three addressed both CTs and primary care. None of the 3 instruments completely captured the concepts or time points of interest. The PREM developed for pre-testing contained 18 core items. All core items had I-CVI scores >0.78 (i.e., high relevance). Four broad themes were identified from the cognitive interviews: ‘Health Literacy’ ( n = 10), ‘Clarity of Terms’ ( n = 7), ‘Concept Measurement’ ( n = 2), and ‘Ability to Comment’ ( n = 4). Minor wording changes and clarification of definitions and instructions addressed most themes. All 18 core items met the criterion for agreement ( > 67%) during the participant validation exercise. Therefore, the final PREM instrument contains 18 core items plus 4 open-text options. The comparison of results from the participant validation exercise and health literacy review confirmed justification for revisions of instrument items. Conclusion. Developing this new PREM instrument which captures patient’ experiences as they move between acute and primary care, with a focus primary care’s supporting role is key to gaining understanding and improving CTs. Future research will further examine the psychometric properties of this PREM as part of a larger ongoing study. Health care quality access and evaluation Continuity of patient care Measure development Patient experience Care transitions Cognitive interviews Figures Figure 1 Background Healthcare quality evaluation and improvement has been a focus of health services research for decades (1,2). In their seminal framework, the Institute of Medicine (IOM) articulates six domains of quality to guide improvement efforts (safety, effectiveness, patient-centredness, timeliness, efficiency, and equity) (3). Patient-centredness has been gaining recognition as a pivotal aspect of healthcare policy and programing to improve healthcare quality (4,5). For the past 20 years, research has been gaining momentum to develop instruments to help measure aspects of patient-centredness in order to guide meaningful improvements in healthcare (4). Patient-reported experience measures (PREMs) are instruments that capture patients’ perspectives of what happened when they received care and how it happened; and are necessary metrics to gain insights into patient-centredness (4,6,7). The importance of evaluating patient experience has been exemplified by numerous countries (e.g., United Kingdom, Australia, China, and the United States) mandating the measurement and reporting of patient experience using PREM instruments (4). Through this quantification, research has shown that improved patient experience has consistent positive associations with other domains of quality (i.e., safety and effectiveness) (5). With the proliferation of PREM instruments and the growing body of evidence positively associating patient experience with other domains of quality (4,5), it is important to shift focus to developing validated instruments in priority areas for improvement. An important focus of evaluation for patient-centred quality improvement is the experiences of patients with complex chronic health conditions during care transitions (CTs) from acute care to primary care. Patients living with chronic health conditions are at risk for adverse events such as medication errors and rehospitalization due to poor discharge coordination and care integration across settings and are at greater risk during the period between hospital discharge and primary care follow-up (8–13). Studies examining the impact of timely follow-up with primary care following a patient’s acute care stay have found reductions in readmission rates and mortality (14–17). Therefore, timely primary care follow-up after discharge is important to improve the overall transition process. Understanding patients’ experiences during these critical transition time points is key to provide evidence to inform system improvements with the potential to improve patient outcomes (18). To date, most PREMs for CTs that exist focus on one time point, i.e., the transition from hospital to home and preparing patients for this transition while in hospital. They do not focus on continuity of care and primary care’s role in a patient’s transition back to the community (e.g., “While I was in hospital, staff helped me to prepare for things that I might find difficult when I go back home...” (19)). Further, although tools have recently been developed that examine patient experiences in the community (20), these tend to focus on care integration solely in this setting rather than across critical transition time points as a patient returns home after a hospital stay. A foundational component of primary care is coordinating care for patients across the care continuum and they are the main team which integrates care into the community after hospital discharge (21,22). Therefore, there is a need to establish a PREM to capture patient experiences throughout the transition process from acute to primary care. The availability of such an instrument will help researchers and policymakers gain important insights into how primary care currently supports transitions across the continuum of care in order to guide improvement strategies. An ongoing research program in Alberta, Canada called A DiseAse-Inclusive Pathway for Transitions in Care (ADAPT) focuses on integrating care by collaborating with primary care providers to enhance CTs for those with complex chronic health conditions. Alberta Health Service’s (AHS) Primary Health Care Integration Network (PHCIN) has been leading the development of the Home to Hospital to Home (H2H2H) Transitions Guideline for several years (23). The ADAPT project is an initiative to support the implementation of key H2H2H guideline elements (23). A major aspect of this initiative is evaluating how patients experience transitions from hospital to home. The purpose of the current study was to develop a PREM to capture patient experiences as they transition from acute to primary care (i.e., when preparing to leave hospital, after leaving hospital but before follow-up with primary care, and during primary care follow-up), and provide evidence for the instrument’s content validity prior to further psychometric testing within the context of the ADAPT project. Methods Our methods included a literature review and concept mapping to develop a preliminary instrument, then content validity testing with content experts by calculating item content validity index (I-CVI) scores (24) and with patients by conducting cognitive interviews (25,26). After modifications of the instrument were made based on the triangulation of results from the cognitive interviews and I-CVI scores, a participant validation exercise (i.e., member checking) with patients was conducted(27). Finally, the PREM underwent a formal health literacy review within AHS and recommendations from this review were compared with the results of the participant validation exercise. Implied consent was used for content experts. Informed consent was received from all patients before completing any interviews. This study received approval from the University of Alberta Health Research Ethics Board (ID: Pro0010674). Literature Review and Concept Mapping Our first step to develop a PREM that captured patient experiences across the care continuum from hospital to home was to conduct an updated literature review to identify previously validated PREM instruments for CTs. We used the results from a systematic review to identify and critically appraise PREMs for measuring transitional patient safety by van Melle et al. (2018) (28) to inform our strategy to identify current validated PREM instruments relevant to CTs. Using the PREMs identified by these authors, we used Google Scholar and Google Advanced to conduct a snowball search of peer-reviewed and grey literature to find any other potentially relevant PREMs published by research groups or organizations (e.g., Canadian Institute for Health Information, National Health Service, or Health Quality Ontario). Search criteria included instruments relevant to the adult population, CTs, and primary care. Available instruments were examined and considered for inclusion if they contained items that addressed both CTs and primary care. The items of each included instrument were mapped according to their stated conceptual domains (e.g., ‘confidence in care management’ and ‘information transfer’). Next, through research team discussions, decisions were made as to which domains and items were relevant to the ADAPT project and logic model outcomes (i.e., concepts of interest): self-efficacy, patient knowledge, care aligned with patient preferences, patient safety, integration/coordination, overall experience, as well as three experience time points of interest: when preparing to leave hospital, after leaving hospital but before follow-up with primary care, and primary care follow-up. After rounds of iterative refinement, we mapped included items according to logic model outcomes as well as how the item was derived (i.e., adapted from a previously validated PREM [if so which instrument] or developed de novo). Content Validity Testing We used the Cognitive Interviewing Reporting Framework (29) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) (30) to inform our process and report our work. Content validity is considered the most important aspect for instrument pre-testing because it should be clear that the content of a measurement instrument is relevant, comprehensive, and comprehensible in regard to the concepts of interest, as well as to the target population (28,30). To help establish the content validity of a PREM, and ensure items are relevant to providers (as well as patients), we collected structured feedback from content experts on the draft PREM instrument (19,31,32). This was conducted electronically and anonymously using the Research Electronic Data Capture (REDCap) secure online platform for building and managing online surveys (33) through the AHS licensing agreement. We asked content experts to rate each item according to its perceived relevance on a 4-point ordinal scale (1 = not relevant, 2 = somewhat relevant, 3 = quite relevant, and 4 = highly relevant). This scale was used in order to calculate an I-CVI score to determine if there was an adequate level of content validity (24). Responses to each item were binary coded as not or somewhat relevant = 0, and quite or highly relevant = 1. An I-CVI score was calculated for each item as the number of experts scoring 1 relative to the total number of experts. Items that score > 0.78 were retained for the next step in pre-testing, as this provides evidence of good content validity (24). Further, content experts were given the opportunity to provide suggestions for edits or changes to wording to help increase clarity. Analyses were performed using Microsoft ExcelÔ for Mac. Content experts were recruited through the research team’s existing professional networks. Eligibility criteria included five or more years of experience in a relevant field to primary care (in a clinical, research, and/or administrative setting) and willing to participate. Sample size requirements were informed by Polit et al. (2007) (24). Concurrent to content validity testing with content experts, further pre-testing for content and face validity was conducted using cognitive interviewing with a sample of patient representatives and caregivers (i.e., patient advisors). Cognitive interviewing has become the most common method and current standard for PREM pre-testing because it deeply explores how patient participants understand and answer items (25,31,34–38). All interviews were conducted using a semi-structured interview guide. We used “think aloud” and “verbal probing” techniques to gain a better understanding of the meaningfulness of the PREM items to patients (i.e., to determine if the question is measuring the intended concept), as well as the cognitive process a person uses to answer questions, including comprehension of the question, retrieval of relevant information from memory, and judgement (25,35,38). The interview guide was developed, based on examples found in the literature (31,38) and can be found in an online supplement ( Additional File 1 ). Patient advisors were recruited through email advertisements sent to the Virtual Patient Engagement Network in Alberta. Eligibility criteria included 18 years of age or older, patient and/or caregiver of a patient with one or more chronic health conditions and a hospital stay (non-elective) within the past 24 months, and willing to participate. Sample size requirements were informed by Peterson et al. (2017) (25). We used inductive content analysis to analyze the interview data (39). All interviews were recorded and transcribed. Two reviewers (SF and JC) conducted a collaborative analysis to aggregate the results (26). Following a period of data familiarization, reviewers met to begin identifying and assigning codes to the data and collaboratively develop a codebook. Reviewers first conducted within interview analyses, followed by across interview analyses (26). Codes were assigned to summarize and describe responses, then codes were grouped into within item themes and broad themes to reflect main issues described by participants. Codes from each interview were entered into a master Microsoft Word document and listed under the item the coded response applied to. There was also a general category to reflect issues that did not relate to a specific item (e.g., layout or instructions). To be considered a theme, the code needed to be reflected in two or more participant interviews. The master document was iteratively examined by reviewers for themes. Results from the content expert review and patient advisor cognitive interviews were triangulated to inform revisions of the PREM instrument (including items, instructions, and layout). To help improve the trustworthiness of our interpretation of results from the first phases of pre-testing and ensure the PREM instrument has adequate content and face validity, six weeks after the completion of all cognitive interviews we conducted a participant validation exercise (27) with patient advisors as a final step in pre-testing. All those who participated in the cognitive interviews participated in the validation exercise. Participants were given the opportunity to review the revised version of the instrument and were asked confirmatory questions to ensure they agree with how we interpreted their feedback in the previous step and incorporated it into final revisions. For any items that were found to not clearly measure the intended concept during the first phase of pre-testing, similar “think aloud” questions were asked prior to confirmatory questions to ensure the revised item more adequately measured the intended concept. Lastly, participants were asked for any final suggestions or feedback requiring further editing. The inclusion criterion used for PREM items was 67% agreement among participants (i.e., agreement among two-thirds of the sample). All interviews, including the participant validation exercise, were conducted using an online platform (Zoom) to remove geographical limitations. Results from the participant validation exercise were compared with the recommendations from the formal health literacy review to confirm justification for revisions to instrument items, as well as make further revisions to the survey instructions. Results A summary of the results from the literature review and concept mapping (i.e., development of PREM items) and content validity testing are presented in Figure 1 . [ insert Figure 1 ] Literature Review and Concept Mapping The literature search yielded 13 potentially relevant PREM instruments which were reviewed by research team members. Table 1 presents a summary of the characteristics of the PREM instruments considered for inclusion. Five instruments were developed in the United States (US) (31,34,37,40–42), four in the United Kingdom (UK) (19,35,43,44), two in Canada (32,45), one in Denmark (46), and one was recently developed for international use (20). The number of items in each PREM instrument ranged from 3 to >100. The majority of PREMs only examined one transition time point, either when being discharged from hospital back to home or during care in the community setting, not both. Seven instruments examined the transition from hospital to home and three examined care in the community. Two of the instruments examining the community context focused on care integration and not transitions across the continuum of care. One instrument examining multiple CT time points focused on patient self-management after discharge and did not examine primary care’s role in supporting a patient’s transition when returning home. Three instruments included items that addressed both CTs and primary care: the new Care Transitions Measure (CTM-NEW) (31), the Patient Continuity of Care Questionnaire (PCCQ) (32), and the Integrated Care Survey (ICS) (37). These three instrument were reviewed for item inclusion. [ insert Table 1 ] Items from the CTM-NEW, PCCQ, and ICS were mapped according to the stated concept domains each covered and compared to ADAPT logic model outcomes as well as time points of interest (see Additional File 2 ). The mapping process exemplified that no single instrument captured all concepts of interest or time points. Through iterative discussion, items were refined to remove redundant items and develop de novo items to adequately capture concepts of interest (i.e., self-efficacy, patient knowledge, care aligned with patient preferences, patient safety, integration/coordination, overall experience) and time points (i.e., Time 1, when preparing to leave hospital; Time 2, after leaving hospital but before follow-up with primary care; Time 3, primary care follow-up). A total of 18 items (Time 1 = 6 items, Time 2 = 4 items, Time 3 = 7 items, and Overall = 1 item) with 4 open-ended text options (one for each time point and overall) were included in the PREM instrument for pre-testing. PREM logic model outcome and item derivation mapping is presented in Table 2 . [ insert Table 2 ] Content Validity Testing The core 18 items were evaluated for relevance using I-CVI scores (i.e., open-text options and branching/subcomponents of questions not included in main analysis). Six content experts meeting eligibility criteria were recruited and completed pre-testing of the PREM instrument: family physician ( n = 3), nurse practitioner ( n = 1), healthcare organization consultant ( n = 1), and researcher/ quality improvement expert ( n = 1). I-CVI scores for the core 18 items ranged from 0.83 to 1.00; as such, all core items met criteria for inclusion. The PREM instrument was tested with six patient advisors. The majority of participants stated that they lived with one or more chronic health conditions and two identified as a key caregiver for someone else living with chronic health conditions. Two-thirds lived in an urban setting, all had some post-secondary education, and all identified having a regular primary care provider (see Table 3 ). When asked if they felt supported during their most recent transition in care results were split. Two participants felt supported, two did not, and two were either unsure or stated they felt supported by their family but not the healthcare system. [ insert Table 3 ] The use of cognitive interviewing allowed the research team to understand whether the PREM items were relevant to patients and caregivers living with chronic health conditions, as well as if the survey was understandable and items captured our intended concepts of measurement. Overall positive feedback was consistent across interviews with participants highlighting that the instrument was highly relevant to patients and caregivers living with chronic health conditions, and that the PREM adequately covered the transition time points of interest (e.g., “....I think these questions are very important to the success of where we want to be in our healthcare system. And I just think that you've done an excellent job just focusing down on that.” [PA_13] and “I think they were very well thought out. They covered the process of discharge and the necessary components for a smooth transition.” [PA_11]). Further, there was agreement across participants that they liked the survey overall, thought the instructions were clear and easy to follow, found it easy to understand, and only minor wording changes were needed (e.g., “So if you want any confirmation about the survey, it's really good... The way it's set up. I like it.” [PA_14] and “I think overall, it was pretty good, like the blurb you got at the start of the section” [PA_17]). Four broad themes were identified from the cognitive interviews that guided revisions of the PREM instrument: ‘Health Literacy’, ‘Clarity of Terms’, ‘Concept Measurement’, and ‘Ability to Comment’. Table 4 presents the broad themes, number of items reflecting each theme, organizing concept, sample of originally worded items with supporting quote examples, and resultant action taken. There were 10 items reflecting the first theme ‘Health Literacy’. At the question-level, participants identified many words within items they viewed as ‘not patient-friendly’ or medical jargon and suggested similar wording changes to improve the readability and understandability of the survey to patients (e.g., using the phrase “taking care of myself” instead of “manage” [Q6], and using words like “complete” and “understandable” instead of “clear and concise” [Q1]). Minor wording changes were done for all 10 items reflected in this theme. Seven items reflected the second theme ‘Clarity of Terms’. Throughout the instrument, participants questioned how understandable the terms “primary care provider” and “primary care team” would be to most patients and suggested providing clearer definitions throughout the survey. To address this theme, a clear definition of “primary care provider” was added to the beginning of each section of the survey, as well as defined in brackets within the first item in which it appears in the instrument. Through other results-based survey revisions, the term “primary care team” was removed completely. Two items reflected the third theme ‘Concept Measurement’. Through the cognitive interviewing process these two items were found to not clearly measure the concepts they were meant to measure (i.e., lacked face validity). For example, five participants interpreted the original wording of item Q17 as asking if informal caregivers provided the patient with care the way they wanted them to, which did not capture the concept of patient preferences regarding formal care (i.e., choice for informal caregiver involvement in primary care follow-up visit). The two items reflecting this theme underwent iterations of revision within the research team prior to further review during the participant validation exercise. There were four items reflecting the final theme ‘Ability to Comment’ in which various participants indicated that they would prefer an open-text option to explain their answer for specific items. To avoid increasing the burden on those completing the survey, a decision was made to keep only one open-text option for each section of the survey. However, the instructions for each section were edited to make it clearer that this option is available so participants can further explain any answer within that section if they choose. [ insert Table 4 ] All six patient advisors that completed a cognitive interview attended the participant validation exercise. Participants were first presented the broad themes and concepts from the cognitive interviews, and how they were addressed, along with the revised version of the survey. Next each item within the PREM was reviewed to ascertain the level of agreement within the group for each revised item. All items ( n = 18) met our agreement criterion of 67% or greater, with the majority of items ( n = 16) attaining 100% agreement. After asking “think aloud” questions and having a group discussion for the items that were found not to have adequate face validity from the cognitive interviews (Q9 and Q17), both revised items were identified as having adequate face validity and there was 100% agreement for the revised item and understanding what the question meant. Lastly, the comparison of results from the participant validation exercise with the formal health literacy review confirmed justification for revisions of instrument items, as many recommendations were congruent with what we heard from patient advisors during the participant validation exercise (e.g., simplifying instructions, definitions, and wording for open-text questions). Changes were made to the survey based on these recommendations to further improve the readability of the survey. Through the entire process of pre-testing, no items were removed or added as content experts and patient advisors found them all to be relevant, and all revised items were found to adequately captured the concept they were meant to measure. Therefore, providing evidence of the PREM instrument’s content and face validity. The final version of the survey is provided in an online supplement ( Additional File 3 ). Discussion There are few validated PREMs in Canada, or elsewhere, that capture patient experiences at multiple critical time points during the transition process from hospital to home. Creating a PREM instrument that captures patient’ experiences as they move between acute and primary care, with a focus on integrating care and primary care’s supporting role is key to gaining understanding and improving CTs. In our study we developed a PREM instrument examining three distinct CT time points from acute to primary care (i.e., when preparing to leave hospital, after leaving hospital but before follow-up with primary care, and primary care follow-up), comprehensively covering key concepts (self-efficacy, patient knowledge, care aligned with patient preferences, patient safety, integration/coordination, and overall experience), and provided evidence for the instrument’s content and face validity through testing with content experts and patient advisors. The importance of this work was highlighted during the literature review which identified only three existing PREM instruments that examined both CTs and primary care follow-up. None of these instruments adequately covered all three time points of interest, identifying a need to develop a new instrument to fully capture the CT process from acute to primary care. The majority of items that were developed de novo related to the period of time after discharge but before primary care follow-up, as well as timeliness of the follow-up appointment. This is a critical gap in knowledge as people living with chronic health conditions are at higher risk of poorer outcomes such as adverse drug events and readmission during the period between hospital discharge and primary care follow-up (8,9), and timely primary care follow-up can improve these outcomes (14–17). For example, Bricard and Or (2019) found primary care follow-up within the first week after discharge reduced patients’ 28-day all-cause readmission risks by nearly 50% (14). Similarly, Saxena et al. (2022) found patients who had early primary care follow-up after an acute hospital stay had lower rates of unplanned readmissions and mortality at 90 days post-discharge (16). The importance of the availability of a PREM instrument covering the entire transition process from acute to primary care was reinforced during pre-testing phases of our newly developed instrument where a group of diverse content experts and a separate group of patient advisors all agreed that this instrument is highly relevant and necessary. A particular strength of our work was the rigorous pre-testing phases conducted to establish the content and face validity of the PREM instrument. We used the Cognitive Interviewing Reporting Framework (29) as well as the COSMIN checklist (30) to inform our work. Currently, there are no agreed upon standards for developing PREMs. Therefore, authors have begun using COSMIN tools which were generated to select, develop, and/or appraise patient-reported outcome measures (PROMs), to help inform similar research related to PREMs (7,28,47). Using transparent and standardized processes for developing PREM instruments helps improve the trustworthiness of these tools for uptake in research and healthcare quality improvement and evaluation. The rigour of our process is exemplified by the steps taken to ensure the developed PREM is relevant to various interest groups. The instrument was reviewed by content experts and patient advisors using structured methods; and these results were triangulated to inform revisions. To further enhance the rigor of our process and validate the results in the first phase of pre-testing, the revised instrument was also examined in a participant validation exercise with patient advisors; and results from this exercise were reinforced by a formal health literacy review. Although a diversity of content experts and patient advisors were sought (e.g., mix of professional backgrounds of experts and mix of rural and urban patient advisors), all those involved currently reside in the same Canadian province (Alberta), which may limit generalizability and is a limitation of our work. However, by transparently publishing our process (including our interview guide and finalized survey from this process) other researchers and organizations can conduct additional testing and contextualization of this PREM instrument for use in other jurisdictions. Conclusion The development of this PREM instrument evaluating CTs from acute to primary care will better inform various interest groups on how different system changes impact the patient experience as they transition from hospital to home. This PREM will provide robust evidence on patient experiences during CTs to support quality improvement work and enhance integration of care. Psychometric testing of the PREM will be done as part of the ADAPT project aimed at improving CTs and integrating healthcare for adult patients with diverse chronic conditions. Abbreviations Care transitions (CTs), patient-reported experience measures (PREMs), item content validity index (I-CVI), Institute of Medicine (IOM), A DiseAse-Inclusive Pathway for Transitions in Care (ADAPT), Alberta Health Service (AHS), Primary Health Care Integration Network (PHCIN), Home to Hospital to Home (H2H2H), COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), Research Electronic Data Capture (REDCap), United States (US), United Kingdom (UK), new Care Transitions Measure (CTM-NEW), Patient Continuity of Care Questionnaire (PCCQ), Integrated Care Survey (ICS), patient-reported outcome measures (PROMs). Declarations Ethics approval and consent to participate This study was designed and conducted according to the principles outlined in the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, which is also in accordance with the Declarations of Helsinki. This study received approval from the University of Alberta Health Research Ethics Board (ID: Pro0010674). Implied consent was used for content experts. Informed consent was obtained from participants before completing any interviews. Consent for publication N/A Availability of data and materials The datasets generated and analysed during the current study are available from the corresponding author on reasonable request. Competing interests Authors declare they have no competing interests to this study Funding This study is supported by an Alberta Innovates Partnership for Research and Innovation in the Health System Grant. Authors’ contributions SND conceived the research idea. Research study was designed by SF, JC, CC and SND. SH conducted the literature review. SF and JC conducted the cognitive interviews, the survey for relevance according to content experts, the participant validation exercise, and all data analysis. The manuscript was first drafted by SF, additional content and draft reviews were provided by JC, CC, SH, and SND. All authors reviewed and approved the final version. Acknowledgements Authors wish to thank all content experts and patient advisors who took part in this study. Further, the authors wish to acknowledge Dr. Judy Seidel (Co-PI) for her contributions in conceiving the research idea for the overall ADAPT project. References Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System [Internet]. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 1999 [cited 2020 Apr 16]. 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Association of Early Physician Follow-up With Readmission Among Patients Hospitalized for Acute Myocardial Infarction, Congestive Heart Failure, or Chronic Obstructive Pulmonary Disease. JAMA Network Open [Internet]. 2022 Jul 12 [cited 2024 Aug 16];5(7):e2222056. Available from: https://doi.org/10.1001/jamanetworkopen.2022.22056 Anderson TS, O’Donoghue AL, Herzig SJ, Cohen ML, Aung N, Dechen T, et al. Differences in Primary Care Follow-up After Acute Care Discharge Within and Across Health Systems: a Retrospective Cohort Study. J GEN INTERN MED [Internet]. 2024 Jun 1 [cited 2024 Aug 15];39(8):1431–7. Available from: https://doi.org/10.1007/s11606-024-08610-3 Carter J, Ward C, Wexler D, Donelan K. The association between patient experience factors and likelihood of 30-day readmission: a prospective cohort study. BMJ Qual Saf [Internet]. 2018 Sep 1 [cited 2024 Mar 20];27(9):683–90. Available from: https://qualitysafety.bmj.com/content/27/9/683 Oikonomou E, Chatburn E, Higham H, Murray J, Lawton R, Vincent C. Developing a measure to assess the quality of care transitions for older people. BMC Health Serv Res [Internet]. 2019 Dec [cited 2024 Mar 30];19(1):1–12. Available from: https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-019-4306-8 Organisation for Economic Co-operation and Development [OECD]. Patient Reported Indicator Surveys: PaRIS Patient Questionnaire (PaRIS-PQ) [Internet]. OECD; 2024. Available from: https://www.oecd.org/en/about/programmes/patient-reported-indicator-surveys-paris.html Frenk J. Reinventing primary health care: the need for systems integration. The Lancet [Internet]. 2009 Jul 11 [cited 2024 Aug 28];374(9684):170–3. Available from: https://www.sciencedirect.com/science/article/pii/S0140673609606930 Hone T, Macinko J, Millett C. Revisiting Alma-Ata: what is the role of primary health care in achieving the Sustainable Development Goals? The Lancet [Internet]. 2018 Oct 20 [cited 2024 Aug 28];392(10156):1461–72. Available from: https://www.sciencedirect.com/science/article/pii/S0140673618318294 Alberta Health Services. Alberta Health Services. 2024 [cited 2024 Aug 18]. Home to Hospital to Home Transitions. Available from: https://www.albertahealthservices.ca/scns/Page14085.aspx Polit DF, Beck CT, Owen SV. Is the CVI an acceptable indicator of content validity? Appraisal and recommendations. Research in Nursing & Health [Internet]. 2007 [cited 2024 Apr 3];30(4):459–67. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/nur.20199 Peterson CH, Peterson NA, Powell KG. Cognitive Interviewing for Item Development: Validity Evidence Based on Content and Response Processes. Measurement and Evaluation in Counseling and Development [Internet]. 2017 Oct 2 [cited 2024 Apr 4];50(4):217–23. Available from: https://doi.org/10.1080/07481756.2017.1339564 Meadows K. Cognitive Interviewing Methodologies. Clin Nurs Res [Internet]. 2021 May 1 [cited 2024 Apr 25];30(4):375–9. Available from: https://doi.org/10.1177/10547738211014099 Birt L, Scott S, Cavers D, Campbell C, Walter F. Member Checking: A Tool to Enhance Trustworthiness or Merely a Nod to Validation? Qual Health Res [Internet]. 2016 Nov 1 [cited 2023 Jul 16];26(13):1802–11. Available from: https://doi.org/10.1177/1049732316654870 van Melle MA, van Stel HF, Poldervaart JM, de Wit NJ, Zwart DLM. Measurement tools and outcome measures used in transitional patient safety; a systematic review. PLoS One. 2018;13(6):e0197312. Boeije H, Willis G. The Cognitive Interviewing Reporting Framework (CIRF). Methodology. 2013 Aug 2;9:87–95. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. Journal of Clinical Epidemiology [Internet]. 2010 Jul 1 [cited 2024 Apr 3];63(7):737–45. Available from: https://www.sciencedirect.com/science/article/pii/S0895435610000909 Kiefe C, Anatchkova M, Santry H, McManus D, Gigliello R. Developing a Survey with Patient and Caregiver Input that Measures the Quality of Care Transitions from Hospital to Home [Internet]. Patient-Centered Outcomes Research Institute; 2020 Jun [cited 2024 Mar 25]. Available from: https://www.pcori.org/research-results/2014/developing-survey-patient-and-caregiver-input-measures-quality-care Hadjistavropoulos H, Biem H, Sharpe D, Bourgault-Fagnou M, Janzen J. Patient perceptions of hospital discharge: reliability and validity of a Patient Continuity of Care Questionnaire. International Journal for Quality in Health Care [Internet]. 2008 Oct 1 [cited 2024 Mar 25];20(5):314–23. Available from: https://doi.org/10.1093/intqhc/mzn030 REDCap [Internet]. [cited 2021 Sep 1]. Available from: https://www.project-redcap.org/ Sorra J, Zebrak K, Carpenter D, Famolaro T, Rauch J, Li J, et al. Development and psychometric properties of surveys to assess patient and family caregiver experience with care transitions. BMC Health Serv Res [Internet]. 2021 Dec [cited 2024 Mar 22];21(1):1–15. Available from: https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06766-w Sugavanam T, Fosh B, Close J, Byng R, Horrell J, Lloyd H. Codesigning a Measure of Person-Centred Coordinated Care to Capture the Experience of the Patient: The Development of the P3CEQ. Journal of Patient Experience [Internet]. 2018 Sep 1 [cited 2024 Mar 29];5(3):201–11. Available from: https://doi.org/10.1177/2374373517748642 Kendir C, Naik R, de Bienassis J, Larrain N, Klazinga N, Guanais F, et al. All hands on deck: Codeveloping the first international survey of people living with chronic conditions: Stakeholder engagement in the design, development, and field trial implementation of the PaRIS survey [Internet]. OECD; 2023. Available from: https://dx.doi.org/10.1787/8b31022e-en Walker KO, Stewart AL, Grumbach K. Development of a survey instrument to measure patient experience of integrated care. BMC Health Services Research [Internet]. 2016 Jun 1 [cited 2024 Mar 25];16(1):193. Available from: https://doi.org/10.1186/s12913-016-1437-z Bobrovitz N, Santana MJ, Kline T, Kortbeek J, Stelfox HT. The use of cognitive interviews to revise the Quality of Trauma Care Patient-Reported Experience Measure (QTAC-PREM). Qual Life Res [Internet]. 2015 Aug 1 [cited 2024 Mar 29];24(8):1911–9. Available from: https://doi.org/10.1007/s11136-015-0919-5 Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277–88. Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development and testing of a measure designed to assess the quality of care transitions. International Journal of Integrated Care [Internet]. 2002 Jun 1 [cited 2024 Aug 15];2(2). Available from: https://ijic.org/articles/10.5334/ijic.60 Parry C, Mahoney E, Chalmers SA, Coleman EA. Assessing the Quality of Transitional Care: Further Applications of the Care Transitions Measure. Medical Care [Internet]. 2008 Mar [cited 2024 Mar 29];46(3):317. Available from: https://journals.lww.com/lww-medicalcare/fulltext/2008/03000/assessing_the_quality_of_transitional_care_.12.aspx Harvard School of Public Health. Patient Perceptions of Integrated Care (PPIC) survey [Internet]. 2017. Available from: https://www.hsph.harvard.edu/ppic/ppic-resources/the-survey/ Scott J, Heavey E, Waring J, De Brún A, Dawson P. Implementing a survey for patients to provide safety experience feedback following a care transition: a feasibility study. BMC Health Services Research [Internet]. 2019 Aug 30 [cited 2024 Mar 25];19(1):613. Available from: https://doi.org/10.1186/s12913-019-4447-9 Care Quality Commission. NHS Adult Inpatient Survey [Internet]. 2023. Available from: https://nhssurveys.org/surveys/survey/02-adults-inpatients/ Health System Performance Network [HSPN]. Ontario Health Team Patient Survey [Internet]. 2022 [cited 2024 Mar 25]. Available from: https://hspn.ca/wp-content/uploads/2022/02/HSPN-OHT-Patient-Experience-Survey-EN-1-02-2022.pdf Danish Ministry of Interior and Health. The National Danish Survey of Patient Experiences [Internet]. 2010. Available from: https://www.regionh.dk/patientinddragelse/udgivelser/udgivelser/Documents/The%20National%20Danish%20Survey%20of%20Patient%20Experiences%20-%20in%20brief.pdf Bull C, Crilly J, Latimer S, Gillespie BM. Establishing the content validity of a new emergency department patient-reported experience measure (ED PREM): a Delphi study. BMC Emergency Medicine [Internet]. 2022 Apr 9 [cited 2024 Mar 30];22(1):65. Available from: https://doi.org/10.1186/s12873-022-00617-5 Tables Tables 1 to 4 are available in the Supplementary Files section. Additional Declarations No competing interests reported. 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In their seminal framework, the Institute of Medicine (IOM) articulates six domains of quality to guide improvement efforts (safety, effectiveness, patient-centredness, timeliness, efficiency, and equity) (3). Patient-centredness has been gaining recognition as a pivotal aspect of healthcare policy and programing to improve healthcare quality (4,5). For the past 20 years, research has been gaining momentum to develop instruments to help measure aspects of patient-centredness in order to guide meaningful improvements in healthcare (4). Patient-reported experience measures (PREMs) are instruments that capture patients’ perspectives of what happened when they received care and how it happened; and are necessary metrics to gain insights into patient-centredness (4,6,7). The importance of evaluating patient experience has been exemplified by numerous countries (e.g., United Kingdom, Australia, China, and the United States) mandating the measurement and reporting of patient experience using PREM instruments (4). Through this quantification, research has shown that improved patient experience has consistent positive associations with other domains of quality (i.e., safety and effectiveness) (5). With the proliferation of PREM instruments and the growing body of evidence positively associating patient experience with other domains of quality (4,5), it is important to shift focus to developing validated instruments in priority areas for improvement.\u003c/p\u003e\n\u003cp\u003eAn important focus of evaluation for patient-centred quality improvement is the experiences of patients with complex chronic health conditions during care transitions (CTs) from acute care to primary care. Patients living with chronic health conditions are at risk for adverse events such as medication errors and rehospitalization due to poor discharge coordination and care integration across settings and are at greater risk during the period between hospital discharge and primary care follow-up (8–13). Studies examining the impact of timely follow-up with primary care following a patient’s acute care stay have found reductions in readmission rates and mortality (14–17). Therefore, timely primary care follow-up after discharge is important to improve the overall transition process. Understanding patients’ experiences during these critical transition time points is key to provide evidence to inform system improvements with the potential to improve patient outcomes (18).\u003c/p\u003e\n\u003cp\u003eTo date, most PREMs for CTs that exist focus on one time point, i.e., the transition from hospital to home and preparing patients for this transition while in hospital. They do not focus on continuity of care and primary care’s role in a patient’s transition back to the community (e.g., “While I was in hospital, staff helped me to prepare for things that I might find difficult when I go back home...” (19)). Further, although tools have recently been developed that examine patient experiences in the community (20), these tend to focus on care integration solely in this setting rather than across critical transition time points as a patient returns home after a hospital stay. A foundational component of primary care is coordinating care for patients across the care continuum and they are the main team which integrates care into the community after hospital discharge (21,22). Therefore, there is a need to establish a PREM to capture patient experiences throughout the transition process from acute to primary care. The availability of such an instrument will help researchers and policymakers gain important insights into how primary care currently supports transitions across the continuum of care in order to guide improvement strategies.\u003c/p\u003e\n\u003cp\u003eAn ongoing research program in Alberta, Canada called A DiseAse-Inclusive Pathway for Transitions in Care (ADAPT) focuses on integrating care by collaborating with primary care providers to enhance CTs for those with complex chronic health conditions. Alberta Health Service’s (AHS) Primary Health Care Integration Network (PHCIN) has been leading the development of the Home to Hospital to Home (H2H2H) Transitions Guideline for several years (23). The ADAPT project is an initiative to support the implementation of key H2H2H guideline elements (23). A major aspect of this initiative is evaluating how patients experience transitions from hospital to home.\u003c/p\u003e\n\u003cp\u003eThe purpose of the current study was to develop a PREM to capture patient experiences as they transition from acute to primary care (i.e., when preparing to leave hospital, after leaving hospital but before follow-up with primary care, and during primary care follow-up), and provide evidence for the instrument’s content validity prior to further psychometric testing within the context of the ADAPT project.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eOur methods included a literature review and concept mapping to develop a preliminary instrument, then content validity testing with content experts by calculating item content validity index (I-CVI) scores (24) and with patients by conducting cognitive interviews (25,26). After modifications of the instrument were made based on the triangulation of results from the cognitive interviews and I-CVI scores, a participant validation exercise (i.e., member checking) with patients was conducted(27). Finally, the PREM underwent a formal health literacy review within AHS and recommendations from this review were compared with the results of the participant validation exercise. Implied consent was used for content experts. Informed consent was received from all patients before completing any interviews. This study received approval from the University of Alberta Health Research Ethics Board (ID: Pro0010674).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eLiterature Review and Concept Mapping\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOur first step to develop a PREM that captured patient experiences across the care continuum from hospital to home was to conduct an updated literature review to identify previously validated PREM instruments for CTs. We used the results from a systematic review to identify and critically appraise PREMs for measuring transitional patient safety by van Melle et al. (2018) (28) to inform our strategy to identify current validated PREM instruments relevant to CTs. Using the PREMs identified by these authors, we used Google Scholar and Google Advanced to conduct a snowball search of peer-reviewed and grey literature to find any other potentially relevant PREMs published by research groups or organizations (e.g., Canadian Institute for Health Information, National Health Service, or Health Quality Ontario). Search criteria included instruments relevant to the adult population, CTs, and primary care. Available instruments were examined and considered for inclusion if they contained items that addressed both CTs and primary care. The items of each included instrument were mapped according to their stated conceptual domains (e.g., ‘confidence in care management’ and ‘information transfer’). Next, through research team discussions, decisions were made as to which domains and items were relevant to the ADAPT project and logic model outcomes (i.e., concepts of interest): self-efficacy, patient knowledge, care aligned with patient preferences, patient safety, integration/coordination, overall experience, as well as three experience time points of interest: when preparing to leave hospital, after leaving hospital but before follow-up with primary care, and primary care follow-up. After rounds of iterative refinement, we mapped included items according to logic model outcomes as well as how the item was derived (i.e., adapted from a previously validated PREM [if so which instrument] or developed de novo).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eContent Validity Testing\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe used the Cognitive Interviewing Reporting Framework (29) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) (30) to inform our process and report our work. Content validity is considered the most important aspect for instrument pre-testing because it should be clear that the content of a measurement instrument is relevant, comprehensive, and comprehensible in regard to the concepts of interest, as well as to the target population (28,30).\u003c/p\u003e\n\u003cp\u003eTo help establish the content validity of a PREM, and ensure items are relevant to providers (as well as patients), we collected structured feedback from content experts on the draft PREM instrument (19,31,32). This was conducted electronically and anonymously using the Research Electronic Data Capture (REDCap) secure online platform for building and managing online surveys (33) through the AHS licensing agreement. We asked content experts to rate each item according to its perceived relevance on a 4-point ordinal scale (1 = not relevant, 2 = somewhat relevant, 3 = quite relevant, and 4 = highly relevant). This scale was used in order to calculate an I-CVI score to determine if there was an adequate level of content validity (24). Responses to each item were binary coded as not or somewhat relevant = 0, and quite or highly relevant = 1. An I-CVI score was calculated for each item as the number of experts scoring 1 relative to the total number of experts. Items that score \u003cu\u003e\u0026gt;\u003c/u\u003e 0.78 were retained for the next step in pre-testing, as this provides evidence of good content validity (24). Further, content experts were given the opportunity to provide suggestions for edits or changes to wording to help increase clarity. Analyses were performed using Microsoft ExcelÔ\u0026nbsp;for Mac.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eContent experts were recruited through the research team’s existing professional networks. Eligibility criteria included five or more years of experience in a relevant field to primary care (in a clinical, research, and/or administrative setting) and willing to participate. Sample size requirements were informed by Polit et al. (2007) (24).\u003c/p\u003e\n\u003cp\u003eConcurrent to content validity testing with content experts, further pre-testing for content and face validity was conducted using cognitive interviewing with a sample of patient representatives and caregivers (i.e., patient advisors). Cognitive interviewing has become the most common method and current standard for PREM pre-testing because it deeply explores how patient participants understand and answer items (25,31,34–38). All interviews were conducted using a semi-structured interview guide. We used “think aloud” and “verbal probing” techniques to gain a better understanding of the meaningfulness of the PREM items to patients (i.e., to determine if the question is measuring the intended concept), as well as the cognitive process a person uses to answer questions, including comprehension of the question, retrieval of relevant information from memory, and judgement (25,35,38). The interview guide was developed, based on examples found in the literature (31,38) and can be found in an online supplement (\u003cstrong\u003eAdditional File 1\u003c/strong\u003e).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePatient advisors were recruited through email advertisements sent to the Virtual Patient Engagement Network in Alberta. Eligibility criteria included 18 years of age or older, patient and/or caregiver of a patient with one or more chronic health conditions and a hospital stay (non-elective) within the past 24 months, and willing to participate. Sample size requirements were informed by Peterson et al. (2017) (25).\u003c/p\u003e\n\u003cp\u003eWe used inductive content analysis to analyze the interview data (39). All interviews were recorded and transcribed. Two reviewers (SF and JC) conducted a collaborative analysis to aggregate the results (26). Following a period of data familiarization, reviewers met to begin identifying and assigning codes to the data and collaboratively develop a codebook. Reviewers first conducted within interview analyses, followed by across interview analyses (26). Codes were assigned to summarize and describe responses, then codes were grouped into within item themes and broad themes to reflect main issues described by participants. Codes from each interview were entered into a master Microsoft Word document and listed under the item the coded response applied to. There was also a general category to reflect issues that did not relate to a specific item (e.g., layout or instructions). To be considered a theme, the code needed to be reflected in two or more participant interviews. The master document was iteratively examined by reviewers for themes.\u003c/p\u003e\n\u003cp\u003eResults from the content expert review and patient advisor cognitive interviews were triangulated to inform revisions of the PREM instrument (including items, instructions, and layout). To help improve the trustworthiness of our interpretation of results from the first phases of pre-testing and ensure the PREM instrument has adequate content and face validity, six weeks after the completion of all cognitive interviews we conducted a participant validation exercise (27) with patient advisors as a final step in pre-testing. All those who participated in the cognitive interviews participated in the validation exercise. Participants were given the opportunity to review the revised version of the instrument and were asked confirmatory questions to ensure they agree with how we interpreted their feedback in the previous step and incorporated it into final revisions. For any items that were found to not clearly measure the intended concept during the first phase of pre-testing, similar “think aloud” questions were asked prior to confirmatory questions to ensure the revised item more adequately measured the intended concept. Lastly, participants were asked for any final suggestions or feedback requiring further editing. The inclusion criterion used for PREM items was 67% agreement among participants (i.e., agreement among two-thirds of the sample). All interviews, including the participant validation exercise, were conducted using an online platform (Zoom) to remove geographical limitations.\u003c/p\u003e\n\u003cp\u003eResults from the participant validation exercise were compared with the recommendations from the formal health literacy review to confirm justification for revisions to instrument items, as well as make further revisions to the survey instructions.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA summary of the results from the literature review and concept mapping (i.e., development of PREM items) and content validity testing are presented in \u003cstrong\u003eFigure 1\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003e[ insert Figure 1 ]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eLiterature Review and Concept Mapping\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe literature search yielded 13 potentially relevant PREM instruments which were reviewed by research team members. \u003cstrong\u003eTable 1\u003c/strong\u003e presents a summary of the characteristics of the PREM instruments considered for inclusion. Five instruments were developed in the United States (US) (31,34,37,40\u0026ndash;42), four in the United Kingdom (UK) (19,35,43,44), two in Canada (32,45), one in Denmark (46), and one was recently developed for international use (20). The number of items in each PREM instrument ranged from 3 to \u0026gt;100. The majority of PREMs only examined one transition time point, either when being discharged from hospital back to home or during care in the community setting, not both. Seven instruments examined the transition from hospital to home and three examined care in the community. Two of the instruments examining the community context focused on care integration and not transitions across the continuum of care. One instrument examining multiple CT time points focused on patient self-management after discharge and did not examine primary care\u0026rsquo;s role in supporting a patient\u0026rsquo;s transition when returning home. Three instruments included items that addressed both CTs and primary care: the new Care Transitions Measure (CTM-NEW) (31), the Patient Continuity of Care Questionnaire (PCCQ) (32), and the Integrated Care Survey (ICS) (37). These three instrument were reviewed for item inclusion.\u003c/p\u003e\n\u003cp\u003e[ insert Table 1 ]\u003c/p\u003e\n\u003cp\u003eItems from the CTM-NEW, PCCQ, and ICS were mapped according to the stated concept domains each covered and compared to ADAPT logic model outcomes as well as time points of interest (see \u003cstrong\u003eAdditional File 2\u003c/strong\u003e). The mapping process exemplified that no single instrument captured all concepts of interest or time points. Through iterative discussion, items were refined to remove redundant items and develop de novo items to adequately capture concepts of interest (i.e., self-efficacy, patient knowledge, care aligned with patient preferences, patient safety, integration/coordination, overall experience) and time points (i.e., Time 1, when preparing to leave hospital; Time 2, after leaving hospital but before follow-up with primary care; Time 3, primary care follow-up). A total of 18 items (Time 1 = 6 items, Time 2 = 4 items, Time 3 = 7 items, and Overall = 1 item) with 4 open-ended text options (one for each time point and overall) were included in the PREM instrument for pre-testing. PREM logic model outcome and item derivation mapping is presented in \u003cstrong\u003eTable 2\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003e[ insert Table 2 ]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eContent Validity Testing\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe core 18 items were evaluated for relevance using I-CVI scores (i.e., open-text options and branching/subcomponents of questions not included in main analysis). Six content experts meeting eligibility criteria were recruited and completed pre-testing of the PREM instrument: family physician (\u003cem\u003en\u003c/em\u003e = 3), nurse practitioner (\u003cem\u003en\u003c/em\u003e = 1), healthcare organization consultant (\u003cem\u003en\u003c/em\u003e = 1), and researcher/ quality improvement expert (\u003cem\u003en\u003c/em\u003e = 1). I-CVI scores for the core 18 items ranged from 0.83 to 1.00; as such, all core items met criteria for inclusion.\u003c/p\u003e\n\u003cp\u003eThe PREM instrument was tested with six patient advisors. The majority of participants stated that they lived with one or more chronic health conditions and two identified as a key caregiver for someone else living with chronic health conditions. Two-thirds lived in an urban setting, all had some post-secondary education, and all identified having a regular primary care provider (see \u003cstrong\u003eTable 3\u003c/strong\u003e). When asked if they felt supported during their most recent transition in care results were split. Two participants felt supported, two did not, and two were either unsure or stated they felt supported by their family but not the healthcare system.\u003c/p\u003e\n\u003cp\u003e[ insert Table 3 ]\u003c/p\u003e\n\u003cp\u003eThe use of cognitive interviewing allowed the research team to understand whether the PREM items were relevant to patients and caregivers living with chronic health conditions, as well as if the survey was understandable and items captured our intended concepts of measurement. Overall positive feedback was consistent across interviews with participants highlighting that the instrument was highly relevant to patients and caregivers living with chronic health conditions, and that the PREM adequately covered the transition time points of interest (e.g., \u003cem\u003e\u0026ldquo;....I think these questions are very important to the success of where we want to be in our healthcare system. And I just think that you\u0026apos;ve done an excellent job just focusing down on that.\u0026rdquo;\u003c/em\u003e [PA_13] and \u003cem\u003e\u0026ldquo;I think they were very well thought out. They covered the process of discharge and the necessary components for a smooth transition.\u0026rdquo;\u003c/em\u003e [PA_11]). Further, there was agreement across participants that they liked the survey overall, thought the instructions were clear and easy to follow, found it easy to understand, and only minor wording changes were needed (e.g., \u003cem\u003e\u0026ldquo;So if you want any confirmation about the survey, it\u0026apos;s really good... The way it\u0026apos;s set up. I like it.\u0026rdquo;\u003c/em\u003e [PA_14] and \u003cem\u003e\u0026ldquo;I think overall, it was pretty good, like the blurb you got at the start of the section\u0026rdquo;\u003c/em\u003e [PA_17]).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFour broad themes were identified from the cognitive interviews that guided revisions of the PREM instrument: \u0026lsquo;Health Literacy\u0026rsquo;, \u0026lsquo;Clarity of Terms\u0026rsquo;, \u0026lsquo;Concept Measurement\u0026rsquo;, and \u0026lsquo;Ability to Comment\u0026rsquo;. \u003cstrong\u003eTable 4\u003c/strong\u003e presents the broad themes, number of items reflecting each theme, organizing concept, sample of originally worded items with supporting quote examples, and resultant action taken. There were 10 items reflecting the first theme \u0026lsquo;Health Literacy\u0026rsquo;. At the question-level, participants identified many words within items they viewed as \u0026lsquo;not patient-friendly\u0026rsquo; or medical jargon and suggested similar wording changes to improve the readability and understandability of the survey to patients (e.g., using the phrase \u0026ldquo;taking care of myself\u0026rdquo; instead of \u0026ldquo;manage\u0026rdquo; [Q6], and using words like \u0026ldquo;complete\u0026rdquo; and \u0026ldquo;understandable\u0026rdquo; instead of \u0026ldquo;clear and concise\u0026rdquo; [Q1]). Minor wording changes were done for all 10 items reflected in this theme. Seven items reflected the second theme \u0026lsquo;Clarity of Terms\u0026rsquo;. Throughout the instrument, participants questioned how understandable the terms \u0026ldquo;primary care provider\u0026rdquo; and \u0026ldquo;primary care team\u0026rdquo; would be to most patients and suggested providing clearer definitions throughout the survey. To address this theme, a clear definition of \u0026ldquo;primary care provider\u0026rdquo; was added to the beginning of each section of the survey, as well as defined in brackets within the first item in which it appears in the instrument. Through other results-based survey revisions, the term \u0026ldquo;primary care team\u0026rdquo; was removed completely. Two items reflected the third theme \u0026lsquo;Concept Measurement\u0026rsquo;. Through the cognitive interviewing process these two items were found to not clearly measure the concepts they were meant to measure (i.e., lacked face validity). For example, five participants interpreted the original wording of item Q17 as asking if informal caregivers provided the patient with care the way they wanted them to, which did not capture the concept of patient preferences regarding formal care (i.e., choice for informal caregiver involvement in primary care follow-up visit). The two items reflecting this theme underwent iterations of revision within the research team prior to further review during the participant validation exercise. There were four items reflecting the final theme \u0026lsquo;Ability to Comment\u0026rsquo; in which various participants indicated that they would prefer an open-text option to explain their answer for specific items. To avoid increasing the burden on those completing the survey, a decision was made to keep only one open-text option for each section of the survey. However, the instructions for each section were edited to make it clearer that this option is available so participants can further explain any answer within that section if they choose.\u003c/p\u003e\n\u003cp\u003e[ insert Table 4 ]\u003c/p\u003e\n\u003cp\u003eAll six patient advisors that completed a cognitive interview attended the participant validation exercise. Participants were first presented the broad themes and concepts from the cognitive interviews, and how they were addressed, along with the revised version of the survey. Next each item within the PREM was reviewed to ascertain the level of agreement within the group for each revised item. All items (\u003cem\u003en\u003c/em\u003e = 18) met our agreement criterion of 67% or greater, with the majority of items (\u003cem\u003en\u003c/em\u003e = 16) attaining 100% agreement. After asking \u0026ldquo;think aloud\u0026rdquo; questions and having a group discussion for the items that were found not to have adequate face validity from the cognitive interviews (Q9 and Q17), both revised items were identified as having adequate face validity and there was 100% agreement for the revised item and understanding what the question meant. Lastly, the comparison of results from the participant validation exercise with the formal health literacy review confirmed justification for revisions of instrument items, as many recommendations were congruent with what we heard from patient advisors during the participant validation exercise (e.g., simplifying instructions, definitions, and wording for open-text questions). Changes were made to the survey based on these recommendations to further improve the readability of the survey.\u003c/p\u003e\n\u003cp\u003eThrough the entire process of pre-testing, no items were removed or added as content experts and patient advisors found them all to be relevant, and all revised items were found to adequately captured the concept they were meant to measure. Therefore, providing evidence of the PREM instrument\u0026rsquo;s content and face validity. The final version of the survey is provided in an online supplement (\u003cstrong\u003eAdditional File 3\u003c/strong\u003e).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThere are few validated PREMs in Canada, or elsewhere, that capture patient experiences at multiple critical time points during the transition process from hospital to home. Creating a PREM instrument that captures patient\u0026rsquo; experiences as they move between acute and primary care, with a focus on integrating care and primary care\u0026rsquo;s supporting role is key to gaining understanding and improving CTs. In our study we developed a PREM instrument examining three distinct CT time points from acute to primary care (i.e., when preparing to leave hospital, after leaving hospital but before follow-up with primary care, and primary care follow-up), comprehensively covering key concepts (self-efficacy, patient knowledge, care aligned with patient preferences, patient safety, integration/coordination, and overall experience), and provided evidence for the instrument\u0026rsquo;s content and face validity through testing with content experts and patient advisors.\u003c/p\u003e\n\u003cp\u003eThe importance of this work was highlighted during the literature review which identified only three existing PREM instruments that examined both CTs and primary care follow-up. None of these instruments adequately covered all three time points of interest, identifying a need to develop a new instrument to fully capture the CT process from acute to primary care. The majority of items that were developed de novo related to the period of time after discharge but before primary care follow-up, as well as timeliness of the follow-up appointment. This is a critical gap in knowledge as people living with chronic health conditions are at higher risk of poorer outcomes such as adverse drug events and readmission during the period between hospital discharge and primary care follow-up (8,9), and timely primary care follow-up can improve these outcomes (14\u0026ndash;17). For example, Bricard and Or (2019) found primary care follow-up within the first week after discharge reduced patients\u0026rsquo; 28-day all-cause readmission risks by nearly 50% (14). Similarly, Saxena et al. (2022) found patients who had early primary care follow-up after an acute hospital stay had lower rates of unplanned readmissions and mortality at 90 days post-discharge (16). The importance of the availability of a PREM instrument covering the entire transition process from acute to primary care was reinforced during pre-testing phases of our newly developed instrument where a group of diverse content experts and a separate group of patient advisors all agreed that this instrument is highly relevant and necessary.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA particular strength of our work was the rigorous pre-testing phases conducted to establish the content and face validity of the PREM instrument. We used the Cognitive Interviewing Reporting Framework (29) as well as the COSMIN checklist (30) to inform our work. Currently, there are no agreed upon standards for developing PREMs. Therefore, authors have begun using COSMIN tools which were generated to select, develop, and/or appraise patient-reported outcome measures (PROMs), to help inform similar research related to PREMs (7,28,47). Using transparent and standardized processes for developing PREM instruments helps improve the trustworthiness of these tools for uptake in research and healthcare quality improvement and evaluation. The rigour of our process is exemplified by the steps taken to ensure the developed PREM is relevant to various interest groups. The instrument was reviewed by content experts and patient advisors using structured methods; and these results were triangulated to inform revisions. To further enhance the rigor of our process and validate the results in the first phase of pre-testing, the revised instrument was also examined in a participant validation exercise with patient advisors; and results from this exercise were reinforced by a formal health literacy review.\u003c/p\u003e\n\u003cp\u003eAlthough a diversity of content experts and patient advisors were sought (e.g., mix of professional backgrounds of experts and mix of rural and urban patient advisors), all those involved currently reside in the same Canadian province (Alberta), which may limit generalizability and is a limitation of our work. However, by transparently publishing our process (including our interview guide and finalized survey from this process) other researchers and organizations can conduct additional testing and contextualization of this PREM instrument for use in other jurisdictions.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe development of this PREM instrument evaluating CTs from acute to primary care will better inform various interest groups on how different system changes impact the patient experience as they transition from hospital to home. This PREM will provide robust evidence on patient experiences during CTs to support quality improvement work and enhance integration of care. Psychometric testing of the PREM will be done as part of the ADAPT project aimed at improving CTs and integrating healthcare for adult patients with diverse chronic conditions.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCare transitions (CTs), patient-reported experience measures (PREMs), item content validity index (I-CVI), Institute of Medicine (IOM), A DiseAse-Inclusive Pathway for Transitions in Care (ADAPT), Alberta Health Service (AHS), Primary Health Care Integration Network (PHCIN), Home to Hospital to Home (H2H2H), COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), Research Electronic Data Capture (REDCap), United States (US), United Kingdom (UK), new Care Transitions Measure (CTM-NEW), Patient Continuity of Care Questionnaire (PCCQ), Integrated Care Survey (ICS), patient-reported outcome measures (PROMs).\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was designed and conducted according to the principles outlined in the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, which is also in accordance with the Declarations of Helsinki. This study\u0026nbsp;received approval from\u0026nbsp;the University of Alberta Health Research Ethics Board (ID: Pro0010674). Implied consent was used for content experts. Informed consent was obtained from participants before completing any interviews.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eN/A\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors declare they have no competing interests to this study\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is supported by an Alberta Innovates Partnership for Research and Innovation in the Health System Grant.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors’ contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSND conceived the research idea. Research study was designed by SF, JC, CC and SND. SH conducted the literature review. SF and JC conducted the cognitive interviews, the survey for relevance according to content experts, the participant validation exercise, and all data analysis. The manuscript was first drafted by SF, additional content and draft reviews were provided by JC, CC, SH, and SND. All authors reviewed and approved the final version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors wish to thank all content experts and patient advisors who took part in this study. Further, the authors wish to acknowledge Dr. Judy Seidel (Co-PI) for her contributions in conceiving the research idea for the overall ADAPT project.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eInstitute of Medicine (US) Committee on Quality of Health Care in America. 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Available from: https://pxjournal.org/journal/vol11/iss1/2\u003c/li\u003e\n\u003cli\u003eDoyle C, Lennox L, Bell D. A systematic review of evidence on the links between patient experience and clinical safety and effectiveness. BMJ Open [Internet]. 2013 Jan 1 [cited 2018 May 17];3(1):e001570. Available from: http://bmjopen.bmj.com/content/3/1/e001570\u003c/li\u003e\n\u003cli\u003eAhmed F, Burt J, Roland M. Measuring Patient Experience: Concepts and Methods. Patient [Internet]. 2014 Sep 1 [cited 2024 Apr 9];7(3):235\u0026ndash;41. Available from: https://doi.org/10.1007/s40271-014-0060-5\u003c/li\u003e\n\u003cli\u003eBull C, Byrnes J, Hettiarachchi R, Downes M. A systematic review of the validity and reliability of patient-reported experience measures. Health Services Research [Internet]. 2019 [cited 2024 Mar 30];54(5):1023\u0026ndash;35. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/1475-6773.13187\u003c/li\u003e\n\u003cli\u003eArmor BL, Wight AJ, Carter SM. 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J Am Geriatr Soc. 2015 Mar;63(3):548\u0026ndash;52. \u003c/li\u003e\n\u003cli\u003eBricard D, Or Z. Impact of early primary care follow-up after discharge on hospital readmissions. Eur J Health Econ [Internet]. 2019 Jun 1 [cited 2024 Aug 15];20(4):611\u0026ndash;23. Available from: https://doi.org/10.1007/s10198-018-1022-y\u003c/li\u003e\n\u003cli\u003eNguyen HQ, Baecker A, Ho T, Huynh DN, Watson HL, Li J, et al. Association between post-hospital clinic and telephone follow-up provider visits with 30-day readmission risk in an integrated health system. BMC Health Services Research [Internet]. 2021 Aug 17 [cited 2024 Aug 16];21(1):826. Available from: https://doi.org/10.1186/s12913-021-06848-9\u003c/li\u003e\n\u003cli\u003eSaxena FE, Bierman AS, Glazier RH, Wang X, Guan J, Lee DS, et al. Association of Early Physician Follow-up With Readmission Among Patients Hospitalized for Acute Myocardial Infarction, Congestive Heart Failure, or Chronic Obstructive Pulmonary Disease. 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Available from: https://doi.org/10.1186/s12873-022-00617-5\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 4 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Health care quality, access, and evaluation, Continuity of patient care, Measure development, Patient experience, Care transitions, Cognitive interviews","lastPublishedDoi":"10.21203/rs.3.rs-5596308/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5596308/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground. \u003c/strong\u003eCare transitions (CTs) from acute care to primary care are an important focus for improvement. Primary care plays a significant role in supporting successful CTs. However, there are few validated patient-reported experience measures (PREMs) on this topic. The purpose of this study is to develop a PREM to capture patients’ experiences of care while transitioning from acute to primary care.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods. \u003c/strong\u003eA preliminary instrument was developed through a literature review and concept mapping, followed by content validity testing with content experts (n = 6) by calculating item content validity index (I-CVI) scores and with patients (n = 6) by conducting cognitive interviews. The instrument was modified based on triangulation of results, then underwent a participant validation exercise (patients, n = 6) and formal health literacy review.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults. \u003c/strong\u003eThe literature review identified 13 potentially relevant PREM instruments, of which three addressed both CTs and primary care. None of the 3 instruments completely captured the concepts or time points of interest. The PREM developed for pre-testing contained 18 core items. All core items had I-CVI scores \u0026gt;0.78 (i.e., high relevance). Four broad themes were identified from the cognitive interviews: ‘Health Literacy’ (\u003cem\u003en\u003c/em\u003e= 10), ‘Clarity of Terms’ (\u003cem\u003en\u003c/em\u003e = 7), ‘Concept Measurement’ (\u003cem\u003en\u003c/em\u003e = 2), and ‘Ability to Comment’ (\u003cem\u003en\u003c/em\u003e = 4). Minor wording changes and clarification of definitions and instructions addressed most themes. All 18 core items met the criterion for agreement (\u003cu\u003e\u0026gt;\u003c/u\u003e 67%) during the participant validation exercise. Therefore, the final PREM instrument contains 18 core items plus 4 open-text options. The comparison of results from the participant validation exercise and health literacy review confirmed justification for revisions of instrument items.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion. \u003c/strong\u003eDeveloping this new PREM instrument which captures patient’ experiences as they move between acute and primary care, with a focus primary care’s supporting role is key to gaining understanding and improving CTs. Future research will further examine the psychometric properties of this PREM as part of a larger ongoing study.\u003c/p\u003e","manuscriptTitle":"Development of a survey instrument to measure patient experiences of care transitions from hospital to home with a focus on primary care’s role","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-03 08:05:26","doi":"10.21203/rs.3.rs-5596308/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"181335120488605941146250118827438316726","date":"2025-11-24T07:09:01+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-21T18:58:24+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-20T11:16:20+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"46898459227240505352081218243839788461","date":"2025-11-18T08:11:31+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"22730006516132578882518032087260080042","date":"2025-11-12T13:09:49+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"293956688371497220308090037508789900989","date":"2025-11-11T15:00:04+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"64396706468276004405480104252284200488","date":"2025-11-11T10:58:14+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-02-10T12:03:09+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"301968907279895935766486623749663219879","date":"2025-01-13T15:52:09+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"176177050500984052548920923370863312505","date":"2024-12-16T14:03:32+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-12-14T09:51:34+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-12-11T10:22:32+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-12-10T22:39:20+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-12-10T16:17:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2024-12-10T16:16:20+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"40e119ea-10bf-4c20-bd3b-b322fd56c3c3","owner":[],"postedDate":"April 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-04-03T08:05:26+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-03 08:05:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5596308","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5596308","identity":"rs-5596308","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}