Healthcare-The Journal of Delivery Science and Innovation最新文献

{"title":"Health system-based housing navigation for patients experiencing homelessness: A new care coordination framework","authors":"David E. Velasquez ,&nbsp;Keizra Mecklai ,&nbsp;Sajen Plevyak ,&nbsp;Brendan Eappen ,&nbsp;Katherine A. Koh ,&nbsp;Alister F. Martin","doi":"10.1016/j.hjdsi.2021.100608","DOIUrl":"10.1016/j.hjdsi.2021.100608","url":null,"abstract":"<div><p><span>Patients experiencing homelessness are among the most disadvantaged in our society, suffering from poor health outcomes and exhibiting disproportionately high hospital utilization and spending. However, to date, hospitals have only scantily devoted time or resources to the housing coordination aspect of homelessness. Implementing better systems to coordinate housing for patients experiencing homelessness may improve health outcomes and reduce health care utilization<span> for this population. This objective is now more important than ever as the economic impact of COVID-19 is expected to exacerbate the homelessness crisis. Ensuring that patients are properly connected to temporary or permanent housing is valuable to patient health, health care system metrics such as excess spending and utilization, and provider performance under </span></span>Accountable Care Organizations or other risk-bearing payment models. Here, we propose a health systems-based housing coordination framework that may improve care delivery for patients experiencing homelessness. This framework relies on the coordination between dedicated hospital-based housing navigators who can identity patients experiencing homelessness and outpatient housing navigators equipped to coordinate short- and long-term housing specifically for patients experiencing homelessness who frequently interact with the health care system.</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"10 1","pages":"Article 100608"},"PeriodicalIF":2.5,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39886328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Providing support in a pandemic: A medical student telehealth service for ambulatory patients with COVID-19","authors":"Annie Zhang ,&nbsp;Matthew GoodSmith ,&nbsp;Steven Server ,&nbsp;Sophia Uddin ,&nbsp;Moira McNulty ,&nbsp;Renslow Sherer ,&nbsp;Jonathan Lio","doi":"10.1016/j.hjdsi.2022.100612","DOIUrl":"10.1016/j.hjdsi.2022.100612","url":null,"abstract":"<div><p>During the early months of the COVID-19 pandemic, when health systems were overwhelmed with surging hospitalizations and a novel virus, many ambulatory patients diagnosed with COVID-19 lacked guidance and support as they convalesced at home. This case report offers insight into the implementation of a telehealth service utilizing third- and fourth-year medical students to provide follow-up to ambulatory patients diagnosed with COVID-19. The service was evaluated using medical student surveys and retrospective chart review to assess the clinical and social needs of patients during the spring of 2020. Students assessed symptoms for 416 patients with COVID-19 from April 8 to May 20 and provided clinical information and resources. Eighteen percent of these patients sought higher levels of medical care, in part from student referrals. Three key implementation lessons from this experience that may be relevant for others include: 1) Vulnerable patient populations face unique stressors exacerbated by the pandemic and may benefit from intensive follow-up after COVID-19 diagnosis to address both medical and social needs; 2) Medical students can play value-added roles in providing patient education to prevent the spread of COVID-19, assisting patients with escalating care or resource connection, and providing emotional support to those who have lost loved ones; 3) Continuous re-assessment of the intervention was important to address evolving patient needs during the COVID-19 outbreak. Future work should focus on identifying high-risk patient populations and tailoring follow-up interventions to meet the unique needs of these patient populations.</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"10 1","pages":"Article 100612"},"PeriodicalIF":2.5,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8758284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39849243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mental health care integration and primary care patient experience in the Veterans Health Administration","authors":"Lucinda B. Leung ,&nbsp;Danielle Rose ,&nbsp;Rong Guo ,&nbsp;Catherine E. Brayton ,&nbsp;Lisa V. Rubenstein ,&nbsp;Susan Stockdale","doi":"10.1016/j.hjdsi.2021.100587","DOIUrl":"10.1016/j.hjdsi.2021.100587","url":null,"abstract":"<div><h3>Background</h3><p>Mental health specialists and care managers facilitate comprehensive care provision within medical homes. Despite implementation challenges, mental health integration is thought to improve patient-centered primary care.</p></div><div><h3>Objectives</h3><p>To examine the relationship between primary care patient experience and mental health integration.</p></div><div><h3>Research design</h3><p>Cross-sectional surveys from 168 primary care clinicians (PCPs) (n = 226) matched with assigned patients’ surveys (n = 1734) in one Veterans Health Administration (VA) region, fiscal years 2012–2013. Multilevel regression models examined patient experience and mental health integration, adjusting for patient and PCP characteristics.</p></div><div><h3>Measures</h3><p>Patient experience outcomes were (1) experience with PCP and (2) receipt of comprehensive care, such as talked about “stress”. Independent variables represented mental health integration— (1) PCP-rated communication with mental health and (2) proportion of clinic patients who saw integrated specialists.</p></div><div><h3>Results</h3><p>50% and 43% of patients rated their PCPs 10/10 and reported receiving comprehensive care, respectively. Neither patient experience or receipt of comprehensive care was significantly associated with PCP's ratings of communication with mental health, nor with proportion of clinic patients who saw integrated specialists. Among a subsample of patients who rated their mental health as poor/fair, however, we detected an association between proportion of clinic patients who saw integrated specialists and patient experience (odds ratio = 1.05, 95% confidence interval = 1.01–1.09, p = .01).</p></div><div><h3>Conclusions</h3><p>No association was observed between mental health integration and primary care patients’ reported care experiences, but a significant association existed among patients who reported poor/fair mental health. More research is needed to understand patient experiences with regard to care model implementation.</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100587"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39481105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Applying behavioral science insights to medical management strategies: the role of validation testing","authors":"Irene Y. Zhang ,&nbsp;Joshua M. Liao","doi":"10.1016/j.hjdsi.2021.100582","DOIUrl":"10.1016/j.hjdsi.2021.100582","url":null,"abstract":"","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100582"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.hjdsi.2021.100582","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39409165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application of the Quadruple Aim to evaluate the operational impact of a telemedicine program","authors":"Neil M. Kalwani ,&nbsp;Katherine M. Wang ,&nbsp;Austin N. Johnson ,&nbsp;Jahnavi D. Deb ,&nbsp;Thomas Gold ,&nbsp;Akhil K. Maddukuri ,&nbsp;Emily G. Savage ,&nbsp;Vijaya Parameswaran ,&nbsp;Rajesh Dash ,&nbsp;David Scheinker ,&nbsp;Fatima Rodriguez","doi":"10.1016/j.hjdsi.2021.100593","DOIUrl":"10.1016/j.hjdsi.2021.100593","url":null,"abstract":"<div><h3>Background</h3><p>In response to the COVID-19 pandemic, telemedicine utilization has increased dramatically, yet most institutions lack a standardized approach to determine how much to invest in these programs.</p></div><div><h3>Methods</h3><p>We used the Quadruple Aim to evaluate the operational impact of CardioClick, a program replacing in-person follow-up visits with video visits in a preventive cardiology clinic. We examined data for 134 patients enrolled in CardioClick with 181 video follow-up visits and 276 patients enrolled in the clinic's traditional prevention program with 694 in-person follow-up visits.</p></div><div><h3>Results</h3><p>Patients in CardioClick and the cohort receiving in-person care were similar in terms of age (43 vs 45 years), gender balance (74% vs 79% male), and baseline clinical characteristics. Video follow-up visits were shorter than in-person visits in terms of clinician time (median 22 vs 30 min) and total clinic time (median 22 vs 68 min). Video visits were more likely to end on time than in-person visits (71 vs 11%, p &lt; .001). Physicians more often completed video visit documentation on the day of the visit (56 vs 42%, p = .002).</p></div><div><h3>Conclusions</h3><p>Implementation of video follow-up visits in a preventive cardiology clinic was associated with operational improvements in the areas of efficiency, patient experience, and clinician experience. These benefits in three domains of the Quadruple Aim justify expanded use of telemedicine at our institution.</p></div><div><h3>Implications</h3><p>The Quadruple Aim provides a framework to evaluate telemedicine programs recently implemented in many health systems.</p></div><div><h3>Level of evidence</h3><p>Level III (retrospective comparative study).</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100593"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8570264/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39600788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sustaining effective research/operational collaborations: Lessons learned from a National Partnered Evaluation Initiative","authors":"Nicholas W. Bowersox ,&nbsp;Veronica Williams ,&nbsp;Linda Kawentel ,&nbsp;Amy M. Kilbourne","doi":"10.1016/j.hjdsi.2021.100588","DOIUrl":"10.1016/j.hjdsi.2021.100588","url":null,"abstract":"<div><h3>Introduction</h3><p>Effective research-operational partnerships require that researchers ask questions targeting top clinical operational priorities. However, disconnects exist between healthcare researchers and operational leadership that result in significant delays between discovery and implementation of breakthroughs in healthcare.</p></div><div><h3>Objective</h3><p>Using the Veterans Health Administration Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (PEI) as a case study, we identified relationship characteristics of collaborative research projects designed to address the research/operations gap.</p></div><div><h3>Methods</h3><p>An interview guide was developed focusing on areas identified as essential for effective research/operational partnerships from previous research. Investigators (N = 14) and their operational leadership partners (N = 14) representing 16 PEIs were interviewed by phone related to the characteristics of their partnerships. All investigators had had advanced degrees in fields related to healthcare delivery and administration and were affiliated with VHA research institutes. All operational partners served in national leadership roles within VHA operational offices. Detailed interview notes collected from interviews were coded and themes identified using thematic analysis.</p></div><div><h3>Results</h3><p>Eight relationship themes were identified: leadership support, shared understanding, investment, trust, agreement on products, mutual benefit, adaptability, and collaboration. Most operational and investigator partners discussed the importance of leadership support, shared understanding, investment, trust and product agreement, suggesting that these may be more essential than other areas in supporting effective operations/research collaborations. One theme (mutual benefit) was mentioned by most investigators but only some operations partners, pointing to potential differences related to this area between the two groups. Facilitators of effective collaboration included obtaining formal leadership support, developing a shared understanding of partner priorities and needs, ongoing discussions about resource needs, expanding collaborations beyond the initial project, having a clearly defined plan, planning for flexibility, plans for regular communication, and active participation in project meetings.</p></div><div><h3>Conclusions</h3><p>Partnership characteristics that facilitate effective collaboration include leadership support, shared understanding of planned work, investment, trust, and product agreement. Future research should assess the overall impact of partnered approaches to healthcare improvement within other large healthcare systems.</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100588"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39911855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the quality of randomization methods in randomized control trials","authors":"Deborah Lai ,&nbsp;Daniel Wang ,&nbsp;Matthew McGillivray ,&nbsp;Shadi Baajour ,&nbsp;Ali S Raja ,&nbsp;Shuhan He","doi":"10.1016/j.hjdsi.2021.100570","DOIUrl":"10.1016/j.hjdsi.2021.100570","url":null,"abstract":"<div><h3>Importance</h3><p><span>The randomization process is considered among the most important components of a randomized control trial<span> (RCTs) and a core advantage of RCTs. Proper randomization should eliminate most population biases, in which some populations, or members of a population are more likely to be selected or not selected than others, such that similar comparison groups are produced to evaluate treatments.</span></span><span>⁴</span>^,<span>⁵</span></p></div><div><h3>Objective</h3><p>To assess the methodologic quality of the descriptions of randomization methods used to allocate participants to comparison groups in randomized controlled trials.</p></div><div><h3>Evidence review</h3><p><span>A cross-sectional review of phase 3 clinical trials reported in </span><span>Clinicaltrials.gov</span><svg><path></path></svg>.</p><p><span>Beginning at all records available (n = 345,278) we included studies only listed for stage 3 RCTs in the U.S. National Library of Medicine database. A total of 1528 protocols were identified as of June 1, 2020. Exclusion criteria involved no protocol listed or non-randomized studies, of which 517 were excluded. There were 693 text articles excluded due to unclear methods of randomization. Inclusion criteria involved randomization methods based on “A review of randomization methods in clinical trials” by Berger and Antsygina.</span><span>1</span></p><p>Each study protocol was extracted to identify the randomization methods described by three independent reviewers. Classification of randomization methods described in the study protocols for randomized clinical trials.</p></div><div><h3>Findings</h3><p>Only 20.8 % of the study protocols described a method for randomly assigning participants to groups. Of this subset that defined protocols, the Permuted-Block Design was used most often (85.9 %). More than three quarters of all study protocols (77.7 %) provided incomplete descriptions about the type of randomization method (i.e. no protocol, n/a, unclear).</p></div><div><h3>Conclusions</h3><p>and Relevance:Proper randomization is required to generate unbiased comparison groups in controlled trials, yet the majority of study protocols for RCTs currently in <span>Clinicaltrials.gov</span><svg><path></path></svg> provide inadequate or unacceptable information regarding their randomization methods.</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100570"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.hjdsi.2021.100570","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39272085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing a person-centered, population based measure of “home time”: Perspectives of older patients and unpaid caregivers","authors":"Nina R. Sperber ,&nbsp;Abigail Shapiro ,&nbsp;Nathan A. Boucher ,&nbsp;Kasey P. Decosimo ,&nbsp;Megan Shepherd-Banigan ,&nbsp;Chelsea Whitfield ,&nbsp;Susan N. Hastings ,&nbsp;Courtney H. Van Houtven","doi":"10.1016/j.hjdsi.2021.100591","DOIUrl":"10.1016/j.hjdsi.2021.100591","url":null,"abstract":"<div><p>Measuring “home time,” number of days not in facility-based care, with medical claims is a promising approach to assess person-centered outcomes on a population level. Generally, spending more time at home matches long-term care preferences and improves quality of life<span>. However, existing “home time” measures have not incorporated key stakeholder perspectives. We sought to understand how patients and family caregivers<span> value time spent in diverse facility-based health care settings (Emergency Department, Nursing Home, Post-Acute Care/Skilled Nursing, Inpatient Hospital) to help determine whether various settings have different effects on quality of life and thus merit different weighting in a “home time” measure. We conducted three focus groups among patients and family caregivers within the U.S. Veterans Health Care System. We identified themes pertaining to patients’ quality of life in each of the four facility-based care settings. Discussions about both emergency department and post-acute/skilled nursing care reflected loss of personal control, counterbalanced by temporary stay. Inpatient hospital care evoked discussion about greater loss of personal control due to the intensity of care. Nursing homes ultimately signified decline. These findings illuminate differences in quality of life across health-care settings and help justify the need for different weights in a measure of “home time.”</span></span></p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100591"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10064480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leadership communication, stress, and burnout among frontline emergency department staff amid the COVID-19 pandemic: A mixed methods approach","authors":"Rohit B. Sangal MD, MBA ,&nbsp;Alexandra Bray ,&nbsp;Eleanor Reid MD ,&nbsp;Andrew Ulrich MD ,&nbsp;Beth Liebhardt RN, MSN ,&nbsp;Arjun K. Venkatesh MD, MBA, MHS ,&nbsp;Marissa King PhD","doi":"10.1016/j.hjdsi.2021.100577","DOIUrl":"10.1016/j.hjdsi.2021.100577","url":null,"abstract":"<div><h3>Background</h3><p>Organizations have a key role to play in supporting healthcare workers (HCWs) and mitigating stress during COVID-19. We aimed to understand whether perceptions of support and communication by local leadership were associated with reduced reports of stress and burnout among frontline HCWs.</p></div><div><h3>Methods</h3><p>We conducted cross-sectional surveys embedded within emergency department (ED) workflow during the first wave of COVID-19 from April 9, 2020 to June 15th, 2020 within three EDs of a multisite health system in the Northeast United States. All ED HCWs were administered electronic surveys during shift via text message. We simultaneously conducted 64 qualitative interviews to better characterize and validate survey responses. Primary survey outcomes were levels of work stress and burnout.</p></div><div><h3>Results</h3><p>Over 10 week study, 327 of 431 (76%) frontline HCWs responded to at least one round of the survey. More useful communication mediated through higher perception of support was significantly associated with lower work stress (<em>B</em> = −0.33, p &lt; 0.001) and burnout (<em>B</em> = −7.84, p &lt; 0.001). A one-point increase on the communication Likert scale was associated with a 9% reduction in stress and a 19% reduction in burnout. Three themes related to effective crisis communication during COVID-19 emerged in interviews: (1) information consolidation prior to dissemination, (2) consistency of communication, and (3) bi-directional communication.</p></div><div><h3>Conclusion</h3><p>This work suggests that effective local leadership communication, characterized by information consolidation, consistency, and bi-directionality, leads to higher perceptions of support and lower stress and burnout among ED frontline workers. As the pandemic continues, these results present an evidence-based framework for leaders to support frontline HCWs through effective crisis communication.</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100577"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.hjdsi.2021.100577","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39327567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research","authors":"Stephanie R. Morain ,&nbsp;Debra J.H. Mathews ,&nbsp;Gail Geller ,&nbsp;Juli Bollinger ,&nbsp;Kevin Weinfurt ,&nbsp;Jeffrey G. Jarvik ,&nbsp;Elizabeth May ,&nbsp;Jeremy Sugarman","doi":"10.1016/j.hjdsi.2021.100586","DOIUrl":"10.1016/j.hjdsi.2021.100586","url":null,"abstract":"<div><p>While the embedded nature of pragmatic clinical trials (PCTs) can improve the efficiency and relevance of research for multiple stakeholders, embedding research into ongoing clinical care can also involve ethical and regulatory challenges. An emergent challenge is the management of pragmatic clinical trial collateral findings (PCT-CFs). While PCT-CFs share some features with incidental or secondary findings that are encountered in conventional clinical trials and clinical care, the PCT context differs in ethically relevant ways that complicate PCT-CF identification and management. We report on the results of a two-year multi-method investigation of PCT-CFs. Overall, five core themes emerged: 1) the liminal nature of PCTs and the implications of this for PCT-CFs; 2) the context-specific nature of PCT-CF management; 3) the centrality of institutions; 4) the importance of prospective planning; and 5) patient expectations. Among the central lessons of this work are that prior ethics guidance from other settings cannot easily be adapted to address PCT-CFs, nor can a single approach readily accommodate all PCT-CFs. Moving forward, stakeholders, including researchers, institutions, ethics oversight bodies, and funders, should anticipate and plan for PCT-CFs in the design, conduct, and analysis of PCTs. Future scholarship is needed to examine experiences with PCT-CFs, and the practical and conceptual issues they raise for the future conduct of PCTs.</p></div>","PeriodicalId":29963,"journal":{"name":"Healthcare-The Journal of Delivery Science and Innovation","volume":"9 4","pages":"Article 100586"},"PeriodicalIF":2.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39479584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}