Show simple item record

dc.contributor.authorTjia, Jennifer
dc.contributor.authorClayton, Margaret
dc.contributor.authorChiriboga, German
dc.contributor.authorStaples, Brooke
dc.contributor.authorPuerto, Geraldine
dc.contributor.authorRappaport, Lynley
dc.contributor.authorDeSanto-Madeya, Susan
dc.date2022-08-11T08:09:59.000
dc.date.accessioned2022-08-23T16:51:29Z
dc.date.available2022-08-23T16:51:29Z
dc.date.issued2021-04-30
dc.date.submitted2021-07-26
dc.identifier.citation<p>Tjia J, Clayton M, Chiriboga G, Staples B, Puerto G, Rappaport L, DeSanto-Madeya S. Stakeholder-engaged process for refining the design of a clinical trial in home hospice. BMC Med Res Methodol. 2021 Apr 30;21(1):92. doi: 10.1186/s12874-021-01275-0. PMID: 33941089; PMCID: PMC8091786. <a href="https://doi.org/10.1186/s12874-021-01275-0">Link to article on publisher's site</a></p>
dc.identifier.issn1471-2288 (Linking)
dc.identifier.doi10.1186/s12874-021-01275-0
dc.identifier.pmid33941089
dc.identifier.urihttp://hdl.handle.net/20.500.14038/41866
dc.description.abstractBACKGROUND: Clinical trials in home hospice settings are important to build the evidence base for practice, but balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is challenging. A stakeholder-engaged process can help inform and refine key aspects of home hospice clinical trials. The aim of this study was to describe a stakeholder-engaged process to refine, design, and implement aspects of an educational intervention trial in home hospice, including recommendations for refining intervention content and delivery, recruitment and enrollment strategies, and content and frequency of outcome measurement. METHODS: A panel of interprofessional (1 hospice administrator, 3 nurses, 2 physicians, 2 pharmacists) and 2 former family caregiver stakeholders was systematically selected and invited to participate based on expertise, representing 2 geographically distinct hospices who were participating in the clinical trial. Teleconferences followed a predetermined procedural sequence: 1. pre-meeting materials distribution and review; 2. pre-meeting email solicitation of concerns in response to materials; 3. teleconference with structured and guided discussion; and 4. documentation and distribution of minutes for accuracy review and future meeting guidance. Discussion topics were distinct for each panel meeting. Written reflections on the stakeholder engagement process were collected from panel members to further refine our process. RESULTS: Five initial biweekly teleconferences resulted in recommendations for recruitment strategy, enrollment process, measurement frequency, patient inclusion, and primary care physician notification of the patient's trial involvement. The panel continues to participate in quarterly teleconferences to review progress and unexpected questions and concerns. Panelist reflections reveal personal and professional benefit from participation. CONCLUSIONS: An interprofessional stakeholder process is feasible and invaluable for developing home hospice intervention studies, contributing to better science, successful trial implementation, and relevant, valid outcomes. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03972163 , Registered June 3, 2019.
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=33941089&dopt=Abstract">Link to Article in PubMed</a></p>
dc.rightsCopyright © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectClinical trial
dc.subjectDeprescribing
dc.subjectHome hospice
dc.subjectOutcome measurement
dc.subjectStakeholder
dc.subjectClinical Trials
dc.subjectHealth Services Administration
dc.subjectHealth Services Research
dc.titleStakeholder-engaged process for refining the design of a clinical trial in home hospice
dc.typeJournal Article
dc.source.journaltitleBMC medical research methodology
dc.source.volume21
dc.source.issue1
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=5703&amp;context=oapubs&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/oapubs/4671
dc.identifier.contextkey24025207
refterms.dateFOA2022-08-23T16:51:29Z
html.description.abstract<p>BACKGROUND: Clinical trials in home hospice settings are important to build the evidence base for practice, but balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is challenging. A stakeholder-engaged process can help inform and refine key aspects of home hospice clinical trials. The aim of this study was to describe a stakeholder-engaged process to refine, design, and implement aspects of an educational intervention trial in home hospice, including recommendations for refining intervention content and delivery, recruitment and enrollment strategies, and content and frequency of outcome measurement.</p> <p>METHODS: A panel of interprofessional (1 hospice administrator, 3 nurses, 2 physicians, 2 pharmacists) and 2 former family caregiver stakeholders was systematically selected and invited to participate based on expertise, representing 2 geographically distinct hospices who were participating in the clinical trial. Teleconferences followed a predetermined procedural sequence: 1. pre-meeting materials distribution and review; 2. pre-meeting email solicitation of concerns in response to materials; 3. teleconference with structured and guided discussion; and 4. documentation and distribution of minutes for accuracy review and future meeting guidance. Discussion topics were distinct for each panel meeting. Written reflections on the stakeholder engagement process were collected from panel members to further refine our process.</p> <p>RESULTS: Five initial biweekly teleconferences resulted in recommendations for recruitment strategy, enrollment process, measurement frequency, patient inclusion, and primary care physician notification of the patient's trial involvement. The panel continues to participate in quarterly teleconferences to review progress and unexpected questions and concerns. Panelist reflections reveal personal and professional benefit from participation.</p> <p>CONCLUSIONS: An interprofessional stakeholder process is feasible and invaluable for developing home hospice intervention studies, contributing to better science, successful trial implementation, and relevant, valid outcomes.</p> <p>TRIAL REGISTRATION: Clinicaltrials.gov, NCT03972163 , Registered June 3, 2019.</p>
dc.identifier.submissionpathoapubs/4671
dc.contributor.departmentDepartment of Population and Quantitative Health Sciences
dc.source.pages92


Files in this item

Thumbnail
Name:
s12874_021_01275_0.pdf
Size:
697.9Kb
Format:
PDF

This item appears in the following Collection(s)

Show simple item record

Copyright © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Except where otherwise noted, this item's license is described as Copyright © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.