Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA)
Abstract Background Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical tria...
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Research Involvement and Engagement |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40900-023-00539-x |
| _version_ | 1797276197115133952 |
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| author | Nicole Zhao Allison M. Cuthel Owen Storms Raina Zhang Rebecca Liddicoat Yamarik Jacob Hill Regina Kaur Kaitlyn Van Allen Mara Flannery Alex Chang Frank Chung Sumeet Randhawa Isabel Castro Alvarez Angela Young-Brinn Constance L. Kizzie-Gillett Dawn Rosini Eric D. Isaacs Ernest Hopkins Garrett K. Chan Juanita Booker-Vaughns Margaret Maguire Martha Navarro Neha Reddy Pidatala Patrick Dunn Pluscedia Williams Robert Galvin Romilla Batra Sally Welsh William Vaughan Jean-Baptiste Bouillon-Minois Corita R. Grudzen |
| author_facet | Nicole Zhao Allison M. Cuthel Owen Storms Raina Zhang Rebecca Liddicoat Yamarik Jacob Hill Regina Kaur Kaitlyn Van Allen Mara Flannery Alex Chang Frank Chung Sumeet Randhawa Isabel Castro Alvarez Angela Young-Brinn Constance L. Kizzie-Gillett Dawn Rosini Eric D. Isaacs Ernest Hopkins Garrett K. Chan Juanita Booker-Vaughns Margaret Maguire Martha Navarro Neha Reddy Pidatala Patrick Dunn Pluscedia Williams Robert Galvin Romilla Batra Sally Welsh William Vaughan Jean-Baptiste Bouillon-Minois Corita R. Grudzen |
| author_sort | Nicole Zhao |
| collection | DOAJ |
| description | Abstract Background Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. Methods A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project’s duration. Results The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. Conclusions Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. Trial Registration: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017. |
| first_indexed | 2024-03-07T15:24:54Z |
| format | Article |
| id | doaj.art-8814e81ad8b344d6891545a61e249748 |
| institution | Directory Open Access Journal |
| issn | 2056-7529 |
| language | English |
| last_indexed | 2024-03-07T15:24:54Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Research Involvement and Engagement |
| spelling | doaj.art-8814e81ad8b344d6891545a61e2497482024-03-05T17:08:50ZengBMCResearch Involvement and Engagement2056-75292024-01-0110111710.1186/s40900-023-00539-xAdvancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA)Nicole Zhao0Allison M. Cuthel1Owen Storms2Raina Zhang3Rebecca Liddicoat Yamarik4Jacob Hill5Regina Kaur6Kaitlyn Van Allen7Mara Flannery8Alex Chang9Frank Chung10Sumeet Randhawa11Isabel Castro Alvarez12Angela Young-Brinn13Constance L. Kizzie-Gillett14Dawn Rosini15Eric D. Isaacs16Ernest Hopkins17Garrett K. Chan18Juanita Booker-Vaughns19Margaret Maguire20Martha Navarro21Neha Reddy Pidatala22Patrick Dunn23Pluscedia Williams24Robert Galvin25Romilla Batra26Sally Welsh27William Vaughan28Jean-Baptiste Bouillon-Minois29Corita R. Grudzen30Renaissance School of Medicine at Stony, Brook UniversityRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineDepartment of Medicine, Tibor Rubin Long Beach Veteran AffairsRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineCharles R. Drew University of Medicine and ScienceLillie’s Circle of CareUniversity of Florida Shands HospitalDepartment of Emergency Medicine, University of California San FranciscoThe Phoenix Group FoundationHealthImpactCharles R. Drew University of Medicine and ScienceCambia Health SolutionsCharles R. Drew University of Medicine and ScienceAmerican Cancer SocietyAmerican Heart AssociationCharles R. Drew University of Medicine and ScienceThe Blackstone GroupSenior Care Action Network (SCAN) Health PlanHospice and Palliative Nurses AssociationPatient AdvocacyRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of MedicineDivision of Supportive and Acute Care Services, Memorial Sloan Kettering Cancer CenterAbstract Background Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. Methods A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project’s duration. Results The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. Conclusions Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. Trial Registration: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.https://doi.org/10.1186/s40900-023-00539-xStudy Advisory CommitteePalliative careStakeholder participationResearch designPatient and public involvement |
| spellingShingle | Nicole Zhao Allison M. Cuthel Owen Storms Raina Zhang Rebecca Liddicoat Yamarik Jacob Hill Regina Kaur Kaitlyn Van Allen Mara Flannery Alex Chang Frank Chung Sumeet Randhawa Isabel Castro Alvarez Angela Young-Brinn Constance L. Kizzie-Gillett Dawn Rosini Eric D. Isaacs Ernest Hopkins Garrett K. Chan Juanita Booker-Vaughns Margaret Maguire Martha Navarro Neha Reddy Pidatala Patrick Dunn Pluscedia Williams Robert Galvin Romilla Batra Sally Welsh William Vaughan Jean-Baptiste Bouillon-Minois Corita R. Grudzen Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA) Research Involvement and Engagement Study Advisory Committee Palliative care Stakeholder participation Research design Patient and public involvement |
| title | Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA) |
| title_full | Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA) |
| title_fullStr | Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA) |
| title_full_unstemmed | Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA) |
| title_short | Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA) |
| title_sort | advancing patient centered research practices in a pragmatic patient level randomized clinical trial a thematic analysis of stakeholder engagement in emergency medicine palliative care access empalla |
| topic | Study Advisory Committee Palliative care Stakeholder participation Research design Patient and public involvement |
| url | https://doi.org/10.1186/s40900-023-00539-x |
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