Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer
Introduction Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers...
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BMJ Publishing Group
2020-07-01
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| Series: | BMJ Open |
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| author | Yuchiao Chang Joshua R Lakin James A Tulsky Elise N Brannen Michael K Paasche-Orlow Charlotta Lindvall Daniel A Gundersen Areej El-Jawahri Angelo Volandes Julie Goldman Brian Sipin Michael J Barry Kathryn I Pollak Miji Sofela Danielle Kennedy S. Yousuf Zafar Maria Torroella Carney Diana Martins-Welch Michael Qiu Jody-Ann McLeggon Craig E Devoe Jon C. Tilburt Charles L Loprinzi Parvez A. Rahman Jeremiah J. Stout Aretha Delight Davis Lisa M. Quintiliani |
| author_facet | Yuchiao Chang Joshua R Lakin James A Tulsky Elise N Brannen Michael K Paasche-Orlow Charlotta Lindvall Daniel A Gundersen Areej El-Jawahri Angelo Volandes Julie Goldman Brian Sipin Michael J Barry Kathryn I Pollak Miji Sofela Danielle Kennedy S. Yousuf Zafar Maria Torroella Carney Diana Martins-Welch Michael Qiu Jody-Ann McLeggon Craig E Devoe Jon C. Tilburt Charles L Loprinzi Parvez A. Rahman Jeremiah J. Stout Aretha Delight Davis Lisa M. Quintiliani |
| author_sort | Yuchiao Chang |
| collection | DOAJ |
| description | Introduction Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by the COVID-19 pandemic.Methods and analysis The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly study is a pragmatic, stepped-wedge cluster randomised trial examining a Comprehensive ACP Program. The programme combines two complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions). We will implement the programme at 36 oncology clinics across three unique US health systems. Our primary outcome is the proportion of eligible patients with ACP documentation completed in the electronic health record. Our secondary outcomes include resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy. From a subset of our patient population, we will collect surveys and video-based declarations of goals and preferences. We estimate 11 000 patients from the three sites will be enrolled in the study.Ethics and dissemination Regulatory and ethical aspects of this trial include Institutional Review Board (IRB) approval via single IRB of record mechanism at Dana-Farber Cancer Institute, Data Use Agreements among partners and a Data Safety and Monitoring Board. We plan to present findings at national meetings and publish the results.Trial registration number NCT03609177; Pre-results. |
| format | Article |
| id | doaj-art-95fd03f0d5b44ae0a30af5e4db2619fb |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-95fd03f0d5b44ae0a30af5e4db2619fb2025-08-20T02:30:43ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2020-040999Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancerYuchiao Chang0Joshua R Lakin1James A Tulsky2Elise N Brannen3Michael K Paasche-Orlow4Charlotta Lindvall5Daniel A Gundersen6Areej El-Jawahri7Angelo Volandes8Julie GoldmanBrian SipinMichael J Barry9Kathryn I PollakMiji SofelaDanielle KennedyS. Yousuf ZafarMaria Torroella CarneyDiana Martins-Welch10Michael QiuJody-Ann McLeggonCraig E DevoeJon C. TilburtCharles L LoprinziParvez A. RahmanJeremiah J. StoutAretha Delight Davis11Lisa M. QuintilianiDepartment of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USADepartment of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA1 Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA1 Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USABoston University School of Medicine, Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts, USADepartment of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USASurvey and Data Management Core, Dana-Farber Cancer Institute, Boston, Massachusetts, USA2 Harvard Medical School, Boston, Massachusetts, USAHarvard Medical School, Boston, Massachusetts, USA4 Harvard Medical School, Boston, Massachusetts, USADepartment of Palliative Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USAACP Decisions, Waban, Massachusetts, USAIntroduction Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by the COVID-19 pandemic.Methods and analysis The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly study is a pragmatic, stepped-wedge cluster randomised trial examining a Comprehensive ACP Program. The programme combines two complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions). We will implement the programme at 36 oncology clinics across three unique US health systems. Our primary outcome is the proportion of eligible patients with ACP documentation completed in the electronic health record. Our secondary outcomes include resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy. From a subset of our patient population, we will collect surveys and video-based declarations of goals and preferences. We estimate 11 000 patients from the three sites will be enrolled in the study.Ethics and dissemination Regulatory and ethical aspects of this trial include Institutional Review Board (IRB) approval via single IRB of record mechanism at Dana-Farber Cancer Institute, Data Use Agreements among partners and a Data Safety and Monitoring Board. We plan to present findings at national meetings and publish the results.Trial registration number NCT03609177; Pre-results.https://bmjopen.bmj.com/content/10/7/e040999.full |
| spellingShingle | Yuchiao Chang Joshua R Lakin James A Tulsky Elise N Brannen Michael K Paasche-Orlow Charlotta Lindvall Daniel A Gundersen Areej El-Jawahri Angelo Volandes Julie Goldman Brian Sipin Michael J Barry Kathryn I Pollak Miji Sofela Danielle Kennedy S. Yousuf Zafar Maria Torroella Carney Diana Martins-Welch Michael Qiu Jody-Ann McLeggon Craig E Devoe Jon C. Tilburt Charles L Loprinzi Parvez A. Rahman Jeremiah J. Stout Aretha Delight Davis Lisa M. Quintiliani Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer BMJ Open |
| title | Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer |
| title_full | Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer |
| title_fullStr | Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer |
| title_full_unstemmed | Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer |
| title_short | Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer |
| title_sort | advance care planning promoting effective and aligned communication in the elderly acp peace the study protocol for a pragmatic stepped wedge trial of older patients with cancer |
| url | https://bmjopen.bmj.com/content/10/7/e040999.full |
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