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.
- palliative care
- medical education & training
- information management
- adult palliative care
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Collaborators The ACP-PEACE Investigators: Julie Goldman, MSW, MS; Brian Sipin, BSc; Michael J Barry, MD; Kathryn I Pollak, PhD; Miji Sofela, MBChB; Danielle Kennedy, MPH; S. Yousuf Zafar, MD; Maria Torroella Carney, MD; Diana Martins-Welch, MD; Michael Qiu, MD, PhD; Jody-Ann McLeggon, MPH; Craig E Devoe, MD; Jon C. Tilburt, MD; Charles L Loprinzi, MD; Parvez A. Rahman, MHI; Jeremiah J. Stout, BA; Aretha Delight Davis, MD, JD; and Lisa M. Quintiliani, PhD
Contributors Study concept and design: AV and JAT. Acquisition of data: JRL, ENB, CL, DAG and The ACP-Peace Investigators. Analysis and interpretation of data: JRL, CL, DAG, YC, JAT, MKP-O, AE-J and AV. Drafting of the manuscript: JRL, ENB, JAT, MKP-O, CL, YC, DAG, AE-J, The ACP-PEACE Investigators and AV. Critical revision of the manuscript for important intellectual content: JRL, ENB and AV. Statistical analysis: YC. Obtained funding: AV and JAT. Administrative, technical or material support: ENB and The ACP-PEACE Investigators. Study supervision: AV and JAT.
Funding Research reported in this publication was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by cooperative agreement UH3AG060626 from the National Institute on Aging. This work also received logistical and technical support from the NIH Collaboratory Coordinating Center through cooperative agreement U24AT009676.
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Competing interests JRL receives funding from the Cambia Health Foundation as part of the Sojourns Scholars Leadership Program. Dr. Barry receives grant support through Massachusetts General Hospital from Healthwise, a nonprofit patient education and decision support organization. Dr. Davis is the CEO of ACP Decisions, a non-profit private foundation. JAT is a Founding Director of VitalTalk, a non-profit organization focused on clinician communication skills training, from which he receives no compensation. AV has a financial interest in ACP Decisions Nous, a non-profit organization developing ACP video decision support tools. His interests were reviewed and are managed by Massachusetts General Hospital and Partners HealthCare in accordance with their conflict of interest policies.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.