Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly
NCT ID: NCT03609177
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
13800 participants
INTERVENTIONAL
2020-04-15
2024-09-30
Brief Summary
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\- It is expected that about 30,000 people will take part in this research study, 29,550 of these patients, the vast majority, will be included only for medical record review.
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Detailed Description
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This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants.
\- This study will involve medical record review of 30,000 people age 65 or older with advanced cancer.
We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct a survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences.
During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 30,000 subjects for the primary outcome at 30 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Advance Care Planning
-Survey:
* A group of older patients with advanced cancer (N=450) will have a survey over the course of the 36 months of recruitment.
* Participants will be provided written copies of the questions to follow along during the interviews
Clinician Communication Skills Training
Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids
Advance Care Planning-Video Declaration
Video Declaration:
* From among this group of 450 participants, the video declaration of preferences activity will be conducted with 240 patients.
* For those participants that agree to the video declaration, they will proceed with recording of their video declarations
* The RA will begin by reading a standardized introduction to aid the subject do the video
Clinician Communication Skills Training
Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids
Video Declarations (ViDec)
Recording of patient advance care planning videos
Comprehensive Record Review of ACP
* A review of Medical orders for resuscitation preferences in the electronic health record
* A review of Medical orders for Palliative care consultations preferences in the electronic health record
* A review of Medical orders for Hospice use preferences in the electronic health record
Clinician Communication Skills Training
Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids
Video Declarations (ViDec)
Recording of patient advance care planning videos
Main Study Arm
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training
Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids
Video Declarations (ViDec)
Recording of patient advance care planning videos
Interventions
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Clinician Communication Skills Training
Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids
Video Declarations (ViDec)
Recording of patient advance care planning videos
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* More than one oncologist
* Serve a patient population that is at least 30% aged 65 or older
* Disease-based oncology clinic
Subject Eligibility: (for the in-person surveys):
\- Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity.
Exclusion Criteria
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Boston Medical Center
OTHER
Northwell Health
OTHER
Mayo Clinic
OTHER
Duke University
OTHER
National Institute on Aging (NIA)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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James A. Tulsky
Principal Investigator
Principal Investigators
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James A. Tulsky, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health
New Hyde Park, New York, United States
Duke Health
Durham, North Carolina, United States
Countries
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References
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Volandes AE, Chang Y, Lakin JR, Paasche-Orlow MK, Lindvall C, Zupanc SN, Martins-Welch D, Carney MT, Burns EA, Itty J, Emmert-Tangredi K, Martin NJ, Sanghani S, Tilburt J, Pollak KI, Davis AD, Garde C, Barry MJ, El-Jawahri A, Quintiliani L, Sciacca K, Goldman J, Tulsky JA. An Intervention to Increase Advance Care Planning Among Older Adults With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e259150. doi: 10.1001/jamanetworkopen.2025.9150.
Lakin JR, Gundersen DA, Lindvall C, Paasche-Orlow MK, Tulsky JA, Brannen EN, Pollak KI, Kennedy D, McLeggon JA, Stout JJ, Volandes A; ACP-PEACE Investigators. A Yet Unrealized Promise: Structured Advance Care Planning Elements in the Electronic Health Record. J Palliat Med. 2021 Aug;24(8):1221-1225. doi: 10.1089/jpm.2020.0774. Epub 2021 Apr 7.
Lakin JR, Brannen EN, Tulsky JA, Paasche-Orlow MK, Lindvall C, Chang Y, Gundersen DA, El-Jawahri A, Volandes A; ACP-PEACE Investigators. 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. 2020 Jul 14;10(7):e040999. doi: 10.1136/bmjopen-2020-040999.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-276
Identifier Type: -
Identifier Source: org_study_id
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