Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly

NCT03609177 | Completed Results

• 2 other identifiers: 18-276UG3AG060626
• Study Type: interventional
• Target: 13,800
• Locations: 1 country
• Sites: 4

Brief Summary

In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery. \- 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.

Conditions

Other Cancer

Keywords

Cancer Care

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Advance Care Planning Documentation

  Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation

  6 months

Secondary Outcomes (6)

• Number of Participants With CODE Status Limitations

  6 months

• Rate of Palliative Care Consultation

  6 months

• Rate of Hospice Use

  6 months

• Confidence in Future Care

  6 months

• Communication and Decisional Satisfaction

  6 months

Study Arms (4)

Advance Care Planning

EXPERIMENTAL

-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

Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids

Advance Care Planning-Video Declaration

EXPERIMENTAL

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

Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; Other: Video Declarations (ViDec)

Comprehensive Record Review of ACP

OTHER

* 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

Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; Other: Video Declarations (ViDec)

Main Study Arm

EXPERIMENTAL

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.

Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; Other: Video Declarations (ViDec)

Interventions

Clinician Communication Skills Training OTHER

Communication skills training

Also known as: Vital Talk Communication Skills Training

Advance Care Planning; Advance Care Planning-Video Declaration; Comprehensive Record Review of ACP; Main Study Arm

Advance Care Planning (ACP) Decisions Videos Decisions Aids OTHER

ACP Decisions video decision aids

Advance Care Planning; Advance Care Planning-Video Declaration; Comprehensive Record Review of ACP; Main Study Arm

Video Declarations (ViDec) OTHER

Recording of patient advance care planning videos

Advance Care Planning-Video Declaration; Comprehensive Record Review of ACP; Main Study Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Clinic eligibility criteria include:
• 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):

You may not qualify if:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Massachusetts General Hospital: collaborator
• Boston Medical Center: collaborator
• Northwell Health: collaborator
• Mayo Clinic: collaborator
• Duke University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

Duke Health

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• 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.

  PMID: 40343696 DERIVED

• 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.

  PMID: 33826860 DERIVED

• 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.

  PMID: 32665394 DERIVED

MeSH Terms

Interventions

Advance Care Planning

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Stepped-wedge designs present challenges. Our study occurred entirely during COVID. We assessed ACP documentation in the EHR to measure whether the ix could lead to better communication. We didn't assess the quality of the documentation in the entire sample. We were not able to track video use at the patient level that allowed linkage to either patients or EHR-based outcomes. The video decision aids in this trial are intended to support clinicians who have been trained in communication skills.

Results Point of Contact

• Title: James Tulsky, MD, Chair of Suppportive Oncology Department
• Organization: Dana Farber Cancer Institute

JamesA_Tulsky@dfci.harvard.edu

617-582-9201

Study Officials

• James A. Tulsky, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 1, 2018
• Study Start: April 15, 2020
• Primary Completion: November 23, 2022
• Study Completion: September 30, 2024
• Last Updated: October 21, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)