Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE)

Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Other Cancer
• Intervention / Treatment: Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; Other: Video Declarations (ViDec)

Detailed Description

The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery.

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.

• Study Type: Interventional
• Enrollment (Estimated): 30000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James A. Tulsky, MD; Phone Number: 617-582-9201; Email: JamesA_Tulsky@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for clinics:

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):

- 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Clinician Communication Skills Training; Communication skills training; Other Names: Vital Talk Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; ACP Decisions video decision aids
Experimental: 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	Other: Clinician Communication Skills Training; Communication skills training; Other Names: Vital Talk Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; ACP Decisions video decision aids; Other: Video Declarations (ViDec); Recording of patient advance care planning videos
Other: 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	Other: Clinician Communication Skills Training; Communication skills training; Other Names: Vital Talk Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; ACP Decisions video decision aids; Other: Video Declarations (ViDec); Recording of patient advance care planning videos
Experimental: 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.	Other: Clinician Communication Skills Training; Communication skills training; Other Names: Vital Talk Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; ACP Decisions video decision aids; Other: Video Declarations (ViDec); Recording of patient advance care planning videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Preferences for Resuscitation	Documented choices regarding CPR and mechanical ventilation in the EHR	4 years
Rate of Palliative Care Consultation	Use of palliative care services (consults, outpatient visits) in the EHR	4 years
Rate of Hospice Use	Use of hospice documented in the EHR	4 years
Confidence in Future Care	(in person survey) patient confidence that they will receive the right care at the right time by their health system	4 years
Communication and Decisional Satisfaction	(In person survey) patient satisfaction with communication and decision making	4 years
Decisional Regret	(In person survey) patient regret regarding decision making	4 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Massachusetts General Hospital; Mayo Clinic; Northwell Health; Duke University; National Institute on Aging (NIA); Boston Medical Center
• Investigators: Principal Investigator: James A. Tulsky, MD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cancer Care
• Other Study ID Numbers: 18-276; UG3AG060626 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No