Skip to main content
Clinical Trials/NCT03609177
NCT03609177
Completed
Not Applicable

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

Dana-Farber Cancer Institute4 sites in 1 country13,800 target enrollmentApril 15, 2020
ConditionsOther Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Other Cancer
Sponsor
Dana-Farber Cancer Institute
Enrollment
13800
Locations
4
Primary Endpoint
Number of Participants With Advance Care Planning Documentation
Status
Completed
Last Updated
6 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
September 30, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James A. Tulsky

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of Participants With Advance Care Planning Documentation

Time Frame: 6 months

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

Secondary Outcomes

  • 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)
  • Decisional Regret(6 months)

Study Sites (4)

Loading locations...

Similar Trials