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

Other Cancer Clinical Trial

— ACP-PEACE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03609177
• Other study ID #: 18-276
• Secondary ID: UG3AG060626
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Other Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Duke Health	Durham	North Carolina
United States	Northwell Health	New Hyde Park	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (7)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Boston Medical Center, Duke University, Massachusetts General Hospital, Mayo Clinic, National Institute on Aging (NIA), Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Preferences for Resuscitation	Documented choices regarding CPR and mechanical ventilation in the EHR	4 years
Secondary	Rate of Palliative Care Consultation	Use of palliative care services (consults, outpatient visits) in the EHR	4 years
Secondary	Rate of Hospice Use	Use of hospice documented in the EHR	4 years
Secondary	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
Secondary	Communication and Decisional Satisfaction	(In person survey) patient satisfaction with communication and decision making	4 years
Secondary	Decisional Regret	(In person survey) patient regret regarding decision making	4 years