Clinical trial NCT03609177: Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly
Official title: Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Cancer
Keywords: Cancer Care
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Boston Medical Center
name: Northwell Health
name: Mayo Clinic
name: Duke University
name: National Institute on Aging (NIA)
First posted: 2018-08-01
Enrollment: 27446
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Advance Care Planning Documentation
timeFrame: 4 years
Secondary outcomes:
measure: Rate of Preferences for Resuscitation
timeFrame: 4 years
measure: Rate of Palliative Care Consultation
timeFrame: 4 years
measure: Rate of Hospice Use
timeFrame: 4 years
measure: Confidence in Future Care
timeFrame: 4 years
measure: Communication and Decisional Satisfaction
timeFrame: 4 years
measure: Decisional Regret
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Durham
country: United States
facility: Duke Health
state: North Carolina
Study officials:
affiliation: Dana-Farber Cancer Institute
name: James A. Tulsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.