Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03516994 |
| Other study ID # |
Pro00091633 |
| Secondary ID |
OLC-1609-36381 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2018 |
| Est. completion date |
April 15, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study compares the effectiveness of two different approaches to advance care planning
among older African Americans and older Whites living in the community. The two approaches
are a structured approach with an advance care planning conversation led by a trained person
using Respecting Choices (First Steps) and a patient-driven approach which includes a Five
Wishes advance care planning form written in plain language. The study will determine which
approach is more effective at increasing advance care planning within each racial group and
reducing differences between the two groups in advance care planning.
Description:
Advance care planning (ACP) involves patients making decisions about the kind of medical care
they would want to receive if they became unable to speak for themselves. Patients share
their wishes in a written document (living will or healthcare proxy) and/or discuss their
wishes with family, friends, and doctors. ACP improves the quality of end-of-life care by
increasing the likelihood that patients receive care that reflects their preferences and
values. Seriously ill African Americans are less likely to take part in advance care planning
and experience lower quality care at the end of life, including poorer communication with
clinicians and a lower likelihood of receiving the kind of care that they would want.
This study will include 800 seriously or chronically ill community-dwelling older adults
(equal number of African Americans and whites) and their caregivers from 10 primary care
practices at five medical centers in the Deep South. Eligible patients include those with
cancer, advanced heart disease, advanced lung disease, end-stage kidney disease, cirrhosis,
diabetes with severe complications, recurrent hospitalizations, or difficulty with basic
activities of daily living. For each enrolled patient, one caregiver who is likely to assist
the patient with healthcare decisions is also eligible to participate.
The goals of the study are to:
- Compare the effectiveness of two approaches to increasing formal advance care planning
(completing written documents like living wills, health care proxies, medical orders for
life-sustaining treatments, or other advance directives) and informal advance care
planning (having conversations with doctors, family, friends, and others about wishes
for future healthcare) for African Americans and for Whites.
- Determine which intervention is most effective in reducing differences between African
Americans and Whites in rates of advance care planning.
- Determine whether the effectiveness of the advance care planning approach differs based
on whether the person assisting with advance care planning is of the same or different
race as the patient.
Administered by community health workers, the two advance care planning approaches which will
be compared are:
- Patient-driven approach which includes a Five Wishes Form (advance directive written in
easy to understand language)
- Structured approach with an advance care planning conversation led by a trained person
using Respecting Choices (First Step) conversation guide.
