Reducing Disparities in the Quality of Advance Care Planning for Older Adults

Reducing Disparities in the Quality of Advance Care Planning for Older Adults

Quick Info:

Enrolling by invitation
Estimated Enrollment:
Treatment Type:
Behavioral: Respecting Choices First Steps & Five Wishes Form
Trial Type:
Randomized, parallel assignment, open label
Duke University
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)

Months Since Onset

Number of months since first
symptoms of ALS
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?

Update Notes:

1/23/2019Recruitment status updated
10/17/2018No significant updates
5/14/2018Trial added


Emory University , Atlanta, 30322
University of Alabama at Birmingham , Birmingham , 35294
University of South Carolina , Columbia, 29208
University of Texas Southwestern , Dallas, 75235

Other Information:

Purpose: 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.
Eligibility: 65 Years and older, all genders, not accepting healthy volunteers
Details: 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.
News Articles and Summaries:
ALS Forum:
First Published on 5/14/2018 ID: NCT03516994
Trial Protocol as Published on