Reducing Disparities in the Quality of Advance Care Planning for Older Adults (EQUALACP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03516994|
Recruitment Status : Not yet recruiting
First Posted : May 7, 2018
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Congestive Heart Failure Chronic Obstructive Pulmonary Disease Parkinson Disease Interstitial Lung Disease Amyotrophic Lateral Sclerosis End Stage Liver Disease End Stage Renal Disease Diabetes Complications||Behavioral: Respecting Choices First Steps Behavioral: Five Wishes Form||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Mixed-methods, longitudinal, multi-site study, cluster randomized trial|
|Masking:||None (Open Label)|
|Official Title:||REducing Disparities in the QUALity of Palliative Care for Older African Americans Through Improved Advance Care Planning (EQUAL ACP)|
|Estimated Study Start Date :||November 19, 2018|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Structured Advance Care Planning
In the structured advance care planning approach, patients will participate in a 60 to 90 minute facilitated advance care planning conversation with a trained person using Respecting Choices (First Steps) guide and will receive a state advance directive form. The advance care planning facilitator will follow-up as needed after the session to answer additional questions.
Behavioral: Respecting Choices First Steps
Advance Care Planning Approach
Active Comparator: Patient Driven Advance Care Planning
In the patient-driven advance care planning approach, patients receive a Five Wishes Form (easy to understand advance directive written in plain language), a state advance directive form, and at least two follow-up phone calls with an advance care planning contact who will answer questions.
Behavioral: Five Wishes Form
Advance Care Planning Approach
- Proportion of African Americans who complete advance care planning [ Time Frame: 12 months ]completion of an advance care planning document (living will, healthcare proxy, medical orders, Five Wishes, other); discussion with clinician documented in chart, patient report of advance care planning discussion (designated decision-maker, discussed values, goals, preferences) with family, friends, or others
- Proportion of Whites who complete advance care planning [ Time Frame: 12 months ]completion of an advance care planning document (living will, healthcare proxy, medical orders, Five Wishes, other); discussion with clinician documented in chart, patient report of advance care planning discussion (designated decision-maker, discussed values, goals, preferences) with family, friends, or others
- Difference in Proportion of Whites versus African Americans who complete advance care planning [ Time Frame: 12 months ]Difference of proportion in whites versus African Americans who complete formal or informal advance care planning
- Patient Readiness to Engage in Advance Care Planning [ Time Frame: 3 months ]Measure assessing patient's readiness to name decision-maker, discuss care preferences, complete legal advance directive
- Patient Quality of Life [ Time Frame: 3 months, 6 months, one year ]Measure (Promis 29) assessing quality of life, including domains of physical functional, emotional, and social well-being
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516994
|Contact: Kimberly S Johnson, MDemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Not yet recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Raegan Durant, MD 205-934-7608|
|Sub-Investigator: Marie Bakitas, DNSc|
|United States, Georgia|
|Emory University||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Tammie Quest, MD 404-712-2000|
|United States, South Carolina|
|University of South Carolina||Not yet recruiting|
|Columbia, South Carolina, United States, 29208|
|Contact: Ronit Elk, MD 803-777-2684|
|United States, Texas|
|University of Texas Southwestern||Not yet recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Romona Rhodes, MD 214-648-9012|
|Principal Investigator:||Kimberly Johnson, MD||Duke University|