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

Sponsor

Duke University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03516994

Collaborator

(none)

800

Enrollment

Locations

Arms

Anticipated Duration (Months)

200

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Mixed-methods, longitudinal, multi-site study, cluster randomized trialMixed-methods, longitudinal, multi-site study, cluster randomized trial

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

REducing Disparities in the QUALity of Palliative Care for Older African Americans Through Improved Advance Care Planning (EQUAL ACP)

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Proportion of African Americans who complete advance care planning [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 [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

Secondary Outcome Measures

Difference in Proportion of Whites versus African Americans who complete advance care planning [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 [3 months]
Measure assessing patient's readiness to name decision-maker, discuss care preferences, complete legal advance directive
Patient Quality of Life [3 months, 6 months, one year]
Measure (Promis 29) assessing quality of life, including domains of physical functional, emotional, and social well-being

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for Patients:

African-American or White
age 65 or greater
English-speaking
residing in non-institutional setting
cognitively able to participate in advance care planning
Serious or chronic illness including: metastatic cancer; end stage renal disease; advanced liver disease, heart disease or lung disease; amyotrophic lateral sclerosis, severe Parkinson's disease; 2 or more unplanned hospitalizations in the last year; requiring assistance with any basic activity of daily living
Serious illness based on the following: Clinician answers "no" to the surprise question: "Would you be surprised if this person died in the next 12 months?"

Exclusion Criteria for Patients:

residence in nursing home or assisted living facility
diagnosis of dementia or unable to consent
documented advance care plan (living will, health care proxy, MOST form, provider note)
current or prior use of hospice
current or prior use of non-hospice palliative care except inpatient palliative care consultation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Emory University	Atlanta	Georgia	United States	30322
3	University of South Carolina	Columbia	South Carolina	United States	29208
4	University of Texas Southwestern	Dallas	Texas	United States	75235