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

Primary Purpose

Metastatic Cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respecting Choices First Steps
Five Wishes Form
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Cancer focused on measuring Advance Care Planning, Disparities, Palliative Care, End of Life Care, African Americans

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham
  • Emory University
  • University of South Carolina
  • University of Texas Southwestern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Structured Advance Care Planning

Patient Driven Advance Care Planning

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of African Americans who complete advance care planning
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
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
Difference of proportion in whites versus African Americans who complete formal or informal advance care planning
Patient Readiness to Engage in Advance Care Planning
Measure assessing patient's readiness to name decision-maker, discuss care preferences, complete legal advance directive
Patient Quality of Life
Measure (Promis 29) assessing quality of life, including domains of physical functional, emotional, and social well-being

Full Information

First Posted
April 30, 2018
Last Updated
January 4, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03516994
Brief Title
Reducing Disparities in the Quality of Advance Care Planning for Older Adults
Acronym
EQUALACP
Official Title
REducing Disparities in the QUALity of Palliative Care for Older African Americans Through Improved Advance Care Planning (EQUAL ACP)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Advance Care Planning, Disparities, Palliative Care, End of Life Care, African Americans

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Mixed-methods, longitudinal, multi-site study, cluster randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structured Advance Care Planning
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Driven Advance Care Planning
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Respecting Choices First Steps
Intervention Description
Advance Care Planning Approach
Intervention Type
Behavioral
Intervention Name(s)
Five Wishes Form
Intervention Description
Advance Care Planning Approach
Primary Outcome Measure Information:
Title
Proportion of African Americans who complete advance care planning
Description
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
Time Frame
12 months
Title
Proportion of Whites who complete advance care planning
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Difference in Proportion of Whites versus African Americans who complete advance care planning
Description
Difference of proportion in whites versus African Americans who complete formal or informal advance care planning
Time Frame
12 months
Title
Patient Readiness to Engage in Advance Care Planning
Description
Measure assessing patient's readiness to name decision-maker, discuss care preferences, complete legal advance directive
Time Frame
3 months
Title
Patient Quality of Life
Description
Measure (Promis 29) assessing quality of life, including domains of physical functional, emotional, and social well-being
Time Frame
3 months, 6 months, one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Johnson, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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