- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516994
Reducing Disparities in the Quality of Advance Care Planning for Older Adults (EQUALACP)
REducing Disparities in the QUALity of Palliative Care for Older African Americans Through Improved Advance Care Planning (EQUAL ACP)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Texas
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Dallas, Texas, United States, 75235
- University of Texas Southwestern
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Advance Care Planning Approach
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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.
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Advance Care Planning Approach
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Proportion of Whites versus African Americans who complete advance care planning
Time Frame: 12 months
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Difference of proportion in whites versus African Americans who complete formal or informal advance care planning
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12 months
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Patient Readiness to Engage in Advance Care Planning
Time Frame: 3 months
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Measure assessing patient's readiness to name decision-maker, discuss care preferences, complete legal advance directive
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3 months
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Patient Quality of Life
Time Frame: 3 months, 6 months, one year
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Measure (Promis 29) assessing quality of life, including domains of physical functional, emotional, and social well-being
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3 months, 6 months, one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kimberly Johnson, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Failure
- Hepatic Insufficiency
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetes Mellitus
- Renal Insufficiency
- Neuromuscular Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Liver Diseases
- End Stage Liver Disease
- Heart Failure
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Parkinson Disease
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Kidney Failure, Chronic
- Lung Diseases, Interstitial
- Diabetes Complications
Other Study ID Numbers
- Pro00091633
- OLC-1609-36381 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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