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

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ClinicalTrials.gov Identifier: NCT03516994
Recruitment Status : Not yet recruiting
First Posted : May 7, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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 Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mixed-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)
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Kimberly S Johnson, MD 919-660-7506 kimberly.s.johnson@duke.edu

Locations
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      
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Kimberly Johnson, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03516994     History of Changes
Other Study ID Numbers: Pro00091633
OLC-1609-36381 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Advance Care Planning
Disparities
Palliative Care
End of Life Care
African Americans

Additional relevant MeSH terms:
Heart Failure
Parkinson Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Liver Diseases
Kidney Failure, Chronic
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neoplasm Metastasis
Lung Diseases, Interstitial
End Stage Liver Disease
Diabetes Complications
Heart Diseases
Cardiovascular Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Respiratory Tract Diseases
Digestive System Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Neuromuscular Diseases
Spinal Cord Diseases