Metastatic CancerEQUALACPNCT03516994
Reducing Disparities in the Quality of Advance Care Planning for Older Adults
A study testing Respecting Choices First Steps and Five Wishes Form in people with Metastatic Cancer and Congestive Heart Failure, run by Duke University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Metastatic Cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Respecting Choices First Steps and Five Wishes Form
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 790 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2018to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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?"
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of South Carolina
Columbia, South Carolina, 29208
University of Texas Southwestern
Dallas, Texas, 75235
About this study
Official title: REducing Disparities in the QUALity of Palliative Care for Older African Americans Through Improved Advance Care Planning (EQUAL ACP)
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.
Read the 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.
- Conditions
- Metastatic Cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Parkinson Disease, Interstitial Lung Disease, Amyotrophic Lateral Sclerosis
- Being tested
- Respecting Choices First Steps, Five Wishes Form
- Keywords
- Advance Care Planning, Disparities, Palliative Care, End of Life Care, African Americans
- Medical subject headings
- Neoplasm Metastasis, Heart Failure, Pulmonary Disease, Chronic Obstructive, Parkinson Disease, Lung Diseases, Interstitial, Amyotrophic Lateral Sclerosis, End Stage Liver Disease, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respecting Choices First StepsBehavioural
Advance Care Planning Approach
Five Wishes FormBehavioural
Advance Care Planning Approach
| Study group | Role | What they receive |
|---|---|---|
| Structured Advance Care Planning | Experimental | 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. Receives: Behavioral: Respecting Choices First Steps |
| Patient Driven Advance Care Planning | Active comparator | 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. Receives: Behavioral: Five Wishes Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 12 months
Patient Readiness to Engage in Advance Care Planning
Measure assessing patient's readiness to name decision-maker, discuss care preferences, complete legal advance directive
Measured: 3 months
Patient Quality of Life
Measure (Promis 29) assessing quality of life, including domains of physical functional, emotional, and social well-being
Measured: 3 months, 6 months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Aug 2018
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed-methods, longitudinal, multi-site study, cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Johnson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516994
- Sponsor's protocol ID
- Pro00091633
- Other IDs
- OLC-1609-36381
- Acronym
- EQUALACP
- Status last verified
- Mar 2024
- First submitted
- 30 Apr 2018
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johnson KS, Ejem D, Platt A, Olsen M, Quest T, Barrett N, Rhodes R, Gangavati A, Elk R, Bakitas M, Hasan M, Bethea K, Williams-Bryant SN, Underwood F, Lowers J, Steinhauser K, Dolor R, Durant RW. Advance Care Planning for Black and White Older Adults With Serious Illness: The EQUAL ACP Randomized Trial. JAMA. 2026 Oct 7:e2617619. doi: 10.1001/jama.2026.17619. Online ahead of print.
PubMed 42842242
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REducing Disparities in the QUALity of Palliative Care for Older African Americans Through Improved Advance Care Planning (EQUAL ACP)
- ClinicalTrials.gov ID
- NCT03516994
- Acronym / sponsor ID
- EQUALACP / Pro00091633
- Conditions
- Metastatic Cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Parkinson Disease, Interstitial Lung Disease, Amyotrophic Lateral Sclerosis
- Keywords
- Advance Care Planning, Disparities, Palliative Care, End of Life Care, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 790 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed-methods, longitudinal, multi-site study, cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Structured Advance Care Planning | Experimental | Behavioral: Respecting Choices First StepsIn 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. |
| Patient Driven Advance Care Planning | Active comparator | Behavioral: Five Wishes FormIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- African-American or White
- age 65 or greater
- English-speaking
- residing in non-institutional setting
- cognitively able to participate in advance care planning
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respecting Choices First StepsAdvance Care Planning Approach | Behavioural | Structured Advance Care Planning |
| Five Wishes FormAdvance Care Planning Approach | Behavioural | Patient Driven Advance Care Planning |
Primary outcome
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
3 secondary outcomes
Difference in Proportion of Whites versus African Americans who complete advance care planning
Time frame: 12 months
Patient Readiness to Engage in Advance Care Planning
Time frame: 3 months
Patient Quality of Life
Time frame: 3 months, 6 months, one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 42842242Johnson KS, Ejem D, Platt A, Olsen M, Quest T, Barrett N, Rhodes R, Gangavati A, Elk R, Bakitas M, Hasan M, Bethea K, Williams-Bryant SN, Underwood F, Lowers J, Steinhauser K, Dolor R, Durant RW. Advance Care Planning for Black and White Older Adults With Serious Illness: The EQUAL ACP Randomized Trial. JAMA. 2026 Oct 7:e2617619. doi: 10.1001/jama.2026.17619. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Johnson, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respecting Choices First Steps and Five Wishes Form in people with Metastatic Cancer and Congestive Heart Failure, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of African Americans who complete advance care planning (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.