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| ID | Type | Description | Link |
|---|---|---|---|
| OLC-1609-36381 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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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.
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:
Administered by community health workers, the two advance care planning approaches which will be compared are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respecting Choices First Steps | Behavioral | Advance Care Planning Approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Patient Readiness to Engage in Advance Care Planning |
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Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Johnson, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Emory University |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 4, 2026 | |
| Reset | Jun 29, 2026 |
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Mixed-methods, longitudinal, multi-site study, cluster randomized trial
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| Five Wishes Form | Behavioral | Advance Care Planning Approach |
|
Measure assessing patient's readiness to name decision-maker, discuss care preferences, complete legal advance directive |
| 3 months |
| Patient Quality of Life | Measure (Promis 29) assessing quality of life, including domains of physical functional, emotional, and social well-being | 3 months, 6 months, one year |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
| University of Texas Southwestern | Dallas | Texas | 75235 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2026 | Jun 29, 2026 |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D010300 | Parkinson Disease |
| D017563 | Lung Diseases, Interstitial |
| D000690 | Amyotrophic Lateral Sclerosis |
| D058625 | End Stage Liver Disease |
| D007676 | Kidney Failure, Chronic |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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