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

NCT03516994 | Completed

• 2 other identifiers: Pro00091633OLC-1609-36381
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Difference in Proportion of Whites versus African Americans who complete advance care planning

  12 months

• Patient Readiness to Engage in Advance Care Planning

  3 months

• Patient Quality of Life

  3 months, 6 months, one year

Study Arms (2)

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.

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.

Behavioral: Five Wishes Form

Interventions

Respecting Choices First Steps BEHAVIORAL

Advance Care Planning Approach

Structured Advance Care Planning

Five Wishes Form BEHAVIORAL

Advance Care Planning Approach

Patient Driven Advance Care Planning

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

University of Texas Southwestern

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Heart Failure; Pulmonary Disease, Chronic Obstructive; Parkinson Disease; Lung Diseases, Interstitial; Amyotrophic Lateral Sclerosis; End Stage Liver Disease; Kidney Failure, Chronic; Diabetes Complications

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Kimberly Johnson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed-methods, longitudinal, multi-site study, cluster randomized trial

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 7, 2018
• Study Start: August 1, 2018
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-03

Locations

US (4)