End-of-Life Care for African Americans

NCT02320123 | Completed Results

• 1 other identifier: STU 032013-051
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Racial differences in health care are documented across the health care continuum and persist in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented minorities often choose more aggressive therapies at the end of life and are less likely to utilize hospice care in the terminal stages of their illness. Potential reasons for these disparities include: lack of knowledge of and misperceptions about palliative and hospice care, spiritual beliefs, and mistrust in the health care system, among others. Despite the literature on disparities in end-of-life (EOL) care and reasons for underuse and the presence of national EOL care guidelines, attempts to address this problem have been limited and often not rigorously evaluated. The majority of interventions to promote EOL care were done in majority populations and focused predominantly on trying to change physician awareness of patient's pain, symptoms, and values or to change physician communication behavior. While these early studies made tremendous contributions to the study of EOL care and the needs of the terminally ill, the interventions associated with these studies did not reach their desired effectiveness. The investigators propose a different strategy that would focus specifically on previously identified barriers to utilization of advance directives, palliative care, and hospice care among African Americans - including physicians' difficulty and discomfort with prognostication, AA patients' knowledge, attitudes and beliefs towards hospice and palliative care, conflict between patients' spiritual beliefs and the general hospice and palliative medicine philosophy of care, and medical mistrust. The goal of this project is to improve methods of prognostication for physicians and increase awareness of EOL care options for AAs. To overcome the dual challenges of physicians' reluctance to discuss EOL care and patients' discomfort in engaging in such conversations, the investigators will use the electronic medical record (EMR) to automatically identify AA patients with life-limiting illness who are eligible for counseling about EOL care options. To change knowledge and attitudes toward EOL care options among AA patients, the investigators will design a culturally sensitive intervention that will combine multimedia materials and a culturally concordant lay health advisor who will deliver tailored education and counseling.

Conditions

Colonic Neoplasms; Breast Neoplasms; Lung Neoplasms

Keywords

Terminal Care; Decision Making; Communication

Outcome Measures

Primary Outcomes (4)

• Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)

  The primary decision-making outcome is change in intent to discuss advance directives based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).

  Within six months after patient enrolls in study, June 2017.

• Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)

  The primary decision-making outcome is change in intent to discuss medical power of attorney based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).

  Within six months after patient enrolls in study, June 2017.

• Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)

  The primary decision-making outcome is change in intent to discuss palliative care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).

  Within six months after patient enrolls in study, June 2017.

• Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)

  The primary decision-making outcome is change in intent to discuss hospice care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).

  Within six months after patient enrolls in study, June 2017.

Secondary Outcomes (5)

• Quality of Life at the End of Life

  Within six months after patient enrolls in study, June 2017.

• Health Care Utilization: Emergency Room

  Within six months after patient enrolls in study, June 2017.

• Number of Patients Who Died

  Within six months after patient enrolls in study, June 2017.

• Utilization of Advance Care Planning and End-of-life Care

  Within six months after patient enrolls in study, June 2017.

• Health Care Utilization: Mean Number of Hospitalizations in Six Months by Group

  Within six months after patient enrolls in study, June 2017.

Study Arms (2)

Patients - intervention

EXPERIMENTAL

For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.

Behavioral: Educational DVD

Patients - Control

NO INTERVENTION

Patients will receive usual care (nor view the DVD or meet with the lay health advisor).

Interventions

Educational DVD BEHAVIORAL

African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.

Patients - intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1 patients must:
• receive their care at Parkland and be diagnosed with advanced cancer (breast, lung, or colon);
• self-identify as AA;
• be proficient in English;
• be competent to give informed consent; and
• have no evidence of cognitive impairment (Mini-Cog score of ≥3 or 1-2 with normal clock draw).
• Aim 2 Patients must:
• be hospitalized at Parkland
• be diagnosed with advanced cancer (breast, lung, or colon)
• self-identify as AA;
• be proficient in English;
• be competent to give informed consent;
• have no evidence of cognitive impairment (Mini-Cog score of ≥3 or 1-2 with normal clock draw); and
• have never received palliative or hospice care.
• All Caregivers (Aim 1 and 2) must be:

You may not qualify if:

• For patients:
• identify with a race other than African American or
• have a diagnosis other than advanced breast, lung, or colorectal cancer.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Breast Neoplasms; Lung Neoplasms; Communication

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Results Point of Contact

• Title: Dr. Ramona Rhodes
• Organization: UT Southwestern Medical Center

ramona.rhodes@utsouthwestern.edu

214-648-9012

Study Officials

• Ethan Halm, MD

  Chair, Department of General Internal Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff conducting assessments for all participants was masked to patients receiving the intervention as well as those assigned to the control group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 19, 2014
• Study Start: May 23, 2016
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Locations

US (1)