End-of-Life Care for African Americans: An Outpatient Intervention

NCT03626402 | Completed

• 2 other identifiers: STU 042016-050CCCDA-16-003-01
• Study Type: interventional
• Target: 72
• 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 in the terminal stages of illness. Main reasons for these EOL disparities include: lack of knowledge of and misperceptions about palliative and hospice care, spiritual beliefs, and mistrust in the health care system. Despite the presence of national hospice guidelines, interventions addressing these disparities have been limited and often not rigorously evaluated. Most 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 investigator proposes an innovative strategy that would focus specifically on previously identified physician and patient barriers to utilization of advance directives, palliative care, and hospice care among AA cancer patients. The goal of this patient-centered project is to increase the awareness of and willingness to discuss EOL care options among AAs with metastatic cancer. To overcome the dual challenges of physicians' difficulty with prognostication and reluctance to discuss EOL care, the investigator will harness data in the electronic medical record (EMR) to automatically identify AA patients with metastatic breast, lung, colorectal, prostate and other serious cancer who are eligible for counseling about palliative and EOL care options. To change AA patients' knowledge and attitudes toward palliative and EOL care options, and address issues of medical mistrust, the investigator will design and pilot test a culturally sensitive, patient-targeted intervention that will combine multimedia materials and a culturally concordant lay health advisor (LHA) who will deliver tailored education and counseling. The investigator has chosen a LHA delivery strategy because past studies have shown that they are best suited to address medical mistrust and perceived conflict between spiritual beliefs and health care decisions.

Conditions

Advance Care Planning

Keywords

advanced cancer; African American

Outcome Measures

Primary Outcomes (3)

• Feasibility of relying upon the intervention algorithm to identify eligible patients

  This will be assessed by the principal investigator reviewing the medical records of patients flagged by the algorithm as eligible for participation to verify their eligibility and confirming those who meet study inclusion criteria.

  This will be assessed from the time of initiating patient recruitment (April 2017) through completion of recruitment of new patients (April 2018), up to 56 weeks.

• Acceptability of intervention among patients randomized to the intervention arm

  Patient acceptability will be determined by the lay health advisor asking the patient, "Is this video something that you would recommend that your family and/or friends watch?" Responses will be noted "yes, no, refused, or don't know." Then they will be asked, "Why/why not?" and their responses written verbatim.

  Assessed at the end of the intervention, which occurs approximately two weeks after the baseline survey with those patients randomized to receive the intervention. This will be assessed beginning in April 2017 and ending in April 2018, up to 52 weeks.

• Participant change in intent to discuss EOL care options

  Changes in intention to discuss EOL care options will be assessed for all patients in both arms of the study by using the Transtheoretical Stages of Change Model.

  Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.

Secondary Outcomes (5)

• Knowledge of prognosis and EOL care options

  Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.

• Decisional conflict about preferences for EOL care

  Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.

• Participant perceptions about their quality of life

  Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks.

• Patient healthcare utilization

  Assessed at 1, 3, and 6 months of baseline beginning May 2017 and ending October 2018, up to 74 weeks.

• Date and place of death

  Assessed at 1, 3, and 6 months of baseline beginning May 2017 and ending October 2018, up to 74 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

These patients will be exposed to the educational intervention, including viewing the video, "Planning for the Care You Want," and meeting with a lay health advisor to discuss advance care planning and initiate plans, as patients wish.

Behavioral: Planning for the Care You Want

Control - Usual Care

NO INTERVENTION

These patients will not be exposed to the educational intervention and will receive usual care. All patients will be mailed an informational brochure about advance care planning with a reminder letter two weeks after completing their baseline survey.

Interventions

Planning for the Care You Want BEHAVIORAL

25-minute culturally specific educational video informing viewers about advance care planning options, palliative care, and hospice care and meeting with a lay health advisor to discuss content of the video.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast, lung, colon, prostate or other advanced cancer diagnosis
• English proficient
• African American
• mentally competent

You may not qualify if:

• \) not currently receiving palliative or hospice care

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.

  PMID: 35802350 DERIVED

Study Officials

• Ramona L Rhodes, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized controlled trial comparing an intervention group to usual care

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: August 13, 2018
• Study Start: April 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: June 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)