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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626402
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Advance Care Planning Behavioral: Planning for the Care You Want Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial comparing an intervention group to usual care
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: End-of-Life Care for African Americans: An Outpatient Intervention
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : October 31, 2018
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
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.

No Intervention: Control - Usual Care
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.



Primary Outcome Measures :
  1. Feasibility of relying upon the intervention algorithm to identify eligible patients [ Time Frame: 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. ]
    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.

  2. Acceptability of intervention among patients randomized to the intervention arm [ Time Frame: 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. ]
    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.

  3. Participant change in intent to discuss EOL care options [ Time Frame: Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks. ]
    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.


Secondary Outcome Measures :
  1. Knowledge of prognosis and EOL care options [ Time Frame: Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks. ]
    Knowledge of prognosis and EOL care options will be measured by using survey questions designed to assess this.

  2. Decisional conflict about preferences for EOL care [ Time Frame: 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 will be assessed by using the Decisional Conflict Scale, a validated tool for scoring uncertainty related to decision making. Patients are asked, "If the doctors told you that your illness could not be cured, which treatment option would you prefer?" Patients must choose one of three choices: 1) "All treatment options available to help me live for as long as possible"; 2) "Palliative care"; or 3) "Hospice." They are then asked 10 follow-up questions to assess their certainty about their choice. The response choices to these 10 questions are "yes," "unsure," or "no." Each response choice is assigned a numeric value, 0, 2, and 4, respectively. The patient's total score is calculated by adding the values for all 10 questions, dividing the sum by 10, then multiplying that figure by 25. The patient's uncertainty score is calculated by adding the values of their responses to questions 9 and 10, dividing by 2, and multiplying that value by 25.

  3. Participant perceptions about their quality of life [ Time Frame: Assessed at baseline and at 1, 3, and 6 months of baseline beginning April 2017 and ending October 2018, up to 78 weeks. ]
    Perceptions of quality of life will be assessed by using the McGill Quality of Life Questionnaire-Revised (MQOL-R), a validated scale to measure the patient's perception of quality of life over the last two days. This instrument includes 15 questions to which patients respond with a number ranging from 0 to 10. For each question, the patient is told what a 0 means and what a 10 means--the definitions vary from question to question. For some questions, a 0 means "very bad" while a 10 means "excellent." For other questions, a 0 means "not a problem" while a 10 means "a tremendous problem." Patients can also refuse to answer or reply that they do not know.

  4. Patient healthcare utilization [ Time Frame: Assessed at 1, 3, and 6 months of baseline beginning May 2017 and ending October 2018, up to 74 weeks. ]
    Patient healthcare utilization will be assessed by research staff conducting chart reviews following each survey interval to quantify emergency department visits and hospitalizations, referrals to palliative care or hospice, and whether or not a patient has completed an advance directive following study initiation.

  5. Date and place of death [ Time Frame: Assessed at 1, 3, and 6 months of baseline beginning May 2017 and ending October 2018, up to 74 weeks. ]
    While conducting scheduled chart reviews, research staff will document the date and place (hospital, hospice, or home) if the medical record indicates that the patient is deceased.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. breast, lung, colon, prostate or other advanced cancer diagnosis
  2. English proficient
  3. African American
  4. mentally competent

Exclusion Criteria:

1) not currently receiving palliative or hospice care


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626402


Locations
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United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Ramona L Rhodes, MD, MPH UT Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by University of Texas Southwestern Medical Center:
Informed Consent Form  [PDF] September 8, 2017

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03626402    
Other Study ID Numbers: STU 042016-050
CCCDA-16-003-01 ( Other Grant/Funding Number: American Cancer Society )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
advanced cancer
African American