End-of-Life Care for African Americans: An Outpatient Intervention
|ClinicalTrials.gov Identifier: NCT03626402|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advance Care Planning||Behavioral: Planning for the Care You Want||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626402
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Ramona L Rhodes, MD, MPH||UT Southwestern Medical Center|