Black Health Identification Program (B-HIP)

Addressing Communication Challenges Confronting Older African Americans With Multiple Chronic Conditions and Their Family Caregivers

Nearly 69% of African American (AA) Medicare beneficiaries have multiple chronic conditions (MCCs) such as cancer and cardiopulmonary diseases. Older age and MCCs are guideline-recommended indications for referral to early palliative care to assist with effective communication and value-solicitation surrounding treatment decision-making. Studies have shown that early palliative care participation achieves beneficial goals of care communication, quality of life (QOL), symptom burden, and mood in older adults with cancer and heart failure as well as among their family caregivers. However, older AAs with MCCs, especially those living in the Deep South, are less likely to have access to early palliative care, even though they generally experience higher symptom burden, healthcare use, and poorer communication around goals of care. This disparity in palliative care use may be, in part, to a lack of culturally-responsive care practices that effectively activate AAs with MCCs to identify their own values and priorities for end-of-life care. While efficacious communication models exist, few have been tested in culturally-diverse samples. Guided by the theory of Social Cognitive Theory and Health Behavior Model, this study's purpose is to conduct a formative evaluation of a Self-directed "My Health Priorities" Identification Program to determine cultural acceptability and feasibility of use in among AAs with MCCs in a primary care setting. The 2-phase study specific aims are to:

Aim 1. (Phase 1) Conduct a single-arm formative evaluation trial of Self-directed "My Health Priorities" Identification Program to determine acceptability and feasibility with a sample of 20 AA patients with MCCs and FCGs and adapt for future efficacy testing.

Aim 2. (Phase 2) To examine the ability of the dyads to complete pre- and post-test measures of perception of care, treatment burden, shared decision-making, and communication exchange.

The findings from the research will directly inform a small-scale pilot grant that will assess acceptability, feasibility, and potential efficacy of a values solicitation and operationalization intervention for AAs with MCCs and caregivers.

Study Overview

• Status: Completed
• Conditions: Multiple Chronic Conditions; Family Members
• Intervention / Treatment: Behavioral: "My Health Priorities" Identification Program

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The Whitaker Clinic at the University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for Patients

• African American (AA)
• ≥ 65 years
• has at least two of the following chronic conditions: cancer, heart disease, kidney disease, liver disease
• English-speaking
• cognitively able to participate in decision-making discussions
• reliable internet and telephone access
• FCG willing to participate in study

Inclusion Criteria for FCG

• AA

  • 18 years
• identified by patient as his/her primary FCG
• English-speaking; and 5) reliable internet and telephone access.

Exclusion Criteria for Patients and FCG

• Axis I psychiatric disorder (schizophrenia, bipolar disorder), dementia
• active substance use disorder
• living in a nursing home or assisted living facility residence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: "My Health Priorities" Identification Program; The intervention, the "My Health Priorities" Identification Program consists of four self-directed, web-based modules intended to guide patients with MCCs in identifying their own health priorities. These priorities can then be used to guide discussions with family caregivers and clinicians regarding specific goals and preferences that they wish to guide future treatment decisions. Most models of palliative care have been developed based on white middle-class populations and may not apply to African Americans (AA) who have a very different cultural value set.

Behavioral: "My Health Priorities" Identification Program; The web-based "My Health Priorities" Identification Program may improve values solicitation and operationalization skills in primary care, but has not been optimized for AAs with MCCs and their FCGs. The Program is a facilitator-led evidence- and values-based care communication model for patients, clinicians, and caregivers that has reduced patient-reported treatment burden by aligning value-based priorities with treatment. The web-based program assists patients in identifying their health priorities as they complete t four online modules that help them to identify specific and actionable health goals and preferences. The final result can be printed and brought to the clinic or uploaded to the Electronic Medical Record to inform subsequent healthcare decision making. Unrecognized cultural preferences of AAs, including the important role of R/S beliefs and family-centered values, can interfere with adequate healthcare communication resulting in healthcare disparities and inequities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A single arm formative evaluation (qualitative interviews) exploring acceptability of the program	Semi-structured interview of patients with multiple chronic illness (MCC)	one-time interview six weeks following baseline questionnaires
A single arm formative evaluation (qualitative interviews) exploring acceptability of program	Semi-structured interview of family caregivers (FCG) of patients with MCC	one-time interview six weeks following baseline questionnaires
System Usability Scale (ISUS)	Measures usability of web-based applications and programs in both patients and FCG,. subscales evaluate how learnable and usable the tested program is; 10 items, 5 items are scored positively and 5 items are scored negatively using a 5 point likert scale with 5 indicating strongly agree and 1 indicating strongly disagree	one-time interview six weeks following baseline questionnaires
Program Completion Statistics	Usability statistics will be obtained about the length of time the participant engaged with the program, and module completion rates	one-time interview six weeks following baseline questionnaires
Older Patient Assessment of Chronic Illness Care (O-PACIC)	Questionnaire of perception of care among patients with MCC. The questionnaire consists of 10 items scored on a 5 point likert scale with 5 indicating "almost always" and 1 indicating "almost never". Higher scores thus reflect patients' perception of better care.	Baseline
Treatment Burden Questionnaire (TBQ)	Patients with MCC perception of QOL and treatment burden related to chronic illness; 15 items rated on a ten point scale with 0 indicating that the item "is not a problem" and 10 indicating that the item reflects a "big problem".	Baseline
Clinical Shared Decision Making Questionnaire (CollaboRATE)	Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)	Baseline
Bakas Caregiver Outcomes (BCOS)	Measures FCG social function, subjective well-being, and somatic health; 10 items rated on a 7 point likert scale with -3 reflecting "changed for the worst" and +3 indicating "changed for the better".	Baseline
Shared Care Instrument (SCI)	PT and FCG's perception of communication exchange regarding illness experience, subscales include communication, decision making, and reciprocity; 19 items divided into 3 summary scales, each item is scored in likert format from 0 to 5 with 0 indicating "completely disagree" and 5 indicating "completely agree". On the communication subscale a higher score indicates better communication. For the patient decision making subscale, higher scores indicate better patient decision making. For the patient reciprocity scale, higher scores indicate more reciprocity between patient and caregiver.	Baseline
Change in Older Patient Assessment of Chronic Illness Care (O-PACIC)	Measure of older patient perception of primary care delivery; 10 items scored on a 5 point likert scale with 1 indicating "almost never" and 5 indicating "almost always". Higher scores reflect that patients have a more positive feeling about their care.	18 weeks post-baseline
Change in Treatment Burden Questionnaire (TBQ)	Patients with MCC perception of QOL and treatment burden related to chronic illness; 15 items rated on a ten point scale with 0 indicating that the item "is not a problem" and 10 indicating that the item reflects a "big problem".	18 weeks post-baseline
Change in Clinical Shared Decision Making Questionnaire (CollaboRATE)	Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)	18 weeks post-baseline
Change in Bakas Caregiver Outcomes (BCOS)	Measures FCG social function, subjective well-being, and somatic health; 10 items rated on a 7 point likert scale with -3 reflecting "changed for the worst" and +3 indicating "changed for the better".	18 weeks post-baseline
Change in Shared Care Instrument (SCI)	PT perception of communication exchange regarding illness experience, subscales include communication, decision making, and reciprocity; 19 items divided into 3 summary scales, each item is scored in likert format from 0 to 5 with 0 indicating "completely disagree" and 5 indicating "completely agree". On the communication subscale a higher score indicates better communication. For the patient decision making subscale, higher scores indicate better patient decision making. For the patient reciprocity scale, higher scores indicate more reciprocity between patient and caregiver.	18 weeks post-baseline

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Deborah Ejem, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: IRB-300007623; Kornfeld Scholar Award (Other Grant/Funding Number: National Palliative Care Research Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No