Clinical trial NCT05129709: Black Health Identification Program (B-HIP)
Official title: Addressing Communication Challenges Confronting Older African Americans With Multiple Chronic Conditions and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions
Family Members
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Social Cognitive Theory (SCT) and the Health Belief Model (HBM) inform this proposal. The SCT posits that human behavior is determined by expectancies- of culture, potential outcomes, and self-efficacy- and incentives. The HBM holds that health-related behavior depends on motivation, the belief that one is susceptible to serious illness, and the belief that following provider advice will reduce the threat. Concepts of health beliefs, self-efficacy, and culture must be considered when developing effective interventions for value solicitations and behavior change. This is especially true for older AAs in the Deep South, who report different lived experiences and experiences with medical icare than Whites. Patient-centered care cannot be realized for AAs without reshaping interventions to consider factors important to seriously ill older AAs with MCCs. Reframing discussion in a culturally-responsive manner is necessary to establish patient and FCG preferences prior to a health crisis.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: A single arm formative evaluation (qualitative interviews) exploring acceptability of the program
timeFrame: one-time interview six weeks following baseline questionnaires
measure: A single arm formative evaluation (qualitative interviews) exploring acceptability of program
timeFrame: one-time interview six weeks following baseline questionnaires
measure: System Usability Scale (ISUS)
timeFrame: one-time interview six weeks following baseline questionnaires
measure: Program Completion Statistics
timeFrame: one-time interview six weeks following baseline questionnaires
measure: Older Patient Assessment of Chronic Illness Care (O-PACIC)
timeFrame: Baseline
measure: Treatment Burden Questionnaire (TBQ)
timeFrame: Baseline
measure: Clinical Shared Decision Making Questionnaire (CollaboRATE)
timeFrame: Baseline
measure: Bakas Caregiver Outcomes (BCOS)
timeFrame: Baseline
measure: Shared Care Instrument (SCI)
timeFrame: Baseline
measure: Change in Older Patient Assessment of Chronic Illness Care (O-PACIC)
timeFrame: 18 weeks post-baseline
measure: Change in Treatment Burden Questionnaire (TBQ)
timeFrame: 18 weeks post-baseline
measure: Change in Clinical Shared Decision Making Questionnaire (CollaboRATE)
timeFrame: 18 weeks post-baseline
measure: Change in Bakas Caregiver Outcomes (BCOS)
timeFrame: 18 weeks post-baseline
measure: Change in Shared Care Instrument (SCI)
timeFrame: 18 weeks post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Whitaker Clinic at the University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Deborah Ejem, PhD
role: PRINCIPAL_INVESTIGATOR
References: