Black Health Identification Program (B-HIP)

Family Members Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129709
• Other study ID #: IRB-300007623
• Secondary ID: Kornfeld Scholar
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Tamara Nix Parker, BA
• Phone: 205-996-0375
• Email: tmnixpar[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Disease
• Family Members
• Multiple Chronic Conditions

Intervention

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.

Locations

Country	Name	City	State
United States	The Whitaker Clinic at the University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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