Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities (PPC Heart)

Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities: A Pilot Study of the Patient Priorities Care Approach at Cooper Green Mercy Health Services Authority (PPC-HEART)

This is formative evaluation trial guided by the Values Clarification Theory25 and the Cultural Values Theory26, with specific aims to: Aim 1. Develop a culturally appropriate version of the PPC Approach for older AAs with CVCs by assembling a community advisory group of 3 primary care clinicians, 3 older AA patients with CVCs, and 3 AA persons who care for AA patients with CVCs to solicit feedback on the PPC Approach. Aim 2. Determine the acceptability (e.g., program appraisal interviews) and feasibility (e.g., avg. length of program sessions, program participation rate, study completion rate) of the PPC Approach among a sample 20 of under-resourced older southern AA patients with CVCs receiving primary care at Cooper Green Mercy Health Services Authority. Aim 3. Examine the ability of participants to complete pre- and post-test (8 weeks post-baseline) measures of perception of care, treatment burden, shared decision-making, and patient-clinician communication exchange.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Disease; Diabetes; Chronic Obstructive Pulmonary Disease (COPD); Cardiovascular; Comorbidity; Inflammatory Joint Diseases; Chronic Kidney Diease

• Study Type: Observational
• Enrollment (Estimated): 29

Contacts and Locations

• Study Contact: Name: Nardakafaria McNeill; Phone Number: 205-934-0707; Email: nmcneill@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • Cooper Green Mercy Hospital
      • Contact: Nardakafaria McNeill; Phone Number: 205-934-0707; Email: nmcneill@uab.edu
      • Principal Investigator: Deborah Ejem, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cooper Green Mercy Hospital

Description

Inclusion Criteria:

• greater than or equal to 50 years old
• at least one CVD (i.e., coronary artery disease, hypertension, heart failure, arrhythmias, cardiomyopathy, peripheral artery disease, stroke, and valvular heart disease)
• at least one coexisting chronic condition (i.e., inflammatory joint disease, COPD/asthma, diabetes, chronic kidney disease, and cancer one-year post-treatment)
• a caregiver of a participant, or a provider who serves this population.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Community Advisory Group (CAG) and Pilot Group; Nine of the 29 participants will participate in Aim 1 of the study, which involves convening a focus group to develop a culturally responsive version of the PPC Approach for underserved African Americans. This number was determined based on qualitative research best practices, which suggest that 6-10 participants per focus group allow for a diverse range of perspectives while maintaining an environment conducive to in-depth discussion. Additionally, this sample size aligns with previous studies that successfully used small, targeted focus groups to refine culturally tailored interventions. Twenty patients will participate in the pilot testing of the newly developed culturally responsive version of the PPC Approach. This number was determined to be satisfactory because it provides a sufficient sample to assess the feasibility and acceptability of the intervention while ensuring a manageable study scope. Prior feasibility studies have demonstrated that sample sizes between 15 and 30 par

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Older Patient Assessment of Chronic Illness Care (O-PACIC) Score	Patient experience with integrated care delivery and self-management support measured using the 10-item Older Patient Assessment of Chronic Illness Care (O-PACIC) questionnaire. Responses to the 10 items will be summed to calculate a total score ranging from 10 to 50. Higher scores indicate more positive perceptions of chronic illness care. Scores will be reported at baseline and 8 weeks post-baseline, along with the change from baseline.	Baseline and eight weeks post- baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Burden Questionnaire (TBQ) Score	Perceived treatment burden measured using the 13-item Treatment Burden Questionnaire (TBQ). Each item is rated from 0, indicating not a problem, to 10, indicating a big problem. Item scores will be summed to calculate a total score ranging from 0 to 130. Higher scores indicate greater perceived treatment burden. Scores will be reported at baseline and 8 weeks post-baseline, along with the change from baseline.	Baseline and eight weeks post- baseline
Perceived Shared Clinical Decision-Making (CollaboRATE Score)	Patient perception of involvement in shared decision-making measured using the 3-item CollaboRATE questionnaire. Responses to the three items will be averaged to calculate an overall mean score ranging from 1 to 9. Higher scores indicate greater perceived involvement in shared decision-making. Scores will be assessed at baseline and 8 weeks post-baseline, and change from baseline will be evaluated.	Baseline and eight week post- baseline

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Deborah Ejem, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 31, 2026
• First Submitted That Met QC Criteria: July 31, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Chronic Kidney Disease; Older Adults; Chronic Obstructive Pulmonary Disease; Shared Decision Making; Care Coordination; Patient-Centered Care; Multiple Chronic Conditions
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Glucose Metabolism Disorders; Lung Diseases, Obstructive; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Multiple Chronic Conditions; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Diabetes Mellitus; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRB-300013717; NIMHD (Other Identifier: National Institute on Minority Health and Health Disparities)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data from this small pilot study will not be shared with other researchers.

Drug and device information, study documents

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