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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Older Patient Assessment of Chronic Illness Care (O-PACIC) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Axis I psychiatric (schizophrenia, bipolar disorder), dementia, suicidal ideation,
- •active substance use disorder nursing home or assisted living facility residence.
研究组 & 干预措施
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
结局指标
主要结局
Older Patient Assessment of Chronic Illness Care (O-PACIC) Score
时间窗: Baseline and eight weeks post- baseline.
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.
次要结局
- Treatment Burden Questionnaire (TBQ) Score(Baseline and eight weeks post- baseline)
- Perceived Shared Clinical Decision-Making (CollaboRATE Score)(Baseline and eight week post- baseline)
研究者
Deborah Ejem
Associate Professor
University of Alabama at Birmingham