Shiyanbola Olayinka O, Maurer Martha A, Piper Megan E, Bolt Daniel, Sharp Lisa K, Ouayogodé Mariétou H, Fisher Edwin
Department of Clinical Pharmacy, University of Michigan College of Pharmacy, United States.
Sonderegger Research Center, University of Wisconsin-Madison School of Pharmacy, United States.
Contemp Clin Trials. 2025 Feb;149:107804. doi: 10.1016/j.cct.2024.107804. Epub 2025 Jan 4.
Black and Hispanic adults with diabetes are more likely to experience diabetes complications and die from diabetes compared to non-Hispanic whites. This disparity may be due to medication adherence being negatively affected by social determinants of health (SDOH) and negative beliefs about diabetes and diabetes medicines. Pharmacist delivered medication therapy management (MTM) improves clinical outcomes. However, pharmacists have limited capacity and expertise to address SDOH barriers and health misperceptions. Supplementing MTM with Community Health Workers (CHWs) to address these factors may be more effective with potential for implementation.
To investigate what combination of two possible components, pharmacist delivered MTM and CHWs addressing SDOH barriers and health misperceptions, represents the optimized intervention for Black and Hispanic adults with uncontrolled diabetes.
METHODS/DESIGN: We will use a 2 × 2 factorial design (MTM, CHW: ON vs. OFF) where participants will be randomized to one of four treatment conditions in a 6-month intervention delivered mostly by phone. We will recruit 376 Black or Hispanic adults with type 2 diabetes and hemoglobin A1C of ≥8 %, a clinical indicator of uncontrolled type 2 diabetes. The primary outcome is A1C measured at 6 months, and at 12 months for sustained change. The secondary outcome is medication adherence. Several psychosocial factors will be examined as potential mediators. An embedded experimental mixed methods approach will be used to obtain participant perspectives through qualitative interviews and integrated to assess intervention acceptability.
Our findings will identify the optimized intervention, e.g., comprising MTM or CHW or both intervention components, that effectively and efficiently improves diabetes outcomes among Black and Hispanic adults with uncontrolled diabetes, informing dissemination.
与非西班牙裔白人相比，患有糖尿病的黑人和西班牙裔成年人更有可能出现糖尿病并发症并死于糖尿病。这种差异可能是由于健康的社会决定因素（SDOH）对药物依从性产生负面影响，以及对糖尿病和糖尿病药物存在负面认知。药剂师提供的药物治疗管理（MTM）可改善临床结局。然而，药剂师解决SDOH障碍和健康误解的能力和专业知识有限。用社区卫生工作者（CHW）补充MTM以解决这些因素可能更有效且具有实施潜力。
研究药剂师提供的MTM和CHW解决SDOH障碍和健康误解这两种可能组成部分的何种组合，是针对糖尿病未得到控制的黑人和西班牙裔成年人的优化干预措施。
方法/设计：我们将采用2×2析因设计（MTM、CHW：开启与关闭），参与者将被随机分配到四种治疗条件之一，进行为期6个月的干预，主要通过电话进行。我们将招募376名患有2型糖尿病且糖化血红蛋白≥8%的黑人和西班牙裔成年人，这是2型糖尿病未得到控制的临床指标。主要结局是在6个月时测量的糖化血红蛋白，以及在12个月时测量的持续变化情况。次要结局是药物依从性。将检查几个心理社会因素作为潜在中介因素。将采用嵌入式实验混合方法，通过定性访谈获取参与者的观点，并进行整合以评估干预措施的可接受性。
我们的研究结果将确定优化干预措施，例如包括MTM或CHW或两者的干预组成部分，该措施能有效且高效地改善糖尿病未得到控制的黑人和西班牙裔成年人的糖尿病结局，为传播提供信息。
