Optimizing Diabetes Management Interventions for Black and Hispanic Adults Using the Multiphase Optimization Strategy: A Randomized Mixed Methods Factorial Trial

Abstract

Background:Black and Hispanic adults with diabetes are more likely to experience diabetes complications and die from diabetes compared to non-Hispanic whites due, in part, 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.Aim: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 2x2 factorial design (MTM, CHW: ON vs. OFF) where participants recruited from community pharmacies will be randomized to one of four treatment conditions. We will recruit 376 Black or Hispanic adults with type 2 diabetes and hemoglobin A1C of ≥ 8%. 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.Discussion:Our findings will identify the optimized intervention, e.g., comprising one or both intervention components, that effectively and efficiently improves diabetes outcomes among Black and Hispanic adults with uncontrolled diabetes, informing translation.

Note:

Clinical Trial Registration Details: The study is registered at ClinicalTrials.gov Identifier: NCT05912647.

Funding Information: This study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases, R01DK136690 (PI: Shiyanbola).

Conflict of Interests: All authors have no competing interests.

Ethical Approval: This study was approved by the health sciences institutional review board of the PI’s university (ID: 2023-0780).

Keywords: Diabetes management, community health workers, pharmacists, mixed methods, Black, Hispanic, social determinants of health, multiphase optimization strategy