Implementing Sustainable Type 2 Diabetes Care: A Hybrid Type 1 RCT to Test a Community Health Worker-Led Evidence-Based Intervention
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ABSTRACT Our current R01 demonstrated that tele-mentored Community Health Workers (CHWs) can scale a diabetes intervention and improve health outcomes for low-income adults. This R01 renewal proposes a hybrid type 1 randomized clinical trial (RCT) to evaluate clinical effectiveness while simultaneously collecting data to support broad, sustained implementation of the intervention. Type 2 diabetes disproportionately affects low-income populations, who experience 60% higher rates of diabetes due to socioeconomic challenges. Debilitating complications reduce quality of life and drive much of the $413 billion in annual U.S. diabetes costs. Implementing evidence-based interventions is critical to improving outcomes and reducing health system burden. Since 2015, our team has conducted RCTs (N>700) to develop a multidimensional CHW-led intervention for low-income adults with diabetes. We tested empowering CHWs as leaders in diabetes, developed robust CHW training, and formed strategies to improve access. Our current R01 streamlined the intervention for scalability by tele-mentoring CHWs to deliver (1) education, (2) telehealth coaching, and (3) a novel Participant–CHW–Clinician Feedback Loop, which tripled recruitment without compromising outcomes. Participants in the 12-month intervention significantly reduced HbA1c compared with usual care (-0.8% vs. +0.1%, p<0.001), demonstrating both the intervention’s effectiveness and the limitations of standard care. Participants also improved guideline adherence (p<0.001–0.02), and CHWs addressed hundreds of participant concerns, reducing unnecessary visits. Clinics expressed interest in sustaining the intervention, but integration exceeded the scope and resources of the current R01. The proposed study addresses the next step: implementing the intervention into routine care. Rigorous clinical trials are vital to advancing medical science, but less than 14% are widely implemented, especially in underserved settings where cost and infrastructure pose major challenges. Selecting appropriate study designs and outcome frameworks that inform the design is critical. Hybrid type 1—3 study designs, common in public health, evaluate both clinical effectiveness and implementation within a single study. Hybrid type 1s are often the first step, evaluating effectiveness while collecting implementation data. Frameworks such as PRISM and RE-AIM are widely used alongside hybrid designs to guide outcome measurement. Building on our current R01, we propose a 12-month hybrid type 1 RCT enrolling 600 low-income adults with type 2 diabetes. Guided by PRISM and RE-AIM, Aim 1 will compare clinical effectiveness and sustainability of the intervention versus control (usual care), Aim 2 will assess contextual factors influencing implementation, and Aim 3 will measure implementation outcomes. We hypothesize that this CHW-led healthcare delivery intervention will improve clinical outcomes (Aim 1), identify key readiness factors (Aim 2), and achieve high reach, fidelity, and acceptability (Aim 3), ultimately supporting scalability to broader populations.
