Diabetes Risk Education and Communication Trial (DiRECT) for Primary Care Patients with Prediabetes

点击翻译按钮获取中文摘要

Project Summary Large randomized trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for preventing diabetes among adults with prediabetes. However, these treatments are rarely used, and little existing research has focused on patient-centered approaches for promoting their use. A large body of evidence suggests that risk communication interventions are a promising method for motivating patients to adopt diverse preventive health behaviors. But this approach has not been definitively studied in the context of diabetes prevention. Therefore, the content, structure, and process for communicating diabetes risk to adults with prediabetes is not known. We plan to address this critical knowledge gap by developing and pilot testing the Diabetes Risk Education and Communication Trial (DiRECT) intervention among primary care patients with prediabetes. This novel intervention, delivered by medical assistants before patients’ routinely scheduled office visits, consists of the following 3 components intended to promote initiation of ILI and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options for preventing diabetes; 2) a “think aloud” exercise; and 3) formulating a preliminary treatment plan. Previous studies report that medical assistants can improve uptake of some preventive health services in primary care, which may also be true for ILI and metformin. We will test this hypothesis by completing the following specific aims. In Aim 1, we will develop the DiRECT intervention using materials that our group has created and pilot tested in the target population. We will engage an Expert Advisory Panel of stakeholders in diabetes prevention, who will help develop the intervention so that can be widely disseminated if found to be effective. Aim 2 will evaluate the effects of the DiRECT intervention on patients’ perceived risk of developing diabetes and their intention to adopt treatment, in addition to other factors that may impact treatment decisions. Aim 3 is a pilot randomized trial of DiRECT vs. usual care in 80 primary care patients with prediabetes (40 in each arm). This pilot pragmatic trial will estimate the preliminary effects of DiRECT on the following 3-month outcomes: initiation of ILI and/or metformin (primary); adherence to these treatment(s); and weight loss. We will also examine the intervention’s acceptability, impact on clinical workflows, and costs. We hypothesize that the empirically developed DiRECT intervention will improve the accuracy of participants’ risk perceptions and increase their initiation of treatments to prevent diabetes. This study will be conducted in a large community health center, in which 90% of patients with prediabetes are racial/ethnic minorities and 83% live in poverty. Our proposal is responsive to PAR-15-158 by: 1) including a low- income, diverse population; 2) using medical assistants, a workforce that is ubiquitous and therefore scalable to most primary care settings; and 3) leveraging an existing data infrastructure to pragmatically assess participants’ eligibility and collect their clinical data.