Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Prediabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is a pragmatic cluster randomized trial testing the effectiveness of the PreDM CDS at inducing weight loss and improving other cardiometabolic markersMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Eighty six million U.S. adults have prediabetes, and up to 75% of them will eventually develop diabetes. Landmark clinical trials have established that intensive lifestyle interventions (ILI) and metformin are safe and effective treatments to prevent or delay diabetes in adults with prediabetes and ...

Eighty six million U.S. adults have prediabetes, and up to 75% of them will eventually develop diabetes. Landmark clinical trials have established that intensive lifestyle interventions (ILI) and metformin are safe and effective treatments to prevent or delay diabetes in adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used and few studies have explored how to promote their uptake in practice. One possible approach for increasing adoption of ILI and metformin in primary care includes clinical decision support (CDS), which uses electronic systems to create tailored recommendations for evidence-based clinical care. While a large body of evidence demonstrates that CDS can improve the delivery of other recommended preventive services, this approach has not been definitively studied for ILI and metformin. The investigators plan to address this critical knowledge gap by developing and evaluating the Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention for community health center patients with prediabetes and overweight/obesity. This novel CDS engages primary care providers and clinical staff to deliver intervention components. By accomplishing the following specific aims, this definitive study will test the potential for CDS to promote diabetes prevention and weight loss efforts in primary care. In Aim 1, study investigators will develop the proposed intervention by translating narrative guidelines about ILI and metformin into CDS, while incorporating extensive feedback from users. Aim 2 is a pragmatic cluster randomized trial, including 6 large community health center sites, which will examine the effectiveness of the PreDM CDS at inducing weight loss and improving other cardiometabolic markers. Aim 3 is a mixed-methods evaluation of the PreDM CDS, exploring its reach, adoption, implementation, maintenance, and cost. Study investigators hypothesize that the proposed PreDM CDS will increase patient's adoption of ILI and metformin, producing weight loss and improvements in other cardiometabolic markers. The resulting data, and an implementation toolkit created by the study team, will support the widespread dissemination of the PreDM CDS if found to be effective in the proposed study.

Tracking Information

NCT #
NCT04335331
Collaborators
  • AllianceChicago
  • Erie Family Health Centers
Investigators
Principal Investigator: Matthew O'Brien, MD, MSc Associate Professor