START Diabetes Prevention: A Multi-Level Strategy for Primary Care Clinics

Abstract

Background Prediabetes, a high-risk state for developing diabetes, affects more than 1 in 3 adults nationally. However, <5% of people with prediabetes are receiving any treatment for prediabetes. Prior intervention studies for increasing prediabetes treatment uptake have largely focused on individual barriers with few multi-level interventions that address clinician- and system-level barriers. Objective To measure the effectiveness of a multi-level intervention on uptake of prediabetes treatment in a primary care clinic. Design Pragmatic study of the START (Screen, Test, Act, Refer and Treat) Diabetes Prevention intervention. Participants The START Diabetes Prevention intervention was implemented in a suburban primary care clinic outside of Baltimore compared to a control clinic in the same area over a 12-month period. Intervention START Diabetes Prevention intervention included a structured workflow, shared decision-making resources and electronic health record clinical decision support tools. Main Measures Uptake of prediabetes treatment, defined as Diabetes Prevention Program referral, metformin prescription and/or medical nutrition referral within 30 days of any PCC visit. Key Results We demonstrated greater uptake of preventive treatment among patients with prediabetes in the intervention clinic vs. control clinic receiving usual care (11.6% vs. 6.7%, p<0.001). More patients in the intervention vs. control clinic reported their PCC discussed prediabetes with them (60% vs. 48%, p=0.002) and more felt overall that they understood what their doctor was telling them about prediabetes and that their opinion was valued. The START Diabetes Prevention Strategy had greater acceptability and usefulness to PCCs at the study end compared to baseline. Conclusions A low-touch multi-level intervention is effective in increasing prediabetes treatment uptake. The intervention was also acceptable and feasible for clinicians, and enhanced patient understanding and their discussions of prediabetes with their clinicians.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT05265312

Funding Statement

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases [Dr. Eva Tseng, K23DK118205].

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Institutional Review Board of Johns Hopkins School of Medicine reviewed and gave ethical approval this study.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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