Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care

Not Applicable

Completed

• Conditions: Prediabetic State; PreDiabetes
• Interventions: Other: START diabetes prevention clinical pathway

• Registration Number: NCT05265312
• Lead Sponsor: Johns Hopkins University

Brief Summary

Prediabetes is a significant public health problem affecting 88 million U.S. adults. Evidence suggest that the vast majority of people with prediabetes are unaware of having this condition and many are not receiving appropriate care for prediabetes, including referral to evidence-based programs like the Diabetes Prevention Programs (DPP). In the investigator's retrospective cohort study of patients with prediabetes from Johns Hopkins Health Systems, the investigators found that the rates of prediabetes clinical care activities are low. In the investigators' qualitative studies, the investigators found that primary care physician (PCP) barriers include low knowledge about Diabetes Prevention Programs and misperceptions of insurance coverage of these programs and inadequate clinical staff to address prediabetes. Common patient barriers to taking action to prevent diabetes include lack of motivation, time and resources.

Based on prior research, comprehensive strategies are urgently needed to improve prediabetes care. Using these findings, the investigators have designed and plan to implement a diabetes prevention clinical pathway which seeks to address some of these common clinician and patient barriers. The investigators hypothesize that the clinical pathway will result in increased clinician screening and intervention and improve patient engagement in diabetes prevention. The investigators will compare results from the intervention clinic compared to a control clinic. If successful, the investigators plan to implement and test the effectiveness of this clinical pathway across the entire health system.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Study Start: 2022-05-31
• Primary Completion: 2023-06-02
• Study Completion: 2023-07-02
• Status Verified: 2024-05
• Results First Submitted: 2024-05-29
• Results First Submitted QC: 2024-05-29
• Last Update Submitted: 2024-05-29
• Results First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1910

Inclusion Criteria

• Prediabetes based on prediabetes registry
• Age ≥ 18 years
• PCP visit during intervention period
• Patient of Johns Hopkins GSS General Internal Medicine or JHCP Internal Medicine clinic.

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Exclusion Criteria

• Visit with clinician who's not their PCP

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention clinic	START diabetes prevention clinical pathway	Patients with prediabetes seen for routine care at intervention clinic

Primary Outcome Measures

Name	Time	Method
Number of Participants Referred to Medical Nutrition Therapy	12 months
Number of Participants Referred to Diabetes Prevention Program	12 months	Number of participants referred to Diabetes Prevention Program during intervention period
Number of Participants Prescribed Metformin	12 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Complete a Follow-up PCP/Team Visit	12 months
Number of Participants Who Attend Medical Nutrition Therapy Visit	12 months
Number of Participants Who Repeat Glycemic Lab Testing	12 months	Fasting glucose or Hemoglobin A1c
Change in Weight	Baseline and 12 months	Change in weight measured in pounds (lbs)
Number of Participants Who Fill Metformin Prescription	12 months
Number of Participants Enrolled in Diabetes Prevention Program	12 months

Trial Locations

Locations (1)

Johns Hopkins General Internal Medicine clinic at Green Spring Station; 🇺🇸 Lutherville, Maryland, United States