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

Study Overview
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Brief Summary
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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.

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

Conditions
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PreDiabetes, Prediabetic State

Intervention / Treatment
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* Other: START diabetes prevention clinical pathway


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Visit with clinician who's not their PCP

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention clinic<br>Patients with prediabetes seen for routine care at intervention clinic | Other: START diabetes prevention clinical pathway<br>* The diabetes prevention clinical pathway will focus on the following steps: Screen/test - testing of eligible patients for prediabetes/diabetes Education - PCPs will be encouraged to take an online learning module and in-person group training on prediabetes management and patients with prediabetes will receive a handout about prediabetes prior to their upcoming PCP visit Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit Referral - patients may be referred to DPPs and/or medical nutrition therapy (MNT) Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes.<br>|
| No Intervention: Control clinic<br>Patients with prediabetes seen for routine care at control clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants referred to Diabetes Prevention Program |  | 12 months | 
| Number of participants prescribed metformin |  | 12 months | 
| Number of participants referred to Medical Nutrition Therapy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants enrolled in Diabetes Prevention Program |  | 12 months | 
| Number of participants who attend Medical Nutrition Therapy visit |  | 12 months | 
| Number of participants who repeat glycemic lab testing | Fasting glucose or Hemoglobin A1c | 12 months | 
| Number of participants who fill Metformin prescription |  | 12 months | 
| Change in weight | Change in weight measured in pounds (lbs) | Baseline and 12 months | 
| Number of participants who complete a follow-up PCP/team visit |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes prevention, Primary care, Clinical pathway, Pragmatic intervention