CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,910 enrolled
Drug / intervention
START diabetes prevention clinical pathwayother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05265312
NCT05265312N/ACompleted

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

Johns Hopkins University·interventional·Posted Mar 3, 2022·Updated Feb 5, 2025

In Brief

A clinical study evaluating START diabetes prevention clinical pathway for PreDiabetes and Prediabetic State. Completed, enrolled 1,910 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 3, 2022
Enrollment StartMay 31, 2022
Primary CompletionJun 2, 2023
Study CompletionJul 2, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.3 years ago

Interventions

START diabetes prevention clinical pathwayother

The diabetes prevention clinical pathway will focus on the following steps: 1. Screen/test - testing of eligible patients for prediabetes/diabetes 2. 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 3. Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit 4. Referral - patients may be referred to DPPs and/or medical nutrition therapy (MNT) 5. Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes.