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

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 Overview

• Status: Completed
• Conditions: PreDiabetes; Prediabetic State
• Intervention / Treatment: Other: START diabetes prevention clinical pathway

• Study Type: Interventional
• Enrollment (Actual): 1910
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Lutherville, Maryland, United States, 21204
      • Johns Hopkins General Internal Medicine clinic at Green Spring Station

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Prediabetes based on prediabetes registry
• Age ≥ 18 years
• PCP visit during intervention period
• Patient of Johns Hopkins Green Spring Station (GSS) General Internal Medicine or Johns Hopkins Community Physicians (JHCP) Internal Medicine clinic.

Exclusion Criteria:

• Visit with clinician who's not their Primary Care Physician (PCP)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention clinic; Patients with prediabetes seen for routine care at intervention clinic	Other: START diabetes prevention clinical pathway; 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.
No Intervention: Control clinic; Patients with prediabetes seen for routine care at control clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit	Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period	12 months
Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days		12 months
Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period	Fasting glucose or Hemoglobin A1c	12 months
Achieve 5% or Greater Reduction in Weight Compared to Baseline	Proportion achieving 5% or greater weight reduction	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Eva Tseng, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): July 2, 2023

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Primary care; Diabetes prevention; Clinical pathway; Pragmatic intervention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB00313490; K23DK118205 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No