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

NCT05265312 | Completed Results

• 2 other identifiers: IRB00313490K23DK118205
• Study Type: interventional
• Target: 1,910
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Prediabetic State

Keywords

Diabetes prevention; Primary care; Clinical pathway; Pragmatic intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period

  12 months

• Achieve 5% or Greater Reduction in Weight Compared to Baseline

  Baseline and 12 months

Study Arms (2)

Intervention clinic

ACTIVE COMPARATOR

Patients with prediabetes seen for routine care at intervention clinic

Other: START diabetes prevention clinical pathway

Control clinic

NO INTERVENTION

Patients with prediabetes seen for routine care at control clinic

Interventions

START diabetes prevention clinical pathway OTHER

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.

Intervention clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins General Internal Medicine clinic at Green Spring Station

Lutherville, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Eva Tseng
• Organization: Johns Hopkins University School of Medicine

etseng3@jhmi.edu

410-583-2774

Study Officials

• Eva Tseng, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: May 31, 2022
• Primary Completion: June 2, 2023
• Study Completion: July 2, 2023
• Last Updated: February 5, 2025
• Results First Posted: June 25, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)