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

NCT ID: NCT05265312

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1910 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-07-02

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention clinic

Patients with prediabetes seen for routine care at intervention clinic

Group Type: ACTIVE_COMPARATOR

START diabetes prevention clinical pathway

Intervention Type: 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.

Control clinic

Patients with prediabetes seen for routine care at control clinic

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

START diabetes prevention clinical pathway

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 Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Tseng, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins General Internal Medicine clinic at Green Spring Station

Lutherville, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23DK118205

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00313490

Identifier Type: -

Identifier Source: org_study_id