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OpenTrials
Completed

NCT Number: NCT05265312

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins General Internal Medicine clinic at Green Spring Station

Lutherville, Maryland, 21204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

START diabetes prevention clinical pathway

Other

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.

Primary outcomes

  1. Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit

    Time frame: 12 months

    Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period

  2. Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days

    Time frame: 12 months

  3. Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

    Fasting glucose or Hemoglobin A1c

  2. Achieve 5% or Greater Reduction in Weight Compared to Baseline

    Time frame: Baseline and 12 months

    Proportion achieving 5% or greater weight reduction

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2022
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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