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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05265312
• Other study ID #: IRB00313490
• Secondary ID: K23DK118205
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: May 2024

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2400
• Est. completion date: May 2024
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prediabetes based on prediabetes registry

• Age = 18 years

• PCP visit during intervention period

• Patient of Johns Hopkins GSS General Internal Medicine or JHCP Internal Medicine clinic.

Exclusion Criteria:

• Visit with clinician who's not their PCP

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins General Internal Medicine clinic at Green Spring Station	Lutherville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants referred to Diabetes Prevention Program		12 months
Primary	Number of participants prescribed metformin		12 months
Primary	Number of participants referred to Medical Nutrition Therapy		12 months
Secondary	Number of participants enrolled in Diabetes Prevention Program		12 months
Secondary	Number of participants who attend Medical Nutrition Therapy visit		12 months
Secondary	Number of participants who repeat glycemic lab testing	Fasting glucose or Hemoglobin A1c	12 months
Secondary	Number of participants who fill Metformin prescription		12 months
Secondary	Change in weight	Change in weight measured in pounds (lbs)	Baseline and 12 months
Secondary	Number of participants who complete a follow-up PCP/team visit		12 months