Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care
Primary Purpose
PreDiabetes, Prediabetic State
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
START diabetes prevention clinical pathway
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes focused on measuring Diabetes prevention, Primary care, Clinical pathway, Pragmatic intervention
Eligibility Criteria
Inclusion Criteria:
- Prediabetes based on prediabetes registry
- Age ≥ 18 years
- PCP visit during intervention period
Exclusion Criteria:
- Visit with clinician who's not their PCP
Sites / Locations
- Johns Hopkins General Internal Medicine clinic at Green Spring Station
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention clinic
Control clinic
Arm Description
Patients with prediabetes seen for routine care at intervention clinic
Patients with prediabetes seen for routine care at control clinic
Outcomes
Primary Outcome Measures
Number of participants referred to Diabetes Prevention Program
Number of participants prescribed metformin
Number of participants referred to Medical Nutrition Therapy
Secondary Outcome Measures
Number of participants enrolled in Diabetes Prevention Program
Number of participants who attend Medical Nutrition Therapy visit
Number of participants who repeat glycemic lab testing
Fasting glucose or Hemoglobin A1c
Number of participants who fill Metformin prescription
Change in weight
Change in weight measured in pounds (lbs)
Number of participants who complete a follow-up PCP/team visit
Full Information
NCT ID
NCT05265312
First Posted
February 22, 2022
Last Updated
June 13, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05265312
Brief Title
Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care
Official Title
Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Prediabetic State
Keywords
Diabetes prevention, Primary care, Clinical pathway, Pragmatic intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention clinic
Arm Type
Active Comparator
Arm Description
Patients with prediabetes seen for routine care at intervention clinic
Arm Title
Control clinic
Arm Type
No Intervention
Arm Description
Patients with prediabetes seen for routine care at control clinic
Intervention Type
Other
Intervention Name(s)
START diabetes prevention clinical pathway
Intervention Description
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 Outcome Measure Information:
Title
Number of participants referred to Diabetes Prevention Program
Time Frame
12 months
Title
Number of participants prescribed metformin
Time Frame
12 months
Title
Number of participants referred to Medical Nutrition Therapy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants enrolled in Diabetes Prevention Program
Time Frame
12 months
Title
Number of participants who attend Medical Nutrition Therapy visit
Time Frame
12 months
Title
Number of participants who repeat glycemic lab testing
Description
Fasting glucose or Hemoglobin A1c
Time Frame
12 months
Title
Number of participants who fill Metformin prescription
Time Frame
12 months
Title
Change in weight
Description
Change in weight measured in pounds (lbs)
Time Frame
Baseline and 12 months
Title
Number of participants who complete a follow-up PCP/team visit
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Tseng, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins General Internal Medicine clinic at Green Spring Station
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care
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