Clinical trial NCT05265312: 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
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Prediabetic State
Keywords: Diabetes prevention
Primary care
Clinical pathway
Pragmatic intervention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-03-03
Enrollment: 1910
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit
timeFrame: 12 months
measure: Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days
timeFrame: 12 months
measure: Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period
timeFrame: 12 months
measure: Achieve 5% or Greater Reduction in Weight Compared to Baseline
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Lutherville
country: United States
facility: Johns Hopkins General Internal Medicine clinic at Green Spring Station
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eva Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References: