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

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Johns Hopkins University

Status

Completed

Conditions

Prediabetic State
PreDiabetes

Treatments

Other: START diabetes prevention clinical pathway

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05265312
K23DK118205 (U.S. NIH Grant/Contract)
IRB00313490

Details and patient eligibility

About

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.

Enrollment

1,910 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,910 participants in 2 patient groups

Intervention clinic
Active Comparator group
Description:
Patients with prediabetes seen for routine care at intervention clinic
Treatment:
Other: START diabetes prevention clinical pathway
Control clinic
No Intervention group
Description:
Patients with prediabetes seen for routine care at control clinic

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Eva Tseng, MD

Data sourced from clinicaltrials.gov

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