Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard)
Condition: Pre-diabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Nearly one in three adults has prediabetes, a condition that substantially increases the risk
      of heart attacks and stroke. The increased cardiovascular risk associated with prediabetes
      can be effectively managed by lifestyle changes or medication therapy, but recent data shows
      few prediabetes patients are treated effectively. In this project, we will adapt, implement,
      and evaluate a proven electronic health record-linked, web-based clinical decision support
      system to identify patients with prediabetes and provide prioritized treatment
      recommendations to patients and providers in a rural health system. The results of the
      project will provide a template for implementation of more efficient and effective rural
      healthcare and have the potential to substantially and improve cardiovascular quality of care
      and clinical outcomes of millions of rural Americans with prediabetes.
    

Detailed description: 
      Nearly one in three adults in rural communities has prediabetes, a condition that increases
      the risk of heart attacks and stroke but can be managed by use of metformin, lifestyle
      interventions, and control of major cardiovascular (CV) risk factors. However, current
      prediabetes care is characterized by: (a) delayed recognition of prediabetes; (b) patient
      unawareness of effective treatment options for prediabetes; (c) poor control of concomitant
      major CV risk factors; (d) very low rates of metformin initiation; and (e) low rates of
      follow up to assess ongoing effectiveness of prediabetes management.1-3 Increased use of
      electronic health records (EHR) in rural communities now provides a new opportunity to
      improve awareness and management of prediabetes and to reduce these patients' significant CV
      risk burden. In this project, we implement and evaluate an EHR-linked, Web-based clinical
      decision support (CDS) system that identifies patients with prediabetes and provides patients
      and their primary care providers personalized, evidence-based CDS and follow up to reduce
      risk of heart attacks or stroke. To accomplish this objective, we randomly allocate 30
      primary care clinics with their 450 primary care providers and estimated 17,000 prediabetes
      patients to one of two intervention arms: Usual Care; or else the prediabetes CDS to optimize
      management and follow up of prediabetes patients with uncontrolled CV risk factors.
      Random-effects models assess intervention impact on: (a) American College of
      Cardiology/American Heart Association (ACC/AHA) pooled CV risk; (b) major CV risk factors
      (blood pressure, lipids, HbA1c, smoking, and BMI); (c) use of evidence-based drugs, including
      metformin, and lifestyle interventions to manage prediabetes; and (d) patient and provider
      satisfaction with the intervention strategy. We also conduct a state-of-the-art cost and a
      cost-effectiveness analysis of the interventions relative to usual care. The Reach,
      Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, supplemented by
      the Consolidated Framework for Implementation Research (CFIR), is used to assess
      implementation processes and outcomes in a rural/urban health system.

      The results of the project will provide a template for implementation of personalized CDS
      tools in rural and urban health settings, resulting in more efficient and effective rural
      healthcare that can be broadly applied across many clinical domains, incorporates patient
      treatment preferences, and has the potential to substantially improve the quality of CV care
      and clinical outcomes of millions of Americans with prediabetes residing in medically
      underserved areas.
    

Intervention name(s): Clinical Decision Support
Intervention type(s): Other
Intervention description(s): an EHR-linked, Web-based clinical decision support (CDS) system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke
Other intervention name(s): CV Wizard
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment