Pre-Diabetes Cardiovascular Care (Pre-Diabetes Wizard)



Status:Enrolling by invitation
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:5/18/2018
Start Date:October 2016
End Date:July 2020

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Improving Prediabetes Cardiovascular Care With EHR-Based Decision Support

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.

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.

Inclusion Criteria:

- Pre-Diabetes Diagnosis or Clinical Lab Values and

- One or more of the following CV risk factors: Current smoking, Hypertension, elevated
LDL, or BMI not within normal range, AND

- at least one subsequent primary care visit to a randomized clinic 12 to 24 months
after the index visit.

Exclusion Criteria:

- Evidence of Diabetes in the previous 12 months

- Pregnant

- Hospice care or Chemotherapy
We found this trial at
1
site
Duluth, Minnesota 55805
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Duluth, MN
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