Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard)

Pre-diabetes Clinical Trial

Official title:

Improving Prediabetes Cardiovascular Care With EHR-Based Decision Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759055
• Other study ID #: HL128614-01
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21664
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• Clinical Decision Support
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

Locations

Country	Name	City	State
United States	Essentia Health	Duluth	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Essentia Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Karve A, Hayward RA. Prevalence, diagnosis, and treatment of impaired fasting glucose and impaired glucose tolerance in nondiabetic U.S. adults. Diabetes Care. 2010 Nov;33(11):2355-9. doi: 10.2337/dc09-1957. Epub 2010 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke	10-year cardiovascular risk was calculated at the index and all post-index patient encounters. A comparison of the difference in model-estimated annual rate of change in cardiovascular risk in Clinical Decision Support versus Usual Care clinics tested the primary efficacy hypothesis. The American College of Cardiology/American Heart Association (ACC/AHA) pooled CV risk calculator provides sex- and race-specific 10-year risk estimates for the first ASCVD event for black & white men & women aged 40-79 years. Variables included in risk assessment equations: age, total cholesterol, high-density lipoprotein cholesterol (HDL-C), systolic blood pressure (SBP) diabetes mellitus (diabetes), and current smoking status. 10-year risk for ASCVD categorized as: Low (<5%), Borderline (5% to 7.4%), Intermediate (7.5% to 19.9%), High (=20%). Numerator: Rate of change in Clinical Decision Support. Denominator: Rate of change in Usual Care. Relative Risk < 1 supports primary hypothesis.	Index visit to 12 months post index visit