NCT02759055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,664

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 16, 2021

Completed
Last Updated

March 16, 2021

Status Verified

December 1, 2020

Enrollment Period

3.2 years

First QC Date

April 27, 2016

Results QC Date

December 29, 2020

Last Update Submit

March 15, 2021

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Clinical Decision Support (CV Wizard)

EXPERIMENTAL

In the Intervention arm, primary care providers will be provided with an EHR-linked, Web-based clinical decision support 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, optimizing management and follow up of pre-diabetes patients with uncontrolled CV risk factors.

Other: Clinical Decision Support

Usual Care

NO INTERVENTION

In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.

Interventions

Clinical Decision SupportOTHER

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

Also known as: CV Wizard
Clinical Decision Support (CV Wizard)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Evidence of Diabetes in the previous 12 months
  • Pregnant
  • Hospice care or Chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Related Publications (3)

  • 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.

    PMID: 20724649BACKGROUND

  • Saman DM, Allen CI, Freitag LA, Harry ML, Sperl-Hillen JM, Ziegenfuss JY, Haapala JL, Crain AL, Desai JR, Ohnsorg KA, O'Connor PJ. Clinician perceptions of a clinical decision support system to reduce cardiovascular risk among prediabetes patients in a predominantly rural healthcare system. BMC Med Inform Decis Mak. 2022 Nov 19;22(1):301. doi: 10.1186/s12911-022-02032-z.

    PMID: 36402988DERIVED

  • Pratt R, Saman DM, Allen C, Crabtree B, Ohnsorg K, Sperl-Hillen JM, Harry M, Henzler-Buckingham H, O'Connor PJ, Desai J. Assessing the implementation of a clinical decision support tool in primary care for diabetes prevention: a qualitative interview study using the Consolidated Framework for Implementation Science. BMC Med Inform Decis Mak. 2022 Jan 15;22(1):15. doi: 10.1186/s12911-021-01745-x.

    PMID: 35033029DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

CDS use was lower than the 80% target rate. Many patients had limited geographic or financial access to diabetes prevention programs. Due to differences in risk equations for patients age 40-75 (American College Cardiology/American Heart Association 10-year) and age 18-40 (Framingham 30 year), and missing lipid data in younger adults, the main analysis focused on age 40-75 years. Many with prediabetes had only modest potential for cardiovascular risk reductions clinicians may not prioritize.

Results Point of Contact

Title
Patrick J O'Connor
Organization
HealthPartners Institute
Patrick.J.OConnor@HealthPartners.Com
952-967-5034

Study Officials

  • Daniel Saman, PhD

    Essentia Institute of Rural Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 3, 2016

Study Start

October 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 16, 2021

Results First Posted

March 16, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)