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

Improving Prediabetes Cardiovascular Care With EHR-Based Decision Support

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02759055
Enrollment
21664
Registered
2016-05-03
Start date
2016-10-31
Completion date
2019-12-31
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes

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.

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.

Interventions

OTHERClinical 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

Sponsors

Essentia Health
CollaboratorOTHER
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or StrokeIndex visit to 12 months post index visit10-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Clinical Decision Support (Cardiovascular Wizard)
In the Intervention arm, primary care providers will be provided with an Electronic Health Record-linked, Web-based clinical decision support system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based Clinical Decision Support and follow up to reduce risk of heart attacks or stroke, optimizing management and follow up of pre-diabetes patients with uncontrolled cardiovascular risk factors. Clinical Decision Support: an Electronic Health Record-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
10,775
Usual Care
In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
7,454
Total18,229

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPatients with no follow-up visit and/or age 18-39 were not included in analyses.1,9271,508

Baseline characteristics

CharacteristicClinical Decision Support (Cardiovascular Wizard)Usual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4444 Participants2741 Participants7185 Participants
Age, Categorical
Between 18 and 65 years
6331 Participants4713 Participants11044 Participants
Age, Continuous61.2 years
STANDARD_DEVIATION 8.8
60.5 years
STANDARD_DEVIATION 8.8
60.9 years
STANDARD_DEVIATION 8.8
Cardiovascular Risk11.2 units on a scale
STANDARD_DEVIATION 8.3
11.1 units on a scale
STANDARD_DEVIATION 8.4
11.2 units on a scale
STANDARD_DEVIATION 8.4
Ethnicity (NIH/OMB)
Hispanic or Latino
49 Participants30 Participants79 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10726 Participants7424 Participants18150 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
172 Participants52 Participants224 Participants
Race (NIH/OMB)
Asian
40 Participants36 Participants76 Participants
Race (NIH/OMB)
Black or African American
77 Participants38 Participants115 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
7 Participants2 Participants9 Participants
Race (NIH/OMB)
Unknown or Not Reported
78 Participants24 Participants102 Participants
Race (NIH/OMB)
White
10399 Participants7299 Participants17698 Participants
Region of Enrollment
United States
10775 participants7454 participants18229 participants
Sex: Female, Male
Female
5428 Participants3808 Participants9236 Participants
Sex: Female, Male
Male
5347 Participants3646 Participants8993 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
207 / 10,775159 / 7,454
other
Total, other adverse events
339 / 10,775255 / 7,454
serious
Total, serious adverse events
1,836 / 10,7751,360 / 7,454

Outcome results

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.

Time frame: Index visit to 12 months post index visit

Population: The patients whose data were included in the primary outcome analysis were those who met eligibility criteria in the eligibility table.

ArmMeasureValue (NUMBER)
Clinical Decision Support (CV Wizard)Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke1.100 units on a scale
Usual CarePredicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke1.096 units on a scale
p-value: <0.0595% CI: [0.998, 1.008]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026