Trial Outcomes & Findings for Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard) (NCT NCT02759055)

Last Updated: 2021-03-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

21664 participants

Primary outcome timeframe

Index visit to 12 months post index visit

Results posted on

2021-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Clinical Decision Support (CV 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 CDS 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(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	Usual Care In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
Overall Study STARTED	12702	8962
Overall Study COMPLETED	10775	7454
Overall Study NOT COMPLETED	1927	1508

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinical Decision Support (CV 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 CDS 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(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	Usual Care In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
Overall Study Patients with no follow-up visit and/or age 18-39 were not included in analyses.	1927	1508

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Decision Support (Cardiovascular Wizard) n=10775 Participants 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	Usual Care n=7454 Participants In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.	Total n=18229 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6331 Participants n=5 Participants	4713 Participants n=7 Participants	11044 Participants n=5 Participants
Age, Categorical >=65 years	4444 Participants n=5 Participants	2741 Participants n=7 Participants	7185 Participants n=5 Participants
Age, Continuous	61.2 years STANDARD_DEVIATION 8.8 • n=5 Participants	60.5 years STANDARD_DEVIATION 8.8 • n=7 Participants	60.9 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	5428 Participants n=5 Participants	3808 Participants n=7 Participants	9236 Participants n=5 Participants
Sex: Female, Male Male	5347 Participants n=5 Participants	3646 Participants n=7 Participants	8993 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	49 Participants n=5 Participants	30 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10726 Participants n=5 Participants	7424 Participants n=7 Participants	18150 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	172 Participants n=5 Participants	52 Participants n=7 Participants	224 Participants n=5 Participants
Race (NIH/OMB) Asian	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Black or African American	77 Participants n=5 Participants	38 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) White	10399 Participants n=5 Participants	7299 Participants n=7 Participants	17698 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	78 Participants n=5 Participants	24 Participants n=7 Participants	102 Participants n=5 Participants
Region of Enrollment United States	10775 participants n=5 Participants	7454 participants n=7 Participants	18229 participants n=5 Participants
Cardiovascular Risk	11.2 units on a scale STANDARD_DEVIATION 8.3 • n=5 Participants	11.1 units on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	11.2 units on a scale STANDARD_DEVIATION 8.4 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Clinical Decision Support (CV Wizard) n=10775 Participants 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 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	Usual Care n=7454 Participants In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke	1.100 units on a scale Interval 1.097 to 1.103	1.096 units on a scale Interval 1.029 to 1.101

Adverse Events

Clinical Decision Support (Cardiovascular Wizard)

Serious events: 1836 serious events

Other events: 339 other events

Deaths: 207 deaths

Usual Care

Serious events: 1360 serious events

Other events: 255 other events

Deaths: 159 deaths

Serious adverse events

Serious adverse events
Measure	Clinical Decision Support (Cardiovascular Wizard) n=10775 participants at risk 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 cardiovascular risk factors. 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	Usual Care n=7454 participants at risk In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
General disorders Hospitalizations	17.0% 1836/10775 • Up to 30 months	18.2% 1360/7454 • Up to 30 months

Other adverse events

Other adverse events
Measure	Clinical Decision Support (Cardiovascular Wizard) n=10775 participants at risk 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 cardiovascular risk factors. 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	Usual Care n=7454 participants at risk In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
Metabolism and nutrition disorders Serum Potassium <= 3.0 mg/dl	1.3% 138/10775 • Up to 30 months	1.3% 97/7454 • Up to 30 months
Metabolism and nutrition disorders Serum Potassium >= 6.5 mg/dl †	0.03% 3/10775 • Up to 30 months	0.04% 3/7454 • Up to 30 months
Musculoskeletal and connective tissue disorders Serum Total CK >= 1200 mg/dl †	0.16% 17/10775 • Up to 30 months	0.11% 8/7454 • Up to 30 months
Vascular disorders SBP < 90 mm Hg †	1.4% 154/10775 • Up to 30 months	1.6% 121/7454 • Up to 30 months
Vascular disorders SBP >= 200 mm Hg †	0.37% 40/10775 • Up to 30 months	0.48% 36/7454 • Up to 30 months

Additional Information

Patrick J O'Connor

HealthPartners Institute

Phone: 952-967-5034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place