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

• Sponsor: HealthPartners Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02759055
• Collaborator: Essentia Health (Other)
• Enrollment: 21,664
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 556

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-diabetes	Other: Clinical Decision Support	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21664 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Improving Prediabetes Cardiovascular Care With EHR-Based Decision Support
• Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clinical Decision Support (CV Wizard) 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; 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; Other Names: CV Wizard
No Intervention: Usual Care In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.

Outcome Measures

Primary Outcome Measures

1. Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke [Index visit to 12 months post index visit]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Essentia Health	Duluth	Minnesota	United States	55805

Sponsors and Collaborators

• HealthPartners Institute
• Essentia Health

Investigators

• Principal Investigator: Daniel Saman, PhD, Essentia Institute of Rural Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 5, 2021

More Information

Publications

• 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.

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT02759055
• Other Study ID Numbers: HL128614-01
• First Posted: May 3, 2016
• Last Update Posted: Mar 16, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prediabetic State; Glucose Intolerance

Study Results

Participant Flow

Arm/Group Title	Clinical Decision Support (CV Wizard)	Usual Care
Arm/Group Description	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	In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
Period Title: Overall Study
STARTED	12702	8962
COMPLETED	10775	7454
NOT COMPLETED	1927	1508

Baseline Characteristics

Arm/Group Title	Clinical Decision Support (Cardiovascular Wizard)	Usual Care	Total
Arm/Group Description	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	In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.	Total of all reporting groups
Overall Participants	10775	7454	18229
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6331 58.8%	4713 63.2%	11044 60.6%
>=65 years	4444 41.2%	2741 36.8%	7185 39.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.2 (8.8)	60.5 (8.8)	60.9 (8.8)
Sex: Female, Male (Count of Participants)
Female	5428 50.4%	3808 51.1%	9236 50.7%
Male	5347 49.6%	3646 48.9%	8993 49.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	49 0.5%	30 0.4%	79 0.4%
Not Hispanic or Latino	10726 99.5%	7424 99.6%	18150 99.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	172 1.6%	52 0.7%	224 1.2%
Asian	40 0.4%	36 0.5%	76 0.4%
Native Hawaiian or Other Pacific Islander	7 0.1%	2 0%	9 0%
Black or African American	77 0.7%	38 0.5%	115 0.6%
White	10399 96.5%	7299 97.9%	17698 97.1%
More than one race	2 0%	3 0%	5 0%
Unknown or Not Reported	78 0.7%	24 0.3%	102 0.6%
Region of Enrollment (participants) [Number]
United States	10775 100%	7454 100%	18229 100%
Cardiovascular Risk (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.2 (8.3)	11.1 (8.4)	11.2 (8.4)

Outcome Measures

1. Primary Outcome

Title	Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Clinical Decision Support (CV Wizard)	Usual Care
Arm/Group Description	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	In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
Measure Participants	10775	7454
Number (95% Confidence Interval) [units on a scale]	1.100	1.096

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clinical Decision Support (CV Wizard), Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.003
	Confidence Interval	(2-Sided) 95%; 0.998 to 1.008
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Up to 30 months
Arm/Group Title	Clinical Decision Support (Cardiovascular Wizard)		Usual Care
Arm/Group Description	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		In the No Intervention arm, patients receive usual care from their primary care clinic and care providers.
All Cause Mortality
	Clinical Decision Support (Cardiovascular Wizard)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	207/10775 (1.9%)		159/7454 (2.1%)
Serious Adverse Events
	Clinical Decision Support (Cardiovascular Wizard)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1836/10775 (17%)		1360/7454 (18.2%)
General disorders
Hospitalizations	1836/10775 (17%)		1360/7454 (18.2%)
Other (Not Including Serious) Adverse Events
	Clinical Decision Support (Cardiovascular Wizard)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	339/10775 (3.1%)		255/7454 (3.4%)
Metabolism and nutrition disorders
Serum Potassium <= 3.0 mg/dl	138/10775 (1.3%)		97/7454 (1.3%)
Serum Potassium >= 6.5 mg/dl †	3/10775 (0%)		3/7454 (0%)
Musculoskeletal and connective tissue disorders
Vascular disorders
SBP < 90 mm Hg †	154/10775 (1.4%)		121/7454 (1.6%)
SBP >= 200 mm Hg †	40/10775 (0.4%)		36/7454 (0.5%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.