Reducing Cardiovascular Risk in Adults With Serious Mental Illness (SMIWizard)

HealthPartners Institute

Status: Completed

Conditions: Mental Disorder; Chronic Disease; Schizophrenia; Bipolar Disorder; Health Behavior

Treatments: Behavioral: Prioritized Clinical Decision Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02451670

A13-154

U19MH092201 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This purpose of this study is to adapt, implement and test the ability of a sophisticated point-of-care electronic health record-based clinical decision support that identifies and prioritizes all available evidence-based treatment options to reduce cardiovascular risk in patients with serious mental illness.

Full description

This study adapted a point-of-care electronic health record-based clinical decision support system (The Cardiovascular Wizard) to help primary care providers identify, provide appropriate care for, and control cardiovascular risk factors for patients with serious mental illness (bipolar disorder, schizophrenia, schizo-affective disorder). The Cardiovascular Wizard is designed to educate primary care providers about the increased risk of cardiovascular disease and mortality in people with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, prioritize these cardiovascular risk based on how much improvement in cardiovascular risk a patient would experience if the cardiovascular risk factor was adequately addressed, recommend specific medications and other interventions to decrease each elevated cardiovascular risk factor, and provide this information in an easy-to-understand format for both patients with serious mental illness and their primary care providers.

The Cardiovascular Wizard was printed in intervention clinics and (i) compiled lab data (most recent glycated hemoglobin, systolic blood pressure and low-density lipoprotein levels), body mass index, smoking status, and aspirin use, (ii) calculated a modifiable 10 year cardiovascular risk for stroke or heart attack using the American College of Cardiology/American Heart Association 10-year atherosclerotic cardiovascular disease risk equation, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to liver and renal function, creatinine kinase level, and previous diagnoses (Congestive Heart Failure, Cardiovascular Disease, Diabetes Mellitus, and (v) provided recommendations for intensification of therapy for glycated hemoglobin, systolic blood pressure, and/or low-density lipoproteins if not at goal. Recommendations were based on evidence-based protocols including Joint National Committee, American Diabetes Association, and the Institute for Clinical Systems Improvement.

Enrollment: 10,347 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serious Mental Illness diagnosis
• Age 18-75
• Index visit during the enrollment period
• First primary care visit where patient was not at goal for at least one of the six cardiovascular risk factor areas, and patient was not pregnant
• One or more post-index visits during the intervention period

Exclusion criteria

• No Serious Mental Illness diagnosis
• Under age 18 or over age 75
• In hospice or nursing home
• At goal for all cardiovascular risk 6 areas
• On research exclusion list

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,347 participants in 2 patient groups

Prioritized Clinical Decision Support

Experimental group

Description:

Patients receiving care in clinics randomized to the intervention arm of the study and their primary care providers were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record-based alert during their primary care visit.

Treatment:

Behavioral: Prioritized Clinical Decision Support

Usual Care

No Intervention group

Description:

Patients receiving care in clinics randomized to the usual care arm of the study and their providers were not presented with the prioritized clinical decision support.