NCT02451670

Reducing Cardiovascular Risk in Adults With Serious Mental Illness

Reducing Cardiovascular Risk in Adults With Serious Mental Illness Using an Electronic Medical Record-based Clinical Decision Support

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,347 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Chronic Disease
• Mental Disorder
• Health Behavior
• Bipolar Disorder
• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	Prioritized Clinical Decision Support	After entry of blood pressure data at all primary care visits, relevant electronic health record data were automatically extracted, encrypted and processed through Web-based clinical algorithms that determined if the patient met intervention eligibility criteria. In intervention clinics, the rooming staff received a best practice alert and printed patient and primary care provider versions of the clinical decision support that identified evidence-based treatment options for any uncontrolled cardiovascular risk factors and prioritized treatment recommendations based on potential cardiovascular risk reduction. Cardiovascular risk factors addressed in study participants were control of lipids, blood pressure, weight, tobacco, glucose and appropriate aspirin use. In control clinics, rooming staff did not receive a best practice alert and patients and primary care providers did not receive and were not able to access the clinical decision support.

Timeline

• Start date: 2016-01-20
• Primary completion: 2018-09-19
• Completion: 2018-09-19
• First posted: 2015-05-22
• Last updated: 2019-11-05
• Results posted: 2019-11-05

Locations

3 sites across 1 country: United States