Reducing Cardiovascular Risk in Adults With Serious Mental Illness

Not Applicable

Completed

• Conditions: Mental Disorder; Chronic Disease; Health Behavior; Bipolar Disorder; Schizophrenia
• Interventions: Behavioral: Prioritized Clinical Decision Support

• Registration Number: NCT02451670
• Lead Sponsor: HealthPartners Institute

Brief 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.

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Study Start: 2016-01-20
• Primary Completion: 2018-09-19
• Study Completion: 2018-09-19
• Status Verified: 2019-03
• Results First Submitted: 2019-09-17
• Results First Submitted QC: 2019-10-16
• Last Update Submitted: 2019-10-16
• Results First Posted: 2019-11-05
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10347

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prioritized Clinical Decision Support	Prioritized Clinical Decision Support	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.

Primary Outcome Measures

Name	Time	Method
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke	Index to 12 months post index visit	A modifiable risk component for each cardiovascular risk factor not at optimal goal at the time of each encounter was calculated as the difference between total 10-year atherosclerotic cardiovascular disease risk with the patient's actual values and the goal value. Total modifiable cardiovascular risk was calculated by summing the modifiable cardiovascula risk components across cardiovascular risk factors not at optimal goal at the time of the encounter, and was calculated for each enrolled patient at the index visit and each subsequent encounter during the intervention period. Annual rate of change in modifiable cardiovascular risk was estimated from all patient encounters. A comparison of the difference in model-estimated rate of change in modifiable cardiovascular risk at 12 months post-index tested the primary efficacy hypothesis.

Trial Locations

Locations (3)

Essentia Health; 🇺🇸 Duluth, Minnesota, United States

Park Nicollet Clinic; 🇺🇸 Minneapolis, Minnesota, United States

HealthPartners; 🇺🇸 Minneapolis, Minnesota, United States