Clinical trial NCT02451670: Reducing Cardiovascular Risk in Adults With Serious Mental Illness
Official title: Reducing Cardiovascular Risk in Adults With Serious Mental Illness Using an Electronic Medical Record-based Clinical Decision Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Mental Disorder
Health Behavior
Bipolar Disorder
Schizophrenia
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Essentia Health
name: National Institute of Mental Health (NIMH)
name: Park Nicollet Clinic
First posted: 2015-05-22
Enrollment: 10347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinics have been randomized into a treatment and a control arm.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke
timeFrame: Index to 12 months post index visit
Secondary outcomes:
Other outcomes:
Locations:
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Minneapolis
country: United States
facility: Park Nicollet Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: HealthPartners
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Rebecca C Rossom, MD
role: PRINCIPAL_INVESTIGATOR
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