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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02451670
Recruitment Status : Completed
First Posted : May 22, 2015
Results First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborators:
Essentia Health
National Institute of Mental Health (NIMH)
Park Nicollet Clinic
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Disease Mental Disorder Health Behavior Bipolar Disorder Schizophrenia Behavioral: Prioritized Clinical Decision Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinics have been randomized into a treatment and a control arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Cardiovascular Risk in Adults With Serious Mental Illness Using an Electronic Medical Record-based Clinical Decision Support
Actual Study Start Date : January 20, 2016
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : September 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451670


Locations
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United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805
Park Nicollet Clinic
Minneapolis, Minnesota, United States, 55416
HealthPartners
Minneapolis, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute
Essentia Health
National Institute of Mental Health (NIMH)
Park Nicollet Clinic
Investigators
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Principal Investigator: Rebecca C Rossom, MD HealthPartners Institute
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02451670    
Other Study ID Numbers: A13-154
U19MH092201 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2015    Key Record Dates
Results First Posted: November 5, 2019
Last Update Posted: November 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Disease
Chronic Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Disease Attributes