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

October 16, 2019 updated by: HealthPartners Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10347

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health
      • Minneapolis, Minnesota, United States, 55416
        • Park Nicollet Clinic
      • Minneapolis, Minnesota, United States, 55425
        • HealthPartners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Index to 12 months post index visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

National Institute of Mental Health (NIMH)
Essentia Health
Park Nicollet Clinic

Investigators

  • Principal Investigator: Rebecca C Rossom, MD, HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2016

Primary Completion (Actual)

September 19, 2018

Study Completion (Actual)

September 19, 2018

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A13-154
  • U19MH092201 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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