Reducing Cardiovascular Risk in Adults With Serious Mental Illness

NCT ID: NCT02451670

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2018-09-19

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prioritized Clinical Decision Support

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essentia Health

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Park Nicollet Clinic

OTHER

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca C Rossom, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

Essentia Health

Duluth, Minnesota, United States

Park Nicollet Clinic

Minneapolis, Minnesota, United States

HealthPartners

Minneapolis, Minnesota, United States

Countries

United States

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Sperl-Hillen JM, Anderson JP, Margolis KL, Rossom RC, Kopski KM, Averbeck BM, Rosner JA, Ekstrom HL, Dehmer SP, O'Connor PJ. Bolstering the Business Case for Adoption of Shared Decision-Making Systems in Primary Care: Randomized Controlled Trial. JMIR Form Res. 2022 Oct 6;6(10):e32666. doi: 10.2196/32666.

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Rossom RC, Hooker SA, O'Connor PJ, Crain AL, Sperl-Hillen JM. Cardiovascular Risk for Patients With and Without Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder. J Am Heart Assoc. 2022 Mar 15;11(6):e021444. doi: 10.1161/JAHA.121.021444. Epub 2022 Mar 9.

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Rossom RC, Crain AL, O'Connor PJ, Waring SC, Hooker SA, Ohnsorg K, Taran A, Kopski KM, Sperl-Hillen JM. Effect of Clinical Decision Support on Cardiovascular Risk Among Adults With Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220202. doi: 10.1001/jamanetworkopen.2022.0202.

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Rossom RC, O'Connor PJ, Crain AL, Waring S, Ohnsorg K, Taran A, Kopski K, Sperl-Hillen JM. Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness. Contemp Clin Trials. 2020 Apr;91:105964. doi: 10.1016/j.cct.2020.105964. Epub 2020 Feb 20.

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U19MH092201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A13-154

Identifier Type: -

Identifier Source: org_study_id