Reducing Cardiovascular Risk in Adults With Serious Mental Illness

NCT02451670 | Completed Results DMC

• 2 other identifiers: A13-154U19MH092201
• Study Type: interventional
• Target: 10,347
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke

  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

Study Arms (2)

Prioritized Clinical Decision Support

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Prioritized Clinical Decision Support 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.

Prioritized Clinical Decision Support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• Essentia Health: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Park Nicollet Clinic: collaborator

Study Sites (3)

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Park Nicollet Clinic

Minneapolis, Minnesota, 55416, United States

Location

HealthPartners

Minneapolis, Minnesota, 55425, United States

Location

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• Rossom RC, Crain AL, Waring S, Sperl-Hillen JM, Hooker SA, Miley K, O'Connor PJ. Differential Effects of an Intervention to Reduce Cardiovascular Risk for Patients With Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia: A Randomized Clinical Trial. J Clin Psychiatry. 2023 Jul 5;84(4):22m14710. doi: 10.4088/JCP.22m14710.

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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.

  PMID: 35261265 DERIVED

• 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.

  PMID: 35254433 DERIVED

• 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.

  PMID: 32087336 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Limitations and Caveats

Because the study was conducted in three large medical groups in the same area of the country, generalizability of results to other care systems or populations is uncertain.

Results Point of Contact

• Title: Rebecca Rossom
• Organization: HealthPartnersInstitute

Rebecca.C.Rossom@HealthPartners.com

952-883-5466

Study Officials

• Rebecca C Rossom, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinics have been randomized into a treatment and a control arm.

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 22, 2015
• Study Start: January 20, 2016
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: November 5, 2019
• Results First Posted: November 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)