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.

Abstract

Objective: To measure the impact of a clinical decision support (CDS) tool on total modifiable cardiovascular risk at 12 months separately for outpatients with 3 subtypes of serious mental illness (SMI) identified via ICD-9 and ICD-10 codes: bipolar disorder, schizoaffective disorder, and schizophrenia.

Methods: This cluster-randomized pragmatic clinical trial was active from March 2016 to September 2018; data were analyzed from April 2021 to September 2022. Clinicians and patients from 78 primary care clinics participated. All 8,922 adult patients aged 18-75 years with diagnosed SMI, at least 1 cardiovascular risk factor not at goal, and an index and follow-up visit during the study period were included. The CDS tool provided a summary of modifiable cardiovascular risk and personalized treatment recommendations.

Results: Intervention patients had 4% relative reduction in total modifiable cardiovascular risk at 12 months compared to controls (relative risk ratio = 0.96; 95% CI, 0.94 to 0.98), with similar intervention benefits for all 3 SMI subtypes. At index, 10-year cardiovascular risk was higher for patients with schizophrenia (mean [SD] = 11.3% [9.2%]) than for patients with bipolar disorder (8.5% [8.9%]) or schizoaffective disorder (9.4% [8.1%]), while 30-year cardiovascular risk was highest for patients with schizoaffective disorder (44% with 2 or more major cardiovascular risk factors, compared to 40% for patients with schizophrenia and 37% for patients with bipolar disorder). Smoking was highly prevalent (47%), and mean (SD) BMI was 32.7 (7.9).

Conclusions: This CDS intervention produced a clinically and statistically significant 4% relative reduction in total modifiable cardiovascular risk for intervention patients versus controls at 12 months, an effect observed across all 3 SMI subtypes and attributable to the aggregate impact of small changes in multiple cardiovascular risk factors.

Trial Registration: ClinicalTrials.gov Identifier: NCT02451670.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Bipolar Disorder* / psychology
  • Cardiovascular Diseases* / epidemiology
  • Cardiovascular Diseases* / prevention & control
  • Heart Disease Risk Factors
  • Humans
  • Psychotic Disorders* / drug therapy
  • Risk Factors
  • Schizophrenia* / drug therapy

Associated data

  • ClinicalTrials.gov/NCT02451670