Abstract
Adults with schizophrenia, schizoaffective disorder, or bipolar disorder, collectively termed serious mental illness (SMI), have shortened life spans compared with people without SMI. The leading cause of death is cardiovascular (CV) disease. To assess whether a clinical decision support (CDS) system aimed at primary care clinicians improves CV health for adult primary care patients with SMI. In this cluster randomized clinical trial conducted from March 2, 2016, to September 19, 2018, restricted randomization assigned 76 primary care clinics in 3 Midwestern health care systems to receive or not receive a CDS system aimed at improving CV health among patients with SMI. Eligible clinics had at least 20 patients with SMI; clinicians and their adult patients with SMI with at least 1 modifiable CV risk factor not at the goal set by the American College of Cardiology/American Heart Association guidelines were included. Statistical analysis was conducted on an intention-to-treat basis from January 10, 2019, to December 29, 2021. The CDS system assessed modifiable CV risk factors and provided personalized treatment recommendations to clinicians and patients. Patient-level change in total modifiable CV risk over 12 months, summed from individual modifiable risk factors (smoking, body mass index, low-density lipoprotein cholesterol level, systolic blood pressure, and hemoglobin A1c level). A total of 80 clinics were randomized; 4 clinics were excluded for having fewer than 20 eligible patients, leaving 42 intervention clinics and 34 control clinics. A total of 8937 patients with SMI (4922 women [55.1%]; mean [SD] age, 48.4 [13.5] years) were enrolled. There was a 4% lower rate of increase in total modifiable CV risk among intervention patients relative to control patients (relative rate ratio [RR], 0.96; 95% CI, 0.94-0.98). The intervention favored patients who were 18 to 29 years of age (RR, 0.89; 95% CI, 0.81-0.98) or 50 to 59 years of age (RR, 0.93; 95% CI, 0.90-0.96), Black (RR, 0.93; 95% CI, 0.88-0.98), or White (RR, 0.96; 95% CI, 0.94-0.98). Men (RR, 0.96; 95% CI, 0.94-0.99) and women (RR, 0.95; 95% CI, 0.92-0.97), as well as patients with any SMI subtype (bipolar disorder: RR, 0.96; 95% CI, 0.94-0.99; schizoaffective disorder: RR, 0.94; 95% CI, 0.90-0.98; schizophrenia: RR, 0.92; 95% CI, 0.85-0.99) also benefited from the intervention. Despite treatment effects favoring the intervention, there were no significant differences in individual modifiable risk factors. This CDS intervention resulted in a rate of change in total modifiable CV risk that was 4% lower among intervention patients compared with control patients. Results were driven by the cumulative effects of incremental and mostly nonsignificant changes in individual modifiable risk factors. These findings emphasize the value of using CDS to prompt early primary care intervention for adults with SMI. ClinicalTrials.gov Identifier: NCT02451670.
Highlights
People with bipolar disorder, schizophrenia, or schizoaffective disorder, collectively termed serious mental illness (SMI), die at 2.3 times the rate of people without SMI, shortening their life spans by 10 to 15 years.[1,2] Cardiovascular (CV) disease is the leading cause of death for people with SMI,[3] associated in part with higher relative risks of dyslipidemia (5-fold), smoking (2-fold to 3-fold), diabetes (2-fold), and obesity (1.5-fold to 2-fold).[4,5] Some SMI medications may increase cardiometabolic risk by adversely affecting weight, insulin resistance, and lipid metabolism.[6-8]
There was a 4% lower rate of increase in total modifiable CV risk among intervention patients relative to control patients
Effect of Clinical Decision Support on Cardiovascular Risk Among Adults With Serious Mental Illness. This Clinical decision support (CDS) intervention resulted in a rate of change in total modifiable CV risk that was 4% lower among intervention patients compared with control patients
Summary
Schizophrenia, or schizoaffective disorder, collectively termed serious mental illness (SMI), die at 2.3 times the rate of people without SMI, shortening their life spans by 10 to 15 years.[1,2] Cardiovascular (CV) disease is the leading cause of death for people with SMI,[3] associated in part with higher relative risks of dyslipidemia (5-fold), smoking (2-fold to 3-fold), diabetes (2-fold), and obesity (1.5-fold to 2-fold).[4,5] Some SMI medications may increase cardiometabolic risk by adversely affecting weight, insulin resistance, and lipid metabolism.[6-8]. Clinical decision support (CDS) tools are typically technology-based interventions that provide patient-specific information, often at the point of care, to improve health and health care.[12]. With improved design and implementation, more recent studies of electronic health record (EHR)–linked CDS tools have achieved high use rates and decreased CV risk in populations without SMI.[19-21]. This pragmatic cluster randomized clinical trial, designed to test the effectiveness of the intervention in real-world clinical practice, assessed whether an EHR-linked CDS system slowed increases in modifiable CV risk among adults with SMI
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