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Randomized Controlled Trial
. 2020 Jun 1;3(6):e207247.
doi: 10.1001/jamanetworkopen.2020.7247.

Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial

Gail L Daumit  1   2   3   4   5   6 , Arlene T Dalcin  1   2 , Faith B Dickerson  7 , Edgar R Miller  1   2   4 , A Eden Evins  8 , Corinne Cather  8 , Gerald J Jerome  1   9 , Deborah R Young  10 , Jeanne B Charleston  1   2   4 , Joseph V Gennusa 3rd  1 , Stacy Goldsholl  1 , Courtney Cook  1 , Ann Heller  1 , Emma E McGinty  5   6 , Rosa M Crum  2   3   4 , Lawrence J Appel  1   2   4 , Nae-Yuh Wang  1   2   4   11
Affiliations
Randomized Controlled Trial

Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial

Gail L Daumit et al. JAMA Netw Open. .

Abstract

Importance: Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment.

Objective: To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness.

Design, setting, and participants: This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019.

Interventions: A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes.

Main outcomes and measures: The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control.

Results: Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.

Conclusions and relevance: An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population.

Trial registration: ClinicalTrials.gov Identifier: NCT02127671.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms Dalcin reported providing consulting services for a commercial telephonic weight loss coaching through Healthways/ShareCare, speaking at a CardioMetabolic conference (Saudi Aramco), and providing consulting to develop patient education videos to treat hypertension. Dr Evins reported receiving grants from Charles River Analytics, National Institutes of Health, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases, and Patient-Centered Outcomes Research Institute; grants and nonfinancial support from Pfizer; and personal fees from Alkermes Inc and Karuna Pharmaceuticals. Dr Cather reported receiving grant funding through Charles River Analytics. Dr Appel reported receiving a grant from Vital Strategies, a nonprofit organization, and receiving royalties for writing chapters for UpToDate, an online education tool for clinicians. Dr McGinty reported receiving grants from the National Institute on Drug Abuse, National Institute of Mental Health, Bloomberg Philanthropies, Arnold Ventures, and the Centers for Disease Control and Prevention outside the submitted work. Dr Crum reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Wang reported receiving grants from the National Institutes of Health during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Screening, Randomization, and Follow-up of Study Participants
CVD indicates cardiovascular disease.
Figure 2.
Figure 2.. Percentage Change in 10-Year Global Framingham Risk Score Over Time According to Study Group
The Global Framingham Risk Score reflects the 10-year probability of a cardiovascular event. The numbers of participants in the intervention group were 132 at baseline, 123 at 6 months, and 124 at 18 months. The numbers of participants in the control group were 137 at baseline, 126 at 6 months, and 132 at 18 months. Percentage change estimates (circles) and 95% CIs (error bars) are derived from mixed-effects repeated measures analysis using all available data from all randomized participants. Compared with the control group, the intervention group experienced a mean relative reduction in Framingham Risk Score of 12.7% (95% CI, 2.5%-22.9%; P = .02).
See this image and copyright information in PMC

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