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

This randomized clinical trial examines 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. Question Does an 18-month intervention incor...

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Veröffentlicht in:JAMA health forum 2020-06, Vol.3 (6), p.e207247, Article 207247
Hauptverfasser: Daumit, Gail L., Dalcin, Arlene T., Dickerson, Faith B., Miller, Edgar R., Evins, A. Eden, Cather, Corinne, Jerome, Gerald J., Young, Deborah R., Charleston, Jeanne B., Gennusa, Joseph, Goldsholl, Stacy, Cook, Courtney, Heller, Ann, McGinty, Emma E., Crum, Rosa M., Appel, Lawrence J., Wang, Nae-Yuh
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container_issue 6
container_start_page e207247
container_title JAMA health forum
container_volume 3
creator Daumit, Gail L.
Dalcin, Arlene T.
Dickerson, Faith B.
Miller, Edgar R.
Evins, A. Eden
Cather, Corinne
Jerome, Gerald J.
Young, Deborah R.
Charleston, Jeanne B.
Gennusa, Joseph
Goldsholl, Stacy
Cook, Courtney
Heller, Ann
McGinty, Emma E.
Crum, Rosa M.
Appel, Lawrence J.
Wang, Nae-Yuh
description This randomized clinical trial examines 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. Question Does an 18-month intervention incorporating behavioral counseling, care coordination, and care management reduce cardiovascular risk in adults with serious mental illness, a population at extremely high risk of cardiovascular disease morbidity and mortality? Findings In this randomized clinical trial enrolling 269 participants with serious mental illness and at least 1 cardiovascular risk factor, the intervention group participants had a 12.7% relative reduction in the 10-year probability of a cardiovascular event, compared with the control group. Meaning These findings support the use of a behavioral counseling, care coordination, and care management intervention to substantially reduce cardiovascular health disparities in this high-risk population. 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
doi_str_mv 10.1001/jamanetworkopen.2020.7247
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Eden ; Cather, Corinne ; Jerome, Gerald J. ; Young, Deborah R. ; Charleston, Jeanne B. ; Gennusa, Joseph ; Goldsholl, Stacy ; Cook, Courtney ; Heller, Ann ; McGinty, Emma E. ; Crum, Rosa M. ; Appel, Lawrence J. ; Wang, Nae-Yuh</creator><creatorcontrib>Daumit, Gail L. ; Dalcin, Arlene T. ; Dickerson, Faith B. ; Miller, Edgar R. ; Evins, A. Eden ; Cather, Corinne ; Jerome, Gerald J. ; Young, Deborah R. ; Charleston, Jeanne B. ; Gennusa, Joseph ; Goldsholl, Stacy ; Cook, Courtney ; Heller, Ann ; McGinty, Emma E. ; Crum, Rosa M. ; Appel, Lawrence J. ; Wang, Nae-Yuh</creatorcontrib><description>This randomized clinical trial examines 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. Question Does an 18-month intervention incorporating behavioral counseling, care coordination, and care management reduce cardiovascular risk in adults with serious mental illness, a population at extremely high risk of cardiovascular disease morbidity and mortality? Findings In this randomized clinical trial enrolling 269 participants with serious mental illness and at least 1 cardiovascular risk factor, the intervention group participants had a 12.7% relative reduction in the 10-year probability of a cardiovascular event, compared with the control group. Meaning These findings support the use of a behavioral counseling, care coordination, and care management intervention to substantially reduce cardiovascular health disparities in this high-risk population. 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.</description><identifier>ISSN: 2574-3805</identifier><identifier>EISSN: 2574-3805</identifier><identifier>EISSN: 2689-0186</identifier><identifier>DOI: 10.1001/jamanetworkopen.2020.7247</identifier><identifier>PMID: 32530472</identifier><language>eng</language><publisher>CHICAGO: Amer Medical Assoc</publisher><subject>Adult ; Blood Pressure ; Cardiovascular disease ; Cardiovascular Diseases - complications ; Cardiovascular Diseases - epidemiology ; Cardiovascular Diseases - prevention &amp; control ; Clinical trials ; Counseling ; Diabetes Mellitus ; Female ; General &amp; Internal Medicine ; Humans ; Hypertension ; Intervention ; Life Sciences &amp; Biomedicine ; Lipids - blood ; Male ; Medicine, General &amp; Internal ; Mental disorders ; Mental Disorders - complications ; Mental Disorders - epidemiology ; Mental health care ; Middle Aged ; Obesity ; Online Only ; Original Investigation ; Psychiatry ; Risk Factors ; Risk Reduction Behavior ; Science &amp; Technology ; Treatment Outcome</subject><ispartof>JAMA health forum, 2020-06, Vol.3 (6), p.e207247, Article 207247</ispartof><rights>2020. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright 2020 Daumit GL et al. .</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>57</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000542043200005</woscitedreferencesoriginalsourcerecordid><cites>FETCH-LOGICAL-c372t-903270ba3a63a972be334d7ed271ab152089a979fa6a55b6d7d6582f3183c1fe3</cites><orcidid>0000-0001-6513-9730</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,865,886,2115,27928,27929,28252,28253</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32530472$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Daumit, Gail L.</creatorcontrib><creatorcontrib>Dalcin, Arlene T.</creatorcontrib><creatorcontrib>Dickerson, Faith B.</creatorcontrib><creatorcontrib>Miller, Edgar R.</creatorcontrib><creatorcontrib>Evins, A. Eden</creatorcontrib><creatorcontrib>Cather, Corinne</creatorcontrib><creatorcontrib>Jerome, Gerald J.</creatorcontrib><creatorcontrib>Young, Deborah R.</creatorcontrib><creatorcontrib>Charleston, Jeanne B.</creatorcontrib><creatorcontrib>Gennusa, Joseph</creatorcontrib><creatorcontrib>Goldsholl, Stacy</creatorcontrib><creatorcontrib>Cook, Courtney</creatorcontrib><creatorcontrib>Heller, Ann</creatorcontrib><creatorcontrib>McGinty, Emma E.</creatorcontrib><creatorcontrib>Crum, Rosa M.</creatorcontrib><creatorcontrib>Appel, Lawrence J.</creatorcontrib><creatorcontrib>Wang, Nae-Yuh</creatorcontrib><title>Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness A Randomized Clinical Trial</title><title>JAMA health forum</title><addtitle>JAMA NETW OPEN</addtitle><addtitle>JAMA Netw Open</addtitle><description>This randomized clinical trial examines 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. Question Does an 18-month intervention incorporating behavioral counseling, care coordination, and care management reduce cardiovascular risk in adults with serious mental illness, a population at extremely high risk of cardiovascular disease morbidity and mortality? Findings In this randomized clinical trial enrolling 269 participants with serious mental illness and at least 1 cardiovascular risk factor, the intervention group participants had a 12.7% relative reduction in the 10-year probability of a cardiovascular event, compared with the control group. Meaning These findings support the use of a behavioral counseling, care coordination, and care management intervention to substantially reduce cardiovascular health disparities in this high-risk population. 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. 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Eden</au><au>Cather, Corinne</au><au>Jerome, Gerald J.</au><au>Young, Deborah R.</au><au>Charleston, Jeanne B.</au><au>Gennusa, Joseph</au><au>Goldsholl, Stacy</au><au>Cook, Courtney</au><au>Heller, Ann</au><au>McGinty, Emma E.</au><au>Crum, Rosa M.</au><au>Appel, Lawrence J.</au><au>Wang, Nae-Yuh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness A Randomized Clinical Trial</atitle><jtitle>JAMA health forum</jtitle><stitle>JAMA NETW OPEN</stitle><addtitle>JAMA Netw Open</addtitle><date>2020-06-12</date><risdate>2020</risdate><volume>3</volume><issue>6</issue><spage>e207247</spage><pages>e207247-</pages><artnum>207247</artnum><issn>2574-3805</issn><eissn>2574-3805</eissn><eissn>2689-0186</eissn><abstract>This randomized clinical trial examines 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. Question Does an 18-month intervention incorporating behavioral counseling, care coordination, and care management reduce cardiovascular risk in adults with serious mental illness, a population at extremely high risk of cardiovascular disease morbidity and mortality? Findings In this randomized clinical trial enrolling 269 participants with serious mental illness and at least 1 cardiovascular risk factor, the intervention group participants had a 12.7% relative reduction in the 10-year probability of a cardiovascular event, compared with the control group. Meaning These findings support the use of a behavioral counseling, care coordination, and care management intervention to substantially reduce cardiovascular health disparities in this high-risk population. 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.</abstract><cop>CHICAGO</cop><pub>Amer Medical Assoc</pub><pmid>32530472</pmid><doi>10.1001/jamanetworkopen.2020.7247</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0001-6513-9730</orcidid><oa>free_for_read</oa></addata></record>
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subjects Adult
Blood Pressure
Cardiovascular disease
Cardiovascular Diseases - complications
Cardiovascular Diseases - epidemiology
Cardiovascular Diseases - prevention & control
Clinical trials
Counseling
Diabetes Mellitus
Female
General & Internal Medicine
Humans
Hypertension
Intervention
Life Sciences & Biomedicine
Lipids - blood
Male
Medicine, General & Internal
Mental disorders
Mental Disorders - complications
Mental Disorders - epidemiology
Mental health care
Middle Aged
Obesity
Online Only
Original Investigation
Psychiatry
Risk Factors
Risk Reduction Behavior
Science & Technology
Treatment Outcome
title Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness A Randomized Clinical Trial
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