Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness.
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ABSTRACT: Background
Cardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk.Methods/design
78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications.Discussion
This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020.Trial registration
ClinicalTrials.gov Identifier: NCT02451670.
SUBMITTER: Rossom RC
PROVIDER: S-EPMC7263956 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundIndependent supported housing (ISH)-services to support independent housing are recommended by current guidelines. However, there is little evidence of ISH models for non-homeless people with severe mental illness (SMI). The aim of this study was to examine the effectiveness of ISH by comparing the clinical outcomes of a newly implemented ISH service with regular housing and support services.MethodsA total of 58 adults with a broad spectrum of mental disorders experiencing housing problems were randomly assigned to either the intervention group (IG) with the possibility to use the ISH service in Zurich providing targeted, individual and flexible support for housing problems or to the control group (CG) with regular housing and support services currently available (trial registration at ClinicalTrials.gov: NCT03815604).ResultsAfter 12 months, almost all participants of the IG were able to live independently and need for inpatient treatment could be significantly reduced. Service utilization varied between 2 and 79 h. In the CG, 70% of the participants wanted to join a waiting list for the ISH service. The results indicated that IHS was comparable to regular housing and support services in terms of social inclusion and other social and clinical outcomes such as quality of life, capabilities, needs, mental state and functioning (p's > 0.05). The costs of service utilization were on average 115 Swiss Francs (about 124 USD) per participant per month.ConclusionsISH is an effective service in housing rehabilitation in terms of social and clinical outcomes and costs. ISH is strongly preferred by service users. In line with the UN Convention on the Rights of Persons with Disabilities, access to ISH services for non-homeless people with SMI should be improved.Clinical trial registrationClinicalTrials.gov, identifier: NCT03815604, December 04, 2019.
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Project description:BackgroundPeople with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority.ObjectiveThe aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains.MethodsIndividuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods.ResultsOverall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3.ConclusionsWe successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond.Trial registrationClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467.
| S-EPMC8663659 | biostudies-literature
Project description:Depressive symptoms have debilitating effects on the physical health and functioning of people with serious mental illness. We examined change in depressive symptoms among overweight and obese adults with serious mental illness (n = 343) using data combined from two randomized trials comparing the 12-month In SHAPE program to a gym membership control condition. In SHAPE consists of a gym membership, weekly individual meetings with a fitness trainer, and instruction on healthy eating and nutrition. Depressive symptoms were measured at baseline, 3, 6, and 12 months. Change in depressive symptoms did not differ between groups, but depressive symptoms decreased over time across the entire sample (p = 0.045). At 12 months, reduced depressive symptoms were associated with clinically significant improved cardiorespiratory fitness (p = 0.030), 10% or more weight loss (p = 0.044), and cardiovascular risk reduction (p = 0.028) across both groups. Our findings suggest that participation in health promotion programs resulting in cardiovascular risk reduction may be associated with reduced depressive symptoms.
| S-EPMC5533633 | biostudies-literature
Project description:Cardiovascular disease is a primary contributor to premature death among people with serious mental illness (SMI). This study used baseline data (N=314) from an effectiveness trial testing a healthy lifestyle intervention for racial/ethnically diverse participants with overweight/obesity and SMI living in supportive housing. We examined the prevalence and correlates of a modified version of the American Heart Association (AHA) metric of ideal cardiovascular health (ICVH). Five AHA ICVH metrics (smoking, body mass index, diet, physical activity, and blood pressure) were used to create a composite ICVH score. The mean ICVH score was 3.15 (range 0-8). Multivariate analysis indicated that higher ICVH scores were associated with lifetime cancer diagnosis and better cardiorespiratory fitness. Lower scores were associated with female gender, racial/ethnic minority status, and antipsychotic use, suggesting that these subgroups of people with SMI may benefit from targeted screening and interventions to improve their cardiovascular health.
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Project description:ImportancePersons 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.ObjectiveTo 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 participantsThis 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.InterventionsA 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 measuresThe 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.ResultsOf 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 relevanceAn 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 registrationClinicalTrials.gov Identifier: NCT02127671.
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Project description:BackgroundOral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment.Methods/designThis is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation.Trial registrationCurrent Controlled Trials ISRCTN63382258.
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Project description:ObjectiveGiven the high prevalence of obesity and diabetes in patients with serious mental illness (SMI) and the lack of evidence on the effects of weight loss programs in SMI patients with diabetes, we evaluated the effectiveness of a behavioral weight loss intervention among SMI participants with and without diabetes.Research design and methodsUsing data from ACHIEVE, a randomized controlled trial to evaluate the effects of a behavioral weight loss intervention among overweight/obese people with SMI, we assessed and compared weight change from baseline to 18 months in participants with and without diabetes using a longitudinal mixed-effects model.ResultsOf the 291 trial participants, 82 (28.2%) participants had diabetes (34 and 48 in intervention and control groups, respectively) at baseline. Participants with diabetes were more likely to be taking antipsychotics (31.7% vs. 18.7%, P = 0.02). At 18 months, participants in the control group with diabetes lost 1.2 lb (0.6%) of body weight compared with 0.8 lb (0.7%) among those without diabetes. In the intervention group, participants with diabetes lost 13.7 lb (6.6%) of their initial body weight compared with 5.4 lb (2.9%) for those without diabetes. Corresponding net effects (intervention minus control) were 4.6 lb (2.2%) and 12.5 lb (6.0%) net weight reduction over 18 months in the no diabetes and the diabetes subgroups, respectively. However, the between-group difference in intervention effects was statistically nonsignificant (absolute weight change: P-interaction = 0.08; % weight change: P-interaction = 0.10).ConclusionsA behavioral weight loss intervention is effective among overweight and obese individuals with SMI regardless of their diabetes status.
| S-EPMC6489111 | biostudies-literature
Project description:BackgroundPeople with a serious mental illness are more likely to smoke more and to be more dependent smokers than the general population. This may be due to a wide range of factors that could include a common aetiology to both smoking and the illness, self medication, smoking to alleviate adverse effects of medications, boredom in the existing environment, or a combination of these factors. It is important to undertake this review to facilitate improvements in both the health and safety of people with serious mental illness who smoke, and to reduce the overall burden of costs (both financial and health) to the smoker and, eventually, to the taxpayer.ObjectivesTo review the effects of smoking cessation advice for people with serious mental illness.Search methodsWe searched the Cochrane Schizophrenia Group Specialized Trials Register up to 2 April 2015, which is based on regular searches of CENTRAL, BIOSIS, PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and trial registries. We also undertook unsystematic searches of a sample of the component databases (BNI, CINHAL, EMBASE, MEDLINE, and PsycINFO), up to 2 April 2015, and searched references of all identified studiesSelection criteriaWe planned to include all randomised controlled trials (RCTs) that focussed on smoking cessation advice versus standard care or comparing smoking cessation advice with other more focussed methods of delivering care or information.Data collection and analysisThe review authors (PK, AC, and DB) independently screened search results but did not identify any trials that fulfilled the inclusion criteria of this review.Main resultsWe did not identify any RCTs that evaluated advice regarding smoking cessation for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to smokers with serious mental illness is possible.Authors' conclusionsPeople with serious mental illness are more likely to smoke than the general population. Yet we could not find any high quality evidence to guide the smoking cessation advice healthcare professionals pass onto service users. This is an area where trials are possible and needed.
| S-EPMC6513396 | biostudies-literature
Project description:ObjectiveFew studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population.MethodPersons with serious mental illness and a body mass index (BMI) >25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program, which included membership in a public fitness club and weekly meetings with a health promotion coach, or to fitness club membership alone. The primary outcome measures were weight and cardiorespiratory fitness (as measured with the 6-minute walk test), assessed at baseline and at 3, 6, 9, 12, and 18 months.ResultsParticipants (N=210) were ethnically diverse (46% were nonwhite), with a mean baseline BMI of 36.8 (SD=8.2). At 12 months, the In SHAPE group (N=104) had greater reduction in weight and improved fitness compared with the fitness club membership only group (N=106). Primary outcomes were maintained at 18 months. Approximately half of the In SHAPE group (51% at 12 months and 46% at 18 months) achieved clinically significant cardiovascular risk reduction (a weight loss ≥5% or an increase of >50 meters on the 6-minute walk test).ConclusionsThis is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness.
| S-EPMC4537796 | biostudies-literature
Project description: Not available
| S-EPMC6546931 | biostudies-literature