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Multimodal lifestyle intervention using a web-based tool to improve cardiometabolic health in patients with serious mental illness: results of a cluster randomized controlled trial (LION).

ABSTRACT: BACKGROUND:Unhealthy lifestyle behaviours contribute to alarming cardiometabolic risk in patients with serious mental illness (SMI). Evidence-based practical lifestyle tools supporting patients and staff in improving patient lifestyle are lacking. METHODS:This multi-site randomized controlled pragmatic trial determined the effectiveness of a twelve-month multimodal lifestyle approach, including a web-based tool to improve patients' cardiometabolic health, versus care-as-usual. Using the web tool, nurses (trained in motivational interviewing) assisted patients in assessing their lifestyle behaviours, creating a risk profile and constructing lifestyle goals, which were discussed during fortnightly regular care visits. Twenty-seven community-care and sheltered-living teams were randomized into intervention (N?=?17) or control (N?=?10) groups, including 244 patients (140 intervention/104 control, 49.2% male, 46.1?±?10.8?years) with increased waist circumference (WC), BMI or fasting glucose. The primary outcomes concerned differences in WC after six and twelve months intervention, while BMI and metabolic syndrome Z-score were secondary outcome measures. RESULTS:General multilevel linear mixed models adjusted for antipsychotic medication showed that differences in WC change between intervention and control were?-?0.15?cm (95%CI: -?2.49; 2.19) after six and?-?1.03?cm (95%CI: -?3.42; 1.35) after twelve months intervention; however, the differences were not statistically significant. No intervention effects were found for secondary outcome measures. The intervention increased patients' readiness to change dietary behaviour. CONCLUSION:A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health. Web-tool use was lower than expected and nurses need more lifestyle coaching knowledge and skills. The type of intervention and delivery mode need optimization to realize effective lifestyle care for SMI patients. TRIAL REGISTRATION:Dutch Trial Registry, www.trialregister.nl , NTR3765, 21 December 2012.

SUBMITTER: Looijmans A

PROVIDER: S-EPMC6833253 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Multimodal lifestyle intervention using a web-based tool to improve cardiometabolic health in patients with serious mental illness: results of a cluster randomized controlled trial (LION).

Looijmans Anne A Jörg Frederike F Bruggeman Richard R Schoevers Robert A RA Corpeleijn Eva E

BMC psychiatry 20191105 1

<h4>Background</h4>Unhealthy lifestyle behaviours contribute to alarming cardiometabolic risk in patients with serious mental illness (SMI). Evidence-based practical lifestyle tools supporting patients and staff in improving patient lifestyle are lacking.<h4>Methods</h4>This multi-site randomized controlled pragmatic trial determined the effectiveness of a twelve-month multimodal lifestyle approach, including a web-based tool to improve patients' cardiometabolic health, versus care-as-usual. Usi ...[more]

PMID: 31690281

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Project description:BackgroundSerious illness conversations (SICs) are an evidence-based approach to eliciting patients' values, goals, and care preferences that improve patient outcomes. However, most patients with cancer die without a documented SIC. Clinician-directed implementation strategies informed by behavioral economics ("nudges") that identify high-risk patients have shown promise in increasing SIC documentation among clinicians. It is unknown whether patient-directed nudges that normalize and prime patients towards SIC completion-either alone or in combination with clinician nudges that additionally compare performance relative to peers-may improve on this approach. Our objective is to test the effect of clinician- and patient-directed nudges as implementation strategies for increasing SIC completion among patients with cancer.MethodsWe will conduct a 2 × 2 factorial, cluster randomized pragmatic trial to test the effect of nudges to clinicians, patients, or both, compared to usual care, on SIC completion. Participants will include 166 medical and gynecologic oncology clinicians practicing at ten sites within a large academic health system and their approximately 5500 patients at high risk of predicted 6-month mortality based on a validated machine-learning prognostic algorithm. Data will be obtained via the electronic medical record, clinician survey, and semi-structured interviews with clinicians and patients. The primary outcome will be time to SIC documentation among high-risk patients. Secondary outcomes will include time to SIC documentation among all patients (assessing spillover effects), palliative care referral among high-risk patients, and aggressive end-of-life care utilization (composite of chemotherapy within 14 days before death, hospitalization within 30 days before death, or admission to hospice within 3 days before death) among high-risk decedents. We will assess moderators of the effect of implementation strategies and conduct semi-structured interviews with a subset of clinicians and patients to assess contextual factors that shape the effectiveness of nudges with an eye towards health equity.DiscussionThis will be the first pragmatic trial to evaluate clinician- and patient-directed nudges to promote SIC completion for patients with cancer. We expect the study to yield insights into the effectiveness of clinician and patient nudges as implementation strategies to improve SIC rates, and to uncover multilevel contextual factors that drive response to these strategies.Trial registrationClinicalTrials.gov , NCT04867850 . Registered on April 30, 2021.FundingNational Cancer Institute P50CA244690.

Project description:Patients with serious chronic illnesses face increasingly complex care and are at risk of poor experience due to a fragmented health system. Most current patient experience tools are not designed to address the unique care aspects of this population and the few that exist are delivered too late in the disease trajectory and are not administered longitudinally which makes them less useful across settings.We developed a new tool designed to address these gaps. The 25 item scale was tested and refined using randomly cross-validated exploratory and confirmatory factor analyses. Participants were not yet hospice eligible but sick enough to receive benefits of a supportive care approach in the last 2 to 3 years of life. Full information maximum likelihood models were run to confirm the factor structure developed in exploratory analyses. Goodness-of-fit was assessed with the Comparative Fit Index, the Tucker-Lewis Index, and the Root Mean Square Error of Approximation. Test-retest reliability was assessed with the intraclass correlation coefficient and internal consistency of the final scale was examined using Cronbach's alpha.Exploratory factor analysis revealed three domains - Care Team, Communication, and Care Goals - after removing weak loading and cross loading items. The initial three domain measurement model suggested in the development cohort was tested in the validation cohort and exhibited poor fit X 2 (206)?=?565.37, p?<?0.001; CFI?=?0.879; TLI?=?0.864; RMSEA?=?0.076. After model respecification, including removing one additional item and allowing paths between theoretically plausible error terms, the final 21 item tool exhibited good fit X 2 (173)?=?295.63, p?<?0.001; CFI?=?0.958; TLI?=?0.949; RMSEA?=?0.048. Cronbach's alpha revealed high reliability of each domain (Care Team?=?0.92, Communication?=?0.83, Care Goals?=?0.77) and the entire scale (??=?0.91). ICC showed adequate test-retest validity (ICC?=?0.58; 95% CI: 0.52-0.65) of the full scale.When administered earlier in the chronic illness trajectory, a new patient experience scale focused on care teams across settings, communication, and care goals, displayed strong reliability and performed well psychometrically.This trial ( NCT01746446 ) was registered at ClinicalTrials.gov on November 27, 2012 (retrospectively registered).

Project description:ImportanceHigh-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently.ObjectiveTo examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes.Design, setting, and participantsA cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat.InterventionsTools, training, and system changes.Main outcomes and measuresThe coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated.ResultsData from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups.Conclusions and relevanceThe results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study.Trial registrationClinicalTrials.gov identifier: NCT01786811.

Project description:BackgroundSelf-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning.MethodsThis is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6?months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery.DiscussionNECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice.Trial registrationClinicalTrials.gov NCT03972735 . Trial registration date 31 May 2019.

Dataset Information

Multimodal lifestyle intervention using a web-based tool to improve cardiometabolic health in patients with serious mental illness: results of a cluster randomized controlled trial (LION).

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Multimodal lifestyle intervention using a web-based tool to improve cardiometabolic health in patients with serious mental illness: results of a cluster randomized controlled trial (LION).

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