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Key Points: Question: Can an antistigma campaign and a mobile technology–based electronic decision support system result in reduced stigma and improved mental health for adults at high risk of common mental disorders at the primary health care level? Findings: This cluster randomized clinical trial included 44 primary health center clusters with 9928 eligible participants (3365 in the high-risk cohort). There was a significant difference in mean depression scores between intervention vs control groups at 12 months, with lower scores in high-risk cohort. Meaning: A multifaceted primary health center intervention with high implementation fidelity may be effective in reducing depression risk. This cluster randomized clinical trial evaluates the use of a digital mental health intervention and community-based antistigma campaign in reducing risk of depression and mental health–related stigma. Importance: More than 150 million people in India need mental health care but few have access to affordable care, especially in rural areas. Objective: To determine whether a multifaceted intervention involving a digital health care model along with a community-based antistigma campaign leads to reduced depression risk and lower mental health–related stigma among adults residing in rural India. Design, Setting, and Participants: This parallel, cluster randomized, usual care–controlled trial was conducted from September 2020 to December 2021 with blinded follow-up assessments at 3, 6, and 12 months at 44 rural primary health centers across 3 districts in Haryana and Andhra Pradesh states in India. Adults aged 18 years and older at high risk of depression or self-harm defined by either a Patient Health Questionnaire–9 item (PHQ-9) score of 10 or greater, a Generalized Anxiety Disorder–7 item (GAD-7) score of 10 or greater, or a score of 2 or greater on the self-harm/suicide risk question on the PHQ-9. A second cohort of adults not at high risk were selected randomly from the remaining screened population. Data were cleaned and analyzed from April 2022 to February 2023. Interventions: The 12-month intervention included a community-based antistigma campaign involving all participants and a digital mental health intervention involving only participants at high risk. Primary health care workers were trained to identify and manage participants at high risk using the Mental Health Gap Action Programme guidelines from the World Health Organization. Main Outcomes and Measures: The 2 coprimary outcomes assessed at 12 months were mean PHQ-9 scores in the high-risk cohort and mean behavior scores in the combined high-risk and non–high-risk cohorts using the Mental Health Knowledge, Attitude, and Behavior scale. Results: Altogether, 9928 participants were recruited (3365 at high risk and 6563 not at high risk; 5638 [57%] female and 4290 [43%] male; mean [SD] age, 43 [16] years) with 9057 (91.2%) followed up at 12 months. Mean PHQ-9 scores at 12 months for the high-risk cohort were lower in the intervention vs control groups (2.77 vs 4.48; mean difference, −1.71; 95% CI, −2.53 to −0.89; P <.001). The remission rate in the high-risk cohort (PHQ-9 and GAD-7 scores <5 and no risk of self-harm) was higher in the intervention vs control group (74.7% vs 50.6%; odds ratio [OR], 2.88; 95% CI, 1.53 to 5.42; P =.001). Across both cohorts, there was no difference in 12-month behavior scores in the intervention vs control group (17.39 vs 17.74; mean difference, −0.35; 95% CI, −1.11 to 0.41; P =.36). Conclusions and Relevance: A multifaceted intervention was effective in reducing depression risk but did not improve intended help-seeking behaviors for mental illness. Trial Registration: Clinical Trial Registry India: CTRI/2018/08/015355. [ABSTRACT FROM AUTHOR]

Dysphagia is a common complication in patients with oral cancer who have undergone free flap transplantation. The aim of this cluster randomized controlled trial was to evaluate the effect of personalized oral exercises on swallowing function in this group of patients. Eligible patients were randomly assigned to the intervention (n = 34) or control (n = 34) group. Intervention group patients received personalized oral exercises starting on day 6 after surgery. Swallowing function was evaluated on days 6 and 15, and at 1 month postoperative using the Mann Assessment of Swallowing Ability–Oral Cancer tool (MASA-OC). On day 15 and at 1 month after surgery, the total MASA-OC score (P = 0.003, P < 0.001) and the mouth opening (P = 0.001, P < 0.001) and lip seal (both P < 0.001) item scores showed a significantly greater improvement in the intervention group than in the control group. Moreover, the changes in salivation (P < 0.001) and tongue movement (P = 0.025) scores at 1 month after surgery were significantly greater in the intervention group than in the control group. There was no significant difference between the groups in the change in tongue strength scores on day 15 or at 1 month postoperative (P = 0.476, P = 0.223). Personalized oral exercises can improve swallowing function in patients with oral cancer after free flap transplantation. [ABSTRACT FROM AUTHOR]

Background: Outpatient physical therapy may be an opportune time to promote aerobic physical activity after knee replacement; however, it is unknown if it is feasible to integrate a physical activity intervention within standard physical therapy. Objective: To examine the feasibility and acceptability of a physical activity intervention delivered within outpatient physical therapy for adults after knee replacement. Methods: As part of a cluster randomized trial, adults with knee replacement starting outpatient physical therapy were recruited across four physical therapy sites. Sites were randomized and physical therapists delivered either an enhanced physical activity intervention or a control condition. The enhanced physical activity intervention consisted of standard postoperative physical therapy plus goal setting, problem‐solving, and use of motivational interviewing techniques to promote 150 minutes/week of aerobic moderate intensity physical activity. The control group received standard postoperative physical therapy only. Feasibility and acceptability were determined based on recruitment and retention rates at 12 weeks after surgery. Outcomes including objectively measured physical activity, pain, and self‐reported function were examined at the baseline postoperative visit and 12 weeks later. Results: Thirty‐three percent of candidates screened were randomized (n = 45) and retention at 12 weeks after surgery was 91% (no difference by condition). Moderate‐intensity activity increased, pain decreased, and self‐reported function improved, but there were no statistically significant group differences between baseline and 12 weeks. Conclusion: Implementing a physical activity intervention within outpatient physical therapy for adults after knee replacement is feasible; however, in this pilot study, changes were not observed in moderate intensity physical activity as compared to standard postoperative physical therapy. Future studies are needed to explore additional low‐cost strategies and the optimal time to promote physical activity after knee replacement. [ABSTRACT FROM AUTHOR]

Key Points: Question: Can a process improvement package in the emergency department targeting suicide prevention using evidence-based practices reduce subsequent suicidal behaviors among patients at risk of suicide? Findings: In this randomized clinical trial including 2761 patients, after a 12-month implementation period, using an interrupted time series model, a significant decrease in incidence of suicidal attempts, ideation, and behavior was observed across the 3 phases of the study (baseline, implementation, and maintenance). Meaning: Department-wide interventions aiming to improve clinic workflow can reduce likelihood of suicide, suicidal ideation, and suicide-related behaviors in the 12 months following the patient's initial ED visit. This randomized clinical trial determines if an emergency department process improvement package, with a subfocus on improving the implementation of collaborative safety planning, reduces subsequent suicide-related behaviors. Importance: Suicide is a leading cause of deaths in the US. Although the emergency department (ED) is an opportune setting, ED-initiated interventions remain underdeveloped and understudied. Objective: To determine if an ED process improvement package, with a subfocus on improving the implementation of collaborative safety planning, reduces subsequent suicide-related behaviors. Design, Setting, and Participants: The Emergency Department Safety Assessment and Follow-up Evaluation 2 (ED-SAFE 2) trial, a stepped-wedge cluster randomized clinical trial conducted in 8 EDs across the US, used an interrupted time series design with three 12-month sequential phases: baseline, implementation, and maintenance. A random sample of 25 patients per month per site 18 years and older who screened positive on the Patient Safety Screener, a validated suicide risk screener, were included. The primary analyses focused on those who were discharged from the ED, while secondary analyses focused on all patients who screened positive, regardless of disposition. Data were collected on patients who presented for care from January 2014 to April 2018, and data were analyzed from April to December 2022. Interventions: Each site received lean training and built a continuous quality improvement (CQI) team to evaluate the current suicide-related workflow in the ED, identify areas of improvement, and implement efforts to improve. Each site was expected to increase their universal suicide risk screening and implement collaborative safety planning for patients at risk of suicide who were discharged home from the ED. Site teams were centrally coached by engineers experienced in lean CQI and suicide prevention specialists. Main Outcomes and Measures: The primary outcome was a composite comprising death by suicide or suicide-related acute health care visits, measured over a 6-month follow-up window. Results: Across 3 phases, 2761 patient encounters were included in the analyses. Of these, 1391 (50.4%) were male, and the mean (SD) age was 37.4 (14.5) years. A total of 546 patients (19.8%) exhibited the suicide composite during the 6-month follow-up (9 [0.3%] died by suicide and 538 [19.5%] of a suicide-related acute health care visit). A significant difference was observed for the suicide composite outcome between the 3 phases (baseline, 216 of 1030 [21%]; implementation, 213 of 967 [22%]; maintenance, 117 of 764 [15.3%]; P =.001). The adjusted odds ratios of risk of the suicide composite during the maintenance phase was 0.57 (95% CI, 0.43-0.74) compared with baseline and 0.61 (0.46-0.79) compared with the implementation phase, which reflect a 43% and 39% reduction, respectively. Conclusions and Relevance: In this multisite randomized clinical trial, using CQI methods to implement a department-wide change in suicide-related practices, including the implementation of a safety plan intervention, yielded a significant decrease in suicide behaviors in the maintenance period of the study. Trial Registration: ClinicalTrials.gov Identifier: NCT02453243 [ABSTRACT FROM AUTHOR]

To reduce cesarean delivery rates in nulliparous women, guidelines for diagnosing nonprogressive labor have been developed by the National Institute of Child Health and Human Development, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine. These are mainly based on data from the Consortium for Safe Labor study. The guidelines have not been tested in a clinical trial, so the efficacy and safety of this new approach is uncertain. This study aimed to assess whether adoption of new guidelines for diagnosing nonprogressing labor would reduce cesarean delivery rates. We conducted a cluster randomized controlled trial of a knowledge translation program of the guidelines in 26 Canadian hospitals (13 control sites and 13 intervention sites). The sites included all intrapartum care sites in Alberta that perform cesarean delivery and deliver at least 70 nulliparous women annually. The baseline period started on January 1, 2015. The intervention was initiated at the first intervention site in January 2017. The follow-up period began at the first intervention site in February 2017 and lasted till February 2020. The primary outcome was the rate of cesarean delivery in nulliparous women with vertex presentation in labor at term. The secondary outcomes included spontaneous vaginal birth and maternal and neonatal safety. The main data source for the primary and secondary outcomes was the Alberta Perinatal Health Program database. The cesarean delivery rates were assessed using repeated measures mixed effects logistic regression applied to individual births. The analysis was based on 45,193 deliveries at intervention sites and 43,725 deliveries at control sites. There was no evidence of a decrease in the rate of cesarean delivery in association with the intervention (baseline-adjusted odds ratio, 0.94; 95% confidence interval [0.85–1.05]; P =.259). The rate of spontaneous vaginal delivery increased slightly (baseline-adjusted odds ratio, 1.10; 95% confidence interval, [1.01–1.18]; P =.024). We did not observe any differences in adverse maternal or neonatal outcomes. Cesarean delivery rates in nulliparous women were not reduced by the application of recent guidelines for the diagnosis of nonprogressive labor. Spontaneous vaginal delivery—a secondary outcome—was increased in the intervention group. The intervention appears to be safe. [ABSTRACT FROM AUTHOR]

Objective: The Student Bodies-Eating Disorders intervention (SB-ED), a digital cognitive behavior therapy-guided self-help intervention for college women with an eating disorder, is effective for reducing eating disorder psychopathology. The purpose of this study was to evaluate moderators and mediators of the SB-ED intervention. To our knowledge, this is the first evaluation of clinical mediators of a digital intervention for women with eating disorders. Method: This is an exploratory secondary analysis of a cluster randomized trial comparing the SB-ED intervention to referral to usual care among 690 women at 27 United States colleges. Moderators included body mass index (BMI), race, ethnicity, weight/shape concerns, eating disorder impairment, thin ideal internalization, depression, anxiety, and motivation for treatment, assessed at baseline. Thin ideal internalization and depressive symptoms were tested as predictors at postintervention and mediators at 2-year follow-up. Outcome was change in global eating disorder psychopathology. Results: BMI moderated the effect of the intervention at follow-up (but not posttreatment), with individuals with a lower BMI experiencing more continued improvements in eating disorder psychopathology following the intervention than individuals with a higher BMI. Thin ideal internalization mediated the effect of the intervention at follow-up, and depression partially mediated the effect of the intervention at follow-up. Conclusions: Results of the mediator analyses suggest that helping college women reduce inflated internalization of the thin ideal and improve depressive symptoms leads to improvements in eating disorder psychopathology. Results also suggest opportunities to optimize the intervention so individuals across the BMI spectrum experience ongoing improvements over time. What is the public health significance of this article?: The digital guided self-help Student Bodies-Eating Disorders intervention reduces women's thin ideal internalization and depressive symptoms, which in turn leads to improvements in eating disorder psychopathology. Women with higher body mass index (BMIs) experienced less continued improvement following the intervention, indicating future directions for intervention optimization. [ABSTRACT FROM AUTHOR]

This cluster randomized clinical trial assesses whether the use of population-based electronic screening in addition to standard targeted clinician education increases the early detection of psychosis and decreases the duration of untreated psychosis, compared with clinician education alone. Key Points: Question: Does population-based electronic screening for first-episode psychosis (FEP) or psychosis spectrum disorder in community settings increase early detection and reduce the duration of untreated psychosis? Findings: In this cluster randomized clinical trial, a population-based technology-enhanced screening plus clinician education identified more individuals with psychosis spectrum disorder than clinician education alone. No significant difference in duration of untreated psychosis for FEP across groups was detected. Meaning: Population-based screening for FEP in community mental health settings substantially increases identification of individuals with psychosis spectrum disorders but does not reduce the overall duration of untreated psychosis, so reduction efforts must also specifically target delays between symptom onset and first contact with mental health services. Importance: Reducing the duration of untreated psychosis (DUP) is essential to improving outcomes for people with first-episode psychosis (FEP). Current US approaches are insufficient to reduce DUP to international standards of less than 90 days. Objective: To determine whether population-based electronic screening in addition to standard targeted clinician education increases early detection of psychosis and decreases DUP, compared with clinician education alone. Design, Setting, and Participants: This cluster randomized clinical trial included individuals aged 12 to 30 years presenting for services between March 2015 and September 2017 at participating sites that included community mental health clinics and school support and special education services. Eligible participants were referred to the Early Diagnosis and Preventative Treatment (EDAPT) Clinic. Data analyses were performed in September and October 2019 for the primary and secondary analyses, with the exploratory subgroup analyses completed in May 2021. Interventions: All sites in both groups received targeted education about early psychosis for health care professionals. In the active screening group, clients also completed the Prodromal Questionnaire–Brief using tablets at intake; referrals were based on those scores and clinical judgment. In the group receiving treatment as usual (TAU), referrals were based on clinical judgment alone. Main Outcomes and Measures: Primary outcomes included DUP, defined as the period from full psychosis onset to the date of the EDAPT diagnostic telephone interview, and the number of individuals identified with FEP or a psychosis spectrum disorder. Exploratory analyses examined differences by site type, completion rates between conditions, and days from service entry to telephone interview. Results: Twenty-four sites agreed to participate, and 12 sites were randomized to either the active screening or TAU group. However, only 10 community clinics and 4 school sites were able to fully implement population screening and were included in the final analysis. The total potentially eligible population size within each study group was similar, with 2432 individuals entering at active screening group sites and 2455 at TAU group sites. A total of 303 diagnostic telephone interviews were completed (178 [58.7%] female individuals; mean [SD] age, 17.09 years [4.57]). Active screening sites reported a significantly higher detection rate of psychosis spectrum disorders (136 cases [5.6%], relative to 65 [2.6%]; P <.001) and referred a higher proportion of individuals with FEP and DUP less than 90 days (13 cases, relative to 4; odds ratio, 0.30; 95% CI, 0.10-0.93; P =.03). There was no difference in mean (SD) DUP between groups (active screening group, 239.0 days [207.4]; TAU group 262.3 days [170.2]). Conclusions and Relevance: In this cluster trial, population-based technology-enhanced screening across community settings detected more than twice as many individuals with psychosis spectrum disorders compared with clinical judgment alone but did not reduce DUP. Screening could identify people undetected in US mental health services. Significant DUP reduction may require interventions to reduce time to the first mental health contact. Trial Registration: ClinicalTrials.gov Identifier: NCT02841956 [ABSTRACT FROM AUTHOR]

Objective: To examine the role of psychological flexibility as a potential mediator in the relationship between involvement in a guided self-help intervention, Self-Help Plus, and psychological distress in a sample of South Sudanese refugee women living in northern Uganda. Method: We conducted secondary analysis of data from a cluster randomized controlled trial conducted in 2018. We used multilevel mediation modeling to explore the relationship of psychological flexibility, as measured by the Acceptance and Action Questionnaire (AAQ-II), as a mediating factor in the relationship between Self-Help Plus involvement and general psychological distress as measured by the Kessler Psychological Distress Scale–6 (K6). Results: We found strong multilevel mediation of decreased K6 scores in the treatment group by AAQ-II scores (multilevel b = −3.28). A more pronounced mediation effect was discovered immediately post intervention (b = −1.09) compared to 3-month follow-up (b = −0.84). This is in line with the current literature that demonstrates the role of psychological flexibility as a primary mechanism of change in ACT-based interventions. Conclusions: Psychological flexibility is a contributing component in the theory of change for this ACT-based intervention. Identifying the core components of interventions allows for more effective adaptation and implementation of relevant services, especially in low-resource contexts. What is the public health significance of this article?: Public mental health in humanitarian settings demands interventions with flexibility in implementation, options for paraprofessional use, and low-resource demand. Accordingly, the purpose of this investigation is to contextualize a promising, low-intensity ACT-based intervention within existing literature and expand on its primary mechanism of change, increases in psychological flexibility. This article suggests that specific elements of this therapy are readily adapted for use in novel cultural settings and facilitate change in psychological flexibility while retaining the key components of an effective intervention. [ABSTRACT FROM AUTHOR]

Importance: Integrated care for children is rarely studied, especially in low- and middle-income countries, where generalists often provide mental health care.Objectives: To explore the effect of adding a child and youth component to an existing adult collaborative care program on mental health outcomes and receipt of care.Design, Setting, and Participants: This cluster randomized trial was conducted within an adult collaborative care program in Tehran, Iran. General practitioners (GPs), their 5- to 15-year-old patients, and patients' parents were included. Children and youths coming for routine medical visits who scored greater than the cutoff on the Strengths and Difficulties Questionnaire (SDQ) were followed up for 6 months. The study was conducted from May 2018 to October 2019, and analysis was conducted from March 2020 to August 2021.Interventions: GPs were randomized to either a 2.5-day training on managing common child mental health problems (intervention) or refresher training on identification and referral (control).Main Outcomes and Measures: Primary outcome was change in SDQ total problems score; secondary outcomes included discussion of psychosocial issues by the GPs and receipt of mental health care during the follow-up period.Results: Overall, 49 GPs cared for 389 children who scored greater than the cutoff on the SDQ (216 children in intervention group, 173 in control group). Patients' mean (SD) age was 8.9 (2.9) years (range, 5 to 15 years), and 182 (47%) were female patients. At 6 months, children in the intervention group had greater odds of receiving mental health care during the study (odds ratio [OR], 3.0; 95% CI, 1.1 to 7.7), parents were more likely to report that intervention GPs had discussed parent (OR, 2.1; 95% Cl, 1.1 to 3.8) and child (OR, 2.0; 95% Cl, 0.9 to 4.8) psychosocial issues, and intervention GPs were more likely to say they had provided counseling (OR, 1.8; 95% Cl, 1.02 to 3.3). However, there was no greater improvement in SDQ scores among children seen by intervention vs control GPs. Adjusted for clustering within GP, the variables used for balanced allocation (practice size, practice ownership, and study wave), and the other variables associated with change in SDQ scores over time, there was not a significant time-treatment interaction at either the 3- or 6-month follow-up points (linear combination of coefficients for intervention, 0.57 [95% CI, -1.07 to 2.22] and -0.08 [95%CI, -1.76 to 1.56], respectively). In a subgroup of GPs with practices composed of 50% or more children, children seen by intervention GPs improved to a significantly greater extent (-3.6 points; 95% CI, -6.7 to -0.46 points; effect size d = 0.66; 95% CI, 0.30 to 1.01) compared with those seen by control GPs.Conclusions and Relevance: In this cluster randomized trial, GP training on managing common child mental health problems did not demonstrate greater improvement in child SDQ scores. Child mental health training for GPs in collaborative care can improve children's access to mental health care, but prior experience working with children and their families may be required for GPs to use a brief training in a way that improves child outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT03144739. [ABSTRACT FROM AUTHOR]

Objective: This cluster randomized controlled trial evaluated the efficacy of participation in the Body Project—a cognitive-dissonance-based preventive intervention that reduces self-reported body dissatisfaction—for reducing body-dissatisfaction-related attentional biases. We hypothesized that women in a Body Project condition would show a greater reduction in attentional biases to weight-related images and words at postintervention than women in a wait-list control condition. Method: Body-dissatisfied university women (N = 168; Mage = 20.50 ± 3.37 years; 42.0% White; MBMI = 23.08 ± 4.45 kg/m2) were randomly assigned to a Body Project, media psychoeducation (i.e., active control), or wait-list control condition. We assessed attentional biases via eye-gaze tracking and body satisfaction using the Body Shape Questionnaire, at baseline and postintervention. Results: Self-reported outcomes from previous literature were replicated. Compared to wait-list, Body Project participation reduced attention to images of thin models (ps <.05; ds =.19,.24), but not to weight-related words. Compared to wait-list, the media psychoeducation condition reduced attention to fat-related images and words (ds =.17,.18). Conclusions: This study, which replicates previous self-report findings, is the first to find that two preventive interventions reduced an objective outcome (attentional bias to weight-related images) in body-dissatisfied women. What is the public health significance of this article?: This study shows that programs that either induce cognitive dissonance or promote critical understanding of how the media portray women can reduce maladaptive attentional biases related to body weight in women who are dissatisfied with their bodies. This reduction in attentional bias may reduce risk for body dissatisfaction and eating disorders. [ABSTRACT FROM AUTHOR]

An editorial is presented which challenges readers to expand their research topics and explore the under-acknowledged topic of unintentional injuries. It outlines an unintentional injuries contribute disproportionally to high morbidity and mortality rates worldwide. It emphasizes the need for increased attention and research on unintentional injuries to improve quality of life, productivity, and disability-adjusted life years (DALYs) globally.

: Digital approaches are frequently described as an ideal way to engage young people with health interventions. However, uptake and adherence to these interventions is often poor. Identifying factors associated with engagement, and the best methods to encourage engagement, is a critical issue for the digital health field. This presentation will discuss young peoples' engagement with a healthy lifestyles app (the Health4Life app). : The Health4Life app is a self-monitoring app for adolescents targeting six key health risk behaviours. Participants were students (n=3610) and teachers randomized to the intervention condition of a cluster randomized controlled trial of the 'Health4Life Initiative'. Students completed an online baseline assessment assessing their health behaviours, mental health and socio-demographic factors and were provided with access to the Health4Life app to complement the in-class Health4Life module. Teachers were asked to complete a logbook documenting if they prompted students to download and use the app. The date and time users accessed the Health4Life app and any self-reported data were also automatically collected. A series of hierarchical regressions were performed to ascertain factors associated with the likelihood that students accessed the app (uptake) and factors associated with how much and for how long students used the app and how much information they entered (use). : Of the 3610 students provided access to the Health4Life app, 407 accessed it. Factors associated with increased likelihood to access the app included teacher prompts, living in a major city and being female. Psychological distress was not a significant predictor of likelihood to access the app. When investigating factors potentially associated with app use all models were found not to be significant. : Teachers are critical in the process of prompting at least initial engagement with health interventions within a school-based context and the need for targeted engagement strategies for a number of sub-groups of young people (e.g. males, those in regional communities). There is a need for more research investigating predictors of actual app use and engagement. : These findings indicate that many clinical factors (e.g., psychological distress) may not be significant barriers to adolescents engaging with digital health interventions. Researchers should carefully consider the implications of excluding participants experiencing mental illness or psychological distress, as is common in research. The results also highlight the importance of researchers establishing good relationships with teachers and clinicians working in a school-based context. [ABSTRACT FROM AUTHOR]

Background and Aims: This study evaluated whether a preventive intervention program for problem gambling would increase managers' inclination to act when concerned about gambling in the workplace. Design: Clusterrandomized controlled trial. Ten workplaces were randomized to either intervention or control condition. Participants: At the 12-month endpoint, there were n = 136 managers and n = 1594 subordinates in the intervention group, and n = 137 managers and n = 1150 subordinates in the waitlist group. Intervention: The intervention consisted of (1) six hours of skill-development training for managers regarding gambling, problem gambling, gaming, and harmful use of psychoactive drugs, and (2) six to eight hours of assistance in developing or improving workplace gambling policy. Measurements: The primary outcome was the managers' self-rated (on a 1 to 10 scale) inclination to act when concerned about an employee's problem gambling 12 months after baseline. Findings: The between-group difference in the managers' inclination for the full intervention group (M = 8) and the control group (M = 7.4) was not significant at the 12-month follow-up, but it was when only including managers who attended the skilldevelopment training (M = 8.2), d = 0.31, p = .04. Conclusion: A workplace prevention program aimed to increase managers' inclination to act when they are concerned regarding an employee's gambling resulted in statistically significant changes for those who attended training, but not for the whole intervention group when non-attendees were included. [ABSTRACT FROM AUTHOR]

Importance: Depression is a major cause of disability worldwide. Although empirically supported treatments are available, there is scarce evidence on how to effectively personalize psychological treatment selection.Objective: To compare the clinical effectiveness and cost-effectiveness of 2 treatment selection strategies: stepped care and stratified care.Design, Setting, and Participants: This multisite, cluster randomized clinical trial recruited participants from the English National Health Service from July 5, 2018, to February 1, 2019. Thirty clinicians working across 4 psychological therapy services were randomly assigned to provide stratified (n = 15) or stepped (n = 15) care. In stepped care, patients sequentially access low-intensity guided self-help followed by high-intensity psychotherapy. In stratified care, patients are matched with either low- or high-intensity treatments at initial assessment. Data were analyzed from May 18, 2020, to October 13, 2021, using intention-to-treat principles.Interventions: All clinicians used the same interview schedule to conduct initial assessments with patients seeking psychological treatment for common mental disorders, but those in the stratified care group received a personalized treatment recommendation for each patient generated by a machine learning algorithm. Eligible patients received either stratified or stepped care (ie, treatment as usual).Main Outcomes and Measures: The preregistered outcome was posttreatment reliable and clinically significant improvement (RCSI) of depression symptoms (measured using the 9-item Patient Health Questionnaire). The RCSI outcome was compared between groups using logistic regression adjusted for baseline severity. Cost-effectiveness analyses compared incremental costs and health outcomes of the 2 treatment pathways.Results: A total of 951 patients were included (618 women among 950 with data available [65.1%]; mean [SD] age, 38.27 [14.53] years). The proportion of cases of RCSI was significantly higher in the stratified care arm compared with the stepped care arm (264 of 505 [52.3%] vs 134 of 297 [45.1%]; odds ratio, 1.40 [95% CI, 1.04-1.87]; P = .03). Stratified care was associated with a higher mean additional cost per patient (£104.5 [95% CI, £67.5-£141.6] [$139.83 (95% CI, $90.32-$189.48)]; P < .001) because more patients accessed high-intensity treatments (332 of 583 [56.9%] vs 107 of 368 [29.1%]; χ2 = 70.51; P < .001), but this additional cost resulted in an approximately 7% increase in the probability of RCSI.Conclusions and Relevance: In this cluster randomized clinical trial of adults with common mental disorders, stratified care was efficacious and cost-effective for the treatment of depression symptoms compared with stepped care. Stratified care can improve depression treatment outcomes at a modest additional cost.Trial Registration: isrctn.org Identifier: ISRCTN11106183. [ABSTRACT FROM AUTHOR]

• ACT-enhanced behavior therapy for adolescents was found to be feasible and acceptable when delivered over Zoom. • Results showed a significant decrease in pulling severity as reported by adolescents. • Medium nonsignificant within condition effect sizes were seen for psychological flexibility. Treatment of adolescent trichotillomania is understudied, and treatment providers are difficult to find. In this pilot study, we compared ACT-enhanced behavior therapy to a waitlist, with treatment delivered over Zoom, to 28 adolescents who met criteria for trichotillomania. This study partially occurred during the COVID-19 pandemic. A detailed description of the treatment protocol is provided for ACT-enhanced behavior therapy adapted to a Zoom format for adolescents. Pretreatment assessments were completed over Zoom by an assessor unaware of study condition; pretreatment and posttreatment questionnaires were completed online. Results indicated that therapy was delivered with fidelity and competence over Zoom, with 100% session completion. Adolescents reported that pulling severity decreased significantly more in the treatment condition than waitlist. No differences were seen in other adolescent or parent-reported pulling severity or distress. However, significant medium to large within-condition effect sizes were observed in the treatment condition. Medium effect size changes were seen in the treatment group on a measure of trichotillomania-related psychological flexibility, and a small effect size was seen for psychological distress. Overall, pilot results provide preliminary support for ACT-enhanced behavior therapy, delivered over Zoom, for adolescent trichotillomania, indicating the need for a fully powered confirmatory efficacy trial. [ABSTRACT FROM AUTHOR]

HOME WORKS! The Teacher Home Visit Program (HOME WORKS!) aims to bridge the gap between school and home, build relationships, reverse distrust, and foster partnerships between teachers and families to improve success at school. This evaluation used a blocked, cluster randomized controlled trial (RCT) design to examine the effects of the HOME WORKS! intervention on student academic outcomes. The version of the home visiting model examined in this study includes two home visits per student per year and two family dinners (at school) per school per year. It was implemented through a partnership between a not-for-profit and participating school districts. Concentric Research & Evaluation, and its partner, Synergy Enterprises Inc., assessed the impact of HOME WORKS! in 11 schools in St. Louis Public Schools (Missouri) during the 2017-18 school year. Study findings revealed that teachers implementing HOME WORKS! reported creating strong connections with families, but also experienced challenges in implementing the program with fidelity. More than 80% of participating teachers reported that their first home visit enabled them to improve their relationship with the student's family. They also mentioned other perceived benefits, including a better understanding of academic challenges, the ability to discuss student growth and progress, and beneficial discussions about student behaviors. At the end of the year, students in HOME WORKS! and comparison classrooms did not differ significantly on academic outcomes and behaviors as measured by available school administrative records data. [ABSTRACT FROM AUTHOR]

Objective: Two key treatment effect modifiers—implementation variability and participant cumulative risk status—are examined as predictors of disruptive behavior outcomes in the context of a large cluster randomized controlled trial of a universal, school-based behavior management intervention. The core components of the Good Behavior Game (GBG) are classroom rules, team membership, monitoring behavior, and positive reinforcement. Children work in teams to win the game, which is played alongside a normal classroom activity, during which their teacher monitors infractions to classroom rules. Teams with four or fewer infractions at the end of the game win and are rewarded. Method: Seventy-seven English primary schools (N = 3,084 children, aged 6–7) were randomly assigned to deliver the GBG or continue their usual practice over 2 years. Results: Intent-to-treat analysis found no discernible impact of the intervention on children's disruptive behavior. Additionally, subgroup analyses revealed no differential gains among children at low, moderate or high levels of cumulative risk exposure (CRE). However, complier average causal effect estimation (CACE) using dosage as a compliance marker identified a large, statistically significant intervention effect (d = −1.35) among compliers (>1,030 min of cumulative intervention exposure). Furthermore, this compliance effect varied by participant CRE, such that children at high and low levels of exposure experienced significantly greater and lesser reductions in disruptive behavior, respectively. Conclusions: These findings highlight the importance of optimizing implementation and demonstrate the utility of CRE as a theoretically informed approach to subgroup moderator analysis. Implications are discussed and study strengths and limitations are noted. What is the public health significance of this article?: This study provides robust evidence that dosage is a powerful treatment effect modifier in the Good Behavior Game (GBG). To produce meaningful reductions in disruptive behavior, teachers need to play the game for at least 1,030 min over a 2-year period. When playing the GBG, children at different levels of cumulative risk exposure experience differential gains from these higher levels of dosage. Notably, those at the highest levels of risk exposure benefit the most. This study highlights the importance of considering "how and why" and "for whom" universal behavior management interventions like the GBG work. [ABSTRACT FROM AUTHOR]

Importance: Long-acting injectable antipsychotics (LAIs) can potentially reduce hospitalization risk by enhancing medication adherence but are rarely considered for early-phase schizophrenia treatment.Objective: To determine whether encouraging use of a LAI compared with usual care delays the time to first hospitalization with patients with early-phase illness.Design, Setting, and Participants: The Prevention of Relapse in Schizophrenia (PRELAPSE) trial was cluster randomized with a follow-up duration of 2 years. The study began in December 2014, was completed in March 2019, and was conducted in 39 mental health centers in 19 US states. Site randomization assigned 19 clinics to encourage treatment with long-acting aripiprazole monohydrate (aripiprazole once monthly [AOM] condition) and 20 to provide treatment as usual (clinician's choice [CC] condition). Participant eligibility criteria included (1) schizophrenia diagnosis confirmed by a structured clinical interview, (2) fewer than 5 years of lifetime antipsychotic use, and (3) age 18 to 35 years. The AOM sites identified 576 potentially eligible participants, of whom 234 (40.6%) enrolled; CC sites identified 685 potentially eligible participants, of whom 255 (37.2%) enrolled.Interventions: There were no restrictions on treatment at CC sites (including using LAIs) or at AOM sites with the exception that aripiprazole monohydrate had to be prescribed within US Food and Drug Administration-approved guidelines.Main Outcomes and Measures: The primary outcome was time to first psychiatric hospitalization based on participant interviews every 2 months, the service use resource form administered every 4 months, and other sources (eg, health records) as available. Potential events were adjudicated by an independent committee masked to treatment assignment.Results: The 489 participants (368 men [75.3%]) had a mean (SD) age of 25.2 (4.2) years and 225 (46.0%) had 1 year or less lifetime antipsychotic use. Fifty-two AOM (22%) and 91 CC participants (36%) had at least 1 hospitalization. The mean survival time until first hospitalization was 613.7 days (95% CI, 582.3-645.1 days) for AOM participants and 530.6 days (95% CI, 497.3-563.9 days) for CC participants. For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34- 0.92; P = .02), favoring AOM. Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants. The number needed to treat to prevent 1 additional hospitalization was 7 participants treated with AOM compared with CC.Conclusions and Relevance: Long-acting injectable antipsychotic use by patients with early-phase schizophrenia can significantly delay time to hospitalization, a personally and economically important outcome. Clinicians should more broadly consider LAI treatment for patients with early-phase illness.Trial Registration: ClinicalTrials.gov Identifier: NCT02360319. [ABSTRACT FROM AUTHOR]

Importance: Publicly funded mental health services play an important role in addressing co-occurring mental health problems in children with autism spectrum disorder (ASD); however, therapists report lacking training to effectively serve this complex population.Objective: To test the effectiveness of training community therapists in An Individualized Mental Health Intervention for ASD (AIM HI) on challenging behaviors across 18 months among children with ASD and identify moderators and mediators of any intervention effects.Design, Setting, and Participants: Cluster randomized trial conducted in 29 publicly funded outpatient and school-based mental health programs in southern California from 2012 to 2017. Programs were randomized to receive immediate AIM HI training or provide usual care followed by receipt of AIM HI training. Therapist participants were recruited from enrolled programs, and child participants were recruited from participant therapists' caseloads. Data were analyzed from 202 children with ASD who were aged 5 to 13 years.Interventions: The AIM HI protocol is a package of parent-mediated and child-focused strategies aimed to reduce challenging behaviors in children with ASD who are 5 to 13 years old. It was designed for delivery in publicly funded mental health services based on a systematic assessment of therapist training needs and child clinical needs. The therapist training and consultation process takes approximately 6 months and includes an introductory workshop, 11 structured consultation meetings as the therapist delivers AIM HI with a current client, and case-specific performance feedback from trainers.Main Outcomes and Measures: Child participants were assessed for challenging behaviors using the Eyberg Child Behavior Inventory (ECBI) and Social Skills Improvement System (SSIS) Competing Problem Behaviors scales based on parent report at baseline and at 6-month intervals for 18 months. Outcomes were analyzed using intent-to-treat models.Results: In total, 202 children with ASD (mean [SD] age, 9.1 [2.4] years; 170 [84.2%] male; 121 [59.9%] Latinx) were eligible, enrolled, and included in the analyses. Statistically significant group by time interactions for the ECBI Intensity (B = -0.38; P = .02) and ECBI Problem (B = -1.00; P = .005) scales were observed, with significantly larger decreases in ECBI Intensity scores in the AIM HI group (B = -1.36; P < .001) relative to the usual care group (B = -0.98; P < .001) and a significantly larger decrease in ECBI Problem scores in the AIM HI group (B = -1.22; P < .001) relative to the usual care group (B = -0.20; P = .29). Therapist fidelity moderated these intervention effects.Conclusions and Relevance: The present findings support the effectiveness of training therapists to deliver the AIM HI model to children with ASD receiving publicly funded mental health services.Trial Registration: ClinicalTrials.gov identifier: NCT02416323. [ABSTRACT FROM AUTHOR]

Objective: Forming implementation intentions (if-then plans) about how to refuse cigarette offers plus antismoking messages was tested for reducing adolescent smoking. Method: Cluster randomized controlled trial with schools randomized (1:1) to receive implementation intention intervention and messages targeting not smoking (intervention) or completing homework (control). Adolescents (11-12 years at baseline) formed implementation intentions and read messages on 8 occasions over 4 years meaning masking treatment allocation was not possible. Outcomes were: follow-up (48 months) ever smoking, any smoking in last 30 days, regular smoking, and breath carbon monoxide levels. Analyses excluded baseline ever smokers, controlled for clustering by schools and examined effects of controlling for demographic variables. Economic evaluation (incremental cost effectiveness ratio; ICER) was conducted. Trial is registered (ISRCTN27596806). Results: Schools were randomly allocated (September- October 2012) to intervention (n= 25) or control (n= 23). At follow-up, among 6,155 baseline never smokers from 45 retained schools, ever smoking was significantly lower (RR= 0.83, 95% CI [0.71, 0.97], p= .016) in intervention (29.3%) compared with control (35.8%) and remained so controlling for demographics. Similar patterns observed for any smoking in last 30 days. Less consistent effects were observed for regular smoking and breath carbon monoxide levels. Economic analysis yielded an ICER of $134 per ever smoker avoided at age 15-16 years. Conclusions: This pragmatic trial supports the use of repeated implementation intentions about how to refuse the offer of a cigarette plus antismoking messages as an effective and cost-effective intervention to reduce smoking initiation in adolescents. [ABSTRACT FROM AUTHOR]

Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods: HIV physicians and advanced practice providers (n=41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n=187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n=170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n=117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US. [ABSTRACT FROM AUTHOR]

Primary care pharmacists are uniquely positioned to improve care quality by intervening within care transitions in the postdischarge period. However, additional evidence is required to demonstrate that pharmacist-led interventions can reduce health care utilization in a cost-effective manner. The study's objective was to evaluate the clinical and economic effectiveness of a pharmacy-led transition of care (TOC) program within a primary care setting. This cluster randomized trial was conducted between 2019 and 2021 and included three primary care practices. Eligible patients were ≥18 years of age and at high risk of readmission. The multifaceted pharmacy intervention included medication reconciliation, comprehensive medication review, and patient and provider follow-up. The primary composite endpoint included hospital readmissions and emergency department (ED) visits within 30 days of discharge. Differences in outcomes were modeled using a generalized estimated equations approach and outcomes were assumed to be distributed as a Poisson random variable. A cost-benefit analysis was embedded within the study and estimated economic outcomes from a provider group/health system perspective. Cost measures included: net benefit, benefit to cost ratio (BCR), and return on investment (ROI). Of 300 eligible patients, 36 were in the intervention group and 264 in the control group. The intervention significantly reduced the primary composite outcome of all-cause readmissions and ED visits within 30 days (adjusted incidence rate ratio [aIRR], 0.54; 95% CI, 0.44–0.66; P < 0.001). There were significant reductions in both 30-day all-cause readmissions (aIRR, 0.64; 95% CI, 0.60–0.67; P < 0.001) and ED visits (aIRR, 0.25; 95% CI, 0.20, 0.31; P < 0.001) between groups. The net benefit of the intervention was $9,078, with a BCR of 2.11 and a ROI of 111%. Sensitivity analyses were robust to changes in economic inputs. This care transition program had positive clinical and economic benefits, providing further support for the essential role pharmacists demonstrate in providing TOC services. [ABSTRACT FROM AUTHOR]

Highlights • The traditional K-means algorithm is improved by the density parameters based initial centers selection method. • A new clustering validity (VCVI) from point of view of spatial distribution of data sets is proposed. • A new partitional clustering algorithm is designed by integrating the improved K-means algorithm with the new introducted VCVI. Abstract As an unsupervised pattern classification method, clustering partitions the input datasets into groups or clusters. It plays an important role in identifying the natural structure of the target datasets. Now, it has been widely used in data mining, pattern recognition, image processing and so on. However, due to different settings of the parameters and random selection of initial centers, traditional clustering algorithms may produce different clustering partitions for a single dataset. Clustering validity index (CVI) is an important method for evaluating the effect of clustering results generated by clustering algorithms. However, many of the existing CVIs suffer from complex computation, low time efficiency and narrow range of applications. In order to make clustering algorithms more stable, traditional K -means is firstly improved by the density parameters based initial center selection method other than randomly selecting initial centers. Then, in order to enlarge the application range of clustering and better evaluate the clustering partition results, a new variance based clustering validity index (VCVI) from the point of view of spatial distribution of datasets is designed. Finally, a new partitional clustering algorithm integrated with the improved K-means algorithm and the newly introduced VCVI is designed to optimize and determine the optimal clustering number (K opt) for a wide range of datasets. Furthermore, the commonly used empirical rule K max ⩽ n is reasonably explained by the newly designed VCVI. The new algorithm integrated with VCVI is compared with traditional algorithms integrated with five commonly used CVIs. The experimental results show that our new clustering method is more accurate and stable while consuming relatively lower running time. [ABSTRACT FROM AUTHOR]

Ensemble of classifiers combines the more than one prediction models of classifiers into single model for classifying the new instances. Unbiased samples could help the ensemble classifiers to build the efficient prediction model. Existing sampling techniques fails to give the unbiased samples. To overcome this problem, the paper introduces a k-modes random sample technique which combines the k-modes cluster algorithm and simple random sampling technique to take the sample from the dataset. In this paper, the impact of random sampling technique in the Ensemble learning algorithm is shown. Random selection was done properly by using k-modes random sampling technique. Hence, sample will reflect the characteristics of entire dataset. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of Motivational Interviewing (MI) conducted by primary care providers on rates of improvement over time for depressive symptoms and remission among low-income patients with newly diagnosed Major Depressive Disorder. Method: Ten care teams were randomized to MI with standard management of depression (MI-SMD; 4 teams, 10 providers, 88 patients) or SMD alone (6 teams, 16 providers, 80 patients). Patients were assessed at 6, 12 and 36 weeks with the Patient Health Questionnaire-9 (PHQ-9). Treatment receipt was ascertained through patient inquiry and electronic records. Audio-recorded index encounters were evaluated for mediators of improved depressive symptoms (providers' MI ability and patient language favoring participating in treatment or other depression related mood-improving behaviors). Results: In Intention-To-Treat analyses, MI-SMD was associated with a more favorable trajectory of PHQ-9 depressive symptom scores than SMD alone (randomization group X time interaction estimate = 0.13, p = .018). At 36 weeks, MI-SMD was associated with improved depressive symptoms (Cohen's d = 0.41, 95% Cl [0.11, 0.72]) and remission rate (Success Rate Difference = 14.53 [1.79, 27.26]) relative to SMD alone. MI-SMD was not associated with a significant group x time interaction for remission, or with increased receipt of antidepressant medication or specialty mental health counseling. The providers' ability to direct clinical discussions toward treating depression, and the patients' language favoring engagement in mood-improving behaviors, mediated the effects of MI-SMD on depressive symptoms (ps < .05). Discussion: Training providers to frame discussions about depression using MI may improve upon standard management for depression. [ABSTRACT FROM AUTHOR]

Objective: This paper describes the multisite, longitudinal cluster randomized controlled trial (RCT) design of the evaluation of the Dating Matters: Strategies to Promote Healthy Relationships initiative, and discusses challenges faced in conducting this evaluation. Method: Health departments in 4 communities are partnering with middle schools in high-risk, urban communities to implement 2 models of teen dating violence (TDV) prevention over 4 years. Schools were randomized to receive either the Dating Matters comprehensive strategy or the "standard of care" strategy (an existing, evidence-based TDV prevention curriculum). Our design permits comparison of the relative effectiveness of the comprehensive and standard of care strategies. Multiple cohorts of students from 46 middle schools are surveyed in middle school and high school, and parents and educators from participating schools are also surveyed. Results: Challenges discussed in conducting a multisite RCT include site variability, separation of implementation and evaluation responsibilities, school retention, parent engagement in research activities, and working within the context of high-risk urban schools and communities. We discuss the strengths and weaknesses of our approaches to these challenges in the hopes of informing future research. Conclusions: Despite multiple challenges, the design of the Dating Matters evaluation remains strong. We hope this paper provides researchers who are conducting complex evaluations of behavioral interventions with thoughtful discussion of the challenges we have faced and potential solutions to such challenges. [ABSTRACT FROM AUTHOR]

Background: Patient education, home-based exercise therapy, and advice on returning to normal activities are established physiotherapeutic treatment options for patients with nonspecific low back pain (LBP). However, the effectiveness of physiotherapy interventions on health-related outcomes largely depends on patient self-management and adherence to exercise and physical activity recommendations. e-Exercise LBP is a recently developed stratified blended care intervention comprising a smartphone app integrated with face-to-face physiotherapy treatment. Following the promising effects of web-based applications on patients' self-management skills and adherence to exercise and physical activity recommendations, it is hypothesized that e-Exercise LBP will improve patients' physical functioning.Objective: This study aims to investigate the short-term (3 months) effectiveness of stratified blended physiotherapy (e-Exercise LBP) on physical functioning in comparison with face-to-face physiotherapy in patients with nonspecific LBP.Methods: The study design was a multicenter cluster randomized controlled trial with intention-to-treat analysis. Patients with nonspecific LBP aged ≥18 years were asked to participate in the study. The patients were treated with either stratified blended physiotherapy or face-to-face physiotherapy. Both interventions were conducted according to the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the Keele STarT Back Screening Tool. The primary outcome was physical functioning (Oswestry Disability Index, range 0-100). Secondary outcomes included pain intensity, fear-avoidance beliefs, and self-reported adherence. Measurements were taken at baseline and at the 3-month follow-up.Results: Both the stratified blended physiotherapy group (104/208, 50%) and the face-to-face physiotherapy group (104/208, 50%) had improved clinically relevant and statistically significant physical functioning; however, there was no statistically significant or clinically relevant between-group difference (mean difference -1.96, 95% CI -4.47 to 0.55). For the secondary outcomes, stratified blended physiotherapy showed statistically significant between-group differences in fear-avoidance beliefs and self-reported adherence. In patients with a high risk of developing persistent LBP (13/208, 6.3%), stratified blended physiotherapy showed statistically significant between-group differences in physical functioning (mean difference -16.39, 95% CI -27.98 to -4.79) and several secondary outcomes.Conclusions: The stratified blended physiotherapy intervention e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term. For both stratified blended physiotherapy and face-to-face physiotherapy, within-group improvements were clinically relevant. To be able to decide whether e-Exercise LBP should be implemented in daily physiotherapy practice, future research should focus on the long-term cost-effectiveness and determine which patients benefit most from stratified blended physiotherapy.Trial Registration: ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203.International Registered Report Identifier (irrid): RR2-https://doi.org/10.1186/s12891-020-3174-z. [ABSTRACT FROM AUTHOR]

Background: Seasonal influenza vaccine (SIV) uptake in the United States remains suboptimal, requiring new and innovative strategies.Objective: To evaluate the impact of a behavioral peer comparison (PC) intervention on SIV uptake in community pharmacies across the United States.Methods: A cluster randomized study was conducted across a national network of Walmart community pharmacies (> 4500 sites) during the 2019-2020 influenza season. The clusters consisted of 416 markets, each containing an average of 11 pharmacies. All pharmacies in a market were randomly assigned to either no intervention or the PC intervention, a software-delivered communication informing on-site staff, including pharmacists and pharmacy technicians, of their pharmacy's weekly performance, measured as SIV doses administered, compared with that of peer pharmacies within their market. The outcome was the pharmacy-level cumulative SIV doses administered during the intervention period (September 1, 2019,-February 29, 2020). Linear regression models were used to estimate the PC impact, with multiway cluster-robust SEs estimated by market and state.Results: A total of 4589 pharmacies were enrolled in the study, with 2297 (50.1%) randomized to the control group and 2292 (49.9%) randomized to the PC intervention group. Overall, compared with the control pharmacies, the PC pharmacies administered 3.7% (95% CI -0.3% to 7.9%) additional SIV doses. Among large-format pharmacies, the PC pharmacies administered 4.1% (95% CI 0.1%-8.3%) additional SIV doses compared with the controls. Historically low-performing large-format PC pharmacies administered 6.1% (95% CI 0.5%-11.9%) additional SIV doses compared with the controls. No statistically significant treatment effects were observed among small-format pharmacies.Conclusion: Our findings demonstrate that PCs can improve SIV uptake among large-format community pharmacies, with historically low-performing pharmacies potentially exhibiting the greatest relative impact. Wide-scale implementation of PCs in community pharmacies may help to further improve SIV uptake in these settings. [ABSTRACT FROM AUTHOR]

Background: There is significant opportunity to improve the nutritional quality of foods packed in children's school lunchboxes. Interventions that are effective and scalable targeting the school and home environment are therefore warranted.Objective: This study aimed to assess the effectiveness of a multicomponent, mobile health-based intervention, SWAP IT, in reducing the energy contribution of discretionary (ie, less healthy) foods and drinks packed for children to consume at school.Methods: A type I effectiveness-implementation hybrid cluster randomized controlled trial was conducted in 32 primary schools located across 3 local health districts in New South Wales, Australia, to compare the effects of a 6-month intervention targeting foods packed in children's lunchboxes with those of a usual care control. Primary schools were eligible if they were not participating in other nutrition studies and used the required school communication app. The Behaviour Change Wheel was used to co-design the multicomponent SWAP IT intervention, which consisted of the following: school lunchbox nutrition guidelines, curriculum lessons, information pushed to parents digitally via an existing school communication app, and additional parent resources to address common barriers to packing healthy lunchboxes. The primary outcome, mean energy (kilojoules) content of discretionary lunchbox foods and drinks packed in lunchboxes, was measured via observation using a validated school food checklist at baseline (May 2019) and at 6-month follow-up (October 2019). Additional secondary outcomes included mean lunchbox energy from discretionary foods consumed, mean total lunchbox energy packed and consumed, mean energy content of core lunchbox foods packed and consumed, and percentage of lunchbox energy from discretionary and core foods, all of which were also measured via observation using a validated school food checklist. Measures of school engagement, consumption of discretionary foods outside of school hours, and lunchbox cost were also collected at baseline and at 6-month follow-up. Data were analyzed via hierarchical linear regression models, with controlling for clustering, socioeconomic status, and remoteness.Results: A total of 3022 (3022/7212, 41.90%) students consented to participate in the evaluation (mean age 7.8 years; 1487/3022, 49.22% girls). There were significant reductions between the intervention and control groups in the primary trial outcome, mean energy (kilojoules) content of discretionary foods packed in lunchboxes (-117.26 kJ; 95% CI -195.59 to -39.83; P=.003). Relative to the control, the intervention also significantly reduced secondary outcomes regarding the mean total lunchbox energy (kilojoules) packed (-88.38 kJ; 95% CI -172.84 to -3.92; P=.04) and consumed (-117.17 kJ; 95% CI -233.72 to -0.62; P=.05). There was no significant difference between groups in measures of student engagement, consumption of discretionary foods outside of school hours, or cost of foods packed in children's lunchboxes.Conclusions: The SWAP IT intervention was effective in reducing the energy content of foods packed for and consumed by primary school-aged children at school. Dissemination of the SWAP IT program at a population level has the potential to influence a significant proportion of primary school-aged children, impacting weight status and associated health care costs.Trial Registration: Australian Clinical Trials Registry ACTRN12618001731280; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376191&isReview=true.International Registered Report Identifier (irrid): RR2-10.1186/s12889-019-7725-x. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has led to worldwide school closures, with millions of children confined to online learning at home. As a result, children may be susceptible to anxiety and digital eye strain, highlighting a need for population interventions. Objective: The objective of our study was to investigate whether a digital behavior change intervention aimed at promoting physical activity could reduce children's anxiety and digital eye strain while undergoing prolonged homeschooling during the COVID-19 pandemic. Methods: In this cluster randomized controlled trial, homeschooled grade 7 students at 12 middle schools in southern China were recruited through local schools and randomly assigned by the school to receive (1:1 allocation): (1) health education information promoting exercise and ocular relaxation, and access to a digital behavior change intervention, with live streaming and peer sharing of promoted activities (intervention), or (2) health education information only (control). The primary outcome was change in self-reported anxiety score. Secondary outcomes included change in self-reported eye strain and sleep quality. Results: On March 16, 2020, 1009 children were evaluated, and 954 (94.5%) eligible children of consenting families were included in the intention-to-treat analysis. Children in the intervention (n=485, 6 schools) and control (n=469, 6 schools) groups were aged 13.5 (SD 0.5) years, and 52.3% (n=499) were male. The assigned interventions were completed by 896 children (intervention: n=467, 96.3%; control: n=429, 91.5%). The 2-week change in square-root–transformed self-reported anxiety scores was greater in the intervention (–0.23, 95% CI –0.27 to –0.20) vs control group (0.12, 95% CI 0.09-0.16; unadjusted difference –0.36, 95% CI –0.63 to –0.08; P =.02). There was a significant reduction in square-root–transformed eye strain in the intervention group (–0.08, 95% CI –0.10 to 0.06) compared to controls (0.07, 95% CI 0.05-0.09; difference –0.15, 95% CI –0.26 to –0.03; P =.02). Change in sleep quality was similar between the two groups. Conclusions: This digital behavior change intervention reduced children's anxiety and eye strain during COVID-19–associated online schooling. Trial Registration: ClinicalTrials.gov NCT04309097; http://clinicaltrials.gov/ct2/show/NCT04309097 J Med Internet Res 2021;23(4):e24316 doi:10.2196/24316 [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has led to worldwide school closures, with millions of children confined to online learning at home. As a result, children may be susceptible to anxiety and digital eye strain, highlighting a need for population interventions.Objective: The objective of our study was to investigate whether a digital behavior change intervention aimed at promoting physical activity could reduce children's anxiety and digital eye strain while undergoing prolonged homeschooling during the COVID-19 pandemic.Methods: In this cluster randomized controlled trial, homeschooled grade 7 students at 12 middle schools in southern China were recruited through local schools and randomly assigned by the school to receive (1:1 allocation): (1) health education information promoting exercise and ocular relaxation, and access to a digital behavior change intervention, with live streaming and peer sharing of promoted activities (intervention), or (2) health education information only (control). The primary outcome was change in self-reported anxiety score. Secondary outcomes included change in self-reported eye strain and sleep quality.Results: On March 16, 2020, 1009 children were evaluated, and 954 (94.5%) eligible children of consenting families were included in the intention-to-treat analysis. Children in the intervention (n=485, 6 schools) and control (n=469, 6 schools) groups were aged 13.5 (SD 0.5) years, and 52.3% (n=499) were male. The assigned interventions were completed by 896 children (intervention: n=467, 96.3%; control: n=429, 91.5%). The 2-week change in square-root-transformed self-reported anxiety scores was greater in the intervention (-0.23, 95% CI -0.27 to -0.20) vs control group (0.12, 95% CI 0.09-0.16; unadjusted difference -0.36, 95% CI -0.63 to -0.08; P=.02). There was a significant reduction in square-root-transformed eye strain in the intervention group (-0.08, 95% CI -0.10 to 0.06) compared to controls (0.07, 95% CI 0.05-0.09; difference -0.15, 95% CI -0.26 to -0.03; P=.02). Change in sleep quality was similar between the two groups.Conclusions: This digital behavior change intervention reduced children's anxiety and eye strain during COVID-19-associated online schooling.Trial Registration: ClinicalTrials.gov NCT04309097; http://clinicaltrials.gov/ct2/show/NCT04309097. [ABSTRACT FROM AUTHOR]

Background: Anxiety symptoms in older adults are prevalent and disabling but often go untreated. Most trials on psychological interventions for anxiety in later life have examined the effectiveness of face-to-face cognitive behavioral therapy (CBT). To bridge the current treatment gap, other treatment approaches and delivery formats should also be evaluated.Objective: This study is the first to examine the effectiveness of a brief blended acceptance and commitment therapy (ACT) intervention for older adults with anxiety symptoms, compared with a face-to-face CBT intervention.Methods: Adults aged between 55-75 years (n=314) with mild to moderately severe anxiety symptoms were recruited from general practices and cluster randomized to either blended ACT or face-to-face CBT. Assessments were performed at baseline (T0), posttreatment (T1), and at 6- and 12-month follow-ups (T2 and T3, respectively). The primary outcome was anxiety symptom severity (Generalized Anxiety Disorder-7). Secondary outcomes were positive mental health, depression symptom severity, functional impairment, presence of Diagnostic and Statistical Manual of Mental Disorders V anxiety disorders, and treatment satisfaction.Results: Conditions did not differ significantly regarding changes in anxiety symptom severity during the study period (T0-T1: B=.18, P=.73; T1-T2: B=-.63, P=.26; T1-T3: B=-.33, P=.59). Large reductions in anxiety symptom severity (Cohen d≥0.96) were found in both conditions post treatment, and these were maintained at the 12-month follow-up. The rates of clinically significant changes in anxiety symptoms were also not different for the blended ACT group and CBT group (χ21=0.2, P=.68). Regarding secondary outcomes, long-term effects on positive mental health were significantly stronger in the blended ACT group (B=.27, P=.03, Cohen d=0.29), and treatment satisfaction was significantly higher for blended ACT than CBT (B=3.19, P<.001, Cohen d=0.78). No other differences between the conditions were observed in the secondary outcomes.Conclusions: The results show that blended ACT is a valuable treatment alternative to CBT for anxiety in later life.Trial Registration: Netherlands Trial Register TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131. [ABSTRACT FROM AUTHOR]

Background: In Australia, secondary school educators are well positioned to recognize mental illness among students and provide support. However, many report that they lack the knowledge and confidence to do so, and few mental health training programs available for educators are evidence based. To address this gap, the Black Dog Institute (BDI) developed a web-based training program (Building Educators' Skills in Adolescent Mental Health [BEAM]) that aims to improve mental health knowledge, confidence, and helping behaviors among secondary school educators in leadership positions. A pilot study of the training program found it to be positively associated with increased confidence and helping behaviors among educators and reduced personal psychological distress. An adequately powered randomized controlled trial (RCT) is needed. Objective: The primary objective of this cluster RCT is to evaluate the effectiveness of the BEAM program for improving educators' confidence in managing student mental health. The trial will also evaluate the effect of the BEAM program in increasing educators' frequency of providing help to students and improving their mental health knowledge and reducing educators' psychological distress and stigma toward students with mental health issues. Methods: The target sample size is 234 educators from 47 secondary schools across New South Wales, Australia. Four waves of recruitment and enrollment into the trial are planned. Schools will participate in one wave only and will be randomized to the intervention or waitlist control conditions. Participants from the same school will be assigned to the same condition. Assessments will be conducted at baseline, posttest (10 weeks after baseline), and follow-up (22 weeks after baseline) using the BDI eHealth research platform. Intervention participants will receive access to the BEAM program for 10 weeks upon completion of baseline, and the control condition will receive access for 10 weeks upon completion of the follow-up assessment. Results: Recruitment for this trial began on July 21, 2020, with the first baseline assessments occurring on August 17, 2020. To date, 295 participants from 71 schools have completed baseline. Due to the unexpected success of recruitment in the first 3 waves, the final fourth wave has been abandoned. Intervention participants are currently receiving the program, with follow-up due for completion in March 2021. Conclusions: This is one of the first RCTs to examine the effectiveness of a web-based adolescent mental health training program for Australian secondary school educators in leadership positions. If found to be effective, this training program will offer a sustainable and scalable delivery method for upskilling educators in caring for students' mental health. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000876998; https://covid-19.cochrane.org/studies/crs-14669208 International Registered Report Identifier (IRRID): DERR1-10.2196/25870 JMIR Res Protoc 2021;10(2):e25870 doi:10.2196/25870 [ABSTRACT FROM AUTHOR]

Background: HIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. Objective: This study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. Methods: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. Results: The study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. Conclusions: This study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. Trial Registration: ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. International Registered Report Identifier (IRRID): DERR1-10.2196/26192 JMIR Res Protoc 2021;10(2):e26192 doi:10.2196/26192 [ABSTRACT FROM AUTHOR]

Background: Telemedicine modalities, such as videoconferencing, are used by health care providers to remotely deliver health care to patients. Telemedicine use in pediatrics has increased in recent years. This has resulted in improved health care access, optimized disease management, progress in the monitoring of health conditions, and fewer exposures to patients with illnesses during pandemics (eg, the COVID-19 pandemic). Objective: We aimed to systematically evaluate the most recent evidence on the feasibility and accessibility of telemedicine services, patients' and care providers' satisfaction with these services, and treatment outcomes related to telemedicine service use among pediatric populations with different health conditions. Methods: Studies were obtained from the PubMed database on May 10, 2020. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. In this review, we included randomized controlled trials from the last 10 years that used a telemedicine approach as a study intervention or assessed telemedicine as a subspecialty of pediatric care. Titles and abstracts were independently screened based on the eligibility criteria. Afterward, full texts were retrieved and independently screened based on the eligibility criteria. A standardized form was used to extract the following data: publication title, first author's name, publication year, participants' characteristics, study design, the technology-based approach that was used, intervention characteristics, study goals, and study findings. Results: In total, 11 articles met the inclusion criteria and were included in this review. All studies were categorized as randomized controlled trials (8/11, 73%) or cluster randomized trials (3/11, 27%). The number of participants in each study ranged from 22 to 400. The health conditions that were assessed included obesity (3/11, 27%), asthma (2/11, 18%), mental health conditions (1/11, 9%), otitis media (1/11, 9%), skin conditions (1/11, 9%), type 1 diabetes (1/11, 9%), attention deficit hyperactivity disorder (1/11, 9%), and cystic fibrosis–related pancreatic insufficiency (1/11). The telemedicine approaches that were used included patient and doctor videoconferencing visits (5/11, 45%), smartphone-based interventions (3/11, 27%), telephone counseling (2/11, 18%), and telemedicine-based screening visits (1/11, 9%). The telemedicine interventions in all included studies resulted in outcomes that were comparable to or better than the outcomes of control groups. These outcomes were related to symptom management, quality of life, satisfaction, medication adherence, visit completion rates, and disease progression. Conclusions: Although more research is needed, the evidence from this review suggests that telemedicine services for the general public and pediatric care are comparable to or better than in-person services. Patients, health care professionals, and caregivers may benefit from using both telemedicine services and traditional, in-person health care services. To maximize the potential of telemedicine, future research should focus on improving patients' access to care, increasing the cost-effectiveness of telemedicine services, and eliminating barriers to telemedicine use. JMIR Pediatr Parent 2021;4(1):e22696 doi:10.2196/22696 [ABSTRACT FROM AUTHOR]

Background: Simulation-based training is a common strategy for improving the quality of facility-based maternity services and is often evaluated using Kirkpatrick's theoretical model. The results on the Kirkpatrick levels are closely related to the quality of the instructional design of a training program. The instructional design is generally defined as the "set of prescriptions for teaching methods to improve the quality of instruction with a goal of optimizing learning outcomes." Objective: The aim of this study is to evaluate the instructional design of a technology-enhanced simulation-based training in obstetrics, the reaction of participants, and the effect on knowledge, teamwork, and skills in a low-income country. Methods: A stepped-wedge cluster randomized trial was performed in a university hospital in Kampala, Uganda, with an annual delivery volume of over 31,000. In November 2014, a medical simulation center was installed with a full-body birthing simulator (Noelle S550, Gaumard Scientific), an interactive neonate (Simon S102 Newborn CPR Simulator, Gaumard Scientific), and an audio and video recording system. Twelve local obstetricians were trained and certified as medical simulation trainers. From 2014 to 2016, training was provided to 57 residents in groups of 6 to 9 students. Descriptive statistics were calculated for ten instructional design features of the training course measured by the 42-item ID-SIM (Instructional Design of a Simulation Improved by Monitoring). The Wilcoxon signed rank test was conducted to investigate the differences in scores on knowledge, the Clinical Teamwork Scale, and medical technical skills. Results: The mean scores on the ten instructional design features ranged from 54.9 (95% CI 48.5-61.3) to 84.3 (95% CI 80.9-87.6) out of 100. The highest mean score was given on the feature feedback and the lowest scores on repetitive practice and controlled environment. The overall score for the training day was 92.8 out of 100 (95% CI 89.5-96.1). Knowledge improved significantly, with a test score of 63.4% (95% CI 60.7-66.1) before and 78.9% (95% CI 76.8-81.1) after the training (P <.001). The overall score on the 10-point Clinical Teamwork Scale was 6.0 (95% CI 4.4-7.6) before and 5.9 (95% CI 4.5-7.2) after the training (P =.78). Medical technical skills were scored at 55.5% (95% CI 47.2-63.8) before and 65.6% (95% CI 56.5-74.7) after training (P =.08). Conclusions: Most instructional design features of a technology-enhanced simulation-based training in obstetrics in a low-income country were scored high, although intervals were large. The overall score for the training day was high, and knowledge did improve after the training program, but no changes in teamwork and (most) medical technical skills were found. The lowest-scored instructional design features may be improved to achieve further learning aims. Trial Registration: ISRCTN Registry ISRCTN98617255; http://www.isrctn.com/ISRCTN98617255 International Registered Report Identifier (IRRID): RR2-10.1186/s12884-020-03050-3 JMIR Med Educ 2021;7(1):e17277 doi:10.2196/17277 [ABSTRACT FROM AUTHOR]

Background: Shared decision making (SDM) is becoming an important part of ulcerative colitis (UC) management because of the increasing complexity of available treatment choices and their trade-offs. The use of decision aids (DA) may be effective in increasing patients' participation in UC management but their uptake has been limited due to high attrition rates and lack of a participatory approach to their design and implementation.Objective: The primary aim of this study is to explore the perspectives of Australian patients and their clinicians regarding the feasibility and acceptability of myAID, a web-based DA, in informing treatment decisions in UC. The secondary aim is to use the findings of this pilot study to inform the design of a cluster randomized clinical trial (CRCT) to assess the efficacy of the DA compared with usual care.Methods: myAID, a DA was designed and developed using a participatory approach by a multidisciplinary team of clinicians, patients, and nonmedical volunteers. A qualitative pilot study to evaluate the DA, involving patients with UC facing new treatment decisions and inflammatory bowel disease clinicians, was undertaken.Results: A total of 11 patients with UC and 15 clinicians provided feedback on myAID. Themes explored included the following: Acceptability and usability of myAID-myAID was found to be acceptable by the majority of clinicians as a tool to facilitate SDM, uptake was thought to vary depending on clinicians' approaches to patient education and practice, potential to overcome time restrictions associated with outpatient clinics was identified, presentation of unbiased information enabling patients to digest information at their own pace was noted, and potential to provoke anxiety among patients with a new diagnosis or mild disease was raised; Perceived role and usefulness of myAID-discordance was observed between patients who prioritized voicing preferences and clinicians who prioritized treatment adherence, and myAID facilitated early discussion of medical versus surgical treatment options; Target population and timing of use-greatest benefit was perceived at the time of initiating or changing treatment and following commencement of immunosuppressive therapy; and Potential concerns and areas for improvement-some perceived that use of myAID may precipitate anxiety by increasing decisional conflict and impact the therapeutic relationship between patient and the clinician and may increase resource requirements.Conclusions: These preliminary findings suggest that patients and clinicians consider myAID as a feasible and acceptable tool to facilitate SDM for UC management. These pilot data have informed a participatory approach to the design of a CRCT, which will evaluate the clinical efficacy of myAID compared with usual care.Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001246370. [ABSTRACT FROM AUTHOR]

The article discusses a study in 2017 that determined whether opportunistic screening in primary care improves the detection of atrial fibrillation (AF) compared with usual care. Highlights include examination of the electrocardiogram results by an experienced assessor supervised by a cardiologist, the difference in the detection rate of newly diagnosed AF over one year, and the number of diagnoses of AF found in patients who had negative index tests.

Background: Person-centered care is critical for delivering high-quality diabetes care. Shared decision making (SDM) is central to person-centered care, and in diabetes care, it can improve decision quality, patient knowledge, and patient risk perception. Delivery of person-centered care can be facilitated with the use of patient decision aids (PtDAs). We developed MyDiabetesPlan, an interactive SDM and goal-setting PtDA designed to help individualize care priorities and support an interprofessional approach to SDM.Objective: This study aims to assess the impact of MyDiabetesPlan on decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care at the individual patient level.Methods: A two-step, parallel, 10-site cluster randomized controlled trial (first step: provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later) was conducted. Participants were adults 18 years and older with diabetes and 2 other comorbidities at 10 family health teams (FHTs) in Southwestern Ontario. FHTs were randomly assigned to MyDiabetesPlan (n=5) or control (n=5) through a computer-generated algorithm. MyDiabetesPlan was integrated into intervention practices, and clinicians (first step) followed by patients (second step) were trained on its use. Control participants received static generic Diabetes Canada resources. Patients were not blinded. Participants completed validated questionnaires at baseline, 6 months, and 12 months. The primary outcome at the individual patient level was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care, and clinician intention to practice interprofessional SDM. Multilevel hierarchical regression models were used.Results: At the end of the study, the intervention group (5 clusters, n=111) had a modest reduction in total decisional conflicts compared with the control group (5 clusters, n=102; -3.5, 95% CI -7.4 to 0.42). Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0).Conclusions: Use of goal-setting decision aids modestly improved decision quality and chronic illness care but not quality of life. Our findings may be due to a gap between goal setting and attainment, suggesting a role for optimizing patient engagement and behavioral support. The next steps include clarifying the mechanisms by which decision aids impact outcomes and revising MyDiabetesPlan and its delivery.Trial Registration: ClinicalTrials.gov NCT02379078; https://clinicaltrials.gov/ct2/show/NCT02379078. [ABSTRACT FROM AUTHOR]

Background: Real-time video communication technology allows virtual face-to-face interactions between the provider and the user, and can be used to modify risk factors for smoking, nutrition, alcohol consumption, physical activity, and obesity. No systematic reviews have examined the effectiveness of individual real-time video counseling for addressing each of the risk factors for smoking, nutrition, alcohol consumption, physical activity, and obesity.Objective: This systematic review aims to examine the effectiveness of individually delivered real-time video counseling on risk factors for smoking, nutrition, alcohol consumption, physical activity, and obesity.Methods: The MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica Database), PsycINFO, Cochrane Register of Controlled Trials, and Scopus databases were searched for eligible studies published up to November 21, 2019. Eligible studies were randomized or cluster randomized trials that tested the effectiveness of individual real-time video communication interventions on smoking, nutrition, alcohol, physical activity, and obesity in any population or setting; the comparator was a no-intervention control group or any other mode of support (eg, telephone); and an English-language publication.Results: A total of 13 studies were eligible. Four studies targeted smoking, 3 alcohol, 3 physical activity, and 3 obesity. In 2 of the physical activity studies, real-time video counseling was found to significantly increase physical activity when compared with usual care at week 9 and after 5 years. Two obesity studies found a significant change in BMI between a video counseling and a documents group, with significantly greater weight loss in the video counseling group than the in-person as well as the control groups. One study found that those in the video counseling group were significantly more likely than those in the telephone counseling group to achieve smoking cessation. The remaining studies found no significant differences between video counseling and telephone counseling or face-to-face counseling for smoking cessation, video counseling and face-to-face treatment on alcohol consumption, video counseling and no counseling for physical activity, and video counseling and face-to-face treatment on BMI. The global methodological quality rating was moderate in 1 physical activity study, whereas 12 studies had a weak global rating.Conclusions: Video counseling is potentially more effective than a control group or other modes of support in addressing physical inactivity and obesity and is not less effective in modifying smoking and alcohol consumption. Further research is required to determine the relative benefits of video counseling in terms of other policy and practice decision-making factors such as costs and feasibility. [ABSTRACT FROM AUTHOR]

Background: Hearing aid (HA) use is known to improve health outcomes for people with hearing loss. Despite that, HA use is suboptimal, and communication issues and hearing-related activity limitations and participation restrictions often remain. Web-based self-management communication programs may support people with hearing loss to effectively self-manage the impact of hearing loss in their daily lives.Objective: The goal of the research is to examine the short- and long-term effects of a web-based self-management SUpport PRogram (SUPR) on communication strategy use (primary outcome) and a range of secondary outcomes for HA users aged 50 years and older.Methods: Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users). SUPR recipients received a practical support booklet and online materials delivered via email over the course of their 6-month HA rehabilitation trajectory. They were encouraged to appoint a communication partner and were offered optional email contact with the HA dispensing practice. The online materials included 3 instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos. Care as usual included a HA fitting rehabilitation trajectory only. Measurements were carried out at baseline, immediately postintervention, 6 months postintervention, and 12 months postintervention. The primary outcome measure was self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI]). Secondary outcome measures included self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids [IOI-HA], Alternative Interventions [IOI-AI]); recommendation of HA dispensing services; self-efficacy for HA handling (Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [MARS-HA]); readiness to act on hearing loss (University of Rhode Island Change Assessment adapted for hearing loss [URICA-HL]); and hearing disability (Amsterdam Inventory for Auditory Disability and Handicap [AIADH]).Results: Linear mixed model analyses (intention to treat) showed no significant differences between the SUPR and control group in the course of communication strategy use (CPHI). Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04). Also, SUPR recipients showed significantly greater HA satisfaction than controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.09 to 0.5; P=.006), which was sustained at 12 months, and significantly greater HA use than the controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.02 to 0.5; P=.03), which was not sustained at 12 months.Conclusions: This study provides ground to recommend adding SUPR to standard HA dispensing care, as long-term, modest improvements in HA outcomes were observed. Further research is needed to evaluate what adjustments to SUPR are needed to establish long-term effectiveness on outcomes in the psychosocial domain.Trial Registration: ISRCTN77340339; http://www.isrctn.com/ISRCTN77340339.International Registered Report Identifier (irrid): RR2-10.1136/bmjopen-2016-015012. [ABSTRACT FROM AUTHOR]

Background: Wearable technology interventions combined with digital behavior change resources provide opportunities to increase physical activity in adolescents. The implementation of such interventions in real-world settings is unknown. The Raising Awareness of Physical Activity (RAW-PA) study was a 12-week cluster randomized controlled trial targeting inactive adolescents attending schools in socioeconomically disadvantaged areas of Melbourne, Australia. The aim was to increase moderate- to vigorous-intensity physical activity using (1) a wrist-worn Fitbit Flex and app, (2) weekly challenges, (3) digital behavior change resources, and (4) email or text message alerts.Objective: This paper presents adolescents' and teachers' perceptions of RAW-PA in relation to program acceptability, feasibility and perceived impact, adolescent engagement and adherence, and the potential for future scale-up.Methods: A mixed methods evaluation of the RAW-PA study assessed acceptability, engagement, feasibility, adherence, and perceived impact. A total of 9 intervention schools and 144 intervention adolescents were recruited. Only adolescents and teachers (n=17) in the intervention group were included in the analysis. Adolescents completed web-based surveys at baseline and surveys and focus groups postintervention. Teachers participated in interviews postintervention. Facebook data tracked engagement with web-based resources. Descriptive statistics were reported by sex. Qualitative data were analyzed thematically.Results: Survey data were collected from 142 adolescents at baseline (mean age 13.7 years, SD 0.4 years; 51% males) and 132 adolescents postintervention. A total of 15 focus groups (n=124) and 9 interviews (n=17) were conducted. RAW-PA had good acceptability among adolescents and teachers. Adolescents perceived the intervention content as easy to understand (100/120, 83.3%) and the Fitbit easy to use (112/120; 93.3%). Half of the adolescents perceived the text messages to be useful (61/120; 50.8%), whereas 47.5% (57/120) liked the weekly challenges and 38.3% (46/120) liked the Facebook videos. Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention. Adolescents perceived the Fitbit Flex to increase their physical activity motivation (85/120, 70.8%) and awareness (93/119, 78.2%). The web-based delivery facilitated implementation of the intervention, although school-level policies restricting phone use were perceived as potential inhibitors to program roll-out.Conclusions: RAW-PA showed good acceptability among adolescents attending schools in socioeconomically disadvantaged areas and their teachers. Low levels of teacher burden enhanced their perceptions concerning the feasibility of intervention delivery. Although adolescents perceived that RAW-PA had short-term positive effects on their motivation to be physically active, adolescent adherence and engagement were low. Future research exploring the feasibility of different strategies to engage adolescents with wearable technology interventions and ways of maximizing system-level embeddedness of interventions in practice would greatly advance the field. [ABSTRACT FROM AUTHOR]