Cluster-randomized Trial Research Articles

Credentialed pharmacist-led home medicines reviews targeting treatable traits and their impact on health outcomes in people with chronic obstructive pulmonary disease: a pre- and post-intervention study.

Patients with chronic obstructive pulmonary disease (COPD) should engage in self-management strategies targeting behavioural traits and lifestyle risk-factors for optimal outcomes. To evaluate the impact of credentialed pharmacist-led home medicines review (HMR) targeting treatable traits (TTs) on health outcomes in COPD in primary care. A pre- and post-intervention study was nested within a cluster-randomised controlled trial. A total of 81 participants with COPD from 21 Australian general practices received an HMR with a credentialed pharmacist targeting TTs. Changes in health outcomes at 6 and 12months from baseline were assessed. Ten TTs were assessed and targeted during the HMR. At baseline, no-one had a written action plan for managing exacerbations, and medication adherence was sub-optimal in 85% of patients. Additionally, 53% of participants demonstrated inadequate inhaler device technique, while 52% were current smokers. At 6-months follow-up, significant improvements were observed in health-related quality of life (St. George's Respiratory Questionnaire score = 34.6 versus 39.1 at baseline, p = 0.006), health status (COPD Assessment Test score = 12 versus 16, p = 0.002), anxiety (Hospital Anxiety and Depression Scale (HADS)-Anxiety score = 2.0 versus 5.0, p < 0.001), depression (HADS-Depression score = 1.0 versus 5.0, p < 0.001), self-reported smoking (47% versus 51.9%, p = 0.031) and treatment adherence (Tool for Adherence Behaviour Screening score = 12.5 versus 10.0, p = 0.002). At 12-months: health status, anxiety, depression, smoking abstinence and adherence to treatment, continued to show statistically significant improvements compared to baseline measurements. HMRs targeting TTs improved health outcomes in people with COPD. Credentialed pharmacists in primary care can work alongside general practitioners to optimise COPD management.

Estimated lifetime impact of a school-based intervention for mental health: A microsimulation study

Abstract Background The prevalence of childhood mental health problems is increasing. School-based interventions have the potential to reduce poor mental health and mental health inequalities. Our aim was to estimate the long-term costs and benefits of the Incredible Years Teacher® Classroom Management (IY-TCM) intervention in primary schools compared to no intervention. Methods LifeSim, an existing microsimulation model, was used to estimate the lifetime costs and benefits of IY-TCM by linking short-term changes in SDQ based on a previous trial in primary schools (Cluster RCT: 2075 children aged 4-9 years with a 30-month follow-up) to long-term health, social, economic and wellbeing outcomes. Benefits were measured in quality adjusted life years and wellbeing adjusted life years. We examined subgroup based on deprivation, conduct scores and parental depression. Results Microsimulation modelling estimated small gains in lifetime outcomes including reduced conduct disorder in adolescence and depression in adulthood. Estimates indicate IY-TCM could be cost-effective with a large amount of uncertainty (Net monetary benefit (NMB)=£21, Estimated CI = -£195, £240). IY-TCM was estimated to be more cost-effective for those with high deprivation (NMB = £231, Estimation CI - -£99, £231) and high conduct problem scores (NMB=£315, Estimated CI = £45, £483). Total net social benefit for a typical year size group was estimated to be £111m. Conclusions IY-TCM could be cost-effective compared to no intervention with a large estimated social benefit supporting wider implementation of IY-TCM, but results indicate a large amount of uncertainty. Greater benefits and higher certainty of cost-effectiveness for children with conduct problems and those living in a deprived area suggest IY-TCM has the potential to reduce mental health inequalities and may be more cost-effective for schools with higher deprivation and/or a high prevalence of conduct problems. Key messages • The Incredible Years Teacher Classroom Management intervention for mental health in primary schools could be considered cost-effective but there is a large amount of uncertainty. • Greater benefits for children with conduct problems and those living in a deprived area indicates the intervention has the potential to reduce mental health inequalities.

Representativeness of disadvantaged pupils in a trial to improve beverage consumption in Belgium

Abstract Background The cluster-randomized controlled trial DRINK was implemented in 2021 to evaluate the effect of interventions aimed at reducing sweetened beverages and increasing tap water consumption among children in French-speaking primary schools in Belgium. Multiple participation issues related to the implementation in the school setting were encountered. Our aim was to describe the individual characteristics of pupils at baseline and their participation in the data collection. Methods In 2021, out of a sample of 168 schools stratified by region and socioeconomic index (SEI), 46 were included. Children in grades 3 to 5 were asked to complete a 4-day diary to record all beverages consumed. Questionnaires were completed by children and parents, from which individual characteristics were summarised, such as the Family Affluence Scale (FAS; in three groups). Results School participation (overall: 29.0%) was higher in Wallonia (33.0%) than in Brussels (22.0%), and in schools with an intermediate SEI (33.0%). At baseline, a total of 3,631 children participated in the data collection, either through the 4-day diary, the child questionnaire, or the parent questionnaire; 2,013 completed all three instruments. Participating children were more likely to be girls, to have an intermediate FAS, to be born in Belgium, and to have two working parents. The proportion of children attending schools in the Brussels region was 27.9% of the total participating children and dropped to 11.5% for those who returned three valid questionnaires. The proportions of low FAS (14.4% to 11.8%), birth outside Belgium (11.8% to 8.7%), and low parents’ schooling (35.3% to 33.8%) were lower among children who completed the three instruments. Conclusions The low participation of Brussels schools, possibly exacerbated by the Covid-19 impact, may explain why disadvantaged children were less represented in the baseline sample. Such knowledge is valuable for interpreting the findings of such a trial. Key messages • Participation issues may have affected the representativeness of less advantaged children. • Documenting such disparities is key to understanding the context in which interventions were implemented.

The impact of a block-based visual programming curriculum: Untangling coding skills and computational thinking

Backgroundand Context: Computer programming is increasingly being taught to young children worldwide. Quality programming curricula are needed to enable students to explore computer science concepts and develop a positive attitude towards programming. However, few studies have been conducted on the available curricula for young learners. ObjectiveThis study aims to provide an evidence-based, public, and free computer science curriculum for early childhood education by investigating the efficacy of the CAL-ScratchJr curriculum, among second graders. MethodA cluster-randomized controlled trial involving 11 schools and 21 second-grade classrooms was conducted to examine the impact of the 24-lesson curriculum on students’ coding proficiency and computational thinking. FindingsThe results indicated that the CAL-ScratchJr curriculum intervention had a medium positive effect on second graders’ coding skills, but no significant impact on computational thinking. ImplicationsResults caution against incorporating disconnected abstract computational thinking practices in education. The features of the curriculum were discussed.

Sex-specific clinical outcomes and healthcare resource utilization in the 5 years following hospitalization for heart failure

Abstract Background Heart failure (HF) a leading cause of hospitalization, and sex differences in care have been described. Purpose We assessed sex-specific clinical outcomes and healthcare resource utilization following hospitalization for HF. Methods This was an exploratory analysis of patients hospitalized for HF across 10 Canadian hospitals enrolled in the Patient-Centred Care Transitions in HF pragmatic cluster-randomized trial. Primary outcome was all-cause mortality. Secondary outcomes included all-cause readmissions, HF readmissions, emergency department (ED) visits, and healthcare resource utilization. Outcomes were obtained via linkages with administrative datasets. Results The 4441 patients (50.7% female) had high event rates. At 5 years of follow-up, 63.6% male and 65.5% of male and female patients, respectively, had died (p=0.19); 85.4% and 84.4% of male and female patients, respectively, were readmitted with no sex differences in mean [SD] all-cause readmissions (males, 2.8 [7.8] and females, 3.0 [8.4], p=0.54) or HF readmissions (males, 0.9 [3.6] and females, 0.9 [4.5], p=0.80) per person. The mean (SD) annual total healthcare costs per patient was $80334 (116762) for males and $81010 (112625) for females, with no sex difference (p=0.90); however, there were sex differences in cost breakdown: males incurred greater costs from specialist, hemodialysis, and day surgical care, and females incurred greater costs from home visits and long-term care. Conclusions Males and females were at similarly high risk of mortality and readmissions, and had similar total healthcare costs following hospitalized for HF. Notwithstanding similar risks, males received relatively more specialist and invasive care, and females received relatively more supportive care.

Shared Medication PLanning In Home Hospice to Address Medication Regimen Complexity and Family Caregiver Burden: A Brief Report.

Objective: Medication management in home hospice is challenging for family caregivers (FCGs). We tested a patient-centered medication review and FCG support program delivered by hospice staff called "Shared Medication PLanning In (SiMPLIfy) Home Hospice." Methods: A pilot cluster-randomized trial at two U.S. home hospice agencies measured the primary outcome of reduction in Medication Regimen Complexity Index (MRCI) (range 0 [no medications]-no upper limit) and secondary outcome of Family Caregiver Medication Administration Hassle Scale (FCMAHS) (range 0 [no hassle-120 [greatest hassle]). Results: Twenty-two patient-FCG dyads enrolled. Mean baseline MRCI in the intervention group = 39 (95% CI: 30.9, 47.1) and control group = 25.5 (95% CI: 21.0-30.1). Half of intervention patients (3 of 6) had reduced MRCI compared with 26.7% (4 of 15) control patients (p = 0.07). MRCI was not significantly associated with caregiver burden. FCMAHS differed between spousal and nonspousal FCGs (p = 0.12). Conclusion: A clinician-FCG-patient communication program in home hospice is feasible and may reduce medication complexity. SiMPLIfy has the potential to reduce polypharmacy.

The role of health literacy in adherence to the Mediterranean diet

Abstract Background Health literacy has emerged as a crucial concept in public health. It is considered a modifiable determinant influencing health-related decision. One such decision is the adoption of specific dietary patterns. The Mediterranean diet has garnered recognition as one of the healthiest diets. This study aims to explore the association between health literacy levels among adults in socially vulnerable contexts and their adherence to the Mediterranean diet. Methods This study is part of a cluster-randomized trial conducted in primary schools from socially vulnerable contexts. A total of 469 parents of school-aged children agreed to participate. Health literacy was assessed using the Health Literacy Survey Questionnaire. Adherence to the Mediterranean diet was evaluated using the MEDAS questionnaire. Anthropometric and sociodemographic variables were self-reported via questionnaire. Parental BMI was calculated using weight/height^2. Education level was categorized into two groups (less than higher education and higher education), while professional status was classified based on the occupational categories of collar color. Generalized linear models were utilized for the analysis. Results Individuals with higher levels of health literacy present a greater odd to adhere to the Mediterranean diet (B = 0.022, 95% CI 0.010-0.035), even after adjusting for potential confounders (B = 0.019, 95% CI 0.006-0.032). Conclusions Health literacy emerges as a crucial factor influencing individuals’ dietary choices, as evidenced by its association with higher adherence to the Mediterranean diet. These findings underscore the importance of implementing policies and initiatives aimed at promoting health literacy, particularly among individuals from socially vulnerable contexts. Enhancing public health interventions to bolster health literacy should be prioritized to foster better dietary decision-making. Key messages • Health literacy plays an important role in the adoption of Mediterranean diet among adults from socially vulnerable contexts. • Implementing policies to aim the promotion of health literacy, particularly among individuals from socially vulnerable contexts are necessary.

Does mindfulness program reduce stress and enhance self-kindness in schools? Healthy Learning Mind

Abstract Introduction There is a scarcity of research with high quality methods on the effectiveness of mindfulness-based interventions (MBIs) on adolescents’ mental well-being. This study investigates the MBI effects on adolescents’ stress and self-kindness with an extensive cluster RCT design, and a role of self-kindness as a mediator for the association between the MBI and stress. Additionally, the study explores how age, gender, and an independent mindfulness practice moderate the effects on the outcomes. Methods Participants (Finnish students, aged 12-15 years) were randomized to a MBI group (N = 1646), an active relaxation control group (N = 1488), and an inactive control group (N = 385). The outcomes were measured at the baseline (T0), at 9-week post-intervention (T9), and at 26-weeks follow-up (T26). Results Overall, the MBI was more effective in stress reduction when compared to the active control at T9 (β = -0.04, p &amp;lt; 0.01, d = -0.11) and T26 (β = -0.04, p = 0.02, d = -0.11). Furthermore, students in the MBI group who carried out their regular mindfulness home practice showed greater decrease of stress. There were no MBI effects on self-kindness, nor did a change of self-kindness mediate the effects of MBI on stress. Discussion These findings demonstrate that the 9-week MBI is slightly more effective to reduce stress relative to relaxation training. Key messages • The result highlight the potential of MBI in increasing the stress management among students in school context. • To ensure the effectiveness of MBIs in school context we need to teach these skills to teacher students already during their basic education in educational institutions and universities.

Effectiveness of the GRACE risk score according to troponin elevation in patients admitted with non-ST elevation acute coronary syndrome: a post-hoc analysis of the UKGRIS cluster RCT

Abstract Background In the United Kingdom GRACE Risk Score (UKGRIS) phase 3 parallel group cluster randomised controlled trial, the Global Registry of Acute Coronary Events (GRACE) risk score (GRS) did not improve adherence to guideline recommended management or reduce cardiovascular events at 12 months in patients admitted with suspected non ST elevation acute coronary syndrome (NSTEACS) compared with standard care.(1) Troponin elevation in the context of NSTEACS is associated with high risk of adverse clinical events, including myocardial infarction, heart failure and death,(2) and in this population the GRS may impact on outcomes. Purpose To investigate the effectiveness of the GRS compared with standard care according to troponin elevation in patients admitted with NSTEACS. Methods Post-hoc analysis of primary and secondary outcome measures according to troponin elevation on admission of the UKGRIS trial across 42 sites in England. Patients aged ≥18 years admitted with suspected NSTEACS and a minimum follow-up of 24 months were eligible. Primary outcome measures were use of guideline recommended management and time to the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospital admission, and readmission for cardiovascular event. Secondary measures included the duration of hospital stay, EQ-5D-5L (five domain, five level version of the EuroQoL index), and the composite endpoint components. Results A total of 3050 patients were randomised in UKGRIS, of whom 2602 had troponin elevation. The effect of GRS compared with standard care on the uptake of guideline recommended care was greater for participants with troponin elevation (odds ratio 1.34, 95% CI 0.84 to 2.13) compared to those without (0.88, 0.52 to 1.47) (Table 1). There was an interaction between troponin elevation and effect of GRS versus standard care on guideline uptake (relative odds ratio 1.52, 95% CI 1.16 to 2.00, P &amp;lt; 0.01). The time to the first composite event was not improved by the GRS among participants with (hazard ratio 0.86, 95% CI 0.67 to 1.12) or without troponin elevation (1.19, 0.80 to 1.77) (Figure 1), with no interaction (relative hazards ratio 0.73, 95% CI 0.51 to 1.03, P = 0.07), and none of the individual components of the composite outcome had a significant interaction between randomisation to GRACE and troponin elevation. Baseline adjusted EQ-5D-5L utility at 12 months and duration of hospital stay at 24 months were not statistically significantly different for the two trial arms among participants with or without troponin elevation. Conclusions For suspected NSTEACS, the effect of the GRS compared with standard care on uptake of recommended processes was greater in those with elevated troponin than in those without. However, this did not translate to a reduction in the composite primary outcomes or secondary outcomes at 24 months.

Development and validation of a measure for father involvement during early childhood in a resource-limited context

BackgroundGlobally, there is mounting evidence about the importance of father involvement for improving child and family wellbeing. However, there are limited measurement tools available for assessing father involvement in low-resource settings globally. The objective of this study was to develop and validate a scale for measuring fathers’ engagement in caregiving activities for young children and families in rural Kenya.MethodsWe used baseline data collected in February–March 2023 from a cluster-randomized controlled trial of a parenting intervention aimed at improving early child development in Nyamira and Vihiga counties in Western Kenya. The analytic sample comprised 460 primary caregivers of children under 18 months of age (91.3% mothers) who were in a relationship with a male caregiver of the young child (i.e., father). The primary caregiver reported on the 25-item father involvement scale. We conducted exploratory and confirmatory factor analyses to determine the dimensionality of the measure and estimated latent variable regression models to assess construct and predictive validity in terms of associations with sociodemographic factors, other paternal and maternal psychosocial measures, and early child development outcomes.ResultsThe scale had a four-factor structure representing father involvement in (1) childcare activities, (2) play and affection, (3) household chores, and (4) early learning activities. Each factor showed good internal consistency reliability and evidence of multiple forms of validity. The four factors were associated with child and household sociodemographic characteristics and more positive paternal and maternal psychosocial outcomes. Father involvement across all four domains was associated with higher early child cognitive, language, motor, and socioemotional development scores.ConclusionsOur findings highlight the multidimensional nature of fathers’ caregiving roles in the lives of young children and their families. We establish a valid tool for assessing father involvement in rural Western Kenya that has potential for use in other similar contexts.

Protocol for a cluster randomised controlled trial to evaluate effectiveness of a self-help group intervention to encourage smoke-free homes in slums of Kochi(Kochi Intervention for tobacco smoke free homes-KIFT)

Background Exposure to second hand smoke (SHS) is a cause for heart disease and lung cancer among non- smokers. This cluster randomized control trial will evaluate the effectiveness of a tobacco smoke free home intervention in reducing exposure to second hand smoke. Protocol The intervention will be conducted among 30 clusters in urban and peri-urban areas of Kochi, India. The sample size is 300 per arm and 15 clusters to detect a minimal difference of 0.03ng/ml in cotinine levels between groups, at 80% power with a two-sided alfa of 0.05 considering variable cluster size. A baseline survey will be undertaken to identify smokers. Data related to smoking, indoor smoking, nicotine dependence, blood pressure (BP) of smokers, morbidity experienced, and lung volume Fev1/Fev6 of smokers will be measured. Urine cotinine, morbidity, BP of spouse and child will be assessed. Air quality monitors measuring PM2.5 will be placed in homes. Trained self-help group women and frontline health workers will implement the intervention. The intervention will consist of monthly home visits to educate the smoker on the harms of second-hand smoke using 3 A’s. The circle of influencers around the smoking men will also be contacted by the members of self-help group to provide support to stop smoking within homes and to quit. They will then organize two-three meetings of community leaders and heads of women’s groups, present data on harms of SHS, and explain the rationale for establishing smoke free homes in their community for a duration of six months. After the intervention a post assessment will be conducted and this will be repeated after six months. Ethics and dissemination The trial protocol was approved by the Institutional Ethical Committee of Amrita Institute of Medical Sciences. Results will be submitted to open access peer reviewed journals and shared with other stakeholders. Trial registration CTRI/2021/06/034478

Effectiveness of a resilience school-based intervention in adolescents at risk: a cluster-randomized controlled trial

IntroductionSchool offers a key context to promote resilience. The aim of this study was to assess the effectiveness of a school-based resilience intervention in 578 at-risk adolescents aged 12 to 15, emphasizing the significance of resilience improving mental health.MethodsA cluster-randomized controlled trial with parallel arms was conducted during the 2021/22 academic course. A specific training of six 55-minute sessions over 6 weeks was carried out for the students. Each session consisted of 5 minutes of mindfulness, followed by 45 minutes of the corresponding activity: introduction to resilience, self-esteem, emotional regulation strategies, social skills, problem solving, community resources, and peer support. Primary outcomes were assessed by the Child Youth Resilience Measure-32 at baseline (T1), post-intervention (T2), and then at the 24-week follow-up (T3). Both groups were compared using the Student’s t-test. The effect size was calculated using Cohen’s d and linear regression models were used.ResultsA total of 578 adolescents were included, 323 in the control group and 255 in the intervention group. Significant differences in both crude and adjusted analyses for Child Youth Resilience Measure were observed at 24 weeks follow-up, showing higher resilience for the intervention group [IG, M = 128.7, SD = 14.2; CG, M = 125.3, SD = 18.4; p = 0.027; d = 0.2; p = 0.043, d = 0.16]. Furthermore, in Depressive symptoms, lower values were found for the intervention group in both crude and adjusted analyses [IG, M = 2.3 (SD = 2.5); CG, M = 2.8 (SD = 2.5); p = 0.04; d = −0.20; p = 0.037, d = −0.18].DiscussionThis study contributes to fostering resilience and positive adolescent development. It also reinforces the potential of multicomponent interventions. More continuous follow-up assessments are needed to identify possible long-term changes in resilience.Clinical Trial RegistrationIdentifier: NCT05133115. https://clinicaltrials.gov/study/NCT05133115.

Safety of single-dose bedaquiline combined with rifampicin for leprosy post-exposure prophylaxis: A Phase 2 randomized non-inferiority trial in the Comoros Islands.

To reduce leprosy risk in contacts of patients with leprosy by around 50%, the World Health Organization (WHO) recommends leprosy post-exposure prophylaxis (PEP) using single-dose rifampicin (SDR). Results from a cluster randomized trial in the Comoros and Madagascar suggest that PEP with a double dose of rifampicin led to a similar reduction in incident leprosy, prompting the need for stronger PEP. The objective of this Phase 2 trial was to assess safety of a bedaquiline-enhanced PEP regimen (intervention arm, bedaquiline 800 mg with rifampicin 600 mg, BE-PEP), relative to the WHO recommended PEP with rifampicin 600 mg alone (control arm, SDR-PEP). From July 2022 to January 2023, consenting participants were screened for eligibility, including a heart rate-corrected QT interval (QTc) <450 ms and liver enzyme tests (ALT/AST) below 3× the upper limit of normal (ULN), before they were individually randomized 1:1 in an open-label design. Recruitment was sequential, by age group. Pediatric dosages were weight adjusted. Follow-up was done at day 1 post-dose (including ECG) and day 14 (including ALT/AST), with repeat of ALT/AST on the last follow-up at day 30 in case of elevation on day 14. The primary outcome was non-inferiority of BE-PEP based on a <10 ms difference in QTc 24 h after treatment administration, both unadjusted and adjusted for baseline QTc. Of 408 screened participants, 313 were enrolled, starting with 187 adults, then 38 children aged 13 to 17 years, and finally 88 children aged 5 to 12 years, of whom 310 (99%) completed all visits. Across all ages, the mean QTc change on BE-PEP was from 393 ms to 396 ms, not significantly different from the change from 392 ms to 394 ms on SDR-PEP (difference between arms 1.8 ms, 95% CI -1.8, 5.3, p = 0.41). No individual's QTc increased by >50 ms or exceeded 450 ms after PEP administration. Per protocol, all children were analyzed together, with no significant difference in mean QTc increase for BE-PEP compared to SDR-PEP, although non-inferiority of BE-PEP in children was not demonstrated in unadjusted analysis, as the upper limit of the 95% CI of 10.4 ms exceeded the predefined margin of 10 ms. Adjusting for baseline QTc, the regression coefficient and 95% CI (3.3; -1.4, 8.0) met the 10 ms non-inferiority margin. No significant differences in ALT or AST levels were noted between the intervention and control arms, although a limitation of the study was false elevation of ALT/AST during adult recruitment due to a technical error. In both study arms, one serious adverse event was reported, both considered unlikely related to the study drugs. Dizziness, nausea, headache, and diarrhea among adults, and headaches in children, were nonsignificantly more frequently observed in the BE-PEP group. In this study, we observed that safety of single-dose bedaquiline 800 mg in combination with rifampicin is comparable to rifampicin alone, although non-inferiority of QTc changes was demonstrated in children only after adjusting for the baseline QTc measurements. A Phase 3 cluster randomized efficacy trial is currently ongoing in the Comoros. ClinicalTrials.gov NCT05406479.

Community Health Workers Linking Clinics and Schools and Asthma Control

Childhood asthma is characterized by pervasive disparities, including 3-fold higher hospitalization rates and 7-fold higher death rates for Black children compared with White children. To address asthma disparities, one must intervene in all lived environments. To determine if a community health worker (CHW) intervention to connect the primary care, home, and school for low-income minoritized school-aged children with asthma and their caregivers improves asthma control. This study was a hybrid effectiveness/implementation trial using a 2 × 2 factorial, cluster randomized clinical trial design of 36 schools crossed with participant-level randomization into a clinic-based CHW intervention. The study was conducted from May 2018 to June 2022. The intervention took place in primary care offices, homes, and 36 West Philadelphia, Pennsylvania, public and charter schools. Children aged 5 to 13 years with uncontrolled asthma were recruited from local primary care practices. Asthma management, trigger remediation, and care coordination occurred in school, home, and primary care settings. Children were followed up for 12 months. The Yes We Can Children's Asthma Program, Open Airways For Schools Plus, and school-based asthma therapy were implemented. Improvement in asthma control, as measured by the Asthma Control Questionnaire, comparing the mean difference between groups 1 year after randomization with their baseline (difference in differences). Both primary care and school interventions were dramatically disrupted by the COVID-19 pandemic; therefore, stratified analyses were performed to assess per-protocol intervention efficacy before the pandemic disruptions. A total of 1875 participants were approached, 1248 were excluded, and 1 was withdrawn. The 626 analyzed study participants (mean [SD] age, 8.7 [2.4] years; 363 male [58%]) self-identified as Black race (96%) and non-Hispanic ethnicity (98%). Although all groups had statistically significant improvements in asthma control from baseline to 12 months (P- group: -0.46; 95% CI, -0.58 to -0.33; P+ group: -0.57; 95% CI, -0.74 to -0.44; S- group: -0.47; 95% CI, -0.58 to -0.35; S+ group: -0.59; 95% CI, -0.74 to -0.44), none of the difference-in-differences estimates from the primary prespecified models showed a clinically meaningful improvement in asthma control. Analysis from the prepandemic interval, however, demonstrated that children in the combined clinic-school intervention had a statistically significant improvement in asthma control scores compared with control (-0.79; 95% CI, -1.40 to -0.18). This randomized clinical trial provides preliminary evidence that connecting all lived environments for care of children can be accomplished through linkages with CHWs.

FORTA Score and Negative Outcomes in Older Adults: Insights from Italian Internal Medicine Wards.

The study aimed to assess the relationship between the Fit fOR The Aged (FORTA) score-a classification system designed to evaluate medication appropriateness in older adults-and several negative outcomes, including impaired cognitive performance, functional status, adverse clinical events, and all-cause mortality at 3, 6, and 12 months after hospital discharge. This retrospective study utilized data from the ELICADHE cohort, a cluster-randomized trial conducted across 20 Italian internal medicine and geriatric wards. The study included patients aged 75 and older with complete FORTA score assessments. Demographics, medication history, and comorbidities were collected. The FORTA classification system assessed medication appropriateness. FORTA scores were calculated and FORTA score cut-offs (3 and 5) were applied. Statistical analyses included descriptive statistics, survival analysis with Cox regression, logistic regression, and negative-binomial regression using SAS 9.4 and RStudio 12.1. Ethical approval was obtained. Of the 506 patients included, 171 (33.8%) were fully assessable with complete FORTA scores. The study found no significant association between higher FORTA scores and impaired cognitive performance, functional status, or mortality. Additionally, no clear relationship was observed between FORTA scores and adverse clinical events or mortality. The analysis indicated that age was a significant factor associated with mortality and adverse clinical events. The study did not find a significant relationship between the FORTA score and negative outcomes in older patients discharged from internal medicine and geriatric wards. Further research is needed to define specific FORTA score cut-off values and expand the criteria to improve medication assessment in this population.

Interventions for Preventing Tobacco Uptake among Adolescents within School Setting in South-East Asia region: A Systematic Review

Abstract Background Tobacco users disproportionately reside in lower-and-middle income countries, with many people beginning consumption of tobacco in adolescence. Countries employ interventions in schools as a means of providing health education thereby creating mass awareness among them. However, research has mostly restricted to developed nations. Objective To examine the impact of interventions implemented in preventing tobacco uptake among adolescents in school setting in South-East Asia region. Method The protocol was registered prospectively on PROSPERO (CRD42022337341). Systematic search was conducted on 6 databases: PubMed, Embase, Scopus, CINAHL, ProQuest and Web of Science. Randomized Control Trials (RCT) and Cluster RCT conducted in school set-up in South-East Asia among adolescents below 18 years’ age were included. Articles between timeline 2002–2022 were considered. Results From a total of 963 articles, total of 13 studies were included. Four were RCT, while nine were Cluster RCT. Most of the studies were targeted at change in prevalence, followed change in knowledge and attitude towards tobacco and impact on susceptibility to use tobacco. Nine studies had interventions based on Health Promoting School Framework, three were Peer-led Interventions and one was Counsellor-centred Intervention. Risk of Bias assessment revealed eight studies had low risk of bias, two had some concerns while three were high risk studies. Conclusion Interventions that focus on building a holistic environment and go beyond the usual classroom environment have primarily been implemented and found to be effective in this region. There is a need for strong, high-quality RCT studies with standardised evaluation techniques to combat tobacco use among adolescents.

Exploring Implementation Processes of a Multicomponent Family Support Intervention in Intensive Care Units (FICUS) Study: A Mixed-Methods Process Evaluation.

To investigate the experience with and progress of the implementation of a Family Support Intervention (FSI) into adult intensive care units (ICUs) as part of the cluster-randomised FICUS trial. A mixed-methods process evaluation using a multiple case study approach guided by the normalisation process theory. This study took place between June 2022 and July 2023 in eight Swiss ICUs randomised to the intervention arm. A tailored implementation strategy was used to introduce the multicomponent FSI, consisting of a new family nursing role and a family care pathway, into interprofessional ICU teams. Participants were 40 ICU key clinical partners. Qualitative data were collected twice, early (3-6 months) and mid-implementation (9-12 months), using small group interviews. A questionnaire with psychometric measures (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Intervention Appropriateness Measure, Normalisation Measure Development Questionnaire) was administered at mid-implementation. RITA pragmatic rapid thematic analysis and descriptive statistics were used to analyse the data. Qualitative and quantitative results were then compared across ICUs (cases). Findings indicated the desired progress of the FSI integration overall and across cases, with high acceptability and appropriateness ratings but only moderate to high feasibility scores. Study-related barriers were noted in all ICUs (i.e., FSI delivery as part of a clinical trial). Implementation barriers included family nurses' limited capacity and clinician's attitudes towards the FSI. Leadership support and interprofessional collaboration were identified as facilitators. Case-based, integrated findings yielded two implementation pathways, namely early and protracted adopters. Implementation barriers were related to the feasibility of FSI delivery within the study context that required a high degree of standardisation and protocol adherence. Implementation progress was shaped by an interprofessional culture of family care, sufficient staff and time resources, and leadership support. The study's findings will inform future implementation of complex health interventions in ICUs. Good reporting of a Mixed-Methods Study (GRAMMS). Within the FICUS trial, a patient and family advisory board with a patient expert, three family members and a patient with own lived experience of critical care collaborate with the research team.

Implementation of a tailored multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for urinary tract infections in frail older adults (ImpresU) in four European countries: a process evaluation alongside a pragmatic cluster randomized controlled trial

BackgroundWe previously performed a pragmatic cluster randomized controlled trial (RCT) in general practices and older adult care organizations in Poland, the Netherlands, Norway, and Sweden. We found that a multifaceted antibiotic stewardship intervention (ASI) substantially reduced antibiotic use for suspected urinary tract infections (UTIs) in frail older adults compared with usual care. We aimed to evaluate the implementation process of the ASI to provide recommendations for clinical practice.MethodsWe conducted a process evaluation alongside the cluster RCT. The ASI consisted of a decision-tool and a toolbox, which were implemented using a participatory-action-research (PAR) approach with sessions for education and evaluation. We documented the implementation process of the intervention and administered a questionnaire to health care professionals (HCPs) from participating organizations in the intervention and usual care clusters. We evaluated the multiple components of the intervention and its implementation following a structured framework.ResultsThe questionnaire was completed by 254 HCPs from the 38 participating clusters. All components were largely delivered according to plan and evaluated as useful. The decision-tool and toolbox materials were reported to facilitate decision-making on UTIs. Regarding the PAR approach, educational sessions focusing on the distinction between UTIs and asymptomatic bacteriuria were held in all 19 intervention clusters. In 17 out of these 19 clusters, evaluation sessions took place, which were reported to help remind HCPs to implement the ASI. During both sessions, HCPs valued the reflection that took place and the resulting awareness of their behavior. It allowed them to explore implementation barriers and to tailor their local implementation process to overcome these. For example, HCPs organized extra educational sessions or revised local policies to incorporate the use of the decision-tool. Various HCPs took key roles in implementation. Staff changes and the COVID-19 pandemic were important contextual barriers.ConclusionsWe found each component of the multifaceted ASI and its implementation to have added value in the process to improve antibiotic prescribing for suspected UTIs in a heterogeneous older adult care setting. We recommend using a multifaceted, multidisciplinary approach that enables HCPs to reflect on their current practice and accordingly tailor local implementation.Trial registrationClinicalTrials.gov NCT03970356. Registered on May 31, 2019.

Waist circumference as a parameter in school-based interventions to prevent overweight and obesity - a systematic review and meta-analysis

BackgroundPreventing childhood obesity remains an important public health issue worldwide. Since visceral fat in particular is understood as an important risk factor for many chronic diseases, waist circumference is recommended as a measurement parameter for global obesity surveillance. This systematic review and meta-analysis focused on waist circumference as an outcome parameter for studies of school-based interventions to prevent overweight and obesity.MethodsA systematic literature search was conducted at the end of 2019 in nine data bases, including Medline and Embase, in order to identify relevant studies evaluating interventions in schools aimed at preventing obesity. Eligibility criteria admitted randomised and non-randomised controlled trials. After screening titles, abstracts and full texts, the data of the identified studies were systematically extracted. Risk of bias was assessed according to study type with the appropriate Cochrane Risk of Bias Tool. The review gives a qualitative overview over all included studies structured by extracted data. Separate meta-analyses were done for the outcome mean difference in change in waist circumference, measured in cm or reported as z-score value, using an inverse variance random-effects model due to study design.ResultsA total of 2421 publications were screened based on titles, abstracts and full texts. Complemented by results of a former systematic literature search 44 studies were identified for inclusion, comprising a total of 39.837 participants (age range: 6 to 18 years). Nearly half of the studies were conducted in Europe, two-thirds combined diet and exercise-based interventions. Likewise two thirds of the studies were conducted as cluster-randomised trials. Most of the reported effects favoured the experimental groups, indicating the basic effectiveness of school-based measures. Based on reported data, only one third of the studies could be included in the meta-analyses. For the difference in mean change of the outcome parameter waist circumference measured in cm (95% CI), we found a pooled effect estimate of -0.95 (-1.87; -0.46). For the difference in mean change of the outcome parameter waist circumference reported as z-score value (95% CI), the pooled effect estimate was -0.10 (-0.15; -0.05). Both effect estimates were in favour of the experimental group. The overall effect sizes were small with a p-value < 0.05.ConclusionsPooled effect estimates were small but in favour of the experimental groups. The same applies to the majority of the effects reported in the included studies. The included cluster of randomised controlled trials demonstrated an especially sound methodological standard. The possibility of achieving larger effects in studies of preventive interventions and health promotion is limited. Schools can only realise their full potential in preventing overweight and obesity in children and adolescents if they are accompanied by measures in other areas of the obesogenic environment.

HED-Start: A Brief Positive Psychology Cluster-Randomized Controlled Trial to Improve Psychological Adjustment in Patients New on Hemodialysis.

Initiation onto hemodialysis marks a critical transition with intense psychosocial demands. Interventions using cognitive-behavioral therapy to improve distress have been variably effective but require trained staff and are typically delivered only to those who screen positive for clinically significant distress. Interventions guided by positive psychology are lacking. To investigate the effectiveness of a brief positive-skills RCT in improving psychological adjustment in new hemodialysis patients. Using a parallel (2:1) design, blinded cluster-randomized controlled trial (cRCT) design, incident patients (<6 months at NKF dialysis centers) undergoing hemodialysis were randomized to intervention or usual care (UC). HED-Start intervention comprised four group sessions delivered by healthcare staff on positive emotions, acceptance, and life-orientated goal setting. Measures were taken at baseline (pre-randomization) and at 12 weeks: distress/mood (HADS; SPANE); quality of life (KDQOL-SF, WHOQOL-BREF); benefit-finding (BFS, BIPQ); life-oriented skills (HEIQ, CD-RISC-2); self-efficacy (CD-SES). A total of 147 participants enrolled in the trial (response rate, 51.0%; retention [assessment], 90.5%). Study arms were comparable on all baseline and outcome variables except for age, diabetic nephropathy, and hypertensive nephrosclerosis which were subsequently controlled for. Repeated measures ANCOVAs (intention to treat) were used. HED-Start yielded significant reductions over time in depression, and increased quality of life, self-efficacy, benefit finding, and skills relative to UC (moderate effect sizes). Rates of clinically significant depression significantly decreased in HED-Start (p < .001) and increased in UC (p = .002). The significant positive effects of HED-Start, a low-intensity and cost intervention, on several adjustment indices, suggest that programs focusing on positive life skills can value add to existing renal care services.