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Background: Few mobile health resistance-based physical activity interventions have targeted community-dwelling adults. "Ecofit" is a multicomponent intervention that promotes resistance and aerobic activities using smartphone technology, outdoor gyms, and social support. This study evaluated process evaluation outcomes of the ecofit randomized controlled trial: (1) the acceptability and usability of the ecofit smartphone app and app user workouts; (2) perceptions of factors influencing outdoor gym use; and (3) the fidelity, reach, recruitment, and dose received of the ecofit program. Methods: Process data were collected through program evaluation surveys at 3 months, and app usage data were collected via the intervention platform for up to 3 months. Data were analyzed using descriptive statistics. Results: The survey was completed by 57% (n = 69) of eligible participants. The majority (93%) believed the app provided them with sufficient information to perform muscle-strengthening activities. Approximately half (51%) agreed that the goal-setting function encouraged them to complete their workouts, and 42% agreed that the self-assessment helped them monitor progress. "Proximity" to outdoor gyms emerged as the most important factor for choosing locations to workout (mean = 5.5, SD = 1.1). Participants logged a median of 5.5 (interquartile range = 19) workouts and 1 (interquartile range = 1) upper- and lower-body muscular fitness self-assessment. Conclusions: The ecofit app provided participants with sufficient skills to perform unsupervised resistance training exercises using mobile health. Only half of the participants regarded self-assessments and goal setting as useful, suggesting a need for modifications to how these are implemented. Mobile health remains a promising delivery platform to promote unsupervised resistance training, although more research is needed to improve uptake. [ABSTRACT FROM AUTHOR]

Background: Women Veterans with co-morbid medical and mental health conditions face persistent barriers accessing high-quality health care. Evidence-based quality improvement (EBQI) offers a systematic approach to implementing new care models that can address care gaps for women Veterans. Objective: This study examines factors associated with the successful deployment of EBQI within integrated health systems to improve primary care for women Veterans with complex mental health needs. Design: Following a 12-site (8 EBQI, 4 control) cluster randomized study to evaluate EBQI effectiveness, we conducted an in-depth case study analysis of one women's health clinic that used EBQI to improve integrated primary care–mental health services for women Veterans. Participants: Our study sample included providers, program managers, and clinic staff at a women Veteran's health clinic that, at the time of the study, had one Primary Care and Mental Health Integration team and one women's health primary care provider serving 800 women. We analyzed interviews conducted 12 months, 24 months, and 4 years post-implementation and call summaries between the clinic and support team. Main Measures: We conducted qualitative thematic analysis of interview and call summary data to identify EBQI elements, clinic characteristics, and reported challenges and successes within project development and execution. Key Results: The clinic harnessed core EBQI elements (multi-level stakeholder engagement, data-driven progress-monitoring, PDSA cycles, sharing results) to accomplish pre-defined project goals, strengthen inter-disciplinary partnerships, and bolster team confidence. Clinic characteristics that facilitated implementation success included prior QI experience and an organizational culture responsive to innovation, while lack of pre-existing guidelines and limited access to centralized databases posed implementation challenges. Conclusions: Successful practice transformation emerges through the interaction of evidence-based methods and site-specific characteristics. Examining how clinic characteristics support or impede EBQI adaptation can facilitate efforts to improve care within integrated health systems. [ABSTRACT FROM AUTHOR]

Background: Poverty is a key social determinant of mental health among forcibly displaced persons. This study aimed to design and pilot test a strategy to integrate existing mental health and economic inclusion interventions for displaced families in Ecuador. Methods: We conducted a series of qualitative interviews (n = 30), focus groups (n = 6), and workshops (n = 3) to develop a set of strategies for integrating cross-cutting and focused mental health and psychosocial support (MHPSS) strategies into an existing economic inclusion program for displaced families in Quito. We non-randomly assigned two field offices in Quito to (1) integrate cross-cutting strategies focused on improving economic outcomes or (2) integrate both those cross-cutting strategies plus focused MHPSS strategies into an economic inclusion program. We measured site-level implementation outcomes (adoption, appropriateness, acceptability, feasibility, fidelity, reach, retention, usability) and participant-level psychosocial (wellbeing, depressive symptoms, anxiety symptoms, functioning) and economic inclusion outcomes (financial resources, diet diversity, social capital/networks, self-reliance) over six months. We conducted a mixed-methods analysis to explore the acceptability and feasibility of the integration strategies and the ability to evaluate their effects in a future cluster randomized trial. Results: We developed a toolkit that included 10 strategies for integrating MHPSS into economic inclusion interventions. Fifty displaced persons participating in an existing economic inclusion program (25 per study condition) were enrolled and 88% remained in the study through the six-month follow-up. Participants and implementers reported that the integration strategy was appropriate, acceptable, feasible, and usable. Implementers, including people without prior experience in delivering mental health services, were able to deliver the intervention with high fidelity. Integration of focused MHPSS intervention components into an economic inclusion program appeared to improve MHPSS outcomes, the strength of social capital and networks, and engagement in economic and other programs. Conclusions: This study provides preliminary evidence of the acceptability and feasibility of integrating MHPSS into economic inclusion programs for displaced people. We found evidence supporting evaluation methods that can be employed in a future study to definitively test the added value of integrated approaches to mental health and economic wellbeing for displaced persons. [ABSTRACT FROM AUTHOR]

ABSTRACT The management of hypertension and diabetes poses significant challenges to China's healthcare system, necessitating seamless patient progression through screening, diagnosis, management, and control. Utilizing the care cascade model, this study aims to systematically identify patient drop‐offs and devise strategies to address healthcare delivery bottlenecks for hypertension and diabetes in rural China. This study consists of three phases. In Phase 1, qualitative interviews are conducted to explore healthcare experiences and identify determinants across the care cascade. Phase 2 involves systematically assessing barriers identified in Phase 1 and collaborating with local stakeholders using intervention mapping and co‐design to generate interventions and implementation strategies. Phase 3 is a cluster randomized controlled trial involving 48 villages, randomly assigned in a 1:1 ratio, to compare changes in hypertension and diabetes care. Intervention villages will implement interventions developed in Phase 2 for 1 year, while control villages will continue with usual care. Primary outcomes include between‐group differences in achieving blood pressure and glycemic targets, along with service and implementation outcomes. This study aims to identify the stage with the largest patient retention gap in the care cascade and develop intervention strategies through participatory co‐design with practitioners, emphasizing feasible, low‐cost approaches. The pragmatic cluster RCT will assess strategy effectiveness, offering valuable insights for practical interventions to enhance hypertension and diabetes care in rural settings, potentially shaping impactful programs and improving healthcare outcomes.Trial Registration: ClinicalTrials.gov. identifier: NCT06141278 [ABSTRACT FROM AUTHOR]

Background: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs. Methods: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation. Discussion: Optimizing cardiac rehabilitation centres' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI. Trial registration: ClinicalTrials.gov. Identifier: NCT05889416. Registered 2023-03-23. [ABSTRACT FROM AUTHOR]

Purpose: The MAKASI intervention aimed to empower Sub-Saharan African immigrants living in precarious situations in the Paris metropolitan area. Because there are factors specifically related to immigration that may increase the risk for common mental disorders, the present study aimed to examine participants' levels of depression and loneliness and analyze the effect of the intervention on depression and loneliness. Methods: The MAKASI study was designed as a stepped wedge cluster randomized trial. Study participants were recruited through an outreach program led by a nongovernmental organization and randomly assigned to two clusters, with an intervention delay of 3 months between them. Participants were assessed for 6 months after inclusion and the effect of the intervention on depression and loneliness was assessed using generalized linear mixed models. The study was conducted from 2018 to 2021 and took in consideration whether being interviewed during one of the Covid-19 confinement had an effect on the results. Results: Between 2018 and 2021 a total of 821 subjects participated in the Makasi study. High levels of depression and loneliness were found in the study population. We found no effect of the intervention on depression [95% CI 0.77 to 2.40]. Similarly, no effect of the intervention was found on loneliness [95% CI 0.87 to 2.54]. Conclusions: The intervention tested did not appear to improve the level of depression and loneliness among participants. However, the high prevalence of mental and emotional problems in the study population suggests a public health crisis among immigrants in the greater Paris area. Clinical Trial Registration Number: Trial registration Clinicaltrials.gov, NCT04468724 (July 13, 2020). [ABSTRACT FROM AUTHOR]

Introduction: Unwanted pregnancy constitutes a huge health issue. Long‐acting reversible contraception (LARC) are the most effective methods for preventing unwanted pregnancy, especially among young women. This study evaluates the intervention effect of structured contraceptive counseling on the choice, initiation, and use of LARC in young women. Material and Methods: This is a secondary analysis of women aged 18–25, enrolled in a multicenter cluster randomized controlled trial performed in abortion, youth, and maternal health clinics across the Stockholm County in Sweden. Clinics were randomized (1:1) to provide structured contraceptive counseling (intervention) or standard counseling (control). Surveys were administered at the clinic visit and follow‐ups at 3, 6, and 12 months. Primary outcome focused on the choice of LARC among women 18–25 years of age. Secondary outcomes included initiation, and use of LARC at 3 and 12 months, satisfaction with the counseling received and information on extended use of combined hormonal contraceptives. The study was registered at Clinicaltrials.gov (NCT03269357). Results: From September 2017 to May 2019, 770 women aged 18–25 years from 28 clinics/clusters were recruited. There was a significant intervention effect on LARC choice (aOR 5.96, 95% CI 3.25–10.94), initiation (aOR 4.43, 95% CI 2.32–8.46), and use at 12 months (aOR 2.21, 95% CI 1.31–3.73). The odds of LARC choice at pre‐booked visits were higher and more women received information about extended‐use regimen for short‐acting reversible contraception in the intervention group compared to the control group. The intervention package was well received, but with higher satisfaction at pre‐booked compared to drop‐in visits. Conclusions: Our study demonstrates that comprehensive structured contraceptive counseling significantly increases LARC choice, initiation and use, with high satisfaction among young participants, especially at pre‐booked visits. The results highlight an approach that merits implementation to increase quality of care in contraceptive services, to enhance reproductive health for adolescents and young adults. [ABSTRACT FROM AUTHOR]

The effectiveness of universal, school-based interventions in preventing the emergence, maintenance, or escalation of behavioral difficulties in children and adolescents is supported by a growing body of research. Nevertheless, this understanding is somewhat limited to "what works" assessments, leaving aside fundamental questions on relevant underlying mechanisms that make an intervention effective under specific circumstances, for some groups, or even at certain times. Using data from the cluster randomized controlled trial of the Good Behavior Game in England, involving 3,084 children in 77 schools, we showcase the latent adherence growth curve model, a multilevel structural equation modeling approach that takes account simultaneously of intervention compliance, subgroup moderator effects, change over time, and higher-level data structures. This statistical framework allowed a more nuanced view of the effects of the Good Behavior Game on the long-term developmental trajectories of disruptive behavior among male and female students. Our approach enabled us to ascertain the effect of child- and school-level covariates on intervention compliance and change in disruptive behavior over time, as well as the effects of both compliance and noncompliance on outcomes. In doing so, we found evidence of positive effects (reduction of disruptive behavior) on female compliers, but also iatrogenic effects among male noncompliers (increased disruptive behavior). We discuss the implications of our approach and findings for further research and practice. Educational Impact and Implications Statement: Analyzing compliance can be as important as noncompliance to understand why interventions in schools may or may not work. We illustrated how to implement a statistical approach that addresses the challenges of understanding why, how, when, and for whom interventions work, by simultaneously addressing longitudinal outcomes, multilevel structures, and unobserved compliance groups. We found not only that compliance with the Good Behavior Game had a positive effect on female pupils' disruptive behavior, but also that noncompliance had an unintended negative effect on male pupils. [ABSTRACT FROM AUTHOR]

Reading comprehension is an essential skill for academic success in K-12 settings and professional success beyond schooling. Unfortunately, approximately 33% of students fail to master this essential skill in elementary grades. Students attending high-poverty schools are at a bigger disadvantage due to high teacher turnover and lack of high-quality instruction. Recent efficacy studies with upper elementary-grade students attending rural and suburban schools have revealed that the text structure strategy focused on generating main ideas and summarization and delivered by a web-based intelligent tutor for structure strategy (ITSS) had a positive impact on reading comprehension measured by standardized and researcher-designed measures. The current study focused on replicating these findings with fifth-grade students attending high-poverty schools. A cluster randomized controlled trial with 33 elementary schools was conducted with 2-day teacher practice-based professional development, pretests at the beginning of the academic year, followed by a year-long implementation of the ITSS with coaching and modeling for teachers to provide consistent instruction, and posttests administered at the end of the academic year. Multilevel analysis of data revealed large effects on researcher-designed measures related to writing the main idea and recall (effect sizes ranged from 0.97 to 1.32). A small, yet not statistically significant, effect (effect size = 0.23) was found that favored the intervention classrooms on the standardized Gray silent reading test. These results replicate findings from previous studies on the ITSS. The positive results provide additional evidence of the impact of ITSS on reading comprehension for students attending high-poverty schools who need support the most. Educational Impact and Implications Statement: In this replication study, fifth-grade students attending high-poverty schools were provided a reading intervention focused on teaching them to identify and use text structures to generate main ideas and summaries. Students used the intelligent tutoring system for the structure strategy, a computer-delivered instructional platform, and teachers provided additional text structure-focused main idea and summarization instruction using guides aligned with the textbook passages. Students who received the text structure-based main idea and summarization instruction showed significant progress on measures related to writing main idea statements and recalling important text information. Teaching students to identify and use text structures to generate main ideas and summaries is beneficial for their reading comprehension. [ABSTRACT FROM AUTHOR]

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]

Type 2 diabetes (T2D) represents a growing disease burden in South Africa. While glycated haemoglobin (HbA1c) testing is the gold standard for long-term blood glucose management, recommendations for HbA1c monitoring frequency are based on expert opinion. This study investigates the effectiveness and cost-effectiveness of alternative HbA1c monitoring intervals in the management of T2D. A Markov model with three health states (HbA1c <7%, HbA1c ≥ 7%, Dead) was used to estimate lifetime costs and quality-adjusted life years (QALYs) of alternative HbA1c monitoring intervals among patients with T2D, using a provider's perspective and a 3% discount rate. HbA1c monitoring strategies (three-monthly, four-monthly, six-monthly and annual tests) were evaluated with respect to the incremental cost-effectiveness ratio (ICER) assessing each comparator against a less costly, undominated alternative. The scope of costs included the direct medical costs of managing diabetes. Transition probabilities were obtained from routinely collected public sector HbA1c data, while health service utilization and health-related-quality-of-life (HRQoL) data were obtained from a local cluster randomized controlled trial. Other parameters were obtained from published studies. Robustness of findings was evaluated using one-way and probabilistic sensitivity analyses. A South African indicative cost-effectiveness threshold of USD2665 was adopted. Annual and lifetime costs of managing diabetes increased with HbA1c monitoring, while increased monitoring provides higher QALYs and life years. For the overall cohort, the ICER for six-monthly vs annual monitoring was cost-effective (USD23 22.37 per QALY gained), whereas the ICER of moving from six-monthly to three-monthly monitoring was not cost effective (USD6437.79 per QALY gained). The ICER for four-monthly vs six-monthly monitoring was extended dominated. The sensitivity analysis showed that the ICERs were most sensitive to health service utilization rates. While the factors influencing glycaemic control are multifactorial, six-monthly monitoring is potentially cost-effective while more frequent monitoring could further improve patient HrQoL. [ABSTRACT FROM AUTHOR]

Objective. To determine the annual incidence of psoriatic arthritis (PsA) in a United Kingdom primary care population with preexisting psoriasis (PsO) followed prospectively over 2 years after excluding baseline prevalence of existing disease. Methods. Total Burden of Psoriasis (TUDOR; ISRCTN registry: ISRCTN38877516) was a multicenter, prospective, 2-arm parallel-group cluster randomized controlled trial of the early identification of PsA by annual rheumatological assessment (termed "Enhanced Surveillance") vs standard care in people with PsO identified in primary care. Incidence of PsA is reported at 12 months and 24 months using patients from the Enhanced Surveillance arm, which allows for the exclusion of patients with prevalent PsA at baseline. Results. Fourteen of 511 participants attending a 12-month screen developed PsA over that interval, giving an incidence of 2.74/100 patient-years (PYs; 95% CI 1.32-4.16). Another 7/444 participants attending the 24-month visit developed PsA, giving an incidence of 1.58/100 PYs (95% CI 0.42-2.74). The combined incidence over 2 years was 2.20/100 PYs (95% CI 1.27-3.13). Conclusion. The estimated annual incidence of PsA over a 2-year period was 2.20/100 PYs, which is in keeping with studies including clinical assessment rather than relying on health records alone. Extended follow-up of the TUDOR cohort with accrual of larger numbers of incident cases will allow risk factors for PsA to be explored in more depth. [ABSTRACT FROM AUTHOR]

ABSTRACT In observational health services research, researchers often use clustered data to estimate the independent association between individual outcomes and several cluster‐level covariates after adjusting for individual‐level characteristics. Generalized estimating equations are a popular method for estimating generalized linear models using clustered data. The conventional Liang–Zeger variance estimator is known to result in estimated standard errors that are biased low when the number of clusters in small. Alternative variance estimators have been proposed for use when the number of clusters is low. Previous studies focused on these alternative variance estimators in the context of cluster randomized trials, which are often characterized by a small number of clusters and by an outcomes regression model that often consists of a single cluster‐level variable (the treatment/exposure variable). We addressed the following questions: (i) which estimator is preferred for estimating the standard errors of cluster‐level covariates for logistic regression models with multiple binary and continuous cluster‐level variables in addition to subject‐level variables; (ii) in such settings, how many clusters are required for the Liang–Zeger variance estimator to have acceptable performance for estimating the standard errors of cluster‐level covariates. We suggest that when estimating standard errors: (i) when the number of clusters is < 15 use the Kauermann–Carroll estimator; (ii) when the number of clusters is between 15 and 40 use the Fay–Graubard estimator; (iii) when the number of clusters exceeds 40, use the Liang–Zeger estimator or the Fay–Graubard estimator. When estimating confidence intervals, we suggest using the Mancl–DeRouen estimator with a t‐distribution. [ABSTRACT FROM AUTHOR]

Background: Cluster randomized trials (CRTs) are increasingly important for evaluating interventions embedded in health care systems. An essential parameter in sample size calculation to detect both overall and heterogeneous treatment effects for CRTs is the intra-cluster correlation coefficient (ICC) of both outcome and covariates of interest. However, obtaining advance estimates for the ICC can be challenging. When trial outcomes will be obtained from routinely collected data sources, there is an opportunity to obtain reliable ICC estimates in advance of the trial. Using USA national Medicare data, we estimated ICCs for a range of outcomes to inform the design of CRTs for people living with Alzheimer's and related dementias (ADRD). Method: Data from 2018 Medicare Fee-for-Service beneficiaries, specifically, 1,898,812 individuals (≥ 65 years) with diagnosis of ADRD within 3436 hospital service areas (treated as clusters) and 306 hospital referral regions (treated as fixed strata), were used to calculate unadjusted and adjusted ICC estimates for three outcomes: death, any hospitalizations, and any emergency department (ED) visits and three covariates: age, race and sex. We present both overall and stratum-specific ICC estimates. We illustrate their use in sample size calculations for overall treatment effects as well as detecting treatment effect heterogeneity. Results: The unadjusted overall ICCs for death, hospitalizations, and ED visits were 0.001, 0.010, and 0.017 respectively. Stratum-specific ICCs varied widely across the 306 HRRs: median 0.001, 0.010 and 0.025 for death, hospitalizations, and ED visits respectively and 0.007, 0.001, and 0.080 for age, sex and race. An interactive R Shiny app is provided that allows users to retrieve estimates overlayed on a map of the USA. Conclusions: We presented both adjusted and unadjusted ICCs for outcomes as well as unadjusted ICCs for covariates of potential interest from population-level data in the USA and demonstrated how the estimates may be used in sample size calculations for CRTs in ADRD. [ABSTRACT FROM AUTHOR]

Background: The fixed effects model is a useful alternative to the mixed effects model for analyzing stepped-wedge cluster randomized trials (SW-CRTs). It controls for all time-invariant cluster-level confounders and has proper control of type I error when the number of clusters is small. While all clusters in a SW-CRT are typically designed to crossover from the control to receive the intervention, some trials can end with unexposed clusters (clusters that never receive the intervention), such as when a trial is terminated early due to safety concerns. It was previously unclear whether unexposed clusters would contribute to the estimation of the intervention effect in a fixed effects analysis. However, recent work has demonstrated that including an unexposed cluster can improve the precision of the intervention effect estimator in a fixed effects analysis of SW-CRTs with continuous outcomes. Still, SW-CRTs are commonly designed with binary outcomes and it is unknown if those previous results extend to SW-CRTs with non-continuous outcomes. Methods: In this article, we mathematically prove that the inclusion of unexposed clusters improves the precision of the fixed effects intervention effect estimator for SW-CRTs with binary and count outcomes. We then explore the benefits of including an unexposed cluster in simulated datasets with binary or count outcomes and a real palliative care data example with binary outcomes. Results: The simulations show that including unexposed clusters leads to tangible improvements in the precision, power, and root mean square error of the intervention effect estimator. The inclusion of the unexposed cluster in the SW-CRT of a novel palliative care intervention with binary outcomes yielded smaller standard errors and narrower 95% Wald Confidence Intervals. Conclusions: In this article, we demonstrate that the inclusion of unexposed clusters in the fixed effects analysis can lead to the improvements in precision, power, and RMSE of the fixed effects intervention effect estimator for SW-CRTs with binary or count outcomes. [ABSTRACT FROM AUTHOR]

Background: In supporting primary healthcare in delivering high-quality care for individuals with type 2 diabetes mellitus (T2DM), previous research emphasized strategies to facilitate communication and collaboration between primary healthcare providers and hospitals. This study aims to evaluate the effectiveness of case discussion conferences between specialists from hospitals and primary healthcare providers in China on the optimization of diabetes management and the improvement of patient health outcomes. Methods: This study will be a parallel cluster randomized controlled trial in which primary healthcare institutions in Shouguang city and Shangsi County will be randomly allocated to the intervention and control groups. The intervention will involve regular case discussion conferences where attendants will meet to discuss complex cases with patients diagnosed with type 2 diabetes mellitus, exchange experiences, and seek and provide expert advice. Family doctor teams from primary healthcare institutions and specialists from secondary or tertiary hospitals will engage in these conferences. Data will be collected at baseline and at the 6- and 12-month follow-ups. The primary clinical outcome measures will focus on the changes in the HbA1c and FBG levels of patients under management. The secondary outcomes will include other physiological indicators, such as blood pressure, BMI, and cholesterol. The evaluation will extend to changes in the capabilities and behaviors of primary healthcare providers. Furthermore, the feasibility and adherence of this intervention will be thoroughly assessed. Discussion: This study is designed to generate robust evidence on the effectiveness of case discussion conferences, an interprofessional collaboration strategy, in enhancing diabetes care delivery in primary healthcare, with the ultimate goal of improving patient health outcomes. Trial registration: Chinese Clinical Trial Registry ChiCTR2300078829. Registered on December 19, 2023. https://www.chictr.org.cn/showproj.html?proj=210293 [ABSTRACT FROM AUTHOR]

This study presents a hybrid (Bayesian‐frequentist) approach to sample size re‐estimation (SSRE) for cluster randomised trials with continuous outcome data, allowing for uncertainty in the intra‐cluster correlation (ICC). In the hybrid framework, pre‐trial knowledge about the ICC is captured by placing a Truncated Normal prior on it, which is then updated at an interim analysis using the study data, and used in expected power control. On average, both the hybrid and frequentist approaches mitigate against the implications of misspecifying the ICC at the trial's design stage. In addition, both frameworks lead to SSRE designs with approximate control of the type I error‐rate at the desired level. It is clearly demonstrated how the hybrid approach is able to reduce the high variability in the re‐estimated sample size observed within the frequentist framework, based on the informativeness of the prior. However, misspecification of a highly informative prior can cause significant power loss. In conclusion, a hybrid approach could offer advantages to cluster randomised trials using SSRE. Specifically, when there is available data or expert opinion to help guide the choice of prior for the ICC, the hybrid approach can reduce the variance of the re‐estimated required sample size compared to a frequentist approach. As SSRE is unlikely to be employed when there is substantial amounts of such data available (ie, when a constructed prior is highly informative), the greatest utility of a hybrid approach to SSRE likely lies when there is low‐quality evidence available to guide the choice of prior. [ABSTRACT FROM AUTHOR]

Background: Stepped-wedge cluster trials (SW-CTs) describe a cluster trial design where treatment rollout is staggered over the course of the trial. Clusters are commonly randomized to receive treatment beginning at different time points in this study design (commonly referred to as a Stepped-wedge cluster randomized trial; SW-CRT), but they can also be non-randomized. Trials with this design regularly have a low number of clusters and can be vulnerable to covariate imbalance. To address such covariate imbalance, previous work has examined covariate-constrained randomization and analysis adjustment for imbalanced covariates in mixed-effects models. These methods require the imbalanced covariate to always be known and measured. In contrast, the fixed-effects model automatically adjusts for all imbalanced time-invariant covariates, both measured and unmeasured, and has been implicated to have proper type I error control in SW-CTs with a small number of clusters and binary outcomes. Methods: We present a simulation study comparing the performance of the fixed-effects model against the mixed-effects model in randomized and non-randomized SW-CTs with small numbers of clusters and continuous outcomes. Additionally, we compare these models in scenarios with cluster-level covariate imbalances or confounding. Results: We found that the mixed-effects model can have low coverage probabilities and inflated type I error rates in SW-CTs with continuous outcomes, especially with a small number of clusters or when the ICC is low. Furthermore, mixed-effects models with a Satterthwaite or Kenward-Roger small sample correction can still result in inflated or overly conservative type I error rates, respectively. In contrast, the fixed-effects model consistently produced the target level of coverage probability and type I error rates without dramatically compromising power. Furthermore, the fixed-effects model was able to automatically account for all time-invariant cluster-level covariate imbalances and confounding to robustly yield unbiased estimates. Conclusions: We recommend the fixed-effects model for robust analysis of SW-CTs with a small number of clusters and continuous outcomes, due to its proper type I error control and ability to automatically adjust for all potential imbalanced time-invariant cluster-level covariates and confounders. [ABSTRACT FROM AUTHOR]

Background: Retrospective and descriptive molecular epidemiology studies have shown that Mycobacterium tuberculosis whole genome sequencing can identify outbreaks and disease transmission events with higher resolution than conventional epidemiological investigations. Those studies have strengthened our understanding of genomic polymorphisms correlating with person-to-person transmission and helped resolve putative transmission clusters. To date, systematic genomic surveillance programs implemented for M. tuberculosis were only implemented in low-incidence settings. The purpose of this study is to determine whether there is an impact of routine M. tuberculosis whole genome sequencing on tuberculosis case detection in a high-incidence setting. Methods: A cluster randomized controlled trial will be performed. Forty-eight rural village groups (or Fokontany) in the Vohibato district of Madagascar will be randomized to one of three interventions arms. Arm 1 (standard of care) involves healthcare facility-based passive case detection with smear microscopy testing. Arm 2 (best practice) consists of active case finding and Xpert MTB/RIF Ultra PCR testing followed by household contact investigations. Arm 3 (novel intervention) includes the same interventions as arm 2, with addition of sputum culture and M. tuberculosis whole genome sequencing for all newly diagnosed cases. In arm 3, molecular suggested putative outbreaks are investigated, and additional TB suspects are appropriately tested. The intervention observational period will be 2 years. The primary outcome will be the number of detected cases/100,000/year in each arm after 1 year of intervention. Discussion: This study is designed to determine whether there is an impact of prospective whole genome sequencing-based molecular typing on tuberculosis case detection in high-incidence settings. Investigating potential outbreaks and focusing active case finding in spatiotemporal settings where disease transmission is suggested by genomic typing is hypothesized to improve case detection in rural communities. Trial registration: ClinicalTrials.gov NCT05406453. Retrospectively registered on June 6, 2022. [ABSTRACT FROM AUTHOR]

Background: 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). Methods and findings: 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. Conclusions: 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. Trial Registration: ClinicalTrials.gov NCT05406479. Bouke C. de Jong and team assess the safety of a Bedaquiline enhanced post-exposure prophylaxis regimen in the Comoros Islands. Author summary: Why was this study done?: Worldwide, leprosy is diagnosed in 200,000 persons annually. Those living near a patient with leprosy can reduce their risk of developing leprosy by half if they take a single dose of the antibiotic rifampicin, known as "post-exposure prophylaxis," or PEP. Dual antibiotic treatment given as PEP may reduce the risk further, and bedaquiline has been shown to have a high degree of effectiveness against leprosy in animal studies, although the safety of PEP containing bedaquiline had not previously been tested. What did the researchers do and find?: In a village in the Comoros affected by leprosy, first adults and then children were invited to participate in a randomized study in which they could receive either a single dose of the regular PEP, or bedaquiline-enhanced PEP, in which regular rifampicin PEP was combined with bedaquiline. They had their heart rhythm and liver enzymes checked before and after taking PEP to screen for asymptomatic drug toxicity. There was no statistically significant difference in the heart rhythm or liver function between the 2 groups. While the analysis in children showed that the spread around the difference just exceeded the predetermined safety margin, the analysis controlled for baseline values did not show increased risk. What do these findings mean?: The findings suggest that regular PEP can safely be combined with bedaquiline, although it is not yet known if this provides stronger protection against developing leprosy. Limitations in this study include a technical error in liver function testing of adult participants, which may have hidden a low-level elevation. [ABSTRACT FROM AUTHOR]

Background: We 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. Methods: We 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. Results: The 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. Conclusions: We 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 registration: ClinicalTrials.gov NCT03970356. Registered on May 31, 2019. [ABSTRACT FROM AUTHOR]

Background: Pediatric depression is a global concern that has fueled efforts for enhanced detection and treatment engagement. As one example, the US Preventive Services Task Force recommends depression screening for adolescents ages 12–18 years. While many health systems have implemented components of depression screening protocols, there is limited evidence of effective follow-up for pediatric depression. A key barrier is timely team communication and coordination across clinicians and staff within and across service areas for prompt service linkage. However, team effectiveness interventions have been shown to improve team processes and outcomes and can be applied in healthcare settings. Methods: This project aims to refine and test a team communication training implementation strategy to improve implementation of an existing pediatric depression screening protocol in a large pediatric healthcare system. The team will be defined as part of the study but is expected to include medical assistants, nurses, physicians, and behavioral health clinicians within and across departments. The implementation strategy will target team mechanisms at the team-level (i.e., intra-organizational alignment and implementation climate) and team member-level (i.e., communication, coordination, psychological safety, and shared cognition). First, the project will use mixed methods to refine the team training strategy to fit the organizational context and workflows. Next, a hybrid type 3 implementation-effectiveness pilot trial will assess the initial effectiveness of the team communication training (implementation strategy) paired with the current universal depression screening protocol (clinical intervention) on implementation outcomes (i.e., feasibility, acceptability, appropriateness, workflow efficiency) and clinical/services outcomes (increased frequency of needed screening and reduced time to service linkage). Finally, the study will assess mechanisms at the team and team member levels that may affect implementation outcomes. Discussion: Team communication training is hypothesized to lead to improved, efficient, and effective decision-making to increase the compliance with depression screening and timely service linkage. Findings are expected to yield better understanding and examples of how to optimize team communication to improve efficiency and effectiveness in the pediatric depression screening-to-treatment cascade. This should also culminate in improved implementation outcomes including patient engagement critical to address the youth mental health crisis. Trial registration: NCT06527196. Trial Sponsor: University of California San Diego. [ABSTRACT FROM AUTHOR]

Background: Management of rheumatoid arthritis (RA) relies on symptoms reported by patients during infrequent outpatient clinic visits. These reports are often incomplete and inaccurate due to poor recall, leading to suboptimal treatment decisions and outcomes. Asking people to track symptoms in-between visits and integrating the data into clinical pathways may improve this. However, knowledge on how to implement this into practice and its impact on services and outcomes remains scarce in RA. Therefore, we evaluate the comparative effectiveness and cost-effectiveness of integrated symptom tracking in people with RA over and above usual care, while generating insights on factors for successful implementation. Methods: In this superiority stepped wedge cluster-randomized controlled trial with continuous recruitment short exposure design, 16 rheumatology outpatient departments (clusters) recruit a total of 732 people with active RA. They initially offer clinic visits according to standard of care before switching in pairs to visits with integrated symptom tracking. Clusters switch in randomized order every 3 weeks. Integrated symptom tracking consists of (1) a mobile app for patients to track their symptoms daily and other RA aspects weekly/monthly, and (2) an interactive dashboard visualizing the app data, which healthcare professionals access from their electronic health record system. Clinic visits happen according to usual practice, with tracked symptom data only reviewed during visits. Our primary outcome is a difference in marginal mean disease activity score at 12 ± 3 months between standard of care and integrated symptom tracking, after accounting for baseline values, cluster, and other covariates. Secondary outcomes include patient-reported disease activity, quality of life and quality-adjusted life-years, medication/resource use, consultation and decision-making experience, self-management, and illness perception. We also conduct interviews and observations as part of a parallel process evaluation to gather information on implementation. Discussion: Our trial will generate high-quality evidence of comparative and cost-effectiveness of integrated symptom tracking compared to standard of care in people with RA, with our process evaluation delivering knowledge on successful implementation. This optimizes the chances of integrated symptom tracking being adopted more widely if we find it is (cost-) effective. Trial registration: Registered 4-Jun-2024 on https://www.isrctn.com/, ISRCTN51539448. Trial open science framework repository: https://osf.io/sj9ha/. [ABSTRACT FROM AUTHOR]

Background: Some settings continue to experience a high malaria burden despite scale-up of malaria vector control to high levels of coverage. Characterisation of persistent malaria transmission in the presence of standard control measures, also termed residual malaria transmission, to understand where and when individuals are exposed to vector biting is critical to inform refinement of prevention and control strategies. Methods: Secondary analysis was performed using data collected during a phase III cluster randomized trial of attractive targeted sugar bait stations in Western Province, Zambia. Two seasonal cohorts of children aged 1–14 years were recruited and monitored monthly during the malaria transmission season, concurrent with entomological surveillance using a combination of human landing catch (HLC) and Centres for Disease Control (CDC) light traps at randomly selected households in study clusters. Behavioural data from cohort participants were combined with measured Anopheles funestus landing rates and sporozoite positivity to estimate the human behaviour-adjusted entomological inoculation rate (EIR). Results: Behavioural data from 1237 children over 5456 child-visits in 20 entomology surveillance clusters were linked with hourly landing rates from 8131 female An. funestus trapped by HLC. Among all An. funestus tested by enzyme-linked immunosorbent assay (ELISA), 3.3% were sporozoite-positive. Mean EIR directly measured from HLC was 0.07 infectious bites per person per night (ib/p/n). When accounting for child locations over the evening and night, the mean behaviour-adjusted EIR was 0.02 ib/p/n. Children not sleeping under insecticide-treated nets (ITNs) experienced 13.6 infectious bites per person per 6 month season, 8% of which occurred outdoors, while ITN users received 1.3 infectious bites per person per 6 month season, 86% of which were received outdoors. Sleeping under an ITN can prevent approximately 90% of potential An. funestus bites among children. Conclusions: In this setting ITNs have a high personal protective efficacy owing to peak An. funestus biting occurring indoors while most individuals are asleep. However, despite high household possession of ITNs (>90%) and high individual use (>70%), children in this setting experience more than one infectious bite per person per 6 month transmission season, sufficient to maintain high malaria transmission and burden. New tools and strategies are required to reduce the malaria burden in such settings. [ABSTRACT FROM AUTHOR]

Background: Soil-transmitted helminths (STH) affect approximately 1.5 billion people globally. The current STH control strategy is annual or twice-annual preventive chemotherapy, typically school-based deworming targeting children and women of reproductive age. Mathematical modeling suggests that it may be possible to interrupt STH transmission through high-coverage community-wide mass drug administration (cMDA). DeWorm3 is a cluster randomized trial testing cMDA for prevalence reduction and transmission interruption. The purpose of this study is to describe coverage of cMDA in study clusters over time and correlates of coverage at individual and cluster levels. Methods: From 2018–2020, DeWorm3 delivered six rounds of cMDA with 400 mg albendazole at sites in Benin, India, and Malawi. We report coverage, treatment uptake, and directly observed therapy across all rounds. Factors associated with coverage at the cluster level were identified using binomial generalized estimating equations, while factors associated with non-treatment at the individual level were identified using binomial mixed-effects models. Results: Coverage was high across all clusters and rounds, exceeding the WHO target of 75% in all sites and across all rounds (78% to 95%); cluster-level coverage tended to increase over time. Younger, unmarried, and migratory adults were more likely to be untreated at all sites; adult males were more likely to be untreated in Benin and Malawi. Among children, girls were more likely to be untreated, as were non-school-attending and migratory children. Higher adult education was associated with greater odds of non-treatment among adults, but lower odds among children in the household. Belonging to a less wealthy or minority language-speaking household was associated with non-treatment among both adults and children. Conclusions: It is possible to deliver community-wide MDA with high coverage. Unique individual and community-level factors influence treatment across settings, and these may be addressed through targeted programming. Trial Registration: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH), NCT03014167. [ABSTRACT FROM AUTHOR]

Background: Mental health symptoms among healthcare professionals (HCP) in intensive care units (ICUs) are a significant concern affecting both HCP well-being and patient care outcomes. Cross-sectional studies among members of the European Society of Intensive Care Medicine (ESICM) report up to 50% burnout rates. Determinants of burnout include communication, team cohesion, psychological support, and well-being promotion. We designed the 'Hello Bundle' intervention to mitigate burnout among ICU-HCPs by fostering positive social interactions and a supportive work environment. This justification synthesizes evidence from social psychology, positive psychology, and healthcare communication research to support the intervention. The 'Hello Bundle' aims to enhance interpersonal relationships, improve team cohesion, and reduce burnout rates. The six components include: Hello campaign posters, email reminders, integrating greetings in morning huddles, hello jars, lead-by-example initiatives, and a daily updated hello board in each ICU. This protocol describes a cluster randomized controlled trial to evaluate the effectiveness of the intervention. Methods: This protocol describes a cluster randomized controlled trial (RCT) conducted among ESICM-affiliated ICUs, consisting of at least 73 clusters with in average of 50 respondents per cluster, totaling approximately 7300 participants. Intervention clusters will implement the 6-component Hello Bundle between October 14 and November 10, 2024, while control clusters will be wait-listed to receive the intervention in January 2025 after the RCT concludes. Clusters will be matched based on ICU size (fewer or more than 20 beds), region, and average 2023 mortality. The primary outcome is the proportion of HCPs with burnout between intervention and control clusters at the end of the intervention. Secondary outcomes include comparing the following between clusters: (1) number of HCPs with high emotional exhaustion; (2) number with high depersonalization; (3) number with loss of accomplishment; (4) perception of ethical climate (5) satisfaction at work (VAS); (6) professional conflicts; (7) intention to leave the ICU (VAS); (8) patient-centered care rating; (9) family-centered care rating. The last secondary outcome is the comparison of burnout rates before and after the intervention in the intervention cluster. Outcomes will be based on HCP reports collected within four weeks before and after the intervention. Discussion: This is the first large trial of healthcare communication, social, and positive psychology intervention among ICU-HCPs. It holds the potential to provide valuable insights into effective strategies for addressing burnout in ICU settings, ultimately benefiting both HCPs and patients. Trial registration: This trial was registered on ClinicalTrials.Gov on June 18, 2024. Registration: NCT06453616. [ABSTRACT FROM AUTHOR]

Background: Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya's national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow. Methods: The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO's effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data. Discussion: We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention's integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented. Trial registration: ClinicalTrials.gov, NCT05187897. The CHV-NEO study was registered on January 12, 2022. [ABSTRACT FROM AUTHOR]

Objective: Research has demonstrated the effectiveness of interventions to reduce organizational skills deficits and homework problems, including the clinic-based Organizational Skills Training (OST-C) program (Abikoff et al., 2013). In this study, OST-C was adapted for schools as a small-group (Tier 2) intervention delivered by school partners (OST-T2). Method: The study was conducted in 22 schools serving students from diverse backgrounds. Students (n = 186; 122 male) in Grades 3–5, ages 8–12 (M = 9.7 years; SD = 0.88) with organizational skills deficits referred by teachers were enrolled. Schools were randomly assigned to OST-T2 or treatment as usual with waitlist. OST-T2 consisted of sixteen 35-min child sessions, two caregivers, and two teacher consultations. Outcomes were evaluated with longitudinal mixed effects modeling at posttreatment, 5-month and 12-month follow-up using caregiver and teacher reports of organizational skills, homework, and academic performance. Results: OST-T2 resulted in reductions in organizational skills deficits on caregiver and teacher report (p <.001) at posttreatment and 5-month follow-up (effect sizes [ES], Cohen's d = 0.96, 1.20). Findings also revealed a reduction in caregiver-reported homework problems at posttreatment and 5-month follow-up (p <.001, ES = 0.60, 0.72), and an improvement in teacher-rated homework at posttreatment (p =.007, ES = 0.64). Effects were attenuated at 12-month follow-up. The effects of OST-T2 on academic measures were not significant. Conclusions: Findings provide evidence for the immediate and short-term effectiveness of OST-T2 delivered by school professionals. What is the public health significance of this article?: This study demonstrated the effectiveness of organizational skills training provided by school professionals for students ages 8–11, with teacher-identified organization, time management, and planning difficulties. [ABSTRACT FROM AUTHOR]

Heterogeneity of outcomes across different clinical trial study sites is often inevitable. Understanding how outcomes differ by site is important for planning future programs and studies. We examined the extent of heterogeneity of hepatitis C virus (HCV) treatment cascade outcomes among persons who inject drugs (PWIDs) across sixteen clinical sites utilized in the HERO Study—a pragmatic randomized trial of HCV treatment support. Treatment cascade outcomes included averages of overall treatment adherence and proportions of treatment initiation, treatment completion, sustained virologic response (SVR) test completion, and SVR achievement. The HERO study utilized 16 clinical sites across the United States (US): eight opioid treatment programs (OTPs) and eight community health centers (CHCs). Variability of the outcomes across the 16 clinical sites was assessed using ranges and intraclass correlation coefficients (ICC) estimated from mixed-effects linear or logistic regression models. Treatment initiation was analyzed in the intention-to-treat (ITT) sample (N = 755); treatment completion, adherence, and SVR test completion in the modified ITT (mITT) sample, which is the sample that initiated treatment (N = 623); and SVR achievement in the mITT and per-protocol (PP, N = 501) samples. Across the 16 clinical sites, the range observed in the averages of overall treatment adherence was from 68% to 81% [ICC = 0.026 (0.005, 0.054)], and the ranges of proportions observed were from 68% to 96% for treatment initiation [ICC (95% CI) = 0.086 (0.051, 0.155)], 60% to 100% for treatment completion [ICC = 0.049 (0.008, 0.215)], 54% to 95% for SVR test completion [ICC = 0.096 (0.006, 0.177)], 46% to 90% for SVR achievement in the mITT sample [ICC = 0.070 (0.014, 0.122)], and 76% to 100% for SVR achievement in the PP sample [ICC = 0.143 (0.021, 0.422)]. The variability of the outcomes across 16 US sites treating HCV among PWIDs appears to be substantial in view of the ranges and ICC values of the outcomes. It is imperative to develop tailored interventions to target the sources of variability and reduce barriers at the patient, provider, clinic, and state policy levels to facilitate more equitable access to HCV treatment and reduce heterogeneity in treatment outcomes. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to assess whether coaching doctors to enhance ethical decision-making in teams improves (1) goal-oriented care operationalized via written do-not-intubate and do-not attempt cardiopulmonary resuscitation (DNI-DNACPR) orders in adult patients potentially receiving excessive treatment (PET) during their first hospital stay and (2) the quality of the ethical climate. Methods: We carried out a stepped-wedge cluster randomized controlled trial in the medical intensive care unit (ICU) and 9 referring internal medicine departments of Ghent University Hospital between February 2022 and February 2023. Doctors and nurses in charge of hospitalized patients filled out the ethical decision-making climate questionnaire (ethical decision-making climate questionnaire, EDMCQ) before and after the study, and anonymously identified PET via an electronic alert during the entire study period. All departments were randomly assigned to a 4-month coaching. At least one month of coaching was compared to less than one month coaching and usual care. The first primary endpoint was the incidence of written DNI-DNACPR decisions. The second primary endpoint was the EDMCQ before and after the study period. Because clinicians identified less PET than required to detect a difference in written DNI-DNACPR decisions, a post-hoc analysis on the overall population was performed. To reduce type I errors, we further restricted the analysis to one of our predefined secondary endpoints (mortality up to 1 year). Results: Of the 442 and 423 clinicians working before and after the study period, respectively 270 (61%) and 261 (61.7%) filled out the EDMCQ. Fifty of the 93 (53.7%) doctors participated in the coaching for a mean (standard deviation [SD]) of 4.36 (2.55) sessions. Of the 7254 patients, 125 (1.7%) were identified as PET, with 16 missing outcome data. Twenty-six of the PET and 624 of the overall population already had a written DNI-DNACPR decision at study entry, resulting in 83 and 6614 patients who were included in the main and post hoc analysis, respectively. The estimated incidence of written DNI-DNACPR decisions in the intervention vs. control arm was, respectively, 29.7% vs. 19.6% (odds ratio 4.24, 95% confidence interval 4.21–4.27; P < 0.001) in PET and 3.4% vs. 1.9% (1.65, 1.12–2.43; P = 0.011) in the overall study population. The estimated mortality at one year was respectively 85% vs. 83.7% (hazard ratio 2.76, 1.26–6.04; P = 0.011) and 14.5% vs. 15.1% (0.89, 0.72–1.09; P = 0.251). The mean difference in EDMCQ before and after the study period was 0.02 points (− 0.18 to 0.23; P = 0.815). Conclusion: This study suggests that coaching doctors regarding ethical decision-making in teams safely improves goal-oriented care operationalized via written DNI-DNACPR decisions in hospitalized patients, however without concomitantly improving the quality of the ethical climate. [ABSTRACT FROM AUTHOR]

Measurement-based care (MBC), which collects session-by-session symptom data from patients and provides clinicians with feedback on treatment response, is a highly generalizable evidence-based practice with significant potential to improve the outcomes of mental health treatment in youth when implemented with fidelity; however, it is rarely used in community settings. This study tested whether an implementation strategy targeting organizational leadership and organizational implementation climate could improve MBC fidelity and clinical outcomes for youth in outpatient mental health clinics. In a cluster randomized trial, 21 clinics were assigned to the Leadership and Organizational Change for Implementation strategy plus training and technical assistance in MBC (k = 11, n = 117) or training and technical assistance only (k = 10, n = 117). Primary outcomes of MBC fidelity (assessed via electronic metadata) and youth symptom improvement (assessed via caregiver-reported change on the Shortform Assessment for Children Total Problem Score) were collected for consecutively enrolled youths (ages 4-18 years) who initiated treatment in the 12 months following MBC training. Outcomes of each youth were assessed for 6 months following baseline. A total of 234 youths were enrolled and included in intent-to-treat analyses. At baseline, there were no significant differences by condition in clinic, clinician, or youth characteristics. Youths in clinics using the Leadership and Organizational Change for Implementation strategy experienced significantly higher MBC fidelity compared with youths in control clinics (23.1% vs 3.4%, p =.014), and exhibited significantly greater reductions in symptoms from baseline to 6 months (d = 0.31, 95% CI: 0.04-0.58, p =.023). Implementation strategies targeting organizational leadership and focused implementation climate can improve fidelity to evidence-based practices and clinical outcomes of youth mental health services. Measurement-based care is an evidence-based intervention that has been shown to improve the outcomes of mental health services in dozens of randomized trials; however, it is not widely used in routine practice. In this randomized controlled trial of 21 outpatient mental health clinics and 234 youth, the authors found an organizational intervention which trained clinic leaders in skills to support the use of measurement-based care increased the extent to which patients received measurement-based care compared to control clinics where clinic leaders did not receive this training (23% vs. 3%). Youth receiving services in the clinics that received the organizational intervention also had greater reductions in mental health symptoms. Working to Implement and Sustain Digital Outcome Measures (WISDOM); https://clinicaltrials.gov/ ; NCT04096274. [ABSTRACT FROM AUTHOR]

• First impact evaluation of phone parenting program for Syrians and Jordanians. • Parenting intervention decreased caregiver-reported depressive symptoms. • No impacts on parenting outcomes were detected. For refugee caregivers who may live in remote areas or be a highly mobile population, creating parenting programs that fit their needs and accommodate their mobility can be highly beneficial. In this article, we evaluate a 6-month, audio-only early childhood development (ECD) intervention delivered via phone (3 calls per month) to caregivers of Syrian and Jordanian backgrounds in Jordan. A sample of stipended community health volunteers (CHVs; N = 99) and their caseloads of caregivers (n = 2,298) was randomized to calls with health and nutritional content (control group) or calls with health, nutritional, and added parenting and caregiver-focused content (including content adapted from the Reach Up and Learn model). Hypothesized outcomes included reduced caregiver depressive and anxiety symptoms, parenting stress, and harsh discipline; increased parent-child learning activities and parenting self-efficacy. Exploratory outcomes (all caregiver-reported) included child development; and caregiver engagement in activities related to health and child learning following the calls. Exposure to the treatment condition resulted in a statistically significant reduction in caregivers' depressive symptoms (d=-0.11). No other statistically significant impacts were found. Implications of these findings for caregiver interventions are discussed. [ABSTRACT FROM AUTHOR]

Subjective cognitive decline (SCD) is prevalent in community-dwelling (pre)frail older adults. This study aimed to investigate whether baseline subjective cognitive decline (SCD) and mild cognitive impairment (MCI) impacted the effectiveness of an exercise intervention among (pre)frail older adults. This is a post hoc analysis of a stepped-wedge cluster randomized trial among (pre)frail older adults across six communities. The intervention effectiveness was examined among (pre)frail older people among subgroups with normal cognition (n = 44), SCD (n = 58), or MCI (n = 30). The normal cognition group had both immediate and persistent treatment responses to most outcomes. The SCD group showed positive responses to frailty (0-, 12-, 24 week), ambulation and dynamic balance (0-week), and depressive symptoms (12-week). The MCI group exhibited immediate improvement in frailty, cognition, depressive symptoms, social support and QoL, which persisted only in frailty status, social support and mental QoL at follow-ups. The MCI group showed superior immediate responses to cognitive function and depressive symptoms compared to another two subgroups. No differences were found between the normal cognition and SCD groups except for cognitive status (12-week). (Pre)frail people with SCD or MCI had fewer improved outcomes compared to those with normal cognition regardless of immediate or persistent improvements. The incorporation of cognitive strategies with exercise interventions are recommended among (pre)frail older adults with SCD or MCI. • The exercise intervention addressed frailty, balance, and depressive symptoms in (pre)frail older people with SCD. • Immediate effects were observed for those with MCI on frailty, cognition, depressive symptoms, social support and QoL. • For those with MCI, persisting effects were only detected in frailty status, social support and mental QoL. • The intervention had comparable effects in (pre)frail people with normal cognition or SCD. • Greater immediate cognitive and depressive improvements were seen in (pre)frail people with MCI. • Cognitive training could be incorporated into exercise interventions in (pre)frail people with dysfunctional cognition. [ABSTRACT FROM AUTHOR]

Multisite cluster randomized trials (MCRTs), in which, the intermediate-level clusters (e.g., classrooms) are randomly assigned to the treatment or control condition within each site (e.g., school), are among the most commonly used experimental designs across a broad range of disciplines. MCRTs often align with the theory that programs are delivered at a cluster-level (e.g., teacher professional development) and provide opportunities to explore treatment effect heterogeneity across sites. In designing experimental studies, a critical step is the statistical power analysis and sample size determination. However, the statistical tools for power analysis of moderator effects in three-level MCRTs are not available. In this study, we derived formulas for calculating the statistical power and the minimum detectable effect size difference (MDESD) with confidence intervals for investigating the effects of various moderators in three-level MCRTs. We considered the levels of the moderators (level-1, −2, and −3), the scales of the moderators (binary and continuous), and random and nonrandomly varying slopes of the (moderated) treatment effects. We validated our formulas through Monte Carlo simulations. Finally, we conclude with directions for future work. [ABSTRACT FROM AUTHOR]

The Proactive Community Case Management (ProCCM) trial in Mali reinforced the health system across both arms with user fee removal, professional community health workers (CHWs) and upgraded primary health centres (PHCs)—and randomized village-clusters to receive proactive home visits by CHWs (intervention) or fixed site-based services by passive CHWs (control). Across both arms, sick children's 24-hour treatment and pregnant women's four or more antenatal visits doubled, and under-5 mortality halved, over 3 years compared with baseline. In the intervention arm, proactive CHW home visits had modest effects on children's curative and women's antenatal care utilization, but no effect on under-5 mortality, compared with the control arm. We aimed to explain these results by examining implementation, mechanisms and context in both arms We conducted a process evaluation with a mixed method convergent design that included 79 in-depth interviews with providers and participants over two time-points, surveys with 195 providers and secondary analyses of clinical data. We embedded realist approaches in novel ways to test, refine and consolidate theories about how ProCCM worked, generating three context-intervention-actor-mechanism-outcome nodes that unfolded in a cascade. First, removing user fees and deploying professional CHWs in every cluster enabled participants to seek health sector care promptly and created a context of facilitated access. Second, health systems support to all CHWs and PHCs enabled equitable, respectful, quality healthcare, which motivated increased, rapid utilization. Third, proactive CHW home visits facilitated CHWs and participants to deliver and seek care, and build relationships, trust and expectations, but these mechanisms were also activated in both arms. Addressing multiple structural barriers to care, user fee removal, professional CHWs and upgraded clinics interacted with providers' and patients' agency to achieve rapid care and child survival in both arms. Proactive home visits expedited or compounded mechanisms that were activated and changed the context across arms. [ABSTRACT FROM AUTHOR]

The objective of the current study is to examine the impact of an in-school computer-assisted learning (CAL) intervention on the math achievement of rural students in Taiwan, including a marginalized subgroup of rural students called Xinzhumin, and the factors associated with this impact. In order to achieve this, we conducted a cluster randomized controlled trial involving 1,840 fourth- and fifth-grade students at 95 schools in four relatively poor counties and municipalities of Taiwan during the spring semester of 2019. While the Intention-To-Treat (ITT) analysis found that the CAL intervention had no significant impacts on student math achievement, the Local Average Treatment Effect (LATE) analysis revealed significant associations with the math performance of the most active 20% of students in the treatment group. LATE estimates suggest that using CAL for more than 20 minutes per week for ten weeks corresponds to higher math test scores, both in general (0.16 SD–0.22 SD), and for Xinzhumin students specifically (0.3 SD–0.34 SD). Teacher-level characteristics were associated with compliance rates. [ABSTRACT FROM AUTHOR]

AbstractStudents with disabilities are at an increased risk of experiencing poorer quality peer relationships than those without disabilities. Previous school-based efforts to promote positive peer interactions among students with and without disabilities have included individual skill development and broader initiatives such as inclusive school practices. In the current study, we investigate the effects of cooperative learning (CL) on peer relationships, peer academic supports, and classroom engagement of middle school students with and without disabilities over two years. Using 4 waves of data from a cluster randomized trial of middle schools, we hypothesized that CL would create positive gains in study outcomes among all students, but we anticipated that effects would be more pronounced among students with disabilities. Results confirmed these hypotheses and highlighted the potential role of CL in creating greater social integration among students with and without disabilities. The implications of these findings for practitioners and policymakers are discussed. [ABSTRACT FROM AUTHOR]

Background: The Ryan White Medical Case Management System, which serves more than half of people living with HIV (PLWH) in the USA, is an opportune setting for identifying and addressing depression among PLWH. A growing body of research suggests that interventions that promote positive emotion may lessen symptoms of depression and improve physical and psychological well-being among people experiencing a variety of health-related stress, including living with HIV. Research on how best to integrate standardized mental health screening and referral to evidence-based interventions in Ryan White Medical Case Management settings has the potential to improve the health and wellbeing of PLWH. Methods: This mixed-methods study will enroll up to N = 300 Ryan White clients who screen positive for depressive symptoms in ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), a web-based, self-guided positive emotion regulation intervention. The study will be conducted in 16 Ryan White Medical Case Management clinics in Chicago, IL. Following pre-implementation surveys and interviews with Medical Case Managers (MCMs) and Supervisors to develop an implementation facilitation strategy, we will conduct a hybrid type 2 implementation-effectiveness stepped wedge cluster randomized trial to iteratively improve the screening and referral process via interviews with MCMs in each wedge. We will test the effectiveness of ORCHID on depression and HIV care outcomes for PLWH enrolled in the program. RE-AIM is the implementation outcomes framework and the Consolidated Framework for Implementation Research is the implementation determinants framework. Discussion: Study findings have the potential to improve mental health and substance use screening of Ryan White clients, decrease depression and improve HIV care outcomes, and inform the implementation of other evidence-based interventions in the Ryan White Medical Case Management System. Trial registration: ClinicalTrials.gov NCT05123144. Trial registered 6/24/2021 [ABSTRACT FROM AUTHOR]

Background: Intraoperative hemorrhage in cardiac surgery increases risk of morbidity and mortality. Low pre-operative and perioperative levels of fibrinogen, a key clotting factor, are associated with severity of hemorrhage and increased transfusion of blood components. The ability to supplement fibrinogen during hemorrhagic resuscitation is delayed 45–60 min because cryoprecipitated antihemophilic factor (cryo AHF) is stored frozen, due to a short post-thaw shelf life. Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) can be kept thawed, at room temperature, for up to 5 days, making it possible to be immediately available for hemorrhaging patients. This trial will investigate if earlier correction of acquired hypofibrinogenemia with IFC in hemorrhaging cardiac surgery patients reduces the total number of perioperatively transfused allogeneic blood products (red blood cells, plasma, and platelets) as compared to cryo AHF. Methods: This is a single center, prospective, cluster randomized trial with an adaptive design. Acquired hypofibrinogenemia will be assessed by rotational thromboelastometry (ROTEM) and the threshold for cryo AHF/IFC transfusion defined as FIBTEM A10 ≤ 10 mm in bleeding patients. IFC/cryo AHF will be randomized by 1-month blocks. Cardiac surgery patients will be enrolled in the study if they have an eligible procedure and at least one dose of a cryo AHF/IFC product (approximately 2 g fibrinogen) is transfused. Data from the electronic health record, including the blood bank and lab information systems, will be prospectively collected from the health system's data warehouse. Discussion: This trial aims to provide evidence of the clinical efficacy of utilizing readily available thawed IFC during acute bleeding in the cardiac surgery setting compared to traditional cryo AHF. Trial registration: ClinicalTrials.gov NCT05711524. Feb 3, 2023. [ABSTRACT FROM AUTHOR]

Background: Previously, we have reported on the efficacy and real-world effectiveness of a parent-oriented mobile health intervention (MINISTOP 1.0 and 2.0), which have shown improvements in pre-school children's lifestyle behaviours. However, there is a need for implementation evidence. The overall aims of this study are to: (i) compare two different implementation strategies for MINISTOP 3.0 (Basic vs. Enhanced) on: acceptability, appropriateness, feasibility, organizational readiness to implement MINISTOP 3.0 within Swedish child healthcare (primary outcomes) as well as reach, costs, and adoption of MINISTOP 3.0 (secondary outcomes); (ii) evaluate cost-effectiveness of MINISTOP 3.0; (iii) explore the sustainability of MINISTOP 3.0; (iv) evaluate the determinants of effectiveness of MINISTOP 3.0 on children's key lifestyle behaviours; and (v) investigate the long-term effects of MINISTOP 3.0 on children's body mass index. Methods: A hybrid type III implementation-effectiveness design will be used. A cluster randomized controlled trial will be conducted to compare the effects of basic versus enhanced implementation strategies on the outcomes at the child healthcare level. A minimum of 50 child healthcare centers across Sweden will participate and we aim to recruit 120 nurses. Child healthcare nurses in both groups will offer the MINISTOP 3.0 app to the families at the 2.5/3-year routine visit. Basic implementation strategies include educational meeting with nurses, formal implementation blueprint, develop/distribute educational materials and enhanced implementation includes all aforementioned strategies plus auditing/providing feedback and ongoing training for nurses. All outcomes will be assessed at baseline and 12 months post-implementation. Implementation outcomes will be assessed quantitatively using questionnaires and sustainability will be assessed qualitatively at 12 months. Children's key lifestyle behaviours will be collected through a parental questionnaire within the MINISTOP app at baseline and 6 months after they have received the app. Children's weight/height will be measured at routine visits at 2.5/3 (baseline), 4 and 5 years of age. Discussion: This study will provide important implementation evidence with regards to implementing mHealth interventions within Swedish child healthcare at scale and these results have the potential to be generalized to other digital interventions being implemented in child healthcare. Trial registration: ClinicalTrials.gov, NCT05667753. Registered December 29, 2022. [ABSTRACT FROM AUTHOR]

Background: Early in the pandemic, the United States population experienced a sharp rise in the prevalence rates of opioid use, social isolation, and pain interference. Given the high rates of pain reported by patients on medication for opioid use disorder (MOUD), the pandemic presented a unique opportunity to disentangle the relationship between opioid use, pain, and social isolation in this high-risk population. We tested the hypothesis that pandemic-induced isolation would partially mediate change in pain interference levels experienced by patients on MOUD, even when controlling for baseline opioid use. Such work can inform the development of targeted interventions for a vulnerable, underserved population. Methods: Analyses used data from a cluster randomized trial (N = 188) of patients on MOUD across eight opioid treatment programs. As part of the parent trial, participants provided pre-pandemic data on pain interference, opioid use, and socio-demographic variables. Research staff re-contacted participants between May and June 2020 and 133 participants (71% response rate) consented to complete a supplemental survey that assessed pandemic-induced isolation. Participants then completed a follow-up interview during the pandemic that again assessed pain interference and opioid use. A path model assessed whether pre-pandemic pain interference had an indirect effect on pain interference during the pandemic via pandemic-induced isolation. Results: Consistent with hypotheses, we found evidence that pandemic-induced isolation partially mediated change in pain interference levels among MOUD patients during the pandemic. Higher levels of pre-pandemic pain interference and opioid use were both significantly associated with higher levels of pandemic-induced isolation. In addition, pre-pandemic pain interference was significantly related to levels of pain interference during the pandemic, and these pain levels were partially explained by the level of pandemic-induced isolation reported. Conclusions: Patients on MOUD with higher use of opioids and higher rates of pain pre-pandemic were more likely to report feeling isolated during COVID-related social distancing and this, in turn, partially explained changes in levels of pain interference. These results highlight social isolation as a key risk factor for patients on MOUD and suggest that interventions promoting social connection could be associated with reduced pain interference, which in turn could improve patient quality of life. Trial registration: NCT03931174 (Registered 04/30/2019). [ABSTRACT FROM AUTHOR]

Background: Women with high-risk breast lesions, such as atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), have a 4- to tenfold increased risk of breast cancer compared to women with non-proliferative breast disease. Despite high-quality data supporting chemoprevention, uptake remains low. Interventions are needed to break down barriers. Methods: The parent trial, MiCHOICE, is a cluster randomized controlled trial evaluating the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. For this pre-implementation analysis, 25 providers participated in semi-structured interviews prior to accessing decision support tools. Interviews sought to understand attitudes/beliefs and barriers/facilitators to chemoprevention. Results: Interviews with 25 providers (18 physicians and 7 advanced practice providers) were included. Providers were predominantly female (84%), white (72%), and non-Hispanic (88%). Nearly all providers (96%) had prescribed chemoprevention for eligible patients. Three themes emerged in qualitative analysis. The first theme describes providers' confidence in chemoprevention and the utility of decision support tools. The second theme elucidates barriers to chemoprevention, including time constraints, risk communication and perceptions of patients' fear of side effects and anxiety. The third theme is the need for early implementation of decision support tools. Conclusions: This qualitative study suggests that providers were interested in the early inclusion of decision aids (DA) in their chemoprevention discussion workflow. The DAs may help overcome certain barriers which were elucidated in these interviews, including patient level concerns about side effects, clinic time constraints and difficulty communicating risk. A multi-faceted intervention with a DA as one active component may be needed. Trial registration: This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT04496739. [ABSTRACT FROM AUTHOR]

Background: Exclusive breastfeeding (EBF) of infants during the first 6 months of their life is strongly recommended. Video‐based communication is an innovative method that could promote EBF. The present study is aimed at assessing the effectiveness of video‐based intervention in promoting breastfeeding practices from birth to 6 months postpartum. This was evaluated through maternal reports, as well as EBF of infants at 3 and 5 months of age, using the deuterium oxide dose‐to‐mother (DTM) technique. Methods: In a cluster randomized community trial, 16 communities were assigned to receive a video‐based behavior change communication (Video‐Health) or standard health care messages (Control). Pregnant women in their first trimester (12 ± 2 weeks) were enrolled and followed up, together with their infants, until 6 months postpartum. Data on breastfeeding practices were collected by questionnaire, monthly, in all the participants (n = 508). Human milk intake (HMI) and nonmilk oral intake (NMOI) were measured in a subsample of 60 mother–infant pairs at 3 and 5 months postpartum using DTM. Mixed models and logistic regression were used to examine the difference in continuous and discrete breastmilk practices between the intervention and the control arms, respectively. Results: The majority of mothers initiated breastfeeding early (92.1%), 82.4% reported colostrum feeding, and 17.5% provided prelacteal feeding. No significant differences were found between Video‐Health and Control arms (p > 0.05). The intervention significantly improved reported EBF rates at 4 and 5 months postpartum (p < 0.05). DTM results showed that the proportion of women practicing EBF was 50%–67% less than reported at 3 months for both arms and at 5 months in the intervention arm. The intervention did not significantly affect measured EBF at 3 and 5 months postpartum but did improve HMI at 3 months. Non significant differences in NMOI were observed at 3 months, but at 5 months, there was a significant difference between the study arms. Conclusions: Video‐based behavior change communication did not result in significant improvements in reported breastfeeding practices, except for a higher reported adherence to EBF beyond 3 months. Additionally, the intervention had no effect on EBF as measured by the DTM. Early introduction of non‐breastmilk foods and liquids persisted, despite self‐reported EBF extending up to 6 months postpartum. Trial Registration: ClinicalTrials.gov identifier: NCT04414527 [ABSTRACT FROM AUTHOR]

Abstract\nIMPLICATIONS FOR REHABILITATIONThis mixed methods study examined the impact of a multi-faceted professional development (PD) program for preschool teachers and classroom assistants on teacher-supported assistive technology (AT) use and early literacy development of children with disabilities. Four special education preschools were randomized into intervention (2 schools, 9 teachers, 50 children) and waitlist control (2 schools, 17 teachers, 42 children) groups. The 24-week PD included online modules, coaching, and AT device kits. Pre-post gains in children’s AT use and early literacy skills were analyzed using χ2 and repeated measures ANOVA. Teacher interviews and reflective commentaries were analyzed using Framework Analysis methodology. From pre- to post-test, the percent of children in the intervention group using some form of AT rose from 36 to 80%. The percent of children using AT in the control group went from 45 to 62%. The difference in change between the two groups was statistically significant, χ2 = 13.93, p=.001. Gains in early literacy skills were not significantly different across groups, F(1,90)=0.010, p=.922. Analysis of the qualitative data revealed three themes: the positive impact of AT on child engagement and participation, the importance of individualizing AT for each student, and barriers teachers faced in AT implementation. The PD program had a positive effect on children’s AT use but not on gains in early literacy. Teachers’ comments highlighted the nuanced relationship between AT use and literacy outcomes, suggesting the need for more targeted implementation of AT during literacy activities.This research emphasized the importance of a comprehensive approach to PD that involves hands-on AT experience and coaching to bolster the AT practices of early childhood educators.The multi-faceted PD provided to preschool staff increased children’s teacher-supported AT use but was not shown to result in increased gains in early literacy skills. These results highlight the need for additional focused research to elucidate how to best leverage AT to advance foundational early literacy competencies.Professional development that trains teachers and classroom assistants collaboratively as a unit promotes inclusive, empowered implementation and allows for integrated AT planning that utilizes assistants’ expanding roles vis-á-vis students with disabilities.Future research should investigate flexible coaching approaches, just-in-time learning, and train-the-trainer models that cultivate site-based AT expertise and on demand resources to provide ongoing, tailored support and build local capacity, promoting sustainability and mitigating barriers like time constraints and high teacher turnover.This research emphasized the importance of a comprehensive approach to PD that involves hands-on AT experience and coaching to bolster the AT practices of early childhood educators.The multi-faceted PD provided to preschool staff increased children’s teacher-supported AT use but was not shown to result in increased gains in early literacy skills. These results highlight the need for additional focused research to elucidate how to best leverage AT to advance foundational early literacy competencies.Professional development that trains teachers and classroom assistants collaboratively as a unit promotes inclusive, empowered implementation and allows for integrated AT planning that utilizes assistants’ expanding roles vis-á-vis students with disabilities.Future research should investigate flexible coaching approaches, just-in-time learning, and train-the-trainer models that cultivate site-based AT expertise and on demand resources to provide ongoing, tailored support and build local capacity, promoting sustainability and mitigating barriers like time constraints and high teacher turnover. [ABSTRACT FROM AUTHOR]

Stepped wedge cluster randomized experiments (SW‐CREs) represent a class of unidirectional crossover designs. Although SW‐CREs have become popular, definitions of estimands and robust methods to target estimands under the potential outcomes framework remain insufficient. To address this gap, we describe a class of estimands that explicitly acknowledge the multilevel data structure in SW‐CREs and highlight three typical members of the estimand class that are interpretable. We then introduce four analysis of covariance (ANCOVA) working models to achieve estimand‐aligned analyses with covariate adjustment. Each ANCOVA estimator is model‐assisted, as its point estimator is consistent even when the working model is misspecified. Under the stepped wedge randomization scheme, we establish the finite population Central Limit Theorem for each estimator. We study the finite‐sample operating characteristics of the ANCOVA estimators in simulations and illustrate their application by analyzing the Washington State Expedited Partner Therapy study. [ABSTRACT FROM AUTHOR]

Background: Intensive lifestyle interventions were effective to reduce the risk of type 2 diabetes mellitus (T2DM) for women with gestational diabetes mellitus (GDM) history. However, reaching these mothers and maintaining participation in lifestyle interventions is suboptimal in real-world settings. Effective, feasible and sustainable new lifestyle interventions are needed. The objectives of this three-arm trial are to (1) compare diabetes risk outcomes of an evidence-based intensive lifestyle modification (ILSM) intervention, a camp-style lifestyle modification program (CAMP) intervention, and usual care among women with GDM history; and (2) evaluate the comparative efficacy of the CAMP versus ILSM intervention on implementation outcomes. Methods: A three-arm cluster randomized clinical trial (RCT) using a hybrid type 2 implementation design will be conducted in two counties in Hunan province in China. Six towns from each county will be randomly selected and assigned to CAMP, ILSM, and the usual care group (25 women from each of 12 towns, 100 women in each arm). The ILSM includes six biweekly in-person sessions and 3-month telephone health consultations, while the CAMP consists of a 2-day camp-based session and 3-month health consultations via a popular social media platform. Both interventions share the same session content, including six lifestyle skills. Efficacy (T2DM risk score and behavioral, anthropometric, psychosocial, and glycemic variables) and implementation outcomes (recruitment, acceptability, feasibility, fidelity, and cost-effectiveness) will be collected at baseline, 6-month, and 12-month. Pre-planned ANOVA F-test and generalized estimating equations will be included to test time-by-arm interactions. Discussion: The CAMP intervention is expected to have better reach, better attendance, and comparable effectiveness in reducing the risk of T2DM, thus improving postpartum care for GDM in China. The delivery of a concentrated format supplemented with technology-based support may provide an efficient and effective delivery model for implementing maternal health promotion programs in primary care settings. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2200058150) on 31st March 2022. [ABSTRACT FROM AUTHOR]

This study investigates the effectiveness of using Hospital Fit as part of usual care physiotherapy on the physical activity (PA) behavior of hospitalized patients compared to patients who received physiotherapy before implementation of Hospital Fit. In addition, a process evaluation is conducted. A prospective, multi-center, mixed-methods stepped wedge cluster randomized trial was performed at the cardiology and medical oncology departments of two Dutch university medical centers. Patients were included in the non-intervention or intervention phase. During the non-intervention phase, patients received usual care physiotherapy. During the intervention phase, Hospital Fit was additionally used. Mean time spent walking, standing, lying/sitting per day and the number of postural transitions from lying/sitting to standing/walking positions were measured using an accelerometer and analyzed using linear mixed models. A process evaluation was performed using questionnaires and semi-structured interviews with patients and focus-group interviews with healthcare professionals. A total of 77 patients were included, and data from 63 patients were used for data analysis. During the intervention phase, the average time spent walking per day was 20 min (95% confidence interval: −2 to 41 min) higher than during the non-intervention phase (p = 0.075). No significant differences were found for mean time spent standing per day, mean time spent lying/sitting per day, or the number of postural transitions per day either. During the intervention phase, 87% of patients used Hospital Fit at least once, with a median daily use of 2.5 to 4.0 times. Patients and healthcare professionals believed that Hospital Fit improved patients' PA behavior and recovery. Insufficient digital skills and technical issues were described as challenges. Although patients and healthcare professionals described Hospital Fit as an added value, no statistically significant effects were found. [ABSTRACT FROM AUTHOR]

A study conducted in Uganda suggests that using C-reactive protein (CRP) levels to guide the evaluation of young children with lower respiratory tract infections (LRTIs) may help reduce the prescription of antimicrobial therapy without increasing treatment failure rates. LRTIs are a leading cause of morbidity and mortality in children, but there is no clinically feasible reference standard for their diagnosis. The study found that incorporating CRP into the routine management of LRTIs among young children resulted in a nearly 25% reduction in antimicrobial therapy prescriptions, with no difference in clinical outcomes. However, further research is needed to determine the optimal CRP level for withholding antimicrobial therapy and to consider the potential inconveniences and costs associated with implementing this approach. [Extracted from the article]

Background: Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. While evidence on poor PCMC prevalence, as well as inequities, expanded in the last decade, there is still a significant gap in evidence-based interventions to address PCMC. We describe the protocol for a trial to test the effectiveness of the "Caring for Providers to Improve Patient Experience" (CPIPE) intervention, which includes five strategies, targeting provider stress and bias as intermediate factors to improve PCMC and address inequities. Methods: The trial will assess the effect of CPIPE on PCMC, as well as on intermediate and distal outcomes, using a two-arm cluster randomized controlled trial in 40 health facilities in Migori and Homa Bay Counties in Kenya and Upper East and Northeast Regions in Ghana. Twenty facilities in each country will be randomized to 10 intervention and 10 control sites. The primary intervention targets are all healthcare workers who provide maternal health services. The intervention impact will be assessed among healthcare workers in the study health facilities and among women who give birth in the study health facilities. The primary outcome is PCMC measured with the PCMC scale, via multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to the intervention), midline (6 months after intervention start), and endline (12 months post-baseline) (N = 2000 across both countries at each time point). Additionally, 400 providers in the study facilities across both countries will be followed longitudinally at baseline, midline, and endline, to assess intermediate outcomes. The trial incorporates a mixed-methods design; survey data alongside in-depth interviews (IDIs) with healthcare facility leaders, providers, and mothers to qualitatively explore factors influencing the outcomes. Finally, we will collect process and cost data to assess intervention fidelity and cost-effectiveness. Discussion: This trial will be the first to rigorously assess an intervention to improve PCMC that addresses both provider stress and bias and will advance the evidence base for interventions to improve PCMC and contribute to equity in maternal and neonatal health. Trial registration: ClinicalTrials.gov: NCT06085105. Protocol version and date: v2-11-07-23 [ABSTRACT FROM AUTHOR]

Background: Poor early childhood development (ECD) is a major global health concern that is associated with various adverse outcomes over the lifecourse. Parenting interventions especially during the earliest years of life can benefit ECD. However, there is limited evidence from Kenya about the effectiveness of parenting interventions for improving ECD outcomes especially across rural disadvantaged communities. This paper describes the study protocol for an impact and implementation evaluation of a community-based group parenting program that aims to improve ECD in rural Kenya. Methods: We will conduct a cluster-randomized controlled trial to determine the effectiveness of a parenting program for caregivers of young children in Homabay and Busia counties in Western Kenya. Sixty-four village clusters will be randomly assigned to either the parenting intervention arm or the waitlist control arm with stratification by county. In each village, 10 primary caregivers with a child aged 0–24 months will be enrolled. The parenting program will be delivered through existing peer groups within communities whereby caregivers will receive counseling and psychosocial support to enhance their parenting skills and wellbeing to in turn promote ECD. The intervention curriculum comprises 21 sessions targeting various nurturing care messages, including early learning, responsive caregiving, child nutrition, health, protection, and caregiver mental health. Group sessions are facilitated by a trained volunteer biweekly for a total of 11 months. The primary trial outcome is an overall measure of ECD using the Global Scales of Early Development long form version. Secondary outcomes include various caregiver outcomes (e.g., parenting practices, mental health) and other child outcomes (e.g., socioemotional development, dietary diversity). All outcomes will be assessed at baseline and endline. We will also conduct a qualitative implementation evaluation at endline and interview various stakeholders to assess program fidelity, quality, and sustainability. Discussion: This trial will evaluate the effectiveness of a parenting intervention on ECD and caregiving outcomes and assess program implementation quality as delivered through existing community-based peer groups. This study will provide rigorous evidence that can be used to inform scale-up of this program model that leverages existing community social networks and resources for improving caregivers' parenting skills and promoting ECD in rural Kenya and other similar settings across LMICs. Trial registration: ClinicalTrials.gov #NCT06165315. Registered on December 11, 2023. [ABSTRACT FROM AUTHOR]