Cluster-randomized Trial Research Articles

An analytical cross-sectional study on optimal (timely or cumulative age-appropriate) routine childhood immunization coverage in the communities of Ebonyi state, Nigeria

Optimal (timely or cumulative age-appropriate) routine childhood immunization coverage (the receipt of every recommended vaccine dose at the recommended age and time-interval between doses) will enhance optimal protection against vaccine-preventable infectious diseases (VPDs) which have been causing significant morbidity and mortality and recurring outbreaks among children younger than five years. This study evaluated optimal routine childhood immunization coverage, and the predictors, in Ebonyi state, Nigeria. This study was a baseline cross-sectional household survey within a cluster-randomised controlled trial and was conducted from July 2 to 16, 2022 among consenting mother–child pairs, in which the children were aged 5–23 months (subdivided into 5–11 and 12–23 months), in 16 randomly selected geographical clusters where the primary health care (PHC) facilities were providing maternal and child health care services including weekly routine childhood immunization. Data was collected using structured interviewer-administered questionnaire in KoBoCollect in android devices. Vaccination data was collected from the vaccination cards of the children. Descriptive analysis and multivariate generalized estimating equations were carried out. Of 1262 children aged 5–11 months, 8.6% had optimal (timely or cumulative age-appropriate) receipt of every recommended birth to 14 weeks vaccine (this was 18.3% of the 596 who had received every recommended vaccine dose) and the median (IQR) receipt timeliness (age-appropriate vaccines receipt) score for the recommended birth to 14 weeks vaccines by these children was 79.3 (64.9–91.7). Of 1166 children aged 12–23 months, 2.9% had optimal receipt of every recommended birth to nine months vaccine (this was 10.6% of the 320 who had received every recommended vaccine dose) and the median receipt timeliness score for the recommended birth to nine months vaccines was 65.0 (45.8–84.4). The most significant predictor of optimal (timely or cumulative age-appropriate) routine childhood immunization coverage of every recommended vaccine was decrease in the travel time to immunization facility. Other predictors were having a mother who completed secondary or higher education, delivery at a health facility, decrease in the age of the husband of the mother, decrease in the birth order of the child, and urban/semi-urban residence. The evidence calls for policy actions and interventions to increase optimal routine childhood immunization coverage, and indicate specific factors to be considered, in the efforts to tackle the recurring outbreaks of VPDs.

Sleep health epidemiology and associations with menstrual health, mental health, and educational performance among in-school female adolescents in Uganda: A longitudinal study.

Few studies have assessed sleep among African adolescents. We aim to understand factors associated with subjective sleep quality among female Ugandan adolescents and the association of poor sleep quality with subsequent menstrual- and mental health, and educational performance. We analyzed data from a cluster-randomized controlled trial that evaluated a menstrual health intervention in 60 Ugandan secondary schools. Data were collected through cross-sectional surveys at baseline (March-June 2022) and endline (July-August 2023), and prospective daily diaries (April-August 2023). We used logistic regression to analyze associations with poor sleep at baseline, and linear regression to analyze associations of poor sleep with subsequent menstrual and mental health, and education performance, adjusting for clustering. Of 3841 female participants (mean age=15.6years), 580 (15.1%) reported poor sleep quality and 829 (21.6%) reported feeling tired at baseline. Poor sleep was associated with socio-economic factors including smaller household size, lower socioeconomic status, and fewer meals consumed the previous day. There was strong evidence that poor sleep at baseline was associated with multiple dimensions of poor menstrual health including menstrual pain (adjusted odds ratio=1.74, 95%CI 1.29-2.33), more unmet menstrual practice needs (adjusted odds ratio=2.68, 95%CI 1.99-3.60), and with mental health problems (adjusted odds ratio=2.40, 95%CI 1.80-3.19). Results were similar for baseline tiredness. Prospectively reported poor sleep quality was associated with subsequent poor menstrual and mental health, and subsequent poor educational performance. Poor sleep is prevalent among in-school female Ugandan adolescents and is associated with subsequent poorer menstrual health, mental health, and educational performance. Improving sleep in this population could benefit menstrual health, mental health and education outcomes.

206. A Cluster Randomized Trial Evaluating Universal Gloving for Reducing Clostridioides difficile Acquisition and Infection in VA: The GloRI Study

Abstract Background Clostridioides difficile infection (CDI), the most common healthcare associated infection (HAI) in U.S. hospitals, causes half a million infections and 30,000 deaths annually. Prevention of hospital-onset (HO) CDI has quickly become a priority for most hospitals. Hospital exposure to C. difficile can occur through cross-contamination of healthcare personnel (HCP) hands or through shared environmental surfaces or equipment. Infection prevention measures focus on HCP hand hygiene and barrier precautions (i.e., gowns and gloves) and cleaning of environmental surfaces, especially for patients with known CDI. However, colonized patients can also serve as a reservoir for cross-contamination, and microbiological screening for C. difficile colonization is not routinely performed in healthcare. Methods We conducted a cluster randomized trial (CRT) in 10 inpatient units at 5 VA hospitals between April 2022 and December 2023 to evaluate the effectiveness of healthcare worker use of gloves for all patient contact (i.e., universal gloving) in reducing acquisition of C. difficile colonization (defined as negative PCR at admission and positive PCR at discharge) and HO-CDI (per NHSN LabID criteria, as adjudicated by facility infection prevention personnel for routine quality reporting). Results Of 9779 admissions, 780 consented to specimen collection. Table 1 displays preliminary data. At admission, 11.6% (intervention group) and 10.3% (control group) of patients tested were colonized with C. difficile. There were 474 patients with both admission and discharge perirectal swabs cultured for C. difficile. The C. difficile colonization acquisition rate was 12.9 per 1000 patient days of care (PDOC) for the intervention group and 10.3 for the control group (p=0.79). Unit-level aggregate data for the HO-CDI rate was 0.29 per 1000 PDOC for the intervention group and 0.57 for the control group (p=0.07). Conclusion No universal reduction in the acquisition of C. difficile was detected in acute care units implementing a gloving intervention compared with standard practice, but only 5% (474/9779) of admissions had complete testing data. A numerically lower but statistically nonsignificant HO-CDI rate was detected in the universal gloving group compared to standard practice. Disclosures Christopher D. Pfeiffer, MD, MHS, Department of Defense/Medpace: Grant/Research Support|Pfizer: Grant/Research Support

P-394. Prevention Of Infections In Cardiac Surgery (PICS)-Prevena Study – a pilot/vanguard factorial cluster cross-over RCT

Abstract Background Sternal surgical site infections (s-SSI) after cardiac surgery can lead to significant morbidity, mortality, and costs. Among cardiac surgery patients, the effects of negative pressure wound management is unknown.Table 1:Baseline CharacteristicsBMI= Body Mass Index; COPD= Chronic obstructive pulmonary disease; CABG= Coronary artery bypass graft; SD= Standard deviation Methods The PICS-PREVENA Vanguard study, a 2x2 factorial, open label, cluster-randomized crossover trial, was conducted at 2 hospitals in Ontario, Canada (NCT03402945). We randomized each site to one of four sequences of the four study arms – each arm combining either cefazolin mono vs. combination prophylaxis with vancomycin (not analyzed) with either standard wound dressing vs. the 3M Prevena incision management system (Prevena). Only diabetic or obese patients (BMI >30kg/m2) were eligible for the latter comparison. For this population, we report the feasibility and efficacy endpoints of the Prevena versus standard wound dressing interventions. Feasability was assessed by adherence to the study protocol and loss to follow-up. The primary efficacy outcome was a composite of deep and organ-space s-SSI within 90-days after surgery. We used mixed logistic regression, accounting for clusters as a random effect for analysis. Funding: KCI USA, Inc.Table 2:Outcomes at end of follow up (90 days)BMI= Body Mass Index; s-SSI= Sternal surgical site infections; SSI= surgical site infections; ICU= intensive care unit; OR= odds ratio; SD= Standard deviation; CI= confidence interval^ Mean Difference* For patients with open venous saphenous harvest Results Among the 4107 included patients, 2230 were obese or diabetic. Of these patients, 1208 underwent surgery during a standard wound dressing period, and 1022 during a Prevena allocated period (Figure and Table 1). Of the latter, 696 (68.1%) had Prevena applied. Loss to follow up was 3.6% for obese or diabetic patients. Deep and organ-space s-SSI occurred in 16 (1.6%) and 17 (1.4%) in the Prevena and standard wound dressing allocated periods, respectively (OR= 1.11, 95% CI: 0.56- 2.20). Other clinical outcomes (Table 2) did not suggest a difference: all s-SSI (3.8% vs. 3.4%, OR: 1.12, 95% CI: 0.71- 1.75), SSI on legs (0.5% vs. 0.3%, OR: 1.41, 95% CI: 0.38- 5.30), and 90-day mortality (3.8% vs. 4.7%; OR: 0.79 (95% CI: 0.52- 1.20). An on-treatment analysis showed similar results.Figure 1:Treatment assignmentBMI= Body Mass Index Conclusion The vanguard study showed challenges with introducing a novel technology as standard of care with only a 68% compliance overall, with non-compliance mostly driven by one of the sites. No conclusions should be drawn regarding the efficacy of Prevena, as this Vanguard phase was not powered for these outcomes. Disclosures Richard Whitlock, PhD, Abbott: Grant/Research Support|Atricure: Grant/Research Support|CytoSorbents: Grant/Research Support PJ Devereaux, MD, PhD, Abbott Diagnostics: Advisor/Consultant|Abbott Diagnostics: Grant/Research Support|AOP Pharma: Grant/Research Support|Astra Zeneca: Advisor/Consultant|Bayer: Advisor/Consultant|CloudDX: Monitoring Devices|Quidel Canada: Advisor/Consultant|Renibus: Advisor/Consultant|Roche Canada: Advisor/Consultant|Roche Diagnostics: Grant/Research Support|Siemens: Grant/Research Support|Trimedic: Advisor/Consultant Dominik Mertz, MD, MSc, KCI Inc. USA: Grant/Research Support

P-1774. Order sets paired with facilitation training to effectively reduce postoperative surgical prophylaxis

Abstract Background Inappropriate surgical antibiotic prophylaxis occurs in up to 40% of cases, primarily reflecting unnecessary postoperative doses ( >24hrs) in clean or clean-contaminated cases. It accounts for approximately 20% of all inappropriate use in children’s hospitals. We described order set outcomes from the Operatic Trial to compare two strategies, order set changes versus order set change with facilitation, to reducing excessive postoperative prophylaxis.Figure 1.Stepped-wedge trial design comparing order set change only (control) versus order set change plus a facilitation workshop (intervention) attended by the ASP team at the beginning of each step. Nine children’s hospitals were randomized to 1 of 3 cluster. Each cluster included 3 hospitals and each step was 6 months in duration. Methods The operatic trial was a stepped-wedge cluster randomized control trial with nine US children’s hospitals (11/1/2020-10/31/2023), with 6 steps lasting 6 months each (Figure 1). Antimicrobial stewardship teams were recruited and enrolled. After 6 months of all hospitals starting in control (step 0) of changing order sets, 3 hospital ASP teams in steps 1-3 participated in a virtual facilitation workshop (int). Facilitation is a strategy that supports people in health services organizations develop the means to change the structure and processes within settings, and clinicians can be educated on the skills and expertise to become an effective facilitator. Hospital ASP teams were surveyed every 2 months to evaluate order set changes. Results Approximately 75% of order set changes attempted were completed (65/85). Table 1 describes completed order set changes demonstrating a variety of specialties targeted and a focus on reducing prophylaxis duration. Importantly, only 4 were initiated and completed in the pre-intervention period, while the remaining were either initiated pre-intervention and completed post-intervention or initiated and completed post-intervention suggesting that facilitation training supported order set change completion. The median time to complete an order set change was 5 months. Individuals also reported other activities to support change, for example data dashboards and paper-based guidance. Conclusion Changing order sets is an effective approach to reduce excess antibiotic use in children’s hospitals. Facilitation played a role in the successful completion of order sets, including potentially assisting teams to complete order set changes that were initiated prior to facilitation training. Disclosures Jason G. Newland, MD, MEd, Moderna: Grant/Research Support|Pfizer: Grant/Research Support

179. INSPIRE Trial: A 92-Hospital Cluster Randomized Trial of INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection versus Routine Antibiotic Selection Practices for Patients with Skin and Soft Tissue Infections

Abstract Background Up to 40% of hospitalized patients receive extended-spectrum (ES) antibiotics despite low risk of multidrug-resistant organism (MDRO) infection, increasing the risk for adverse effects and future resistance. We evaluated whether computerized physician order entry (CPOE) prompts providing patient-specific MDRO risk estimates could reduce ES antibiotic use compared to routine stewardship practices in patients hospitalized with skin and soft tissue (SST) infections. Methods This 92-hospital cluster-randomized trial compared CPOE prompts providing patient-specific absolute risk estimates for MDRO SST infection and recommending standard-spectrum antibiotics for risk < 10% vs. routine stewardship. Trial population: adults treated with antibiotics for SST infection in non-ICUs in the first 3 days of admission (empiric period). Prompts were triggered if ES antibiotics were ordered. Trial periods: 12-month Baseline (Jan 2019-Dec 2019); 5-month Phase-in (Aug 2022–Dec 2022); 12-month Intervention (Jan 2023-Dec 2023). Primary outcome: ES antibiotic days of therapy (ES-DOT) per patient per empiric day; secondary outcome was anti-pseudomonal DOT per empiric day. Unadjusted, as-randomized analyses used (1) generalized linear mixed effects models to assess differences in ES-DOT rates across intervention and baseline periods between groups, clustering by patient, hospital, and period and (2) proportional hazards models to assess safety outcomes: days to ICU transfer and hospital LOS. Results We randomized 92 hospitals in 15 states. Across the baseline and intervention periods there were 60,654 and 57,655 non-ICU patients with skin and soft tissue infection in the routine and CPOE prompt groups, respectively. The CPOE prompt group had a 28% reduction in ES-DOT compared to routine care (rate ratio 0.72 [95% CI 0.67-0.79], p< 0.001). Anti-pseudomonal DOT was reduced by 28% (Table, Figure 1) without significant differences in LOS or ICU transfers. Conclusion INSPIRE CPOE prompts providing patient-specific MDRO risk estimates recommending standard spectrum antibiotics in low risk patients significantly reduced empiric ES prescribing in adults admitted with skin and soft tissue infection. Disclosures Ken Kleinman, ScD, Xttrium Laboratories: Conducting studies in which participating hospital patients received contributed antiseptic products outside the submitted work Richard Platt, MD, MSc, GlaxoSmithKline: Contract to academic department|Janssen: Contract to academic department|Pfizer: Contract to academic department Susan Huang, MD, MPH, Xttrium Laboratories: Conducting studies in which participating hospital patients received contributed antiseptic products outside the submitted work

444. SHEA FEATURED ORAL ABSTRACT: INSPIRE Trial: A 92-Hospital Cluster Randomized Trial of INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection versus Routine Antibiotic Selection Practices for Patients with Abdominal Infections

Abstract Background Up to 40% of hospitalized patients receive empiric extended-spectrum (ES) antibiotics despite low risk of multidrug-resistant organism (MDRO) infection, increasing the risk for adverse effects and future resistance. We evaluated whether computerized physician order entry (CPOE) prompts providing patient-specific MDRO risk estimates could reduce ES antibiotic use compared to routine stewardship in patients hospitalized with abdominal infections. Methods This 92-hospital cluster-randomized trial compared CPOE prompts providing patient-specific absolute risk estimates for MDRO abdominal infection and recommending standard-spectrum antibiotics for risk < 10% vs. routine stewardship. Trial population: adults treated with antibiotics for abdominal infection in non-ICUs in the first 3 days of admission (empiric period). Prompts were triggered if ES antibiotics were ordered. Trial periods: 12-month Baseline (Jan 2019-Dec 2019); 5-month Phase-in (Aug 2022–Dec 2022); 12-month Intervention (Jan 2023-Dec 2023). Primary outcome: ES antibiotic days of therapy (ES-DOT) per patient per empiric day; secondary outcomes were a) vancomycin and b) anti-pseudomonal DOT per empiric day. Unadjusted, as-randomized analyses used (1) generalized linear mixed effects models to assess differences in ES-DOT rates across intervention and baseline periods between groups clustering by patient, hospital, and period and (2) proportional hazards models to assess safety outcomes: days to ICU transfer and hospital LOS. Results We randomized 92 hospitals in 15 states. Across baseline and intervention periods there were 100,890 and 97,680 non-ICU patients with abdominal infection in the routine and CPOE prompt groups, respectively. The CPOE prompt group had a 35% reduction in ES-DOT compared to routine care (rate ratio 0.65 [95% CI 0.60-0.71], p< 0.001). Vancomycin and anti-pseudomonal DOT were reduced by 20% and 39%, respectively (Table, Figure 1) without significant differences in LOS or ICU transfers. Conclusion INSPIRE CPOE prompts providing patient-specific MDRO risk estimates recommending standard spectrum antibiotics in low risk patients significantly reduced empiric ES prescribing in adults admitted with abdominal infection. Disclosures Ken Kleinman, ScD, Xttrium Laboratories: Conducting studies in which participating hospital patients received contributed antiseptic products outside the submitted work Richard Platt, MD, MSc, GlaxoSmithKline: Contract to academic department|Janssen: Contract to academic department|Pfizer: Contract to academic department Susan Huang, MD, MPH, Xttrium Laboratories: Conducting studies in which participating hospital patients received contributed antiseptic products outside the submitted work

Neonatal outcomes and resuscitation practices following the addition of heart rate-guidance to basic resuscitation.

To evaluate the impact of heart rate-guided basic resuscitation compared to Helping Babies Breathe on neonatal outcomes and resuscitation practices in the Democratic Republic of the Congo. We conducted a pre-post clinical trial comparing heart rate-guided basic resuscitation to Helping Babies Breathe in three facilities, enrolling in-born neonates ≥28 weeks gestation. We collected observational data during a convenience sample of resuscitations and extracted clinical data from the medical record for all participants. We evaluated our primary outcome of effective breathing at three minutes after birth among newborns not breathing well at 30 seconds after birth employing generalized linear models using maximum likelihood estimation. Among 1,284 newborns with observational data, there was no difference in the proportion effectively breathing at three minutes (adjusted relative risk 1.08 [95% CI 0.81, 1.45]). Among 145 receiving bag mask ventilation, time to bag mask ventilation decreased 64.3 seconds during heart rate-guided resuscitation (p<0.001). Among 10,906 enrolled in the trial, perinatal mortality was unchanged (adjusted relative risk 1.19 [95% CI 0.96, 1.48]) and death before discharge increased (adjusted relative risk 1.43 [95% CI 1.03, 1.99]). Expert review of stillborn cases demonstrated a stillbirth misclassification rate of 33.3% during Helping Babies Breathe versus 5.9% in heart rate-guided resuscitation. During heart rate-guided basic resuscitation, time to bag mask ventilation was reduced by greater than one minute. The increase in death before discharge and unchanged perinatal mortality may be due to resuscitation of newborns with a higher risk of mortality who were previously presumed stillborn. A cluster-randomized trial of heart rate-guided basic resuscitation is needed to evaluate its impact on neonatal mortality in low-resource settings.

Protocol for the economic evaluation of integrated community-based care compared with integrated facility-based care for HIV, hypertension and diabetes in Tanzania and Uganda (INTE-COMM trial)

Background The number of people living with multiple chronic conditions in sub-Saharan Africa is increasing, but health facilities are unable to meet demand. To improve health system capacity and access to care, community models of HIV care have been trialled in countries such as Tanzania and Uganda. However, no evidence exists to inform policymakers on the effectiveness and cost-effectiveness of integrated community-based models of care for HIV and chronic non-communicable conditions. This protocol outlines a within-trial economic evaluation to address this gap. Methods &amp; analysis We will estimate the costs and cost-effectiveness of integrated community-based care for HIV, hypertension and diabetes compared with facility-based care within the INTE-COMM pragmatic cluster-randomised trial in Tanzania and Uganda. Analyses will adopt a 52-week time horizon, the duration of trial follow-up. The full enrolled trial sample will be analysed from a societal perspective, comprising provider and patient perspectives. Economic costs will be estimated, which includes valuing inputs such as donated goods or time foregone by participants because of receiving care. For provider costs, participant case report forms will inform resource use along with data from facilities and community sites. Resources will be valued using project accounts, facility spending, and locally available cost data. Patient costs will be estimated based on a care-seeking and cost questionnaire administered to participants. Estimated costs will be analysed with co-primary trial outcomes on plasma viral load suppression, glycaemia and blood pressure control to calculate incremental cost-effectiveness ratios (ICER). We will also calculate ICERs for secondary trial outcomes related to health-related quality of life and wellbeing. Cost drivers and outcomes will be varied within confidence bounds in a two-way sensitivity analysis. We will investigate equity impact by estimating the mean difference in outcomes between integrated community-based and facility-based care across household socio-economic quintiles and by measuring whether participants incurred catastrophic health expenditures. Trial registration number The ISRCTN Registry: ISRCTN15319595. Registered on 07 June 2022: https://doi.org/10.1186/ISRCTN15319595

Addressing healthcare disparities and improving osteoporosis management in rural communities: a cluster randomized control trial.

Rural communities face limited healthcare access, financial constraints, and transportation barriers leading to health disparities. This study examined interventions that reduced health disparities in increasing the outpatient attendance and treatment rate of anti-osteoporosis medication (AOM), while identifying factors contributing to therapy refusal in rural communities. A total of 567 patients were randomized at the community level into three groups: multicomponent integrated care (MIC), osteoporosis care only (OC), and usual care (UC). Fracture Risk Assessment Tool and dual-energy X-ray absorptiometry scans were used to evaluate the osteoporosis and osteoporotic fracture risk. High- and moderate-risk patients were advised to pursue further hospital-based assessments and treatment. Both the MIC and OC groups received five interventions to address rural barriers, including specialist access, disease education, overcoming transportation barriers, peer support, and dedicated case managers. However, UC excluded transportation assistance, peer support, and case management. Outcomes measured included outpatient attendance, AOM treatment rates, and factors affecting hospital assessment refusal, analyzed via multivariable logistic modeling. In the MIC group, 73.3% of patients attended the outpatient clinic and 58.6% received AOM. In the OC group, 81% patients attended and 69.3% received AOM. Conversely, in the UC group, only 4.1% attended and received AOM. Significant differences in attendance and AOM rates were found between the MIC and UC groups and between the OC and UC groups (p < .001 for both). Common barriers included beliefs that treatment was unnecessary and lack of hospital access. Risk factors hindering outpatient attendance include male sex, low education, low budget, multiple disabilities, and osteopenia diagnosis. Addressing transportation barriers and implementing dedicated case management are crucial for improving healthcare access among rural patients. ClinicalTrials.gov NCT05104034.

A randomised controlled implementation trial of the feasibility and effectiveness of school staff delivery of a selective substance use and mental health program during the COVID-19 pandemic

BackgroundPreventure is a selective school-based personality-targeted program that has shown long-term benefits in preventing student alcohol use, internalising and externalising problems when delivered by psychologists. In this first Australian randomised controlled trial of school staff implementation of Preventure, we aimed to examine i) acceptability, feasibility, and fidelity and ii) effectiveness of Preventure on student alcohol use, internalising, and externalising symptoms.MethodsA cluster-randomised controlled implementation trial was conducted in Sydney, Australia and was guided by the RE-AIM framework (Glasgow et al. 1999); which measures reach, effectiveness, adoption, implementation, and maintenance. Schools were randomly assigned to either the Preventure intervention or active control (health education as usual). Nominated school staff from intervention schools received training and delivered the program to students with elevated scores on one of four personality types targeted in the program. School staff completed surveys on RE-AIM measures, which were analysed using descriptive statistics and thematic analysis. Students completed surveys at baseline and six months post-intervention; mixed-effects regression examined intervention by time interactions on alcohol use, internalising and externalising problems, at six-month follow-up. The study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000790943, registration date 6 August 2020).Results553 students across 8 schools participated in the baseline survey. Of these, 40% had elevated scores on one of the four personality profiles, resulting in 220 students in the current study (102 students in intervention schools, 118 students in control schools; mean age 13.6, 45.7% female). Most RE-AIM domains showed high ratings, with school staff showing good adherence and confidence in delivery. However, teachers reported difficulties with feasibility, particularly a lack of time. Student outcomes: There were significant improvements in depression and conduct problems across both intervention and control across time. There were no significant main or interaction effects of the intervention on student alcohol use, internalising, or externalising problems.DiscussionTeachers and students rated the program highly. However, concerns around feasibility may limit teacher-led application of the program in the Australian context. Alternative approaches, such as delivery by dedicated personnel within schools without a teaching load, may be critical in implementing such evidence-based interventions at scale.Trial registrationThe study was prospectively registered with the Australian New Zealand Clinical Trials Registry, registration number: ACTRN12620000790943, registration date: 6 August 2020.

Community benefits of mass distribution of three types of dual-active-ingredient long-lasting insecticidal nets against malaria prevalence in Tanzania: evidence from a 3-year cluster-randomized controlled trial

BackgroundLong-lasting insecticidal nets (LLINs) were once fully effective for the prevention of malaria; however, mosquitoes have developed resistance to pyrethroids, the main class of insecticides used on nets. Dual active ingredient LLINs (dual-AI LLINs) have been rolled out as an alternative to pyrethroid (PY)-only LLINs to counteract this. Understanding the minimum community usage at which these LLINs elicit an effect that also benefits non-users against malaria infection is important.MethodsWe conducted a secondary analysis of a 3-year randomized controlled trial (RCT) in 84 clusters in North-western Tanzania to evaluate the effectiveness of three dual-AI LLINs: pyriproxyfen and alpha(α)-cypermethrin, chlorfenapyr and α-cypermethrin, and the piperonyl-butoxide (PBO) and permethrin compared to α-cypermethrin only LLINs. We measured malaria infection prevalence using 5 cross-sectional surveys between 2020 and 2022. We assessed net usage at the cluster level and malaria infection in children aged from 6 months to 14 years in 45 households per cluster. The trial was registered as a clinical trial on www.clinicaltrials.gov: ClinicalTrials.gov (NCT03554616) on 2018-06-13.ResultsA total of 22,479 children from 12,654 households were tested for malaria using rapid diagnostic tests in January 2020, 2021, & 2022 and July 2020 & 2021. Among non-users, community-level usage of > 40% of dual-AI LLIN was significantly associated with protection against malaria infection: chlorfenapyr arm (OR: 0.44 (95% CI: 0.27–0.71), p = 0.0009), PBO arm (OR: 0.55 (95% CI: 0.33–0.94), p = 0.0277) and pyriproxyfen arm (OR: 0.61 (95% CI: 0.37–0.99), p = 0.0470) compared with non-users in clusters with > 40% usage of pyrethroid-only LLINs. There were indications of some protection against malaria infection to non-users in the chlorfenapyr arm when community-level usage was ≤ 40% (OR: 0.65 (95% CI: 0.42–1.01), p = 0.0528) compared to those living in clusters with > 40% usage of pyrethroid-only LLINs.ConclusionOur study demonstrated that at a community usage of 40% or more of dual-AI LLINs non-users benefited from the presence of these nets. Noticeably, even when usage was ≤ 40% in the chlorfenapyr arm, non-users were better protected than non-users in the higher coverage pyrethroid-only arm. The greater difference in malaria risk observed between users and non-users indicates that LLINs play a crucial role in providing personal protection against malaria infection for the people using the net.

Coding as another language: an early childhood programming curriculum in Argentina

ABSTRACT Background and context Early childhood computer science (CS) education is a high-priority focus worldwide, but early childhood CS tools are primarily developed and researched within the United States and Europe. As an example, the Coding as Another Language ScratchJr (CAL-ScratchJr) curriculum is used in multiple countries but was developed and evaluated in the United States. Objectives This paper describes the implementation and evaluation of an adapted CAL-ScratchJr curriculum in Mendoza and Corrientes, Argentina. Method We used mixed methods and a cluster-randomized control trial to evaluate curriculum success, measured by validated assessments and teacher interviews. Findings The curriculum significantly improved student coding knowledge and computational thinking. Teachers saw the curriculum as successful across multiple domains. Implications These findings reinforce that the success of CS education programs should be evaluated not only with internationally validated assessments but also by local understandings of success..

Use of the structured emergency nursing framework HIRAID® improves patient experience: A stepped-wedge cluster randomised control trial in rural, regional and metropolitan Australia.

Emergency departments have high levels of uncertainty, long wait times, resource shortages, overcrowding and a constantly changing environment. Patient experience and patient safety are directly linked, yet levels of patient experience are stagnant. To improve emergency nursing care and patient experience, an emergency nursing framework HIRAID® (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, communication, and reassessment) was implemented in 29 Australian emergency departments. To evaluate HIRAID® on patient experience in the emergency department. This modified stepped-wedge cluster randomised control trial was conducted in 29 Australian rural, regional and metropolitan emergency departments and involved over 1300 emergency nurses. A total 2704 (1456 control, 1248 intervention) surveys were completed. We hypothesised implementation of HIRAID® would result in an at least 5% increase in patient experience per Schmidt's Perceptions of Nursing Care Survey and Australian Hospital Patient Experience Question Set. Patients (of all ages) and/or their carers completed a phone interview. Data were analysed using descriptive statistics and Generalized Estimating Equations approaches. Median (IQR) participant age was 54 (31-67) years. The most common presenting problems were abdominal, chest and respiratory issues. Greater than 5% improvement in all categories of the Schmidt's Perceptions of Nursing Care Survey, and 10 out of 12 Australian Hospital Patient Experience Question Set was achieved. The implementation of the HIRAID® emergency nursing framework in Australian emergency departments significantly improved patient experience with emergency care. Demand for emergency care is increasing. Evaluating what methods work to effectively translate evidence to emergency practice, improve patient experience in the complex emergency setting is crucial. We present how a behaviour change informed implementation strategy enabled maximum, sustained uptake of an intervention that improved patient experience in a variety of emergency settings despite the COVID-19 pandemic and catastrophic flooding. ANZCTR, ACTRN12621001456842. 25.10.2021.

Implementation of An Advance Care Planning Intervention in Dialysis Clinics.

Sharing Patient's Illness Representations to Increase Trust (SPIRIT) is an evidence-based advance care planning intervention targeting dialysis patients and their surrogate decision-makers. To address SPIRIT's implementation potential, we report on a process evaluation in our recently completed five-state cluster-randomized trial. A descriptive study of implementation within a randomized clinical trial. 231 patient-surrogate dyads and 60 dialysis care providers in the 22 active intervention clinics. Status as a patient/surrogate, care provider, or care provider "champion" who all were randomized to clinics implementing the SPIRIT implementation. OUTCOME(S): (1) Intervention reach (e.g., number of dyads who received SPIRIT relative to each clinic's census); (2) fidelity (e.g., champions' self-evaluation checklists, patient and surrogate surveys); (3) sustainability (patient, surrogate and dialysis care provider acceptability surveys); and (4) context (e.g., clinic characteristics). 191 (82.7%) completed SPIRIT session 1 and 146 (76.4% of 191) completed the optional session 2. Of the 40 champions, 34 completed at least one SPIRIT session 1. Champions reported that all six intervention steps were completed in 98% to 100% of their sessions. The median duration of session 1 and session 2 were 60 minutes and 15 minutes, respectively. The acceptability surveys suggested a high-level of acceptance by patients, surrogates, and providers. Champions reported the main benefits of SPIRIT to be enhanced learning; communication; and improved relationships for patients, surrogates, and providers. The challenges champions reported were scheduling a time that worked for the patient, surrogate, and champion; feeling torn between SPIRIT and other clinical demands; and the emotional burden on the champions themselves. The lack of data on actual continued use of SPIRIT and low provider participation in acceptability survey. This study suggests that SPIRIT was delivered with high fidelity and was experienced positively by stakeholders. However, challenges such as staffing and emotional burden required clinic-level support and warrant future studies testing implementation strategies to address these barriers.

DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care

ObjectivesProton pump inhibitors (PPIs) are widely prescribed medications and commonly used for the treatment of gastric acid-related disorders. Nevertheless, PPIs are often overused leading to potential adverse effects and unnecessary...

Acceptability and effectiveness of a study information video in improving the research consent process for youth: a non-inferiority trial

IntroductionObtaining informed consent for research includes the use of information sheets, which are often long and may be difficult for participants to understand. We conducted a trial to investigate whether...

Effects of an intervention on immigrant parents' knowledge and attitudes toward their children's oral health: A cluster randomized trial in Norway.

There are no interventional studies on the oral health of immigrant children in Norway. This study aimed to assess the effectiveness of a culturally adapted oral health intervention for parental knowledge, attitude to oral hygiene, attitude to diet, and indulgence (permissiveness toward oral hygiene and sugar intake) concerning their children's oral health. A cluster randomized control trial, including immigrant parents of newborns, was conducted at seven health centers in Bergen (Norway) involving a 2-session one-to-one motivational interviews, toothbrushing demonstrations and pamphlets in the participants' native languages at baseline and after 6 months. Mean differences in outcome scores were assessed and compared between intervention and control groups using generalized linear mixed model. In an intention-to-treat (ITT) analysis (n=345), the estimated mean difference in parental attitude to diet and indulgence between the groups indicated more improvement in the control than in the intervention group in the adjusted models. For all outcomes within both groups, a slight positive change was observed in marginal mean scores from baseline to follow-up. The two culturally adapted intervention sessions had no impact on oral health-related knowledge, attitudes, and indulgence of immigrant parents. These findings suggest that more comprehensive interventions may be needed to improve parental knowledge and attitudes toward children's oral health. Trial Registration number: ClinicalTrials.gov Identifier: NCT05758454.

Promoting water consumption among children through a social network intervention: a cluster randomized controlled trial on a Caribbean island

Abstract Aim This study examined the effect of the evidence-based adapted social network intervention named Kies Awa (translation: Choose Water) on children’s water and sugar-sweetened beverages (SSB) consumption. It also examined the moderating role of children’s descriptive and injunctive norms of water and SSB consumption on the intervention’s effect. Subject and methods We conducted a cluster randomized control trial (RCT) where schools were randomized to one of two clusters: the intervention group (IG; Kies Awa intervention; 156 participants; M = 11.08, SD = 1.00; 53.8% girls) or the control group (CG; no intervention; 144 participants; M = 11.32, SD = 0.96; 52.8% girls). The primary outcome measure was water consumption and the secondary outcome was SSB consumption. Results Linear mixed modeling analyses showed that water consumption increased significantly more among IG participants than in the CG (β = 0.141; p = 0.015). The effect on SSB consumption was moderated by perceived injunctive norms, which refer to social disapproval of consuming SSBs. Specifically, the intervention reduced SSB consumption for participants reporting high levels of injunctive norms (β = -0.052; p = 0.037). Conclusion These findings suggest that Kies Awa, an evidence-based adapted intervention, could be implemented in other Caribbean islands to improve children’s water consumption. This approach could be integrated into school health programs, contributing to public health. These findings may help achieve the United Nations’ goal of ensuring healthy lives for all children, even in under-researched world regions. Clinical Trial Registration: Main ID number: NL-OMON26157, preregistration date 2018-12-20. https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON26157.

The Effects of Glucagon-Like Peptide-1 Receptor Agonists on Mitochondrial Function Within Skeletal Muscle: A Systematic Review.

Obesity is a chronic disease associated with increased risk of multiple metabolic and mental health-related comorbidities. Recent advances in obesity pharmacotherapy, particularly with glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), have the potential to transform obesity and type 2 diabetes mellitus (T2DM) care by promoting marked weight loss, improving glycaemic control and addressing multiple obesity-related comorbidities, with added cardio-renal benefits. Dual agonists combining GLP-1 with other enteropancreatic hormones such as glucose-dependent insulinotropic polypeptide (GIP) have also been developed in recent years, leading to greater weight loss than using GLP-1 RAs alone. However, up to 40% of the weight lost with GLP-1 RAs comes from lean body mass, raising concerns about potential adverse effects on skeletal muscle function. Mitochondrial dysfunction, characterized by reduced mitochondrial size and activity, is prevalent in individuals with obesity and T2DM and is a known contributor to muscle wasting in ageing and some chronic diseases. This systematic review investigates the impact of GLP-1-based therapies on skeletal muscle mitochondrial function in individuals with obesity and T2DM or in related animal and cell models. A comprehensive search of MEDLINE, Scopus, CINAHL and clinicaltrials.gov was conducted. Inclusion criteria included randomized controlled trials, randomized crossover trials, cluster randomized control trials and basic science studies involving any GLP-1 RA or GLP-1/GIP dual agonist. Outcomes of interest were skeletal muscle respiratory function either in the form of measurements of mass, number, content, oxidative capacity/respiratory function, mitochondrial dynamics, mitochondrial biogenesis and mitophagy. Eight studies were eligible for analysis; no human studies were identified. All of the included studies used GLP-1 RAs (single agonists) as intervention. The emerging evidence suggests that GLP-1 RAs increase mitochondrial area, number and morphology (i.e., reduces swelling). Data are conflicting on the effect of GLP-1 RAs upon mitochondrial mass, respiration and the expression of uncoupling proteins and PGC-1α. Data also demonstrate muscle specific (i.e., soleus vs. extensor digitorum longus) responses to GLP-1 RAs. GLP-1 RAs appear to have a positive effect upon mitochondria area, number and morphology, but effects upon other aspects of mitochondrial health remain inconclusive. Data are very limited and solely presented in animal and invitro models. Future studies should be conducted in human populations in order to begin to understand the effect of GLP-1 RAs and GLP-1-based therapies on human skeletal muscle mitochondria.