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Background: This study compares aspirin to enoxaparin for symptomatic VTE prophylaxis within 90 days of any type of hip or knee arthroplasty performed for any diagnosis, in patients enrolled in the CRISTAL trial. Materials and methods: CRISTAL was a cluster-randomised crossover, registry-nested non-inferiority trial across 31 hospitals in Australia. The primary publication was restricted to patients undergoing primary total hip or knee arthroplasty for a diagnosis of osteoarthritis. This report includes all enrolled patients undergoing hip or knee arthroplasty procedures (partial or total, primary or revision) performed for any indication. Hospitals were randomized to administer patients aspirin (100mg daily) or enoxaparin (40mg daily), for 35 days after hip arthroplasty and 14 days after knee arthroplasty. Crossover occurred after the patient enrolment target had been met for the first group. The primary outcome was symptomatic VTE within 90 days. Analyses were performed by randomization group. Results: Between April 20, 2019 and December 18, 2020, 12384 patients were enrolled (7238 aspirin group and 5146 enoxaparin). Of these, 6901 (95.3%) given aspirin and 4827 (93.8%) given enoxaparin (total 11728, 94.7%) were included in the final analyses. Within 90 days, symptomatic VTE occurred in 226 (3.27%) aspirin patients and 85 (1.76%) enoxaparin patients, significant for the superiority of enoxaparin (estimated treatment difference 1.85%, 95% CI 0.59% to 3.10%, p = 0.004). Joint-related reoperation within 90 days was lower in the enoxaparin group (109/4827 (2.26%) vs 171/6896 (2.47%) with aspirin, estimated difference 0.77%; 95% CI 0.06% to 1.47%, p = 0.03). There were no significant differences in the other secondary outcomes. Conclusion: In patients undergoing hip or knee arthroplasty (of any type, performed for any indication) enrolled in the CRISTAL trial, aspirin compared to enoxaparin resulted in a significantly higher rate of symptomatic VTE and joint-related reoperation within 90 days. These findings extend the applicability of the CRISTAL trial results. Trial registration: Anzctr.org.au, identifier: ACTRN12618001879257. [ABSTRACT FROM AUTHOR]

Background: Environmentally sustainable food initiatives accompanying nutrition education, such as the Food Education and Sustainability Training (FEAST) program, have gained traction in school settings. The aim of this trial was to conduct an impact and process evaluation of FEAST, to evaluate its effect on children's fruit and vegetable (F&V) intakes, and secondary outcomes: F&V variety consumed, nutrition knowledge, food preparation/cooking skills, self-efficacy and behaviours, food waste knowledge and behaviours, and food production knowledge. Methods: FEAST was a 10-week curriculum-aligned program, designed to educate children about healthy eating, food waste, and sustainability, while teaching cooking skills. It was implemented by classroom teachers, face-to-face and online, during COVID-19 school closures, in Australia in 2021. A custom designed survey was used to collect baseline and post-intervention data from students. Generalised linear mixed models (GLMM) estimated group differences in pre-post changes for primary and secondary outcomes. Surveys were also administered to students and teachers to evaluate intervention implementation. Results: Twenty schools participated and self-selected to be either intervention schools (n = 10) or wait-list control (WLC) schools (n = 10). A total of 977, 5th and 6th grade children participated in the trial with a mean age of 11.1 years (SD ± 0.7). The FEAST intervention, compared to WLC, did not result in significant increases in primary outcomes nor secondary outcomes. The process evaluation revealed FEAST was well-received by students and teachers, but COVID-19 school closures hindered implementation fidelity with a less intense program delivered under the constraints of pandemic lockdowns. Conclusions: This is the first cluster non-randomized controlled trial designed to independently evaluate FEAST in the primary-school setting. No evidence was found for improved F&V intakes in children, nor secondary outcomes. However, the positive process evaluation results suggest that further trials of the program are warranted. If implemented as originally designed (pre-pandemic), with increased duration and complemented by supporting school policies, such programs have the potential to improve children's daily F&V intakes, cooking skills and food waste behaviours. This would support the Australian curriculum and contribute to: health promotion within schools and sustainable schools initiatives, the national agenda to reduce food waste and sustainable development goals. Australian and New Zealand Clinical Trials Registry: [ACTRN12620001347954]- Registered prospectively on 14/12/2020. [ABSTRACT FROM AUTHOR]

Background: Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices. Methods: The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Discussion: TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections. Trial registration: ClinicalTrials.gov NCT03816111. Registered on 24 January 2019. [ABSTRACT FROM AUTHOR]

The Seniors Exercise Park program is an evidence-based outdoor physical and social activity program designed originally for older people with no cognitive impairment. This study aimed to pilot this program for people living with dementia in residential aged care. We examined the feasibility of delivering the program, evaluating its structure, safety, and supervision needs. In addition, physical, social, health and cognitive benefits of participation were examined. Method This was a feasibility pilot randomised controlled design. Adults aged ≥ 60 years with symptoms of dementia and/or diagnoses of dementia were recruited from an aged care facility in Australia. Participants allocated to the intervention underwent a 12-week structured supervised physical activity program using the outdoor Seniors Exercise Park equipment followed by a 12-week maintenance phase, while the controls received usual care programs. Assessments occurred at baseline, 12 and 24-weeks. Feasibility evaluation included recruitment rate, retention, attendance, overall adherence, dropout rate, adverse events, program delivery modifications and supervision requirements. A suite of cognitive and health-related questionnaires and physical function measures were also collected. Results Sixteen participants were recruited (recruitment rate: 58.6%), eight for the intervention (83.3 ± 7.5 years, 87.5% women) and eight for the control (age 87.5 ± 3.0 years, 87.5% women). Eighty-eight percent completed the 12-week structured program, with 75% retention at 24-weeks. Across the 24-week period, 84.3% participation adherence was reported. No falls or adverse events occurred. Modifications of the program mainly related to method of communication, cueing and adjustments to suit individual personality and characteristics. A ratio of one trainer to two participants was practical and safe. There were no significant changes over time between groups in any of the secondary outcomes. High level of engagement, enjoyment and mood was reported throughout the exercise program. Conclusion The Seniors Exercise Park physical activity program was safe and feasible for people living with dementia in residential care, with high levels of enjoyment, positive attitude, and engagement reported in the intervention group. Individualised communication during program delivery was needed to facilitate motivation and participation. Further research is needed to assess the program effectiveness on physical and cognitive function on a larger scale. Trial registration This trial is registered with the Australian New Zealand Clinical Trials Registry—Registry Number ACTRN12620000733976. Registered on the 13/07/2020. [ABSTRACT FROM AUTHOR]

Background: Childcare centres are important environments for promoting physical activity and healthy eating. Blended approaches to professional learning may help overcome existing challenges for educators in promoting these behaviours. This study aimed to test the effect of a blended professional learning program on healthy eating and physical activity in childcare.Methods: Cluster randomized stepped-wedge trial in 15 childcare centres in Tasmania, Australia. Children aged 2-5y who attended at least two days per week were eligible to participate. Random assignment occurred at the centre level. Centre names were drawn out of a hat and then subsequently allocated to one of the three steps. The intervention comprised a 12-week blended professional learning program for educators. The main outcome was centre-level physical activity and healthy eating, assessed using the Environment and Policy Assessment Observation System (EPAO). All data collectors were blinded to step allocation. Analyses were according to intention to treat. The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12618000346279, date registered: 07/03/2018).Results: Centres were recruited between January 2016 and February 2016. All centres were retained for the duration of the study. A total of 313 children were recruited with 291 analysed at the completion of the study (93%). The difference between groups for the EPAO total score was significant at the end of the maintenance period (adjusted difference = 14.63, 95% CI [1.33, 27.92], p = 0.03). Significant differences were found for the percentage of time children spent in light-intensity physical activity at the end of the intervention (adjusted difference = 0.01, 95% CI [0.00,0.01], p = 0.02) and maintenance periods (adjusted difference = 0.01, 95% CI [0.00,0.02], p = 0.04). To the best of the authors knowledge, there were no adverse events.Conclusion: This intervention achieved a sustained improvement in physical activity and healthy eating in childcare centres. Further, it can be easily integrated into existing service provision, especially among centres with limited access to professional learning.Trial Registration: The study was registered with the Australian and New Zealand Clinical Trials Registry ( ACTRN12618000346279 , date registered: 07/03/2018). [ABSTRACT FROM AUTHOR]

Background: Males in Australia and many other countries account for three-quarters of all deaths by suicide. School-based programs to support young men's wellbeing have become increasingly common in recent years and show much promise to tackle the issue of male suicide by fostering protective factors and mitigating harmful factors. However, only a few of these programs have been evaluated. This trial seeks to address the lack of knowledge about the potential for school-based gender-transformative programs to have a positive impact on boys. Breaking the Man Code workshops, delivered by Tomorrow Man in Australia, challenge and transform harmful masculinities with young men with a view to ultimately reducing their suicide risk. The trial aims to examine whether adolescent boys who participate in the Breaking the Man Code workshop demonstrate an increase in their likelihood of seeking help for personal or emotional problems compared to boys waiting to take part in the workshop.Methods: A stratified cluster randomized controlled superiority trial with two parallel groups will be conducted. Schools will be randomly allocated 1:1, stratified by location of the schools (rural or urban), state (Victoria, NSW, or WA), and mode of workshop delivery (face-to-face or online), to the intervention group and waitlist control group.Discussion: The Breaking the Man Code workshops show great promise as a school-based prevention intervention. The trial will fill a gap in knowledge that is critically needed to inform future interventions with boys and men. Some methodological challenges have been identified related to the COVID-19 pandemic in Australia, such as delays in ethics approvals and the need for Tomorrow Man to introduce an online delivery option for the workshop. The trial protocol has been designed to mitigate these challenges. The findings from the trial will be used to improve the workshops and will assist others who are designing and implementing suicide prevention interventions for boys and men.Trial Registration: Australian New Zealand Clinical Trials Registry ( ACTRN12620001134910 ). Registered on 30 October 2020. [ABSTRACT FROM AUTHOR]

The availability of direct‐acting antivirals (DAAs) sparked efforts to eliminate hepatitis C virus (HCV) in Australia. We evaluated whether an educational intervention of a 1‐h discussion among staff using audit and feedback data from the MedicineInsight GP programme would improve DAA uptake. Of 296 eligible general practices in MedicineInsight, 11% opted out. Randomization stratified by practice caseload allocated 130 practices to the intervention arm and 129 to control. The primary outcome was the number of patients started on DAAs over 6 months using the negative binomial regression model adjusted for DAA prescription history and clustering by practice. Data for analysis were available for 78% of practices, which included 101 practices and 2469 DAA‐naive patients with confirmed/possible HCV in the intervention arm, and 100 practices and 2466 patients in the control arm. At baseline, 49.5% of practices had prescribed ≥1 DAA in the past year; 18.9% of HCV patients had already been treated with DAAs; the mean age of DAA‐naive HCV patients was 43 years old, and 57% were men. Over 6 months, 43 patients in the intervention arm and 36 in the control arm started DAAs (adjusted IRR 1.19; 95% CI 0.67–2.11, p = 0.55). In the first 3 months, 27 vs 16 patients started DAAs (adjusted IRR 1.77, 0.88–3.58; p = 0.111). Few patients were started on DAAs, and a facilitated discussion in HCV management did not lead to a significant increase. Alternative measures, such as incentivizing GP initiations or patients, are suggested to address remaining barriers to DAA uptake in Australian primary care. Australian New Zealand Clinical Trial Registry (ANZCTR) Registration Number: ACTRN12619000508178p. [ABSTRACT FROM AUTHOR]

Purpose: To determine whether acute respiratory infection (ARI) decision aids and a general practitioner (GP) training package reduces antibiotic dispensing rate and improves GPs' knowledge of antibiotic benefit-harm evidence.Methods: A cluster randomized trial of 27 Australian general practices (13 intervention, 14 control) involving 122 GPs. Intervention group GPs were given brief decision aids for 3 ARIs (acute otitis media, acute sore throat, acute bronchitis) and video-delivered training. Primary outcome was dispensing rate of target antibiotic classes (routinely used for ARIs), extracted for 12 months before, and following, randomization. Secondary outcomes were GPs' knowledge of antibiotic benefit-harm evidence; prescribing influences; acceptability, usefulness, and self-reported resource use; and dispensing rate of all antibiotics.Results: The baseline mean dispensing rate of ARI-related antibiotics was 3.5% (intervention GPs) and 3.2% (control GPs) of consultations. After 12 months, mean rates decreased (to 2.9% intervention; 2.6% control): an 18% relative reduction from baseline but similar in both groups (rate ratio 1.01; 95% CI, 0.89-1.15). Greater increases in knowledge were seen in the intervention group than control; a significant increase (average 3.6; 95% CI, 2.4-4.7, P <.001) in the number of correct responses to the 22 knowledge questions. There were no between-group differences for other secondary outcomes. The intervention was well received, perceived as useful, and reported as used by about two-thirds of intervention GPs.Conclusions: A brief shared decision-making intervention provided to GPs did not reduce antibiotic dispensing more than usual care, although GPs' knowledge of relevant benefit-harm evidence increased significantly. [ABSTRACT FROM AUTHOR]

Background: Implementing evidence into clinical practice is a key focus of healthcare improvements to reduce unwarranted variation. Dissemination of evidence-based recommendations and knowledge brokering have emerged as potential strategies to achieve evidence implementation by influencing resource allocation decisions. The aim of this study was to determine the effectiveness of these two research implementation strategies to facilitate evidence-informed healthcare management decisions for the provision of inpatient weekend allied health services.Methods and Findings: This multicentre, single-blinded (data collection and analysis), three-group parallel cluster randomised controlled trial with concealed allocation was conducted in Australian and New Zealand hospitals between February 2018 and January 2020. Clustering and randomisation took place at the organisation level where weekend allied health staffing decisions were made (e.g., network of hospitals or single hospital). Hospital wards were nested within these decision-making structures. Three conditions were compared over a 12-month period: (1) usual practice waitlist control; (2) dissemination of written evidence-based practice recommendations; and (3) access to a webinar-based knowledge broker in addition to the recommendations. The primary outcome was the alignment of weekend allied health provision with practice recommendations at the cluster and ward levels, addressing the adoption, penetration, and fidelity to the recommendations. The secondary outcome was mean hospital length of stay at the ward level. Outcomes were collected at baseline and 12 months later. A total of 45 clusters (n = 833 wards) were randomised to either control (n = 15), recommendation (n = 16), or knowledge broker (n = 14) conditions. Four (9%) did not provide follow-up data, and no adverse events were recorded. No significant effect was found with either implementation strategy for the primary outcome at the cluster level (recommendation versus control β 18.11 [95% CI -8,721.81 to 8,758.02] p = 0.997; knowledge broker versus control β 1.24 [95% CI -6,992.60 to 6,995.07] p = 1.000; recommendation versus knowledge broker β -9.12 [95% CI -3,878.39 to 3,860.16] p = 0.996) or ward level (recommendation versus control β 0.01 [95% CI 0.74 to 0.75] p = 0.983; knowledge broker versus control β -0.12 [95% CI -0.54 to 0.30] p = 0.581; recommendation versus knowledge broker β -0.19 [-1.04 to 0.65] p = 0.651). There was no significant effect between strategies for the secondary outcome at ward level (recommendation versus control β 2.19 [95% CI -1.36 to 5.74] p = 0.219; knowledge broker versus control β -0.55 [95% CI -1.16 to 0.06] p = 0.075; recommendation versus knowledge broker β -3.75 [95% CI -8.33 to 0.82] p = 0.102). None of the control or knowledge broker clusters transitioned to partial or full alignment with the recommendations. Three (20%) of the clusters who only received the written recommendations transitioned from nonalignment to partial alignment. Limitations include underpowering at the cluster level sample due to the grouping of multiple geographically distinct hospitals to avoid contamination.Conclusions: Owing to a lack of power at the cluster level, this trial was unable to identify a difference between the knowledge broker strategy and dissemination of recommendations compared with usual practice for the promotion of evidence-informed resource allocation to inpatient weekend allied health services. Future research is needed to determine the interactions between different implementation strategies and healthcare contexts when translating evidence into healthcare practice.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000029291. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to test the effectiveness of the Whole of Systems Trial of Prevention Strategies for Childhood Obesity (WHO STOPS Childhood Obesity) for behavioral, health-related quality of life (HRQoL), and BMI outcomes.Methods: This was a cluster randomized trial of 10 communities randomly allocated (1:1) to start intervention in 2015 (step 1) or in 2019 (after 4 years) in South West Victoria, Australia. Data were collected from participating primary schools in April to June of 2015 (73% school participation rate), 2017 (69%), and 2019 (63%). Student participation rates were 80% in 2015 (1,792/2,516 invited), 81% in 2017 (2,411/2,963), and 79% in 2019 (2,177/2,720). Repeat cross-sectional analyses of measured height and weight (grades two, four, and six [aged approximately 7 to 12 years]), self-reported behavior, and HRQoL (grades four and six) were conducted.Results: There was an intervention by time interaction in BMI z scores (P = 0.031) and obesity/overweight prevalence (P = 0.006). BMI z score and overweight/obesity prevalence decreased between 2015 and 2017 and increased between 2017 and 2019 in intervention communities. The intervention significantly reduced takeaway food consumption (P = 0.034) and improved physical (P = 0.019), psychosocial (P = 0.026), and global (P = 0.012) HRQoL. Water consumption increased among girls (P = 0.033) in the intervention communities, as did energy-dense, nutrient-poor snack consumption among boys (P = 0.006).Conclusions: WHO STOPS had a positive impact on takeaway food intake and HRQoL. [ABSTRACT FROM AUTHOR]

Background: Despite increasing investment in suicide prevention, Australian suicide rates have increased steadily in the past decade. In response to growing evidence for multicomponent intervention models for reducing suicide, the LifeSpan model has been developed as the first multicomponent, evidence-based, system-wide approach to suicide prevention in Australia. The LifeSpan model consists of nine evidence-based strategies. These include indicated, selective and universal interventions which are delivered simultaneously to community and healthcare systems over a 2-year implementation period. This study will evaluate the effectiveness of the LifeSpan model in reducing suicide attempts and suicide deaths in four geographically defined regions in New South Wales, Australia.Methods: We outline the protocol for a stepped-wedge, cluster randomized controlled trial. Following a 6-month transition phase, the trial sites will move to the 2-year active implementation phase in 4-monthly intervals with evaluation extending a minimum of 24 months after establishment of the full active period. Analysis will be undertaken of the change attributable to the invention across the four sites. The primary outcome for the study is the rate of attempted suicide in the regions involved. Rate of suicide deaths within each site is a secondary outcome.Discussion: If proven effective, the LifeSpan model for suicide prevention could be more widely delivered in Australian communities, providing a valuable new approach to tackle rising suicide rates. LifeSpan has the potential to significantly contribute to the mental health of Australians by improving help-seeking for suicide, facilitating early detection, and improving aftercare to reduce re-attempts. The findings from this research should also contribute to the evidence base for multilevel suicide prevention programs internationally.Trial Registration: Australia New Zealand Clinical Trials Register, ID: ACTRN12617000457347. Prospectively registered on 28 March 2017. https://www.anzctr.org.au/TrialSearch.aspx#&&conditionCode=&dateOfRegistrationFrom=&interventionDescription=&interventionCodeOperator=OR&primarySponsorType=&gender=&distance=&postcode=&pageSize=20&ageGroup=&recruitmentCountryOperator=OR Protocol Version: 1.0, 31 May 2019. [ABSTRACT FROM AUTHOR]

Trial planning requires making efficient yet practical design choices. In a cluster randomized crossover trial, clusters of subjects cross back and forth between implementing the control and intervention conditions over the course of the trial, with each crossover marking the start of a new period. If it is possible to set up such a trial with more crossovers, a pertinent question is whether there are efficiency gains from clusters crossing over more frequently, and if these gains are substantial enough to justify the added complexity and cost of implementing more crossovers. We seek to determine the optimal number of crossovers for a fixed trial duration, and then identify other highly efficient designs by allowing the total number of clusters to vary and imposing thresholds on maximum cost and minimum statistical power. Our results pertain to trials with continuous recruitment and a continuous primary outcome, with the treatment effect estimated using a linear mixed model. To account for the similarity between subjects' outcomes within a cluster, we assume a correlation structure in which the correlation decays gradually in a continuous manner as the time between subjects' measurements increases. The optimal design is characterized by crossovers between the control and intervention conditions with each successive subject. However, this design is neither practical nor cost-efficient to implement, nor is it necessary: the gains in efficiency increase sharply in moving from a two-period to a four-period trial design, but approach an asymptote for the scenarios considered as the number of crossovers continues to increase. [ABSTRACT FROM AUTHOR]

Purpose: To assess the efficacy of a food service implementation intervention designed to increase provision of foods consistent with nutrition guidelines on child consumption of fruit, vegetables, breads/cereals, meat/alternatives, dairy, and diet quality in care.Design: Exploratory cluster randomized controlled trial.Setting: Twenty-five childcare centers in New South Wales, Australia.Sample: Three hundred ninety-five children aged 2 to 5 years.Intervention: Centers were randomized to the intervention or control group. Intervention development was guided by the Theoretical Domains Framework and included securing executive support, provision of group training, resources, audit and feedback, and one-on-one support. The intervention was delivered across six months and the study was conducted between March and December 2016.Measures: Child diet was assessed by educators using a validated questionnaire modified for completion in childcare center.Analysis: Data were analyzed in SAS using generalized linear mixed models adjusted for clustering.Results: Children in the intervention group consumed significantly higher number of serves of vegetables (0.4 serves; P < .001), wholegrain cereals (0.7 serves; P = .02), and meat/alternatives (0.5 serves; P < .001), and had higher diet quality scores (10.3; P < .001).Conclusions: A food service intervention targeting the provision of food significantly improved child dietary intake in care. Such findings are relevant to health promotion practitioners responsible for supporting improvements in child diet. [ABSTRACT FROM AUTHOR]

Purpose: The aim was to evaluate the effectiveness of computer-assisted input-based intervention for children with speech sound disorders (SSD). Method: The Sound Start Study was a cluster-randomized controlled trial. Seventy-nine early childhood centers were invited to participate, 45 were recruited, and 1,205 parents and educators of 4- and 5-year-old children returned questionnaires. Children whose parents and educators had concerns about speech were assessed (n = 275); 132 children who were identified with phonological patternbased errors underwent additional assessment. Children with SSD and no difficulties with receptive language or hearing, typical nonverbal intelligence, and English as their primary language were eligible; 123 were randomized into two groups (intervention n = 65; control n = 58), and 3 withdrew. The intervention group involved Phoneme Factory Sound Sorter software (Wren & Roulstone, 2013) administered by educators over 9 weeks; the control group involved typical classroom practices. Participants were reassessed twice by a speech-language pathologist who was unaware of the initial assessment and intervention conditions. Results: For the primary outcome variable (percentage of consonants correct), the significant mean change from pre- to postintervention for the intervention group (mean change = +6.15, p < .001) was comparable in magnitude to the significant change for the control group (mean change = +5.43, p < .001) with a small between-groups effect size for change (Cohen's d = 0.08). Similar results occurred for measures of emergent literacy, phonological processing, participation, and well-being. Conclusion: Computer-assisted input-based intervention administered by educators did not result in greater improvement than typical classroom practices. [ABSTRACT FROM AUTHOR]

Background: Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown.Objective: The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection.Methods: In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months.Results: Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018).Conclusions: GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents. [ABSTRACT FROM AUTHOR]

Background: In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs could optimise diabetes management and improve patient outcomes at a population level. The study aimed to describe the uptake of a continuing medical education intervention for rural GPs and its impact on the viability of a cluster randomised controlled trial of the effects of continuing medical education on whole-town diabetes monitoring and control.Method: Trial design: the cluster randomised controlled trial involved towns as the unit of allocation and analysis with outcomes assessed by de-identified pathology data (not reported here). The intervention programme consisted of an online active learning module, direct electronic access to specialist advice and performance feedback. Multiple rounds of invitation were used to engage GPs with the online intervention content. Evidence-based strategies (e.g. pre-notification, rewards, incentives) were incorporated into the invitations to enrol in the programme. Recruitment to the programme was electronically monitored through the hosting software package during the study intervention period.Results: Eleven matched pairs of towns were included in the study. There were 146 GPs in the 11 intervention towns, of whom 34 (23.3%) enrolled in the programme, and 8 (5.5%) completed the online learning module. No town had more than 10% of the resident GPs complete the learning module. There were no contacts made by GPs regarding requests for specialist advice. Consequently, the trial was discontinued.Conclusion: There is an ongoing need to engage primary care physicians in improving diabetes monitoring and management in rural areas. Online training options, while notionally attractive and accessible, are not likely to have high levels of uptake, even when evidence-based recruitment strategies are implemented.Trial Registration: Australian New Zealand Clinical Trials Registry, identifier: ACTRN12611000553976 . Retrospectively registered on 31 May 2011. [ABSTRACT FROM AUTHOR]

Background: School-based physical education is an important public health initiative as it has the potential to provide students with regular opportunities to participate in moderate-to-vigorous physical activity (MVPA). Unfortunately, in many physical education lessons students do not engage in sufficient MVPA to achieve health benefits. In this trial we will test the efficacy of a teacher professional development intervention, delivered partially via the Internet, on secondary school students' MVPA during physical education lessons. Teaching strategies covered in this training are designed to (i) maximize opportunities for students to be physically active during lessons and (ii) enhance students' autonomous motivation towards physical activity.Method: A two-arm cluster randomized controlled trial with allocation at the school level (intervention vs. usual care control). Teachers and Year 8 students in government-funded secondary schools in low socio-economic areas of the Western Sydney region of Australia will be eligible to participate. During the main portion of the intervention (6 months), teachers will participate in two workshops and complete two implementation tasks at their school. Implementation tasks will involve video-based self-reflection via the project's Web 2.0 platform and an individualized feedback meeting with a project mentor. Each intervention school will also complete two group peer-mentoring sessions at their school (one per term) in which they will discuss implementation with members of their school physical education staff. In the booster period (3 months), teachers will complete a half-day workshop at their school, plus one online implementation task, and a group mentoring session at their school. Throughout the entire intervention period (main intervention plus booster period), teachers will have access to online resources. Data collection will include baseline, post-intervention (7-8 months after baseline) and maintenance phase (14-15 months after baseline) assessments. Research assistants blinded to group allocation will collect all data. The primary outcome will be the proportion of physical education lesson time that students spend in MVPA. Secondary outcomes will include leisure-time physical activity, subjective well-being, and motivation towards physical activity.Discussion: The provision of an online training platform for teachers could help facilitate more widespread dissemination of evidence-based interventions compared with programs that rely exclusively on face-to-face training.Trial Registration: Australia and New Zealand Clinical Trials Registry- ACTRN12614000184673 . Registration date: February 19, 2014. [ABSTRACT FROM AUTHOR]

Despite the benefits of factorial designs in quantifying the relative benefits of different school-based approaches to prevent unhealthy weight gain among students, few have been undertaken. The aims of this 2 × 2 cluster randomized factorial trial was to evaluate the impact of a physical activity and nutrition intervention on child weight status and quality of life. Twelve primary schools in New South Wales, Australia randomly allocated to one of four groups: (i.) physical activity (150 min of planned in-school physical activity); (ii.) nutrition (a healthy school lunch-box); (iii.) combined physical activity and nutrition; or (iv.) control. Outcome data assessing child weight and quality of life were collected at baseline and 9-months post-baseline. Within Grades 4-6 in participating schools, 742 students participated in anthropometric measurements, including child body mass index (BMI) and waist circumference, at baseline and follow-up. Findings indicated that students that received the nutrition intervention had higher odds of being classified in the BMI category of underweight/healthy weight (OR 1.64 95%CI 1.07, 2.50; p = 0.0220), while those who received the physical activity intervention reported a lower waist circumference (mean difference - 1.86 95%CI -3.55, -0.18; p = 0.030). There were no significant effects of the nutrition or physical activity intervention on child BMI scores or child quality of life, and no significant synergistic effects of the two interventions combined. Future research assessing the longer-term impact of both intervention strategies, alone and combined, is warranted to better understand their potential impact on child health. TRIAL REGISTRATION: Australian Clinical Trials Registry ACTRN: ACTRN12616001228471. [ABSTRACT FROM AUTHOR]

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

Over the past decade, we have seen some positive changes in the use of alcohol and other drugs among teenagers in Australia and around the world [[1]]. Schools themselves decide between available alcohol and other drug education programs, of which there are many, but government funding can significantly influence this decision. 15 Champion KE, Newton NC, Barrett EL, Teesson M. A systematic review of school-based alcohol and other drug prevention programs facilitated by computers of the internet. [Extracted from the article]

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

Background: Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines. Still, many of them did not measure individual-level impact. This study aimed to make a posthoc comparison of the clinical outcomes of patients in the "Thrombolysis ImPlementation in Stroke (TIPS)" study, which aimed to improve rates of intravenous thrombolysis in Australia.Methods: A posthoc analysis was conducted using individual-level patient data. Excellent (Three-month post treatment modified Rankin Score 0-2) and poor clinical outcome (Three-month post treatment modified Rankin Score 5-6) and post treatment parenchymal haematoma were the three main outcomes, and a mixed logistic regression model was used to assess the difference between the intervention and control groups.Results: There was a non-significant higher odds of having an excellent clinical outcome of 57% (odds ratio: 1.57; 95% CI: 0.73-3.39) and 33% (odds ratio: 1.33; 95% CI: 0.73-2.44) during the active-and post-intervention period respectively, for the intervention compared to the control group. A non-significant lower odds of having a poor clinical outcome was also found in the intervention, relative to control group of 4% (odds ratio: 0.96; 95% CI: 0.56-2.07) and higher odds of having poor outcome of 44% (odds ratio: 1.44 95% CI: 0.61-3.41) during both active and post-intervention period respectively. Similarly, a non-significant lower odds of parenchymal haematoma was also found for the intervention group during the both active- (odds ratio: 0.53; 95% CI: 0.21-1.32) and post-intervention period (odds ratio: 0.96; 95% CI: 0.36-2.52).Conclusion: The TIPS multi-component implementation approach was not effective in reducing the odds of post-treatment severe disability at 90 days, or post-thrombolysis hemorrhage.Trial Registration: Clinical Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN12613000939796 . [ABSTRACT FROM AUTHOR]

Keywords: General practice; Primary care; Health services research; Research support EN General practice Primary care Health services research Research support 398 398 1 05/19/20 20200530 NES 200530 Opportunities to recognise and invest in general practice research need to be realised General practice research is essential to quality general practice, building an evidence base for over 27 000 general practitioners working within the specialty who provide medical care to the majority of Australians.[1] Over eight in ten Australians consult with their GP at least once per year, and two million people are seen each week in general practice.[[2]] General practice, a medical specialty, is the first point of access to the health system, providing longitudinal care for all. Without general practice, the health outcomes of the population will be poorer and less equitable, and associated with increased health costs.[4] Contextual knowledge of primary care is essential for credible and relevant general practice research. Without GP involvement, research outcomes are unlikely to be fit for the general practice environment or appropriate for patients attending primary care. Academic GPs play important roles in both research and teaching, including training academic GP registrars and supervision of primary care researchers and students more broadly. [Extracted from the article]

Background: Long-active reversible contraceptives reduce unintended pregnancy and abortions, but uptake is low. Interventions to increase uptake in family medicine settings are untested.Objective: The Australian Contraceptive ChOice pRoject, which was adapted from the successful US Contraceptive CHOICE study, aimed to evaluate whether a complex intervention in family medicine practices resulted in increased long-active reversible contraceptive uptake.Study Design: This cluster randomized controlled trial was set in family practices in metropolitan Melbourne, Australia. From April 2016 to January 2017, we recruited 57 family physicians by mail invitation. Each family physician aimed to recruit at least 14 female patients. Eligible family physicians worked ≥3 sessions per week in computerized practices. Eligible women were English-speaking, sexually active, not pregnant, not planning a pregnancy in the next year, 16-45 years old, and interested in discussing contraception or in starting a new, reversible method. With the use of a randomization sequence with permuted blocks that were stratified by whether the family physician performed long-active reversible contraceptive insertion or not, family physicians were assigned randomly to a complex intervention that involved training to provide structured effectiveness-based contraceptive counselling and access to rapid referral to long-active reversible contraceptive insertion clinics. The 6-hour, online educational intervention was based on the US Contraceptive CHOICE Project and adapted for the Australian context. The control family physicians received neither the educational intervention nor access to the long-active reversible contraceptive rapid referral clinics and conducted their usual contraception counselling. We used the chi-square test, which was adjusted for clustering and stratification by whether the family physician inserted long-active reversible contraceptives, and binary regression models with generalized estimating equations and robust standard errors to compare, between the intervention and control groups, the proportions of women who had a long-active reversible contraceptive inserted. The primary outcome was the proportion of women with long-active reversible contraceptives that were inserted at 4 weeks. Secondary outcomes included women's choice of contraceptive method, quality of life, and long-active reversible contraceptive use at 6 and 12 months. Analyses were performed according to intention-to-treat.Results: A total of 25 intervention and 32 control family physicians recruited 307 and 433 women, respectively (N=740). Within 4 weeks, 19.3% of women in the intervention group and 12.9% of women in the control group had long-active reversible contraceptive inserted (relative risk, 2.0; 95% confidence interval, 1.1-3.9; P=.033). By 6 months, this number had risen to 44.4% and 29.3%, respectively (relative risk, 1.6; 95% confidence interval, 1.2-2.17; P=.001); by 12 months, it had risen to 46.6% and 32.8%, respectively (relative risk, 1.5; 95% confidence interval, 1.2-2.0; P=.0015). The levonorgestrel intrauterine system was the most commonly chosen long-active reversible contraceptive by women in the intervention group at all time points. Differences between intervention and control groups in mean quality-of-life scores across all domains at 6 and 12 months were small.Conclusion: A complex intervention combination of family physician training on contraceptive effectiveness counselling and rapid access to long-active reversible contraceptive insertion clinics resulted in greater long-active reversible contraceptive uptake and has the potential to reduce unintended pregnancies. [ABSTRACT FROM AUTHOR]

Background: Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. Objective: This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. Methods: The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. Results: The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. Conclusions: This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/13973 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Background: The current and declining physical activity levels of children is a global concern. Integrating physical activity into the school curriculum may be an effective way not only to improve children's physical activity levels but also enhance educational outcomes. Given the recent national focus in Australia on improving the literacy levels of children in primary school, and an increasing proportion of time spent on explicitly teaching these skills, integrating physical activity into English could be a viable strategy to improve literacy levels and physical activity at the same time. The aim of this study is to evaluate the impact of the 'Thinking While Moving in English' (TWM-E) program on children's physical activity, on-task behavior in the classroom, academic achievement, and executive function.Methods: Grade 3-4 children from 10 public schools in New South Wales, Australia will be randomly allocated to intervention (n = 5) or control (n = 5) groups. All teachers will receive 1-day workshop of registered professional learning and a TWM-E equipment pack (e.g., chalk, lettered bean bags). Intervention schools will be asked to adapt their English lessons to embed movement-based learning in their daily program for three 40-min lessons per week, over a six-week period. The primary outcome is children's physical activity levels across the school day (measured using accelerometry). Secondary outcomes are children's on-task behavior during English lessons, academic achievement in English, and executive function. A detailed process evaluation will be undertaken including questionnaires, fidelity checks, and teacher and student interviews.Discussion: The TWM-E program has the potential to improve primary school children's physical activity levels, along with academic outcomes (on-task behavior, cognition, and academic achievement), and provide stakeholders with exemplar lessons and guidelines which illustrate how to teach English to children whilst they are moving.Trial Registration: Australian and New Zealand Clinical trial Register ACTRN12618001009202 Date registered: 15/06/2018 retrospectively registered. [ABSTRACT FROM AUTHOR]