scholarly journals Children and Young People’s Health Partnership (CYPHP) Evelina London model of care: protocol for an opportunistic cluster randomised controlled trial (cRCT) to assess child health outcomes, healthcare quality and health service use

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e027301 ◽  
Author(s):  
James Joseph Newham ◽  
Julia Forman ◽  
Michelle Heys ◽  
Simon Cousens ◽  
Claire Lemer ◽  
...  
Keyword(s):  
Service Use ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Model Of Care ◽  
Cluster Randomised ◽  
Health Partnership ◽  
Randomised Controlled ◽  
The Impact ◽  
London Model

IntroductionChildren and young people (CYP) in many high-income settings have poor healthcare outcomes, especially those with long-term conditions (LTCs). Emergency and outpatient hospital service use is increasing unsustainably. To address these problems, the Children and Young People’s Health Partnership (CYPHP) has developed and is evaluating an integrated model of care as part of a health systems strengthening programme across two boroughs of London, UK that are characterised by mixed ethnic populations and varying levels of deprivation. The CYPHP Evelina London model of care comprises proactive case-finding and triage, specialist clinics and transformative education and training for professionals working with CYP. Services are delivered by multidisciplinary health teams with an emphasis on increased coordination across primary, community and hospital settings and integration of physical and mental healthcare that accounts for the CYP’s social context.Methods and analysisThe phased roll out of the CYPHP Evelina London model allows an opportunistic population-based evaluation using a cluster randomised controlled trial design. Seventy general practices across two London boroughs, grouped into 23 clusters, were randomised to provide either the CYPHP model of care (n=11) or enhanced usual care (n=12).The evaluation will measure the impact of the CYPHP Evelina London model of care on child and parent health and well-being, healthcare quality and health service use up to 2 years postimplementation. A population-level evaluation will use routinely collected pseudonymised healthcare data to conduct a service-use analysis for all CYP registered with a participating general practice (n=~90 000) with the rate of non-elective admissions as the primary outcome. We will seek consent from a subset of this population, with specific conditions (target n=2138) to assess the impact on patient-reported outcomes using the Paediatric Quality of Life Inventory (PedsQL) and Warwick-Edinburgh Mental Well-Being Scale (WEBWMS) as, respectively, the child- and parent-related primary outcomes.Ethics and disseminationEthics approval obtained from South West-Cornwall & Plymouth Research Ethics Committee. Results will be submitted for publication in peer-reviewed journals. Findings will be generalisable to community-based models of care, especially in urban settings. Our process evaluation will identify barriers and enablers of implementation and delivery of care salient to the context and condition.Trial registration numberNCT03461848; Pre-results.

scholarly journals Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Human Health ◽  
Controlled Trial ◽  
Informal Settlements ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Abundance And Diversity ◽  
Randomised Controlled ◽  
Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

scholarly journals School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029044 ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Implementation Evaluation ◽  
Cluster Randomised ◽  
Parallel Group ◽  
Randomised Controlled

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

scholarly journals Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial

2019 ◽  
Vol 53 (4) ◽  
pp. 1801530 ◽  
Author(s):  
Jenifer Liang ◽  
Michael J. Abramson ◽  
Grant Russell ◽  
Anne E. Holland ◽  
Nicholas A. Zwar ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Lung Function ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Smoking Abstinence ◽  
Model Of Care ◽  
Cluster Randomised ◽  
Randomised Controlled

We evaluated the effectiveness of an interdisciplinary, primary care-based model of care for chronic obstructive pulmonary disease (COPD).A cluster randomised controlled trial was conducted in 43 general practices in Australia. Adults with a history of smoking and/or COPD, aged ≥40 years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD. The model of care comprised smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase). Main outcomes included changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function at 6 and 12 months.We identified 272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase. Intention-to-treat analysis showed no statistically significant difference in change in SGRQ at 6 months (adjusted between-group difference 2.45 favouring intervention, 95% CI –0.89–5.79). Per protocol analyses showed clinically and statistically significant improvements in SGRQ in those receiving the full intervention compared to usual care (difference 5.22, 95% CI 0.19–10.25). No statistically significant differences were observed in change in CAT, dyspnoea, smoking abstinence or lung function.No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care. Low uptake was a limitation.

scholarly journals mHealth tool to improve community health agent performance for child development: study protocol for a cluster-randomised controlled trial in Peru

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e028361 ◽  
Author(s):  
Christopher Michael Westgard ◽  
Natalia Rivadeneyra ◽  
Patricia Mechael
Keyword(s):  
Child Development ◽  
Child Health ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Child Rearing ◽  
Development Indicators ◽  
Cluster Randomised ◽  
Health And Development ◽  
Randomised Controlled ◽  
The Impact

IntroductionCultivating child health and development creates long-term impact on the well-being of the individual and society. The Amazon of Peru has high levels of many risk factors that are associated with poor child development. The use of ‘community health agents’ (CHAs) has been shown to be a potential solution to improve child development outcomes. Additionally, mobile information and communication technology (ICT) can potentially increase the performance and impact of CHAs. However, there is a knowledge gap in how mobile ICT can be deployed to improve child development in low resource settings.Methods and analysisThe current study will evaluate the implementation and impact of a tablet-based application that intends to improve the performance of CHAs, thus improving the child-rearing practices of caregivers and ultimately child health and development indicators. The CHAs will use the app during their home visits to record child health indicators and present information, images and videos to teach key health messages. The impact will be evaluated through an experimental cluster randomised controlled trial. The clusters will be assigned to the intervention or control group based on a covariate-constrained randomisation method. The impact on child development scores, anaemia and chronic malnutrition will be assessed with an analysis of covariance. The secondary outcomes include knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services. The process evaluation will report on implementation outcomes. The study will be implemented in the Amazon region of Peru with children under 4. The results of the study will provide evidence on the potential of a mHealth tool to improve child health and development indicators in the region.Ethics and disseminationThe study received approval from National Hospital ‘San Bartolome’ Institutional Ethics Committee on 8 November 2018 (IRB Approval #15463–18) and will be disseminated via peer-reviewed publications.Trial registration numberISRCTN43591826.

scholarly journals Social capital is associated with lower mosquito vector indices: secondary analysis from a cluster randomised controlled trial of community mobilisation for dengue prevention in Mexico

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Víctor Alvarado-Castro ◽  
Sergio Paredes-Solís ◽  
Elizabeth Nava-Aguilera ◽  
Arcadio Morales-Pérez ◽  
Miguel Flores-Moreno ◽  
...  
Keyword(s):  
Social Capital ◽  
Multivariate Analysis ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cluster Randomised Controlled Trial ◽  
Community Mobilisation ◽  
Cluster Randomised ◽  
Camino Verde ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Control of the Aedes aegypti mosquito is central to reducing the risk of dengue, zika, chikungunya, and yellow fever. Randomised controlled trials, including the Camino Verde trial in Mexico and Nicaragua, demonstrate the convincing impact of community mobilisation interventions on vector indices. These interventions might work through building social capital but little is known about the relationship between social capital and vector indices. Methods A secondary analysis used data collected from 45 intervention clusters and 45 control clusters in the impact survey of the Mexican arm of the Camino Verde cluster randomised controlled trial. Factor analysis combined responses to questions about aspects of social capital to create a social capital index with four constructs, their weighted averages then combined into a single scale. We categorised households as having high or low social capital based on their score on this scale. We examined associations between social capital and larval and pupal vector indices, taking account of the effects of other variables in a multivariate analysis. We report associations as odds ratios and 95% confidence intervals. Results The four social capital constructs were involvement, participation, investment, and communication. Among the 10,112 households, those in rural communities were much more likely to have a high social capital score (OR 4.51, 95% CIca 3.26–6.26). Households in intervention sites had higher social capital, although the association was not significant at the 5% level. Households with high social capital were more likely to be negative for larvae or pupae (OR 1.38, 95% CIca 1.12–1.69) and for pupae specifically (OR 1.37, 95% CIca 1.08–1.74). There was interaction between intervention status and social capital; in multivariate analysis, a combined variable of intervention/high social capital remained associated with larvae or pupae (ORa l.56, 95% CIca 1.19–2.04) and with pupae specifically (ORa 1.65, 95% CIca 1.20–2.28). Conclusion This is the first report of an association of high social capital with low vector indices. Our findings support the idea that the Camino Verde community mobilisation intervention worked partly through an interaction with social capital. Understanding such interactions may help to maximise the impact of future community mobilisation interventions.

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