scholarly journals All-Wales Licensed Premises Intervention (AWLPI): a randomised controlled trial of an intervention to reduce alcohol-related violence

2015 ◽  
Vol 3 (10) ◽  
pp. 1-152 ◽  
Author(s):  
Simon C Moore ◽  
Mohammed Fasihul Alam ◽  
David Cohen ◽  
Kerenza Hood ◽  
Chao Huang ◽  
...  
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Research ◽  
Controlled Trial ◽  
Public Health Research ◽  
Licensed Premises ◽  
Randomised Controlled ◽  
And Control

BackgroundViolence in and around premises licensed for the on-site sale and consumption of alcohol continues to burden the NHS with assault-related injuries.Trial designA randomised controlled trial with licensed premises as the unit of allocation, with additional process and cost-effectiveness evaluations.MethodsPremises were eligible (n = 837) if they were licensed for on-site sale and consumption of alcohol, were within 1 of the 22 local authorities (LAs) in Wales and had previously experienced violence. Data were analysed using Andersen–Gill recurrent event models in an intention-to-treat analysis. An embedded process evaluation examined intervention implementation, reach, fidelity, dose and receipt. An economic evaluation compared costs of the intervention with benefits.InterventionPremises were randomised to receive a violence-reduction intervention, Safety Management in Licensed Environments (SMILE), which was delivered by an environmental health practitioner (EHP; the agent). SMILE consisted of an initial risk audit to identify known risks of violence, a follow-up audit scheduled to enforce change for premises in which serious risks had been identified, structured advice from EHPs on how risks could be addressed in premises and online materials that provided educational videos and related material.ObjectiveTo develop intervention materials that are acceptable and consistent with EHPs’ statutory remit; to determine the effectiveness of the SMILE intervention in reducing violence; to determine reach, fidelity, dose and receipt of the intervention; and to consider intervention cost-effectiveness.OutcomeDifference in police-recorded violence between intervention and control premises over a 455-day follow-up period.RandomisationA minimum sample size of 274 licensed premises per arm was required, rounded up to 300 and randomly selected from the eligible population. Licensed premises were randomly assigned by computer to intervention and control arms in a 1 : 1 ratio. Optimal allocation was used, stratified by LA. Premises opening hours, volume of previous violence and LA EHP capacity were used to balance the randomisation. Premises were dropped from the study if they were closed at the time of audit.ResultsSMILE was delivered with high levels of reach and fidelity but similar levels of dose to all premises, regardless of risk level. Intervention premises (n = 208) showed an increase in police-recorded violence compared with control premises (n = 245), although results are underpowered. An initial risk audit was less effective than normal practice (hazard ratio = 1.34, 95% confidence interval 1.20 to 1.51) and not cost-effective. Almost all eligible intervention premises (98.6%) received the initial risk audit; nearly 40% of intervention practices should have received follow-up visits but fewer than 10% received one. The intervention was acceptable to EHPs and to some premises staff, but less so for smaller independent premises.ConclusionsSMILE was associated with an increase in police-recorded violence in intervention premises, compared with control premises. A lack of follow-up enforcement visits suggests implementation failure for what was seen as a key mechanism of action. There are also concerns as to the robustness of police data for targeting and assessing outcome effectiveness, while intervention premises may have received greater attention from statutory agencies and, therefore, the identification of more violence than control premises. Although SMILE had high reach and was feasible and acceptable to EHPs, it was found to be ineffective and associated with increased levels of violence, compared with normal practice and it requires additional work to promote the implementation of follow-up enforcement visits. Future work will aim to better understand the role of intervention dose on outcomes and seek more objective measures of violence for use in similar trials.Trial registrationCurrent Controlled Trials ISRCTN78924818.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 10. See the NIHR Journals Library website for further project information.

scholarly journals An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Breastfeeding Initiation ◽  
Before And After ◽  
Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

Abstract Background : Older people are frequent Emergency Department (ED) users who present with complex issues that are linked to poorer health outcomes post-index visit, often have increased ED length of stay and tend to have raised healthcare costs. Encouraging evidence suggests that ED teams involving health and social care professionals (HSCPs) can contribute to enhanced patient flow and improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCPs teams assessing and intervening with older adults in the ED is limited and identifies important methodological limitations, highlighting the need for more robust and comprehensive investigations of this model of care. This study aims to evaluate the impact of a dedicated ED-based HSCP team on the quality, safety, clinical and cost-effectiveness of care of older adults when compared to usual care. Methods : The study is a single-site randomised controlled trial whereby patients aged ≥65 years who present to the ED of a large Irish hospital will be randomised to the experimental group (ED-based HSCP assessment and intervention) or the control group (usual ED care). The recruitment target is 320 participants. The HSCP team will provide a comprehensive functional assessment as well as interventions to promote a safe discharge for the patient. The primary outcome is ED length of stay (from arrival to discharge). Secondary outcomes include: rates of hospital admissions from the ED, ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days, four and six-month follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; costs-effectiveness in terms of costs associated with ED-based HSCP compared to usual care; and perceptions on implementation by ED staff members. Discussion : This is the first randomised controlled trial testing the impact of HSCPs working in teams in the ED on the quality, safety, clinical and cost-effectiveness of care for older patients. The findings of the study will provide important information on the effectiveness of this model of care for future implementation. Trial registration : ClinicalTrials.gov, NCT03739515; registered on 12 th November 2018. Protocol version 1. URL: https://clinicaltrials.gov/ct2/show/NCT03739515

scholarly journals Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Antenatal Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
The World ◽  
Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

scholarly journals Sit–stand desks to reduce sedentary behaviour in 9- to 10-year-olds: the Stand Out in Class pilot cluster RCT

2020 ◽  
Vol 8 (8) ◽  
pp. 1-126
Author(s):  
Stacy A Clemes ◽  
Daniel D Bingham ◽  
Natalie Pearson ◽  
Yu-Ling Chen ◽  
Charlotte Edwardson ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Health Research ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Public Health Research ◽  
Sitting Time ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

Background Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. The school classroom represents an ideal setting for environmental change through the provision of sit–stand desks. Objectives The aim of this study was to undertake a pilot cluster randomised controlled trial of the introduction of sit–stand desks in primary school classrooms, to inform a definitive trial. Objectives included providing information on school and participant recruitment and retention, acceptability of the intervention, and outcome measures. A preliminary estimate of the intervention’s effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. Design A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. Setting Primary schools in Bradford, West Yorkshire, UK. Participants Children in Year 5 (i.e. aged 9–10 years). Intervention Six sit–stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit–stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. Main outcome measures Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL™ (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. Results Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of –30.6 minutes per day (95% confidence interval –56.42 to –4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of £78,986 per quality-adjusted life-year gained. Conclusion This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. Preliminary evidence suggests that the intervention may have a positive direction of effect on weekday sitting time, which warrants testing in a full cluster randomised controlled trial. Lessons learnt from this trial will inform the planning of a definitive trial. Trial registration Current Controlled Trials ISRCTN12915848. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 8. See the NIHR Journals Library website for further project information.

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