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New Zealand's new alcohol laws: protocol for a mixed-methods evaluation.

ABSTRACT: Alcohol consumption is a major cause of mortality and morbidity globally. In response to strong calls from the public for alcohol law reform, the New Zealand Government recently reduced the blood alcohol limit for driving and introduced the Sale and Supply of Alcohol Act which aim to (1) improve community input into local decision-making on alcohol; (2) reduce the availability of alcohol; and (3) reduce hazardous drinking and alcohol-related harm. In this project we seek to evaluate the new laws in terms of these objectives.A policy evaluation framework is proposed to investigate the implementation and outcomes of the reforms. We will use quantitative and qualitative methods, employing a pre-post design. Participants include members of the public, local government staff, iwi (Māori tribal groups that function collectively to support their members) and community group representatives. Data will be collected via postal surveys, interviews and analysis of local government documents. Liquor licensing, police and hospital injury data will also be used. Community input into local government decision-making will be operationalised as: the number of objections per license application and the number of local governments adopting a local alcohol policy (LAP). Outcome measures will be the 'restrictiveness' of LAPs compared to previous policies, the number (per 1000 residents) and density (per square kilometre) of alcohol outlets throughout NZ, and the number of weekend late-night (i.e., post 10 pm) trading hours. For consumption and harm, outcomes will be the prevalence of hazardous drinking, harm from own and others' drinking, community amenity effects, rates of assault, and rates of alcohol-involved traffic crashes. Multiple regression will be used to model how the outcomes vary by local government area from before to after the law changes take effect. These measures will be complemented by qualitative analysis of LAP development and public participation in local decision-making on alcohol.The project will evaluate how well the reforms meet their explicit public health objectives.

SUBMITTER: Maclennan B

PROVIDER: S-EPMC4710993 | biostudies-other | 2016 Jan

REPOSITORIES: biostudies-other

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Project description:INTRODUCTION:Achieving effective integration of healthcare across primary, secondary and tertiary care is a key goal of the New Zealand (NZ) Health Strategy. NZ's regional District Health Board (DHB) groupings are fundamental to delivering integration, bringing the country's 20 DHBs together into four groups to collaboratively plan, fund and deliver health services within their defined geographical regions. This research aims to examine how, for whom and in what circumstances the regional DHB groupings work to improve health service integration, healthcare quality, health outcomes and health equity, particularly for Māori and Pacific peoples. METHODS AND ANALYSIS:This research uses a mixed methods realist evaluation design. It comprises three linked studies: (1) formulating initial programme theory (IPT) through developing programme logic models to describe regional DHB working; (2) empirically testing IPT through both a qualitative process evaluation of regional DHB working using a case study design; and (3) a quantitative analysis of the impact that DHB regional groupings may have on service integration, health outcomes, health equity and costs. The findings of these three studies will allow refinement of the IPT and should lead to a programme theory which will explain how, for whom and in what circumstances regional DHB groupings improve service integration, health outcomes and health equity in NZ. ETHICS AND DISSEMINATION:The University of Otago Human Ethics Committee has approved this study. The embedding of a clinician researcher within a participating regional DHB grouping has facilitated research coproduction, the research has been jointly conceived and designed and will be jointly evaluated and disseminated by researchers and practitioners. Uptake of the research findings by other key groups including policymakers, Māori providers and communities and Pacific providers and communities will be supported through key strategic relationships and dissemination activities. Academic dissemination will occur through publication and conference presentations.

Project description:BackgroundETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or Therapeutic education for alcohol-related harm reduction) is a multicentre community-based mixed-methods study, which aims to evaluate the effectiveness of the innovative therapeutic patient education (TPE) programme 'Choizitaconso' in a sample of French people with alcohol use disorder (people with AUD). Choizitaconso teaches people with AUD psychosocial skills to help them (re)establish controlled drinking and reduce alcohol-related harms. Recruitment started in October 2019. We present here the protocol of the ETHER study.MethodsETHER's quantitative component involves a 6-month controlled intervention study which evaluates Choizitaconso's effectiveness by comparing 30 people with AUD following the programme with a control group of 60 people with AUD not enrolled in it, using a questionnaire co-constructed by the research team and members of the people with AUD community. Thirty-four alcohol-related harms are assessed and summed to provide an individual measure of the 'harm burden' from consuming alcohol (primary outcome). Secondary outcomes are anticipated and internalized stigma, alcohol consumption measures, craving for alcohol, coping strategies, health-related quality of life, self-confidence to control or abstain from drinking, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments, and capabilities (a measure of wellbeing in adults). Data will be collected in face-to-face and phone-based interviews at enrolment and 6 months later. Linear regression models will be used to assess the impact of the TPE programme on changes in the primary and secondary outcomes, while adjusting for other correlates and confounders. The study's qualitative component comprises semi-structured interviews with 16 people with AUD who have already completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis.Results and conclusionsETHER is the first evaluation study of an innovative TPE programme specifically designed to reduce alcohol-related harms and reach controlled drinking in France. The involvement of the people with AUD community in selecting which experienced and perceived alcohol-related harms to measure ensures that ETHER will provide healthcare staff and researchers with a relevant set of harm reduction criteria for use in future research. Finally, ETHER will provide scientific justification for implementing novel alcohol-related harm reduction approaches and champion controlled drinking as a therapeutic goal. Trial registration ClinicalTrials.gov, NCT03954054. Registered 17 May 2019-Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03954054?cond=alcohol&cntry=FR&city=Marseille&draw=1&rank=1 .

Project description:INTRODUCTION:Long-term and late effects of cancer treatments can cause functional limitations and reduce quality of life. Cancer rehabilitation services, which can comprise physical exercise, psychological support and educational interventions depending on the individual's needs, have been found to have a positive effect on health-related quality of life worldwide. However, accessibility or the lack of awareness on available help can act as barriers and influence the uptake of services, resulting in people having unmet rehabilitation needs. In Wales, UK, 41% of people, who have had health and social care needs resulting from cancer and its treatments, reported that they did not receive care when needed. The reason for this lack of support has not yet been fully investigated. The aim of this study is to investigate the conditions in which cancer rehabilitation services work and their underpinning mechanisms in South Wales, UK, specifically addressing barriers, facilitators and costs. METHODS AND ANALYSIS:Realist evaluation, which explains for whom a service works in what circumstances and how through context-mechanism-outcome pattern conjunctions, will be used in three phases to investigate the conditions in which cancer rehabilitation services work and their underpinning mechanisms. Phase 1 will be secondary analysis of a cancer rehabilitation database from a local Health Board to give context to who are accessing rehabilitation. Phase 2 will be thematic analysis of face-to-face, semistructured rehabilitation participant (n=20) and healthcare professional (n=20) interviews to explore the mechanisms of how cancer rehabilitation works. Phase 3 will be two case studies and cost-consequences analysis of cancer rehabilitation services. ETHICS AND DISSEMINATION:This study received favourable ethical opinion from London South-East Research Ethics Committee (17/LO/2123) in December 2017. This project is part of the author's PhD thesis and it is expected that the findings will be disseminated in academic journals and at local and international conferences.

Project description:IntroductionThe prevalence of type 2 diabetes is rising steeply. National Health Service England (NHSE) is exploring the potential of a digital diabetes prevention programme (DDPP) and has commissioned a pilot with embedded evaluation.Methods and analysisThis study aims to determine whether, and if so, how, should NHSE implement a national DDPP, using a mixed-methods pretest and post-test design, underpinned by two theoretical frameworks: the Coventry, Aberdeen and London - Refined (CALO-RE) taxonomy of behavioural change techniques for the digital interventions and the Consolidated Framework for Implementation Research (CFIR) for implementation processes. In eight pilot areas across England, adults with non-diabetic hyperglycaemia (NDH) (glycated haemoglobin (HbA1c) 42-47 mmol/mol or fasting plasma glucose 5.5-6.9 mmol/L) and adults without NDH who are overweight (body mass index (BMI) >25 kg/m2) or obese (BMI >30 kg/m2) will be referred to one of five digitally delivered diabetes prevention interventions. The primary outcomes are reduction in HbA1c and weight (for people with NDH) and reduction in weight (for people who are overweight or obese) at 12 months. Secondary outcomes include use of the intervention, satisfaction, physical activity, patient activation and resources needed for successful implementation. Quantitative data will be collected at baseline, 6 months and 12 months by the digital intervention providers. Qualitative data will be collected through semistructured interviews with commissioners, providers, healthcare professionals and patients. Quantitative data will be analysed descriptively and using generalised linear models to determine whether changes in outcomes are associated with demographic and intervention factors. Qualitative data will be analysed using framework analysis, with data pertaining to implementation mapped onto the CFIR.Ethics and disseminationThe study has received ethical approval from the Public Health England Ethics and Research Governance Group (reference R&D 324). Dissemination will include a report to NHSE to inform future policy and publication in peer-reviewed journals.

Project description:BackgroundA new dashboard, the 360ºCHILD-profile, was developed to adopt personalized health care within preventive child health care. On this profile, holistic health data are visualized in a single image to provide parents, adolescents, and caregivers direct access to a manageable résumé of a child's medical record. Theoretical ordering, conforming to "International Classification of Functioning, Disability and Health for Children and Youth", guides clinical reasoning toward the biopsychosocial concept of health. It is yet unknown if and how this promising tool functions in practice, and a variety of feasibility questions must be addressed.ObjectiveThis paper describes the design and methods of a feasibility randomized controlled trial (RCT), with the aim of evaluating the RCT's feasibility (recruitment, response, measure completion, and intervention allocation) and 360ºCHILD-profile's feasibility (usability and potential effectiveness).MethodsA pragmatic mixed methods study design was chosen, starting with an RCT to measure feasibility and health literacy in 2 parallel groups (1:1). Qualitative research will then be used to understand and explain quantitative findings and to explore the stakeholders' perspectives on the potential of the 360ºCHILD-profile. Participants will include child health care professionals (n≥30), parents (n≥30), and caregivers (n≥10) of children who experience developmental problems (age 0-16 years). Children will only be able to participate if they are older than 11 years (adolescents, n≥10). The 2 groups included in the study will receive standard care. The experimental group will additionally receive personalized 360ºCHILD-profiles.ResultsAfter an intervention period of 6 months, quantitative outcomes will be measured, analyzed (descriptive feasibility statistics and preliminary between-group differences) and used to purposively sample for semistructured interviews.ConclusionsStudy results will provide knowledge for building theory on the 360ºCHILD-profile and designing future (effect) studies.Trial registrationNetherlands Trial Register NTR6909; https://www.trialregister.nl/trial/6731.International registered report identifier (irrid)DERR1-10.2196/21942.

Project description:INTRODUCTION:The lack of understanding of how complex integrated care programmes achieve their outcomes due to the lack of acceptable methods leads to difficulties in the development, implementation, adaptation and scaling up of similar interventions. In this study, we evaluate an integrated care network, the National University Health System (NUHS) Regional Health System (RHS), consisting of acute hospitals, step down care, primary care providers, social services and community partners using a theory-driven realist evaluation approach. This study aims to examine how and for whom the NUHS-RHS works to improve healthcare utilisations, outcomes, care experiences and reduce healthcare costs. By using a realist approach that balances the needs of context-specific evaluation with international comparability, this study carries the potential to address current research gaps. METHODS AND ANALYSIS:This evaluation will be conducted in three research phases: (1) development of initial programme theory (IPT) underlying the NUHS-RHS; (2) testing of programme theory using empirical data; and (3) refinement of IPT. IPT was elicited and developed through reviews of programme documents, informal discussions and in-depth interviews with relevant stakeholders. Then, a convergent parallel mixed method study will be conducted to assess context (C), mechanisms (M) and outcomes (O) to test the IPT. Findings will then be analysed according to the realist evaluation formula of CMO in which findings on the context, mechanisms will be used to explain the outcomes. Finally, based on findings gathered, IPT will be refined to highlight how to improve the NUHS-RHS by detailing what works (outcome), as well as how (mechanisms) and under what conditions (context). ETHICS AND DISSEMINATION:The National Healthcare Group, Singapore, Domain Specific Review Board reviewed and approved this study protocol. Study results will be published in international peer-reviewed journals and presented at conferences and internally to NUHS-RHS and Ministry of Health, Singapore.

Project description:IntroductionHospital group models represent an organisational form that aims to bring together multiple provider organisations with a central headquarters and unified leadership responsible for locally managed operating units, standardised systems and a value-set shared across the group. These models seek to improve outcomes by reducing unwarranted variations in care provision and reducing costs through economies of scale. There is limited evidence on the impact and processes of implementing these models, so this study aims to evaluate one case study of a hospital group model.Methods and analysisWe will conduct a formative, mixed-methods evaluation using an embedded research approach to analyse the implementation of the model and its impact on outcomes and costs. We will carry out a multisited ethnography to analyse the programme theory for model design and implementation, the barriers and facilitators in the implementation; and wider contextual issues that influence implementation using semi-structured interviews (n=80), non-participant observations (n=80?hours), 'shadowing' (n=20?hours) and documentary analysis. We will also carry out an economic evaluation composed of a cost-consequence analysis and a return on investment analysis to evaluate the costs of creating and running the model and balance these against the potential cost-savings.Ethics and disseminationThe study protocol was reviewed by the local R&D Office and University College London Ethics Committee and classified as a service evaluation, not requiring approval by a research ethics committee. We will follow guidelines for informed consent, confidentiality and information governance, and address issues of critical distance prevalent in embedded research. Findings will be shared at regular time points to inform the implementation of the model. The evaluation will also generate: an evaluation framework to evaluate future changes; recommendations for meaningful baseline data and measuring improvement; identification of implementation costs and potential cost-savings; and lessons for the National Health Service on implementing these models.

Project description:IntroductionThe growing political emphasis on the early years reflects the importance of these formative years of life. Health visitors in the UK are uniquely positioned to improve health outcomes for children and families and to reduce health inequalities. Recently, there has been a policy change in Scotland in an attempt to enhance the delivery of the universal health visiting service. This study aims to examine the extent to which the enhanced Universal Health Visiting Pathway is implemented and delivered across Scotland and to assess any associated impacts.Methods and analysisA mixed-methods study incorporating four methodological components and uses realist evaluation as the overall conceptual framework. It comprises three phases (1) initial programme theory development; (2) programme theory validation and (3) programme theory refinement. The programme theory validation will use interview and focus group data of parents and health visitors, and conduct a case note review at five study sites. It also involves a national survey of parents and health visitors and routine data analysis of existing secondary data. The analyses of the ensuing qualitative and quantitative data will be carried out using a convergent mixed-methods approach to ensure continuous triangulation of multiple data. The findings of the evaluation will provide contextually relevant understanding of how the Universal Health Visiting Pathway works and evidence the impact of increased investments in health visiting in Scotland.Ethics and disseminationThis protocol has been approved by the School of Health in Social Science Research Ethics Committee, University of Edinburgh. Additional approvals have been granted/will be sought from the Public Benefit and Privacy Panel for health and social care in Scotland for the case note review,survey and routine data analysis elements of the evaluation. The findings will be prepared as reports to the funders and presented at conferences. It will be submitted for publication in peer-reviewed journals.

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New Zealand's new alcohol laws: protocol for a mixed-methods evaluation.

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