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Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

ABSTRACT: INTRODUCTION:Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS:A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION:The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers.

SUBMITTER: Napier AD

PROVIDER: S-EPMC5695469 | biostudies-other | 2017 Nov

REPOSITORIES: biostudies-other

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Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

Napier A David AD Nolan John J JJ Bagger Malene M Hesseldal Louise L Volkmann Anna-Maria AM

BMJ open 20171108 11

<h4>Introduction</h4>Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those ...[more]

PMID: 29122782

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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: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:BackgroundThe Theory of Planned Behaviour (TPB) has been proposed as a useful framework to investigate professional behaviour, however, was not yet applied to the evaluation of an educational intervention. This study will address this gap by utilising the TPB to evaluate the effectiveness of an education programme delivered by the professional regulator for UK doctors in enhancing three professional behaviours: raising concerns, engaging in reflective practice, and use of regulator confidentiality guidance.MethodsThis is a comprehensive mixed methods study combining qualitative (interviews) and quantitative (quasi-experiment) data. Intervention participants were asked to complete a survey measuring the variables in the TPB (attitudes, subjective norms, perceived behavioural control, and intention) for the three professional behaviours before, immediately post, and 3-months later following the education programme. Ninety-four doctors completed the survey pre/post intervention and 38 at all three times. One hundred and eleven doctors from the same hospital trust who did not take part in the intervention completed the survey at two time points and formed the control group. Forty-two interviews were conducted with intervention participants.ResultsThe quantitative study revealed that the educational intervention significantly improved attitudes (raising concerns, using confidentiality guidance), subjective norms (raising concerns, reflective practice, using confidentiality guidance), perceived control (raising concerns, using confidentiality guidance), and intentions (using confidentiality guidance) (Group and Time interaction; Fs ≥ 3.996, ps ≤ .047, ηp2 ≥ .020). Non-UK graduate doctors' subjective norms towards raising concerns and confidentiality guidance increased significantly after the intervention (Fs ≤ 6.602, ps ≥ .011, ηp2 = .032 F = 6.602, p = .011, ηp2 = .032), but not UK graduates (p > .05). Interviews revealed that doctors had positive views about professional behaviours but also mentioned numerous barriers to actually engage in more complex, context dependent behaviours.ConclusionsThis study demonstrates that an educational intervention was successful in improving the TPB variables of three professional behaviours. It also revealed that teaching professionalism does not happen in isolation and, therefore, personal and contextual factors are crucial to consider. To change complex professional behaviours, barriers at all levels i.e., personal, organisational and system, should be addressed.

Project description:INTRODUCTION:Vaccine hesitancy is a complex public health issue referring to concerns about the safety, efficacy or need for vaccination. Relatively little is known about vaccine hesitancy in Switzerland. This ongoing study (2017-2021) focuses on biomedical and complementary and alternative medicine (CAM) providers and their patients since healthcare professionals play important roles in vaccination decision-making. This national research programme seeks to assess the sociocultural determinants of vaccine hesitancy regarding childhood and human papillomavirus vaccines in Switzerland. We aim to provide a detailed characterisation of vaccine hesitancy, including CAM and biomedical perspectives, patient-provider interactions, and sociocultural factors, to establish the mediating effects of vaccine hesitancy on underimmunisation, and to design an intervention to improve vaccination communication and counselling among physicians, parents and adolescents. METHODS AND ANALYSIS:Our transdisciplinary team employs a sequential exploratory mixed-methods study design. We have established a network of more than 150 medical providers across Switzerland, including more than 40 CAM practitioners. For the qualitative component, we conduct interviews with parents, youth, and biomedical and CAM providers and observations of vaccination consultations and school vaccination information sessions. For the quantitative component, a sample of 1350 parents of young children and 722 young adults (15-26 years) and their medical providers respond to questionnaires. We measure vaccine hesitancy with the Parent Attitudes about Childhood Vaccines 15-item survey and review vaccination certificates to assess vaccination status. We administer additional questions based on findings from qualitative research, addressing communication with medical providers, vaccine information sources and perceptions of risk control vis-à-vis vaccine-preventable diseases. The questionnaires capture sociodemographics, political views, religion and spirituality, and moral foundations. ETHICS AND DISSEMINATION:The study was approved by the local ethics committee. The results will be published in peer-reviewed journals and disseminated to healthcare professionals, researchers and the public via conferences and public presentations.

Project description:BackgroundIn the UK, type 2 diabetes mellitus (T2D) is largely managed in primary care. Delay in the intensification to injectable therapy, a form of clinical inertia, is associated with worse glycaemic control. UK general practice is highly computerised, with care being recorded on computerised medical record systems; this allows for quantitative analysis of clinical care but not of the underpinning decision-making process. The aim of this study is to investigate perceptions of patients and clinicians in primary care on the initiation of injectable therapies in T2D, and the context within which those decisions are made.MethodsThis is a mixed methods study, taking a "realist evaluation" approach. The qualitative components comprise focus groups, interviews, and video recordings of simulated surgeries; the quantitative analysis: an overview of participating practices, elements of the video recording, and an online survey. We will recruit primary care clinicians (general practitioners and nurses) and patients from a representative sample of practices within the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. Participants will be patients with T2D, and primary care clinicians. Focus groups and semi-structured interviews will be recorded, transcribed verbatim and analysed using Framework Analysis. The simulated surgeries will include cases that might be escalated to injectable therapy. The consultation will be reviewed using the Calgary-Cambridge model to assess communication and determination of adherence to national prescribing guidelines. We will conduct multi-channel video recording including screen capture, clinician and patient facial expressions, wide angle view of the consultation, and the computerised medical record screen. This allows annotation and qualitative analysis of the video recordings, and statistical analyses for the quantitative data. We will also conduct an online survey of primary care clinicians' attitudes to, and perceptions of, initiation of injectable therapies, which will be analysed using summary statistics.DiscussionResults aim to provide a detailed insight into the dynamic two-way decision-making process underpinning use of injectable therapy for T2D. The study will provide insights into clinical practice and enable the development of training, interventions and guidelines that may facilitate, where appropriate, the intensification to injectable therapy.

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Project description:INTRODUCTION:Schools are promising settings for physical activity promotion; however, they are complex and adaptive systems that can influence the quality of programme implementation. This paper presents an evaluation of a school-based running programme (Marathon Kids). The aims of this study are (1) to identify the processes by which schools implement the programme, (2) identify and explain the contextual factors affecting implementation and explications of effectiveness and (3) examine the relationship between the level of implementation and perceived outcomes. METHODS:Using a realist evaluation framework, a mixed method single-group before-and-after design, strengthened by multiple interim measurements, will be used. Year 5 (9-10 years old) pupils and their teachers will be recruited from six state-funded primary schools in Leicestershire, UK.Data will be collected once prior to implementation, at five discrete time points during implementation and twice following implementation. A weekly implementation log will also be used. At time point 1 (TP1) (September 2016), data on school environment, teacher and pupil characteristics will be collected. At TP1 and TP6 (July 2017), accelerometry, pupil self-reported physical activity and psychosocial data (eg, social support and intention to be active) will be collected. At TP2, TP3 and TP5 (January, March and June 2017), observations will be conducted. At TP2 and TP5, there will be teacher interviews and pupil focus groups. Follow-up teacher interviews will be conducted at TP7 and TP8 (October 2017 and March 2018) and pupil focus group at TP8. In addition, synthesised member checking will be conducted (June 2018) with a mixed sample of schools. ETHICS AND DISSEMINATION:Ethical approval for this study was obtained through Loughborough University Human Participants Ethics Subcommittee (R16-P032 & R16-P116). Findings will be disseminated via print, online media and dissemination events as well as practitioner and/or research journals.

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Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

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Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

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