Title: Increasing uptake of effective self-management education programmes for type 2 diabetes in multi-ethnic primary care settings
Funder: Department of Health and Social Care

Abstract: Background: Type 2 diabetes (T2DM) is a serious chronic disease affecting ~3 million people in theUK(Diabetes UK 2013). Evidence demonstrates that structured T2DM self-management education improves biomedical and psychological outcomes, reduces diabetes medication, and is cost-effective (Davies 2008, Deakin 2006,Jacobs-van der Bruggen 2009, Khunti 2012, Trento 2010). The Diabetes National Service Framework and NICE recommend self-management education for individuals with T2DM (DoH 2001, NICE 2011). Nevertheless, referral to and uptake of self-management education remains low, and has been reducing since 2006 (Healthcare Commission 2006). In 2012, only 5% of people with T2DM were offered education and 1% attended (National Diabetes Audit 2013), with similar data from DAWN2 in 2013 (6%; Davies 2013a). The multi-factorial reasons for this disconnect occur at patient, healthcare professional (HCP) and organisational levels (Funnell 2006); in DAWN2, over half of GPs remained unconvinced about education benefits, whilst most patients wanted to attend education (Davies 2013a). However, local audit (NHS Cumbria, 2010) demonstrates structured education can be successfully embedded. We hypothesise that uptake of self-management education could be substantially increased if we understood and addressed barriers at patient, HCP and organisation levels, developing a tailored package leading to the integration of education in routine care. This project will develop and test such a package, assessing its cost-effectiveness and sustainability. It will include enablers at the patient (e.g. diabetes awareness, campaign), HCP (e.g. clear messages regarding evidence for effectiveness and cost-effectiveness of embedded self-management education) and organisation (e.g. commissioning toolkit) levels. Methods: Defined objectives across four workstreams (WSs) will be addressed, with continuous consultation/ collaboration with key stakeholders, including PPI groups. WS1 builds directly on the PDG (Davies 2013b) to develop an embedding package - a set of solutions to address barriers and enablers to uptake identified by systematically mapping existing qualitative research data, theory-based implementation and behaviour change literature onto an evaluation framework. A modified nominal group technique will be employed to engage stakeholders in designing the 'embedding package'. WS2 will be a feasibility study piloting the embedding package in 5-8 GP practices. This will ensure quantitative data collection methods are in place for the randomised controlled trial (RCT) and that data are accurate and complete. An integrated ethnographic study, beginning in WS2 and continuing through WS3 and WS4, will provide detailed contextual data on the implementation process, the sustainability of the change and the fit of the embedding package within routine practice (Jansen 2009). WS2 concludes with the refinement of the intervention package using data from the ethnographic study. We will also target aspects of behaviour change in HCPs and patients which affect referral to and uptake of structured education (NICE 2014, Michie 2011). In WS3, a stepped wedge wait-list RCT randomised at the practice level will compare the embedding package with usual care in 80 practices. Baseline data will be collected before randomisation. Practices will be randomised to receive the package from the start of the RCT (months 1-18) or to the wait-list group who will continue usual care for the first 9 months and receive the package for months 10-18 (see &ldquo;Appendix_RCT design&rdquo;). The primary outcome will be difference in HbA1c. Secondary outcomes will include: uptake to education, process outcomes (e.g. referrals to education), and biomedical outcomes additional to HbA1c. Primary analysis will be by intention-to-treat and use methods to account for practice-level clustering and repeated outcomes. The ethnographic study begun during WS2 will continue to refine the embedding package in the second step, a common feature of this design, to better understand its working, and to provide generalisable knowledge for other organisations, and within other long term conditions. WS4 will test the sustainability of changes observed in WS3, evaluate the embedding package s cost-effectiveness, and develop the implementation toolkit. After the RCT, the embedding package will not be reinforced by the study team; we will collect follow-up data after 12 months to examine whether changes were sustained. There will be a within-trial cost-effectiveness analysis at practice and CCG levels and long-term cost-effectiveness modelling. The toolkit will be a practical means of easily distributing the embedding package, thereby enabling its adoption nationally. Team: The multi-disciplinary team of experts with an array of complementary skills, have developed, tested and implemented applied clinical research which has significantly changed practice and benefited the NHS, such as the Diabetes UK adopted Leicester Diabetes Risk Score. Outputs: Interim milestones will be met at 30 months. Final outputs will include the completed embedding package. The team have a track record in dissemination and implementation of research outputs in collaboration with PPI representatives, colleagues in CLAHRCs and AHSNs, and using established mechanisms, to ensure this work will impact beneficially on patient care in theUK within five years.

Lay abstract: Type 2 diabetes is a disease with serious consequences (e.g. heart attack, stroke) if not well controlled. People s lifestyle choices, especially around diet and exercise, can affect diabetes, which is why NHS guidelines recommend that everyone with diabetes should have the opportunity to gain knowledge and skills to support them to live healthy lives. These opportunities are usually given through &ldquo;structured education&rdquo; meeting national standards. While many GPs provide some opportunities for structured education to people with Type 2 diabetes, this isn t always the case throughout the UK. There are also many reasons why people don t go to education sessions when these are offered. For example, education may be provided at times and places which make it hard for people to attend. Sometimes GPs and nurses aren t sure how to book people on education sessions. Sometimes GPs feel these sessions are not a good use of public money, and don't provide much benefit, so do not offer them at all. But research shows that structured education can have great benefits in helping people with diabetes live healthier lives. Our project wants to know why some people aren t offered education and why some of those who are, do not attend. Once we know what the problems are, we can begin to solve them. We will develop and try out a package of practical solutions for GPs to support more people with Type 2 diabetes having structured education. The package will include offering a choice in how people get education e.g. group sessions, home study. It will support GPs and nurses to understand the benefits of structured education so they can encourage people to attend. It will create some practical tools to support GP practices and healthcare organisations like CCGs, to spread the word to people with Type 2 diabetes about the benefits of structured education. We will try out this package in a group of local GP practices to get feedback and make improvements. We will then test the package in different regions across the UK. We will meet and talk to people who have helped us test the package. We will also work out whether the package gives value for money. As a result of our research, we would expect the number of people taking part in structured education to double compared to current levels. We expect this could be done through a better use of health service money. At the end of the project, we will make the package available across the UK, so all GPs can provide better access to education to everyone with Type 2 diabetes in their area. Lessons learned from this project could be used in other long term conditions, such as heart disease.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: METABOLIC AND ENDOCRINE