Title: An evaluation of quality improvement collaboratives aligned to a national audit to improve the uptake of insulin pumps for people with diabetes
Funder: Department of Health and Social Care

Abstract: Why do we want to do this study? People with diabetes who have raised blood sugar level are at increased risk of complications such as sight loss, kidney disease and nerve damage. An insulin pump is a small electronic device that reduces blood sugar by giving insulin throughout the day via a small tube. Since 2008, national guidelines have recommended insulin pumps for people with type 1 diabetes people who have high blood sugar. Around 90,000 people in England have high blood sugar but do not use an insulin pump. Importantly, insulin pump use varies according to where people live and their age, sex and ethnicity. People with diabetes, healthcare professionals and NHS England have all said that increasing insulin pump use is important. The National Diabetes Audit (NDA) measures how many people with diabetes receive care recommended by guidelines. The NDA aims to drive changes that improve care by providing feedback to patients, policymakers and clinical teams. Despite giving feedback since 2016, large gaps in insulin pump use remain. We think that we can increase insulin pump use by supporting specialist diabetes teams (doctors, nurses and others) to act more effectively following NDA feedback. We have developed and tried a programme of workshops, coaching and sessions where teams learn from each other. The programme helps teams to choose actions according to their own circumstances and commit to these actions. The programme will be delivered virtually by the NDA and will be free to the teams. What will we achieve? We will: • evaluate whether the support leads to greater change than feedback alone • understand how the support is delivered and how teams respond • evaluate whether the support is value for money What would the study involve? All diabetes teams will be offered the support programme. Participating teams will be randomly assigned to get the support during or after the study. The teams will be able to opt out from the research but still receive the support. We will measure how many people start and stay on the pumps for three months by gathering prescription data. This data is routinely extracted from medical records unless patients opt out. We will compare insulin pump use between those diabetes teams that got the support and those that did not. Immediately after the study, we will give the support to all teams that did not receive it during the study. To see how those involved deliver and use the programme, we will observe what happens in the virtual workshops, coaching and shared learning meetings. We will read documents that are produced. We will interview people who delivered the support programme, and diabetes team members who did or did not receive the support. We will describe the cost of delivering and receiving the support and evaluate whether the benefits outweigh the costs. Our findings will help the NDA decide whether to provide support in the same way in future. Our findings will also help other national clinical audits (e.g. for cancer, heart disease) decide whether to provide similar support to improve patient care. How are patients and the public involved? The research team includes an Expert by experience and a member of a diabetes charity employed to engage stakeholders. We will continue to discuss the project with people with diabetes and members of the public; they will help us to finalise the research plan, refine the support programme, and interpret and publicise our findings.

Lay abstract: Background: People with poorly controlled type 1 diabetes are at greater risk of retinopathy, nephropathy, neuropathy, cardiovascular disease, sexual health problems and foot disease. Since 2008, NICE has recommended continuous subcutaneous 'insulin pump' therapy for people with type 1 diabetes whose HbA1c is above 69 mmol/mol. Insulin pump use can improve quality of life, cut cardiovascular risk and increase treatment satisfaction. About 90,000 people in England and Wales meet NICE criteria for insulin pumps but do not use one. The National Diabetes Audit (NDA) has identified increasing insulin pump use as a key improvement priority. Progress has been slow and insulin pump use also varies markedly by deprivation, ethnicity, sex and location. Whilst patient preferences are important, much variation is likely to be attributable to staff and local organisational factors. Limited capabilities of healthcare providers to mount effective responses to feedback from national audits, such as the NDA, undermines efforts to improve care. We have worked in partnership with patients and carers, national audits and healthcare providers to co-develop a theoretically- and empirically-informed, quality improvement collaborative (QIC) to strengthen local responses to feedback. Piloting has demonstrated feasibility, acceptability, appropriateness, scalability and fidelity of delivery, receipt and enactment of target behaviours. The NDA plans to roll out the QIC to all specialist diabetes teams but its effectiveness and value for money are unknown. Aim and objectives: To evaluate a QIC to improve the uptake of insulin pumps following NDA feedback. We will: • Evaluate the effectiveness of NDA feedback with QIC compared to NDA feedback alone; • Understand intervention implementation, engagement, fidelity and tailoring of actions; • Estimate value for money of NDA feedback with QIC. Research questions: Does a QIC delivered alongside NDA feedback increase insulin pump use, and equality of use, compared to standalone NDA feedback? How do participants engage with, and respond to, the QIC? Is the QIC cost-effective? Methods Design: Efficient cluster randomised trial with parallel process and economic evaluations using routine NDA data. Participants: Diabetes specialist teams in England. Intervention: QIC delivered alongside the NDA, involving virtual coaching sessions, workshops and multisite facilitation, and delivered as part of the new NDA contract. Control: Standalone NDA feedback. Outcomes: The proportion of people with poorly controlled type 1 diabetes (HbA1c above 69 mmol/mol) who start and continue insulin pump use during 18 months (primary), with subgroup analyses by ethnicity, sex, age and deprivation; HbA1c levels; first use of insulin pumps (secondary), all via NDA data. Process evaluation: Theory-informed investigation of diabetes specialist teams’ engagement, implementation, fidelity and tailoring. Economic evaluation: We will micro-cost the QIC, estimate cost-effectiveness of NDA feedback with QIC and estimate the budget impact of NHS-wide QIC roll out. Timescale: July 2022 to April 2025 Anticipated impact and dissemination: Our rigorous evaluation will deliver evidence on effectiveness, equality, mechanisms of action, and value for money of an intervention which other national audits can adapt. We will leverage existing relationships with national audit providers and commissioners to support dissemination and implementation.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: METABOLIC AND ENDOCRINE