An evaluation of quality improvement collaboratives aligned to a national audit to improve the uptake of insulin pumps for people with diabetes

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.