An evaluation of two large-scale quality improvement interventions embedded with a national clinical audit to improve the care for young adults with type 2 diabetes

Background: People with type 2 diabetes and raised blood glucose levels are at high risk of complications, including cardiovascular disease, sexual health problems and foot disease. This is compounded in young adults (18-39 years) by a longer duration of diabetes and a more aggressive genotype. NICE recommends an HbA1c <48mmol/mol and specifies additional care where HbA1c is =58 mmol/mol; 65,000 young adults in England have HbA1c =58 mmol/mol. Young adults with type 2 diabetes face challenges engaging with care, such as stigma, work or family commitments. Addressing modifiable care factors, such as ways of working and staff knowledge and skills may better support young adults to engage with and respond to care. Improving their care is an NHS England priority. To stimulate improvements, the National Diabetes Audit (NDA) collects data on people with diabetes and provides feedback to general practices and primary care networks (PCNs). Whilst audit and feedback modestly improves care, adding co-interventions may result in greater improvement. We have developed two facilitation interventions for delivery at scale to all PCNs in England. NHS England has agreed to fund intervention delivery, but (cost) effectiveness and impacts on equity are unknown. Aim: To evaluate two facilitation co-interventions added to NDA feedback to improve the achievement of blood glucose goals in young adults with type 2 diabetes. Objectives 1. Assess the effectiveness of NDA feedback with (i) medium-intensity facilitation and (ii) low-intensity facilitation compared to NDA feedback alone in reducing the HbA1c of young adults with type 2 diabetes and HbA1c =58 mmol/mol. 2. Understand facilitation implementation, engagement, fidelity and tailoring of actions. 3. Estimate the cost-effectiveness of medium- and low-intensity facilitation. Research questions 1. Does medium- or low-intensity facilitation delivered at scale alongside NDA feedback improve achievement of blood glucose goals compared to NDA feedback alone? 2. How do targeted participants engage with, and respond to, the two versions of facilitation? 3. Does facilitation added to NDA feedback represent a cost-effective and equitable way to achieve blood glucose goals? Design: Efficient 3-arm cluster randomised trial with parallel process and economic evaluations using routine NDA data. Participants: PCNs Interventions: Medium-intensity feedback facilitation, delivered through webinars and multi-site calls to support commitment to change, tailoring and collaboration. Low-intensity feedback facilitation contains similar content delivered through email and virtual worksheets. Waitlist control: NDA feedback alone. Primary outcome: HbA1c of young adults with type 2 diabetes and baseline HbA1c =58 mmol/mol. Secondary outcomes: Achievement of HbA1c targets; delivery of recommended care processes. Process evaluation: Theory-informed exploration of intervention implementation and fidelity and of PCN engagement. Economic evaluation: An intention-to-treat, distributional cost-effectiveness analysis with a lifetime horizon, using patient-level registry data, cost data, and an existing simulation model. Timescale: March 2025 – June 2027 Impact and dissemination: We will evidence (cost) effectiveness, equity and mechanisms of action of two interventions which other national audits can adapt. We will leverage existing relationships with national audit providers and commissioners to support implementation.