Digital multi-component intervention to IMPROVE the care of older people living with Diabetes and chronic Kidney Disease: a type 2 hybrid effectiveness-implementation cluster randomised trial in primary care (Short title: IMPROVE DKD Trial)

Background: In the UK type-2 diabetes (T2D) accounts for 50% of chronic kidney disease (CKD), 30% of end-stage kidney disease (ESKD), and associated high morbidity, mortality, and NHS cost. Early intervention slows progression of diabetic CKD (DKD). The UK guidelines recommend multicomponent evidence-based intervention. Our recent analysis shows a stark unmet need and inequality in DKD management in primary care. Research shows point-of-care computer reminders are effective in delivering multiple clinical recommendations in primary care despite increasing workload, complexity of management and time pressure. Aim: To evaluate the implementation and effectiveness of a digital management tool to improve evidence-based care and outcomes for people with DKD in general practice (GP) Research questions: 1 Can a low cost, digital management tool be embedded in GP computer systems to improve clinician adherence to DKD guidelines recommendations? 2 Is the implementation of a digital management tool (intervention) clinically and cost-effective in slowing progression of DKD? Design: Type II hybrid effectiveness-implementation cluster randomised trial Setting: General practices in England Population: GP staff and patients with T2D, aged 60-80 years with estimated glomerular filtration rate (eGFR) 59-30 ml/min/1.73m2 Recruitment: General practices through Clinical Practice Research Datalink (CPRD) Interventional Research Service Platform (IRSP) Intervention: Multicomponent intervention based on UK guideline recommendations 1. Digital management tool: GP-facing automatic point-of-care computer reminders reinforcing 5 guideline recommendations: 1) optimising blood pressure (target systolic <130 mmHg); 2) glycaemic control (target HbA1c 52-58 mmol/mol); use of 3) optimum doses of renin angiotensin system inhibitor (RAASi), 4) sodium glucose co-transporter-2 inhibitor (SGLT2i) & 5) statin 2. Patient-facing multimedia life-style advice: low salt intake (<5 g/day), moderate alcohol intake (men <2 units/ day, women <1unit/ day), moderate intensity physical exercise (≥150 min/ week), smoking cessation, maintaining healthy BMI (18.5-25 Kg/m2) Comparator: Usual care in control practices Randomisation: 1:1 GP practices Co-Primary endpoints: • Implementation: adherence to the five UK guideline recommendations • Effectiveness: Change in eGFR from baseline to 2 years Secondary endpoints: A composite of eGFR decline >50%, ESKD, all-cause death, cardiovascular (CV) and adverse events Sample size: 60 general practices with 1,500 people with DKD, allowing for 5% attrition Data collection: From electronic health record though CPRD, linked to Hospital Episodes Statistics and Office of National Statistics Health economics: A decision model-based economic evaluation will be undertaken to evaluate the costeffectiveness of an implementation strategy (digital management tool) for the management of DKD versus current care from an NHS/Personal Social Services (PSS) perspective Study Within A Trial: Will assess the value of modelling trial outcomes using process of care and intermediate and later clinical outcomes Expected impact: If primary endpoints are achieved, the digital tool can be scaled up and embedded in GP computer systems across the UK at a low cost. This will improve the care of people with DKD and reduce the risk of ESKD, CV events and mortality, and cost to the NHS.