Objectives: To describe the trial design and baseline characteristics of individuals participating in a targeted, multifactorial intervention in a high risk, multi-ethnic population with type 2 diabetes (T2DM) and microalbuminuria (MA) delivered by health care professionals in a community based setting.Design: Cluster randomised controlled trial.Setting: Community based across Leicester City and Leicestershire County, UK.Participants: Healthcare professionals at participating GP (General Practitioner) practices comprising a total patient population size of 232,639, of which 2721 individuals with a confirmed diagnosis of T2DM and MA have been recruited to the study. 22 GP practices have been randomised to intervention (n=10) and control (n=12) arms of the study.Intervention: A complex, multifaceted intervention comprising a software 'prompt' with an evidence based treatment algorithm installed on GP computer systems alerting healthcare professionals to eligible study individuals not meeting tight CV risk factor targets, healthcare professional education, clinician email support, three monthly feedback and dissemination of performance data illustrating proportion of individuals meeting risk factor targets, practice based mean CV risk factor targets and prescribing patterns.Outcome measures: Primary outcome is proportion of eligible participants meeting tight CV risk factor targets including systolic and diastolic blood pressure (<130/80mmHg) and total cholesterol (<3.5mmol/l) at 24 months. Secondary outcomes include proportion of individuals with HbA1c <58mmol/mol(7.5%), change in medication prescribing, changes in MA and renal function (eGFR), incidence of major adverse CV events and mortality, and coding for microalbuminuria in patient records. Cost-effectiveness of the intervention will be assessed.Results: Among 2721 eligible study individuals, mean (SD) age was 62.9 (10.0), duration of diabetes 10.46 (7.22) years. Mean (SD) HbA1c was 59.3 (17.4) mmol/mol, systolic and diastolic BP (mmHg) was 134.3 (14.6) and 76.1 (9.5) mmHg, respectively and total cholesterol was 4.1 (0.98) mmol/l. Overall, 131 (4.8%) of study individuals achieved all three 'tight' CV risk factor targets. CV risk factor burden increased two-fold in those with GFR < 60 compared to those with GFR ≥ 60 ml/min/1.73m 2 . Prevalence of MA was 22.8%. In total, 1076 (39.5%) individuals were coded for microalbuminuria or proteinuria on their primary care medical record.
Conclusions:The GP Prompt study is the largest UK primary care-based, technology driven, randomised controlled trial to support intensive intervention in high risk group of multi-ethnic individuals with T2DM and MA. This paper provides contemporary estimates for prevalent cardiovascular disease and adherence to evidence based cardiovascular risk factor targets at baseline in a population with T2DM and MA. The main trial results, including cost effectiveness data will be submitted for publication in early 2018.