Future Health Today: Protocol for a pragmatic stratified cluster randomised head-to-head trial of quality improvement activities in general practice compared to active control.
Pragmatic 12-month two-arm cluster randomised controlled trial of QI activities in general practice (pharmacological therapies to reduce CV risk in people with CKD and appropriate investigation of people at increased risk of undiagnosed cancer) compared to active control. The primary outcome for the CKD arm is proportion of eligible patients with a diagnosis or pathology results consistent with CKD at baseline prescribed ACE inhibitors or Angiotensin receptor blockers and/or statins consistent with current guideline recommendations. The primary outcome for the cancer arm is the proportion of eligible patients identified as at risk of undiagnosed prostate, oesophageal, gastric, colorectal, endometrial, lung or ovarian cancer that have been assessed and investigated. Secondary outcomes include clinical measures and number of general practice encounters. Marginal logistic regression model using Generalised Estimating Equations with robust standard errors to adjust for correlation of outcomes within general practice will be used to estimate the intervention effect for primary binary outcomes. A health economics analysis and process evaluation will be conducted.