Protocol of the DECIDE Study: Computerised decision support for poorly-controlled type 2 diabetes mellitus: A randomised pilot controlled trial in Irish General Practice

Problem

Poorly controlled type 2 diabetes mellitus (T2DM) is associated with significant morbidity, mortality and healthcare costs. A failure among health professionals to intensify medications for patients with poor control of T2DM is called clinical inertia is one contributory factor to poor control of T2DM.

Approach

This study outlines the second stage of the MRC guideline for the development of a complex intervention, which aims to identify T2DM patients with poor glycaemic and blood pressure control and support GP treatment escalation where appropriate. This incorporates the results of piloting, simulation and practice-pilot evaluation. The complex intervention is called DECIDE, comprising; a) A remote finder tool to help GPs identify patients with poor control of T2DM in their practice; b) A training programme/ academic detailing of target GPs; and c) A web-based clinical decision support system.

Findings

Based upon the pilot study, DECIDE will proceed to be tested in a cluster randomised pilot study in Irish general practice, which will involve 14 practices (clusters) and 168 patients. Only patients who have poorly controlled T2DM (defined as HbA1c > 70mmol/mol or BP > 155/95) will be included. The primary outcome will be HbA1c. Secondary outcomes include medication intensification, blood pressure and lipids. A process evaluation will be performed to determine whether the intervention is delivered as intended and treatment fidelity assessed to monitor and enhance the reliability and validity of interventions.

Consequences

The DECIDE study will aim to determine the effectiveness of a complex intervention - through a randomised pilot study- which aims to improve appropriate prescribing for patients with poorly controlled T2DM in Irish General Practice.