Abstract
BackgroundPoorly controlled type 2 diabetes mellitus (T2DM) is associated with significant morbidity, mortality and healthcare costs. Control of T2DM can be challenging for healthcare professionals for a number of reasons, including poor concordance with medications, difficulties modifying lifestyle behaviour and also clinical inertia, which is defined as a reluctance among health professionals to intensify medications. A complex intervention, called ComputeriseD dECisIonal support for poorly controlleD typE 2 Diabetes mellitus in Irish General Practice (DECIDE), was developed, identifying T2DM patients with poor glycaemic and blood pressure control and aiming to target clinical inertia, by supporting therapeutic action, including GP-led medication intensification where appropriate. A small-scale, uncontrolled, non-randomised feasibility study highlighted the acceptability of the DECIDE intervention within Irish General Practice. This paper presents a protocol for a pilot cluster randomised controlled trial (RCT) of the DECIDE intervention.Methods/DesignThe pilot cluster RCT will involve 14 practices and 140 patients in Irish General Practice. Intervention GPs will participate in the DECIDE intervention, comprising (a) a training programme for the practices and (b) a web-based clinical decision support system supporting treatment escalation, tailored to specific patient information. Only patients who have poorly controlled T2DM (defined as HbA1c > 70 mmol/mol and/or BP > 150/95) will be included. The primary outcomes will include measures of feasibility such as recruitment and retention of practices and acceptability of the intervention and also HbA1c. Secondary outcomes will include medication intensification, blood pressure and lipids. Control GPs will continue to provide usual care. 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. An exploratory health economic analysis will examine the potential costs and cost effectiveness of the intervention relative to the control.DiscussionA pilot cluster RCT will establish the feasibility of a complex intervention which aims to support primary care for patients with poorly controlled T2DM in Irish General Practice.Trial registrationThe protocol for the pilot cluster RCT is registered on the ISRCTN Registry at: ISRCTN69498919.
Highlights
Controlled type 2 diabetes mellitus (T2DM) is associated with significant morbidity, mortality and healthcare costs
A pilot cluster randomised controlled trial (RCT) will establish the feasibility of a complex intervention which aims to support primary care for patients with poorly controlled T2DM in Irish General Practice
We have reported the findings of a non-randomised feasibility study of a complex intervention, which aims to support general practitioner (GP)-based management of poorly controlled T2DM
Summary
Control T2DM is a major contributor to both morbidity and mortality of patients and increasing economic costs [1]. We have reported the findings of a non-randomised feasibility study of a complex intervention, which aims to support GP-based management of poorly controlled T2DM. A web-based CDSS, called the DECIDE intervention, was developed to support evidence-based prescribing for patients with poorly controlled T2DM. The non-randomised feasibility study showed that focussing on the medication intensification in poorly controlled T2DM in general practice is suitable, but should consider non-pharmacological intensification options, such as more frequent reviews and referral to other healthcare professionals. DECIDE aims to support GPs in Irish Primary Care to intensify medications, where appropriate, for patients with poorly controlled T2DM, mediated through a complex intervention comprising a CDSS and an educational component
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