Supporting GPs and people with hypertension to maximise medication use to control blood pressure: Protocol for a pilot cluster RCT of the MIAMI intervention

Background: Hypertension is one of the most important risk factors for stroke and heart disease. Recent international guidelines have stated that 'poor adherence to treatment – in addition to physician inertia - is the most important cause of poor blood pressure control'. The MaxImising Adherence, Minimising Inertia (MIAMI) intervention, which has been developed using a systematic, theoretical, user-centred approach, aims to support general practitioners (GPs) and people with hypertension to maximise medication use, through the facilitation of adequate information exchange within consultations about long-term antihypertensive medication use and adherence skill development. The aim of the MIAMI pilot cluster randomised controlled trial (RCT) is to gather and analyse feasibility data to allow us to (1) refine the intervention, and (2) determine the feasibility of a definitive RCT. Methods: GP practices (n = 6) will be recruited and randomised to the intervention arm (n = 3) or usual care control arm (n = 3). Each practice will recruit 10 patient participants. For a patient to be eligible they must have a diagnosis of hypertension, be on two or more anti-hypertensive medications, must not be achieving recommended blood pressure levels, and be over the age of 65 years. Participants in the intervention arm will meet their GP and receive the MIAMI intervention twice over three months. Quantitative data collection will take place at baseline and three month follow up. A pilot health economic analysis and a qualitative sub-study will also be incorporated into the study. Discussion: This pilot cluster RCT of the MIAMI intervention will allow us to gather valuable acceptability and feasibility data to further refine the intervention so it optimally designed for both GP and patient use. In particular, the qualitative component will provide an insight into GP and patient experiences of using the intervention.