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Supporting GPs and people with hypertension to maximise medication use to control blood pressure: a pilot cluster RCT
E C Morrissey1, L O'Grady2, P J Murphy3
1School of Psychology, University of Galway, Galway, Ireland. eimear.morrissey@universityofgalway.ie.
Insights
The MIAMI intervention shows promise for improving hypertension management by addressing treatment adherence and physician inertia. Further refinements are needed before a large-scale trial can be considered.
Area of Science:
- Cardiovascular Medicine
- Health Services Research
- Clinical Trials
Background:
- Hypertension is a major modifiable risk factor for cardiovascular disease.
- Poor treatment adherence and physician inertia impede effective blood pressure control.
- The MIAMI intervention aims to improve medication adherence and manage hypertension.
Purpose of the Study:
- To assess the feasibility of the MIAMI intervention in a pilot cluster randomized controlled trial (RCT).
- To gather data for refining the MIAMI intervention for a future definitive RCT.
- To evaluate the feasibility of conducting a larger RCT.
Main Methods:
- A pilot cluster RCT comparing the MIAMI intervention to usual care.
- Quantitative data collection (clinical measures, questionnaires) at baseline and 12 weeks.
- Qualitative data collection through semi-structured interviews with GPs and patients.
- Assessment of intervention fidelity, health economics, and participant acceptability.
Main Results:
- High retention rates: 6/6 GP practices and 92% of patients were retained.
- Good fidelity to the protocol, with minor deviations identified.
- The MIAMI intervention was largely acceptable and feasible for GPs and patients.
- Implementation cost estimated at €490 per participant; urine test component posed logistical challenges.
Conclusions:
- The MIAMI intervention is largely acceptable and feasible for hypertension management.
- Modifications to intervention components and trial processes are recommended.
- A definitive RCT is considered worthwhile with proposed adjustments.
Background:
Hypertension, or high blood pressure, is a key modifiable risk factor for heart disease and stroke. International guidelines have highlighted 'poor adherence to treatment' and 'physician inertia' as major barriers to effective blood pressure management. The Maximising Adherence, Minimising Inertia (MIAMI) intervention, a theory-based complex intervention, supports General Practitioners (GPs) and people with hypertension in maximising medication use to manage blood pressure. This pilot cluster randomised control trial (RCT) aimed to collect and analyse feasibility data to refine the MIAMI intervention and assess the feasibility of a definitive RCT.
Method:
A pilot cluster RCT with a MIAMI intervention arm and usual care control arm was conducted. Quantitative data collection consisting of clinical measures and a self-report questionnaire took place at baseline and twelve week follow up. Semi-structured interviews with GP and patient participants were conducted. Fidelity (as measured by a protocol checklist and through qualitative interviews) and health economics costings were assessed.
Results:
Six GP practices (intervention arm n = 3, control arm n = 3) and 52 patients (intervention arm n = 25, control arm n = 27) took part. All six GP practices and 92% of patients were retained. Fidelity, as measured by a checklist and through qualitative interviews, was good but three deviations from protocol were identified. Outcomes and measures used were acceptable. The implementation cost of the MIAMI intervention was estimated at €490 per participant. The qualitative data demonstrated that the intervention was considered acceptable and feasible by both GP and patient participants, except for the urine test component, which GPs found difficult to incorporate into practice due to logistical challenges.
Conclusions:
The MIAMI intervention was considered largely acceptable and feasible. Some changes to both intervention components and trial processes are required but with these in place a definitive RCT could be considered worthwhile.
Trial Registration:
ISRCTN registry, ISRCTN85009436, registered 17/1/23.
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