Scalable low-cost interventions to support medication adherence in people prescribed treatment for hypertension in primary care

Aims and objectives 1. To develop a scalable low-cost intervention to support medication adherence in people prescribed treatment for hypertension in primary care. The intervention will consist of two components: (i) a very brief face-to-face intervention delivered by a practice nurse or healthcare assistant that signposts the patient to (ii) a digital intervention designed to provide ongoing support between practice visits. 2. To evaluate the acceptability and feasibility of the two-component intervention and the feasibility of conducting a (cost-) effectiveness trial. 3. To provide precise and robust estimates of the effectiveness and cost-effectiveness of the intervention compared with usual care. 4. To develop an economic model of cost-effectiveness of medication adherence interventions. 5. To inform a decision on whether to implement the two-component intervention in primary care. Background and rationale Non-adherence to medications in people with long-term conditions is a serious problem that is not currently addressed in the National Health Service. Almost eight million people in England receive treatment for hypertension from their general practice. However, a substantial proportion of this patient group do not take their medications as prescribed. Non-adherence reduces the effectiveness of treatment and increases the cost to the NHS from hospital admissions, additional consultations, referrals, investigations and medicine wastage. Improvements in antihypertensive medication adherence would result in substantial health benefits and would save the NHS an estimated £100 million a year. Primary care practitioners have an important role in supporting patients to adhere to their treatments. However, they lack the time to do this, and their time is expensive. One solution is to use low-cost, digital interventions designed to support medication adherence between consultations. In this service model, the practitioner (practice nurse or healthcare assistant) continues to provide usual care but, in addition, delivers a very brief intervention signposting the patient to a digital intervention to support medication adherence. Research plan The target group will be patients receiving treatment for hypertension in primary care who have a blood pressure reading above 140/90 mmHg, recruited from practices in the East of England and East London. Workstream 1 will provide the evidence to inform the development of the interventions through qualitative interviews with patients and practitioners, a meta-ethnography of qualitative studies, a systematic review and meta-analysis, and an expert consultation. In Workstream 2, we will further develop and operationalise the interventions (using several different methods) and program the digital intervention. Workstream 3 is a randomised feasibility study in six practices with individual allocation to usual care (N = 40) or to the intervention arm (N = 60; very brief face-to-face intervention followed by a digital intervention) and follow-up at three months. The aim is to assess the feasibility and acceptability of the intervention and the feasibility of the trial proposed in Workstream 4. Workstream 4 is a randomised controlled trial with sufficient power (N = 764 patients randomised, from 50 practices) to provide precise and robust estimates of the effectiveness and cost-effectiveness of the two-component intervention compared with usual care. The primary outcome will be systolic BP measured at 12 months, a reliable and valid clinical outcome measure. A process evaluation will be conducted as part of Workstreams 3 and 4. Workstream 5 will develop an economic model of cost-effectiveness of medication adherence interventions, from the perspectives of the NHS and social services over a lifetime horizon. Informed by literature reviews, a decision model will be developed, then updated in two iterations with the results from Workstreams 3 and 4 respectively. A value of infor