Title: Scalable low-cost interventions to support medication adherence in people prescribed treatment for hypertension in primary care
Funder: Department of Health and Social Care

Abstract: 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 &pound;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 information analysis will also be conducted. Projected outputs & dissemination plans In addition to peer-reviewed papers, projected outputs include: WS1. Evidence to inform the development of the interventions. Provisional intervention description. WS2. A very brief intervention and a digital intervention. Detailed intervention description. Intervention script for practitioners. WS3. Evidence to inform the design of the main trial. WS4. Robust estimates of effectiveness and cost-effectiveness. WS5. An economic model of cost-effectiveness. Target audiences for dissemination include: the academic community; commissioners (NHS England, CCGs, local authorities); policy-makers (DH, NHS England); health practitioners (GPs, practice nurses, healthcare assistants, community pharmacists); professional bodies (RCGP, RCN, RPS); charities (Diabetes UK; BHF) ; patients and the general public. Benefits to patients and the NHS The cost per patient of delivering an intervention of this kind is likely to be less than &pound;6. Given its low cost, if the intervention is effective, it is likely to be highly cost-effective. If the findings are positive, the intervention could be rapidly implemented in the NHS, with immediate and longer-term benefits to patients and to the NHS. Benefits to patients include improved blood pressure control, reducing risk of complications and preventing condition-related events such as heart disease, stroke and transient ischaemic attack. Benefits to the NHS include reduced hospital admissions, consultations, referrals, investigations and medicine wastage, saving an estimated &pound;100 million a year.

Lay abstract: Almost eight million people in England receive treatment for high blood pressure (hypertension) from their general practice, including many patients with other conditions such as diabetes, heart disease and stroke. Treatment for high blood pressure usually consists of one or more blood pressure lowering medicines, known as antihypertensives. Many patients will also be prescribed other medicines including statins (to lower cholesterol) and glucose-lowering medicines. Taking medication as prescribed can significantly reduce risks, complications and early deaths associated with these conditions. However, many people with these conditions do not take their medication as prescribed. This reduces how well such treatment works, leading to increased heart attacks and strokes. It also means that a lot of medicines are wasted, which costs the NHS several hundred million pounds a year. GPs and nurses can support patients in taking their medication, but they have limited time and their time is expensive. There is therefore a need for low-cost interventions that help patients to take their tablets as prescribed. A promising approach is to use digital interventions such as text messaging, smartphone apps , and internet-based interventions that are accessible from smartphones. Such interventions have several advantages: they can be fully automated; they can provide information that is highly tailored to the individual; they can be interactive; they can be available at any time; they can deliver support in real time; the content can be easily updated; and, once they have been developed, they are relatively inexpensive to deliver. We are proposing that a digital intervention could be used in combination with a brief face-to-face intervention from the practice nurse or healthcare assistant. Practitioners would give brief advice and support to patients during consultations such as blood pressure checks and annual reviews. As part of this, they would signpost patients to a digital intervention which would support them to take their medicines between visits to the practice. With the help of patients, practitioners and other experts, and informed by a review of existing evidence, we will develop a new intervention that has two parts: (i) a very brief face-to-face intervention (lasting under five minutes) delivered by a practice nurse/healthcare assistant that signposts the patient to (ii) a digital intervention designed to provide ongoing support between practice visits. We will test whether this two-part intervention is feasible and acceptable to patients and practitioners. Then we will test whether the intervention helps people take their medicines as prescribed and reduces their blood pressure (i.e. whether it is effective) compared with usual care, and also whether it provides value for money. If the findings are positive, the intervention could be rapidly implemented in the NHS, with immediate and long-term benefits to patients and to the health service.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CARDIOVASCULAR