Title: Improving medication adherence: a qualitative study of the effect of using urine assays on consultations about antihypertensive medications
Funder: Department of Health and Social Care

Abstract: Background Hypertension is the single strongest risk factor for premature death and disease burden globally.1,2 Almost eight million people in England receive treatment for hypertension. Some hypertensive patients appear resistant to antihypertensive medicines, prompting expensive and intrusive investigations for secondary causes. Poor adherence to prescribed medication is one of the major causes of apparent resistant hypertension (&ldquo;pseudo-resistance&rdquo;). Urine analysis by liquid chromatography-tandem mass spectrometry has recently emerged as an inexpensive and accurate method of detecting commonly prescribed antihypertensives using a spot random urine sample, offering the possibility of widespread screening. The assay s use has already confirmed widespread non-adherence in our own clinic populations. The challenge is now how best to incorporate the test into routine practice. Previous research on adherence suggests successful approaches need to be patient-centred. The impact of urine assays on communication about medication and on motivation to improve adherence is currently unknown: they might be perceived as a way of facilitating more honest communication with clinicians, avoiding additional intrusive tests, or conversely could result in conflict and mistrust between patient and clinician. Aims We aim to investigate whether non-adherence testing by urine assay offers an opportunity for patients and clinicians to have honest conversations about medicines and develop new patient-centred treatment strategies to improve outcomes for patients with resistant hypertension. We hypothesise the results could provide a direct stimulus for patient-clinician conversation, prompting consideration of intentional and non-intentional causes for non-adherence. Our primary research question is: What is the effect of using urine assay tests on motivation to improve medication adherence and on patient-clinician relationships in apparently resistant hypertensive patients? Plan of Investigation Eligible patients (uncontrolled blood pressure despite treatment with &ge;3 antihypertensives, i.e. resistant hypertension) who are newly referred to two hypertension clinics will be invited to participate. We will observe consultations discussing urine assay results of consenting participants shown to be non-adherent and adherent, and undertake a detailed microanalysis of the moment-by-moment unfolding of interactions. To enable detailed exploration of the acceptability of using urine assay tests, we will undertake qualitative interviews with 50 patients shortly after the consultation, along with all participating clinicians. We will analyse questionnaire data from participants (a) before taking urine, (b) after the adherence test results consultation, and (c) at three months follow-up. Using validated scales we will assess motivation and beliefs about medicines, and collect data on patient characteristics (e.g. length of time on treatment; number of medications prescribed) and assess their relationship to adherence and response to assay results. Benefits to Patients and the NHS Patients with apparent resistant hypertension, estimated as 5&ndash;30% of the hypertensive population, are particularly important for public health. They have higher prevalence of secondary hypertension and target organ damage, higher risk of cardiovascular events, and require greater healthcare expenditure. Tackling non-adherence is essential as it is associated with suboptimal patient outcomes and increased NHS costs from hospital admissions, consultations, investigations, and medicines waste. We will evaluate whether urine tests for adherence should be more widely used by examining acceptability to patients, effect on motivation for adherence, and effect on the patient-clinician relationship. Approached correctly, the assays could improve health outcomes while reducing clinic time and unnecessary tests. They could allow for more honest communication, empowering patients to negotiate new treatment strategies, e.g. de-prescribing to a more manageable number of medications, and resolving clinical inertia (failure to intensify therapy due to concerns about overtreatment when non-adherence is suspected). Clinicians using urine assay consultations have identified a need to ascertain how best to handle the consultation. We will generate guidance on the most effective communication strategies to ensure the most desirable patient and clinician outcomes.

Lay abstract: We want to find out what are the consequences of using a new approach to measure whether patients take their medication for high blood pressure as prescribed by their clinicians. The new method involves testing patients urine and has been shown to be very accurate. We want to explore whether this method is acceptable to patients and medical professionals, and if it is effective in changing the way doctors and patients think and communicate about their medication. We know many people do not take their tablets as prescribed for many different reasons, and that clinicians do not always know this. If patients don t take their medication, their blood pressure may remain high or rise higher. This can lead to people being offered even more tablets, or ones with stronger side effects, or in some cases being sent for costly and unpleasant tests to try to find out other reasons why their blood pressure is not coming down. Though there have been many studies to try to find ways to improve patients medication taking, most have not been very successful, but most experts agree one important thing is for patients to be fully involved in decisions about their care. For this reason, we want to know if discussing the results of the urine test, showing if someone has been taking their tablets or not, improves or worsens the relationship between the doctor and patient, whether it makes it easier or harder to discuss different approaches to treatment and care, whether it helps the doctor and patient discuss the reason why someone was not taking their tablets before, and by so doing whether it changes the way patients think about their medication. We will assess this by observing video recordings of consultations and by interviewing both patients and clinicians.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: CARDIOVASCULAR