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Background and study aims Older patients (aged 65 years or older) often have to take many medicines to treat several long-term medical conditions. This can include taking medicines in a range of different forms (e.g. tablets, inhalers, patches) and at different times throughout the day. Previous research has shown that these factors can make it difficult for older patients to take medicines as prescribed by their General Practitioner (GP). Patients who have difficulty taking their medications as recommended and agreed with their GP are described as non-adherent and older patients may be at increased risk of this. Non-adherence can lead to poorer control of medical conditions for patients, increased hospital and GP visits and increases in healthcare costs. A number of studies have previously tried to improve non-adherence in older patients but these generally showed only limited benefits. Previous approaches have often been developed based on what researchers think might work well, rather than being developed in a logical manner, taking into consideration the views and opinions of patients and trying to change behaviour. To overcome the limitations of previous research, a new approach to tackle non-adherence to medicines has been developed in line with current recommendations. This involved using the latest published evidence, asking patients about the problems they faced when taking many medicines, what helped them overcome those problems, and then considering the best ways that might help improve adherence. This approach was used to select the best solutions that might help patients. The aim of this study is to test these solutions as part of a new approach (intervention) to improve adherence to medicines. Who can participate? Patients aged 65 or older who take four or more regular medications What does the study involve? The intervention has been developed to be used in the community pharmacy by trained pharmacists over a period of 12 months. Patients are asked to attend three (30-40 minutes) appointments in the pharmacy from which they normally collect their medicines. Patients are asked about any difficulties they experience when taking several medicines (Appointment 1) and together, the patient and pharmacist choose the best solutions to help overcome any difficulties (Appointment 2). For example, patients are offered a medication diary to record when they have taken their medicines. This diary also includes a list of the patient’s regular medicines, instructions on when and how to take each medicine and the reasons why medicines have been prescribed. After four weeks, the pharmacist and patient then review whether the recommended solutions have been helpful (Appointment 3). The findings show how these solutions might work in practice and whether this type of intervention is acceptable and useful for both patients and community pharmacists. This study also aims to find out if study procedures (e.g. asking patients to take part, collecting information) work well or what would be done to improve these. The research team also review all the paperwork completed by pharmacists during the study and ask for feedback on the intervention from patients and pharmacists during telephone and face-to-face interviews, respectively. Together, this information will determine whether this new approach can be used in community pharmacies as intended. What are the possible benefits and risks of participating? Participation in this study may be beneficial for both pharmacists and patients, as it will help to determine whether the intervention needs to be changed before further tests can be undertaken. In the long term, it is hoped that this type of intervention will lead to improvements in medication adherence, reduce GP visits and hospitalisations and lead to improvements in older people’s quality of life. Due to the nature of the study, the risk of harm to participants is considered to be low. However, it is possible that discussions between the pharmacist and patient may prompt the patient to think of upsetting or distressing aspects of their medical conditions. This risk will be minimised by having a study information sheet that clearly outlines what will happen at each appointment. The appointments will also be held in the community pharmacy that the patient normally attends and the intervention will be delivered by a pharmacist with whom the patient is likely to be familiar. There is a low risk that we may identify poor practice by healthcare professionals during the study. In the unlikely event that poor practice is identified by the researcher, then the case will be reported to the Chief Investigator who will, in the first instance, refer the case to the healthcare professional(s) involved and if necessary, the case will be reported to the appropriate regulatory authority. The procedure for disclosing cases of poor practice will be outlined in the study information sheets received by all participants. Where is the study run from? Queen's University Belfast (UK) When is the study starting and how long is it expected to run for? March 2016 to March 2017 Who is funding the study? Harold and Marjorie Moss Charitable Trust Fund (UK) Who is the main contact? Prof. Carmel Hughes

Inclusion criteria

• Non-adherence to polypharmacy in older adults

Links

• isrctn