Title: Optimising a whole-person-centred approach to stopping medicines in older people with multimorbidity and polypharmacy: the Tailor Medication Synthesis
Funder: Department of Health and Social Care

Abstract: The Tailor Medication Synthesis will provide clinicians with the evidence base they need to safely and effectively stop medication in older people living with multiple long term conditions and at risk of problematic polypharmacy. We will address two research questions: RQ1. What quantitative and qualitative evidence exists to support the safe, effective and acceptable stopping of medication in older people with multimorbidity and polypharmacy? RQ2. How, for whom and in what contexts can safe and effective individual tailoring of clinical decisions related to medication use work to produce desired outcomes? Design: Two parallel reviews conducted from a shared search strategy to address 2 distinct needs. 1) A Scoping Review. Clinicians need data to inform decisions about the benefits and harms of stopping medicines, a complex intervention, for which scoping reviews are the recommended approach. 2) A Realist Review. Our research, and the wider literature, shows that data on benefits and harms alone are insufficient to change clinical practice. Clinicians have indicated a need for a framework that will help them deliver the necessary compromise on, or individual tailoring of, medication use to address problematic polypharmacy. Realist review is a robust way of examining what works for whom in what circumstances; it is particularly useful for examining complex interventions. This review will produce a realist programme theory, outlining principles for best practice in stopping medications effectively and safely. Strategy for reviewing the literature: We will develop a structured approach to identifying relevant literature from as many relevant sources on the complex intervention of stopping medications and individual tailoring of their use. Our scoping review will follow the methods recommended by the Briggs Institute to extract, collate, and report data from our search. Our realist review will use an iterative cross-case analysis to critically examine how and why actions related to stopping medicines and beneficial/harmful outcomes occurred in different studies. Target population: Adults aged at least 50 (when comorbidities start to become more frequent) with at least 2 long term conditions (multimorbidity as defined by NICE), taking at least 5 long term medicines (identified as significant burden). Health technologies being assessed: Any intervention aimed at stopping or reducing medications, including tapering, tailoring, or withdrawing medicines and deprescribing. Measurement of outcomes: We will collate data on outcomes, including efficacy, harms, acceptability to patients and professionals, and medication burden. Outputs: We will deliver three key outputs, including : 1) a reference data set for clinicians working in this area, detailing a classification of approaches used for stopping medicines, and what is known on effectiveness, harms, and acceptability; 2) a set of recommendations on best practice in individual tailoring of medicines, based on our realist programme theory of stopping; 3) a submitted application for funding for an implementation study, which will incorporate the findings of this study into a new whole system model of practice. We will report our results in peer reviewed journals, through educational events for clinicians, and in patient-facing formats. Project timetable: 21 months – 3 months set up, including stakeholder engagement, 15 months for the two reviews, 3 months targeted dissemination. Team Expertise: We have assembled a team of research experts in the area of problematic polypharmacy in vulnerable adults (the PRIME prescribing team – JR, RB, JK, and public partners Ranson/Dickenson; DM), experts in review methods (KM, GW, NR (realist expertise), LM (synthesis); and academic and clinical advisors from across primary/secondary /ambulatory care (DL, TF, EW, NB, TW, JA) . We will work closely with key stakeholders throughout the project, to ensure that our analysis is grounded in the needs of end users; and to optimise our dissemination strategy

Lay abstract: Many patients take several medicines a day for the long-term. For some, their medicines do them good, but for others, their medicines may be a burden or even be harmful. These patients may do better if long-term medicines are stopped. The Tailor Medication Synthesis project aims to provide clinicians and patients with the information they need to make individual decisions about which medicines provide benefit and which they could stop. Doctors and patients alike have described feeling anxious about knowing when and how to stop long term medicines. Uncertainty about the risks involved can prevent people from making decisions. Patients ask their doctor, ‘what will happen if I stop this medicine?’. Until now, doctors may not have had access to the right information to be able to give a good answer. To create the knowledge needed to help patients and doctors to stop medications safely we will use two methods to critically review and pull together what is already know from published literature. We will undertake a scoping review. Our team will look for all the published studies on stopping medicines, especially those involving people who have many medical conditions and who take many tablets every day. When we have collected all the studies, we will summarise what they tell us about when and how to stop medicines and what effect doing so has on patients. We hope that we will then know when it is safe to stop which medicines and how to do it. At the same time we will also do a realist review. For some medicines, we may find there are no research studies to tell us what will happen if medicines are stopped. In that case, doctors and patient have to work together to make the best decisions they can, drawing on all the information available – the research evidence, the patient's own knowledge about their priorities and daily life, and the doctor’s professional wisdom. Doctors have asked for guidance on how best to do this. In order to answer this question, we will use an established research method called “realist synthesis” to pull together all the evidence, so that we can describe the principles of best practice and advise doctors and patients how to proceed. To do this work, we have assembled a team of people with expertise in prescribing and the use of medicines; academics with experience of the methods used in these sorts of reviews; and patients. As well as writing formal reports of our results, we will share our findings with both doctors, by running educational events in partnership with the Royal College of GPs, and patients, by producing a video summary of our work (e.g. for display in doctors’ surgeries). We will also use our results to further develop a project our team has been working on, called PRIME Prescribing. This is a new model of clinical practice that helps doctors and patients make better individualized decisions about medicines. Ed Ranson is our lead patient partner. Ed has worked with us over a number of years in developing our ideas. He will be a member of our core Advisory Group, commenting on all aspects of the study. He will also support our new patient partners at three stakeholder events, where we will share our work and invite feedback on our findings and how they might be best put to use.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: GENERIC HEALTH RELEVANCE