Title: Developing a framework for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in older people on complex medication regimens resident in the community.
Funder: Department of Health and Social Care

Abstract: Background Older people are the major users of medication. The Francis Report emphasised that patients should be protected from avoidable harm. Yet, there is increasing evidence that medication is poorly managed exposing older people to harm. Medication related adverse events have been estimated to be responsible for 5,700 deaths and cost the UK £750 million every year. Realist research approaches are designed to explore how and why a complex social programme involving human actions may or may not work. Outcomes from medication management interventions are caused by multiple context sensitive mechanisms. Outcomes happen, not because of the intervention, but because of the ways people respond (“mechanism”) to the intervention. Realist research aims to explain how the context (situations around a person) affects any mechanism, to generate an outcome (intended or not), and so answer the question; “What works for whom, in what circumstances, how and why?” This project combines a literature review with interviews to inform the design of a complex intervention(s). Aim: to develop a framework for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in older people on complex medication regimens resident in the community. WP1: Literature Review Contains five stages to develop a programme theory (PrT) using the literature: 1. Focussing: the focus is to develop a PrT for an intervention(s) to support older people in the community to manage their medication 2. Developing Initial PrT: sets out how and why outcomes occur. The initial PrT will be refined as the synthesis progresses with input from project team members and stakeholders. 3. Developing Search Strategy: a CIMO (Context, Intervention, Mechanisms, Outcome) framework will be used to construct an initial sampling frame from which distinct subsets of literature may be selected to test the PrT. 4. Selection and Appraisal: based on relevance and rigour. Relevant data will be coded into NVIVO. 5. Data Analysis and synthesis: will develop and refine the PrT and CMO configurations by piecing together data from different sources. WP2: Interviews Realist interviews will explore and refine our understanding of the CMO configurations and PrT developed in WP1. Realist interviews are a type of qualitative interview where the researcher does a ‘show and tell’ with the participant. The participant is questioned in as neutral a way as possible about the PrT. Sample size: Up to 30 older people and their informal carers (15 older people with multi-morbidity, 10 informal carers and 5 older people with dementia), and 20 care staff. Data Analysis: NVIVO will be used to organise and understand the data. The data will be coded in a similar way to the data from WP1. WP3: Developing a Framework for the Intervention(s)/Dissemination Data from WP1 and WP2 will be combined to refine the realist PrT for the intervention(s) to identify: a. most important mechanisms that need to be ‘triggered’; b. contexts related to these ‘key’ mechanisms; Ultimately, we will identify which intervention strategies we might be able to use to change the contexts in such a way that ‘key’ mechanisms are triggered. This will provide information on the development of required intervention strategies. These strategies will be presented to the project event to obtain further feedback and develop the framework for a future intervention(s)

Lay abstract: Background The number of older people is increasing rapidly. Half of people aged 75 or more live with two or more long-term conditions. Safe and effective use of medication to manage such long-term conditions is a key challenge for health and social care services. Medicines used for one long-term illness can worsen another illness and cause harm. People with a number of illnesses may take many medicines and thus remembering to take the medicines may be difficult. Medication errors may also be more common, when people take many medicines. Doctors, nurses and pharmacists all may support older people with their medication. Some older people will manage their medications on their own, others will have help from both informal (family/friend) and formal (paid) carers. The level of support an older person gets from all those involved varies and this support needs to be co-ordinated. The consequences of getting things wrong are stark. In the UK every year, medication related adverse events have been estimated to be responsible for 5,700 deaths, 5 to 8% of unplanned hospital admissions, and cost the NHS £750 million. If we can improve the use of medication in older people with multiple long-term conditions this will reduce avoidable harm and improve quality of life. Aim To develop outline way(s) (‘intervention[s]’) of supporting older people living in the community and their carers to safely manage their medication. Design and Methods Used We will learn lessons from the literature and from interviews with people with experience and knowledge. 1. Literature Review We will be using a particular method of literature review (“realist synthesis”) that is ideally suited for making sense of complex processes. Documents containing information on supporting older people in the community to manage their medication will be brought together to identify ‘what works for whom, in what circumstances, how and why?’ The review will enable us to build an overall understanding of why processes are more or less successful and under which situations. 2. Interviews The interviews will build on and expand the literature review; if the interviews identify new areas we will go back and review the literature in that area. Older people, including carers, and clinicians will be asked what helps them, or the people they care for manage their medication. Finally, we will combine information from the research literature with information from the interviews to develop a proposed approach for supporting older people living in the community in managing their medication. Key stakeholders will attend a project event and help us to develop our approach. We will seek further funding to finalise our approach and test whether it is helpful in a clinical trial. Dissemination (sharing what we find) We will make our results widely available, those who may benefit include: 1. Other RESEARCHERS working on how to improve the way that medicines are managed for different groups by helping them to develop their interventions. 2. POLICY MAKERS and CLINICIANS; the findings should help them develop their current services. 3. For SERVICE USERS we will produce information on how they may better make use of existing medication management encounters. Patient and public involvement representatives will be equal partners in dissemination and advise on communication strategies. Older people will be equal partners at the project event.

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