Title: MEDIcation optimisATion in severE mental illness (MEDIATE)
Funder: Department of Health and Social Care

Abstract: Development work question How we can optimise medication regimens through working with people with severe mental illness (SMI)? Background Severe mental illnesses (e.g. schizophrenia) are associated with significant morbidity and mortality. People with SMI often receive complex medication regimens to treat mental and physical health needs. Optimising these regimens can be challenging and the consequences of failing to optimise the regimen devastating both in terms of untreated mental illness and medication related side-effects (which increase the risk of non-adherence and relapse). MEDIATE uses a realist approach with extensive engagement with experts-by-experience to make sense of the complexities and identify potential solutions. Aims/Objectives Aim: Use the literature and experts-by-experience engagement to build an understanding of what works, for whom, in what circumstances, to optimise medication with people living with SMI. Objectives: i. To undertake a realist review to develop a programme theory and from this identify potential intervention strategies. ii. To enhance the programme theory through engagement with experts-by-experience to identify the key problems and possible solutions. iii. To build the research team for subsequent research. Expert-by-Experience Engagement: Lived Experience (LEG; up to 15 service users/family carers) and Stakeholder Groups (SG; up to 15 practitioners) will actively input into developing the Programme Theory and interventional strategies, and refine dissemination strategy. Development work plan/timelines (Work package 1): Stage 1: Focussing review (month 1): We will hold initial meetings with the LEG and SG to explain our plans, to obtain their views. Stage 2: Developing Initial Programme Theories (month 2-3): We will develop a rough and ready explanation for what needs to be done, by whom, how and why, and in what contexts. Stage 3: Developing Search Strategy (month 3-5): The programme theory will be refined with secondary data. Our initial sampling frame is: Context: adults living with SMI on medication. Intervention: to optimise medication usage. Mechanisms: triggered by intervention. Outcomes: e.g. quality of life, adherence etc. Stage 4: Selection/Appraisal (month 4-8): Documents will be screened by title, abstract/keywords and full text against inclusion and exclusion criteria. Selection will be based on: relevance (to programme theory development) and rigour (data sufficiently trustworthy). Stage 5: Data Extraction and Analysis/Synthesis (month 7-10): A realist logic of analysis will be used to interpret the data with input from the LEG and SG. Contexts, mechanisms and outcomes will be coded in NVivo with document characteristics recorded on Excel. Stage 6: Programme Theory Development (month 10-11): Refined programme theories will be based on: a. Key outcomes important to experts-by-experience. b. Strategies required to change contexts to trigger the key mechanisms for these outcomes. Anticipated Impact, Bid Development and Dissemination (Work Package 2: month 0-12) The research team and identified collaborators for follow-on research will participate in three online meetings to develop the Programme grant. Our key findings and plans for the next stage will also be discussed with the LEG and SG. Knowledge dissemination strategies will be tailored to specific stakeholders, working closely with our SG and LEG, and include videos, newsletters, website, short summaries, publications and conferences.

Lay abstract: Aims: To understand how doctors, nurses, pharmacists and other healthcare staff can work with people living with severe mental illness and family carers to optimise medication. Background: Severe mental illnesses, such as schizophrenia, can have a devastating impact. One of the main treatments is medication. For some people, the side-effects of these medications are unpleasant and reduce quality of life. Sometimes, this leads to people stopping taking these medications, which can result in a relapse of their mental illness. Additionally, people with severe mental illness often have physical illnesses that require medications; some of the medications used for severe mental illness can cause or worsen physical illnesses, such as diabetes. Clearly, people with severe mental illness have complex medication needs and should be involved in making decisions about what medications they are taking. Medication optimisation is &ldquo;a person-centred approach to safe and effective medicine use, to ensure the best possible outcomes&rdquo;. It works out the best combination of medications for a given individual and the best doses and times. Currently, there is little research on medication optimisation with people living with severe mental illness. We suggest that for those with mental health problems a team approach is needed where they are equal partners with the staff caring for them, and their families, to truly tailor medication use to their individual needs. Our research will focus on how such a team could best operate in practice. Work plan: We will learn lessons from what is already known by studying academic papers and other documents. We will aim to find any documents with information about staff and people living with severe mental illness working together to improve their medication regime. We will work out what works for whom, when, how and why? We will also aim to understand if there are differences in different groups, such as ethnic minorities. A key part of understanding how to get the medication right will be learning from people living with severe mental illness, family carers and staff (&ldquo;key stakeholders&rdquo;). Our findings from the literature will be regularly discussed with people from these groups. These stakeholders will help us interpret and question our findings according to the &ldquo;real world.&rdquo; Building on our findings we plan, in future research, to develop a &ldquo;new approach&rdquo; to optimise medication and then test this &ldquo;new approach&rdquo;. Patient/public involvement (PPI): PPI is central throughout MEDIATE and fully funded. It will be led by a Lived Experience Group containing up to 15 service users and family carers. Sharing our findings: We will share our findings with key stakeholder groups, including the public, policy-makers, doctors, nurses and pharmacists. Our Lived Experience Group will advise us on the best ways to share our findings.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH