Title: Developing and user testing iSWITCHED (implementing SWITCHing EDucational intervention) to support switching antipsychotics to improve physical health outcomes in people with severe mental Illness
Funder: Department of Health and Social Care

Abstract: AIM_x000D_ We aim to develop and test a new intervention to support medication reviews for people with severe mental illness (SMI). The intervention will help guide decision-making about switching of antipsychotics, which could help improve the physical health of people with SMI._x000D_ _x000D_ BACKGROUND_x000D_ Nearly 500,000 people are living in England with SMI, such as schizophrenia. People with SMI are 2-3 times more likely to die at an earlier age compared to those without SMI. Many of these deaths are due to physical health problems, such as heart disease or stroke. Some medications used to manage SMI symptoms add to the risks of these physical health problems._x000D_ _x000D_ There is little different between the effectiveness of commonly used antipsychotics in managing SMI symptoms, but there can be important differences in unwanted side-effects. Excessive weight gain, raised cholesterol and blood sugar are of particular concern, increasing the risk of diabetes, heart disease and stroke. While these side-effects can happen with any antipsychotic, some are more likely to cause them than others._x000D_ _x000D_ Switching antipsychotics to one with a lower risk for these unwanted side-effects could improve both quality and length of life of people with SMI. However, a lack of training and guidance often prevents clinicians from talking to people with SMI about switching their antipsychotic medication._x000D_ _x000D_ DESIGN AND METHODS_x000D_ Our proposed research uses different methods to develop and test the two parts of the iSWITCHED intervention: (1) A tool (a set of questions and guidance) to help clinicians and patients to review their medications together and discuss switching antipsychotics. (2) Training to support clinicians to use the new tool. Patient information to raise awareness about switching and support understanding will also be created._x000D_ _x000D_ To develop the iSWITCHED intervention, we will identify appropriate psychological theory to support behaviours around switching. We will interview patients and caregivers to understand their views on switching. We will agree with clinicians, patients and caregivers important factors to include in medication reviews. We will use role-play situations with simulated patients to help refine the intervention._x000D_ _x000D_ To test the intervention, we will train clinicians to use the iSWITCHED medication review tool in real world settings. We will identify and invite patients to medication review appointments with these trained clinicians. Clinicians and patients will use the tool together to reach a shared decision on whether to switch medications or not – patients will not be expected to switch if they do not want to._x000D_ _x000D_ We will evaluate the iSWITCHED intervention through questionnaires and interviews with clinicians, patients and caregivers. We will also discuss wider use of the intervention with NHS healthcare managers and commissioners._x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT_x000D_ The McPin Foundation and a local patient group “Hear our Voices” have supported development of this research proposal. We have a named PPI representative co-applicant. A Patient and Caregiver Advisory Group will provide input on public-facing documents, education materials, and sharing of findings. _x000D_ _x000D_ DISSEMINATION_x000D_ We will share findings with lay, clinical and academic audiences. We will work with the Patient and Caregiver Advisory Group to develop appropriate and accessible ways of sharing findings with people with SMI. We will hold an end of study conference open to the public.

Lay abstract: BACKGROUND_x000D_ Nearly 500,000 people in England live with severe mental illness (SMI), such as schizophrenia and bipolar disorder. The SMI population has 2-3 times higher risk for premature death than the general population. Over 60% of this higher mortality is due to potentially preventable physical illnesses, mainly cardiovascular disease, such as heart disease or stroke. Some antipsychotic medications increase physical health morbidity and may increase mortality by causing weight gain and metabolic dysregulation. Switching from high- to low-risk antipsychotic may improve both the quality and length of life for people with SMI. However, gaps in evidence on the optimum strategies for switching, the unavailability of appropriate training, and clinical uncertainty among healthcare practitioners to implement switching for fear of relapse pose critical barriers._x000D_ _x000D_ AIM AND OBJECTIVES_x000D_ The proposed research seeks to develop and user-test a new intervention (iSWITCHED) that will enable mental health professionals to implement evidence-based guidance on reviewing and switching high-risk antipsychotics, and improving the communication with patients and caregivers during this process. The iSWITCHED intervention is to comprise a structured medication review tool and training package. _x000D_ _x000D_ METHODS_x000D_ A mixed-methods design planned across three interconnected work packages (WPs) to develop and evaluate the iSWITCHED intervention, underpinned by a theoretical framework informed by psychological and sociological behaviour change perspectives, shared-decision making principles and implementation science. WP1 will include theory of behaviour change workshops to identify and embed key theory from the start, semi-structured interviews with people with SMI and caregivers to capture views on shared decision-making in switching, and development of guidance for switching. WP2 will support co-production and prototyping of the intervention components: the decision-making tool and training package for mental health professionals. WP3 will facilitate user-testing through delivery of iSWITCHED training to healthcare practitioners and real-world consultations with people with SMI (and carers) about switching. Primary and secondary outcome data will be collected pre- and post-consultation to assess acceptability, communication, and relevant clinical measures. Economic and qualitative evaluation will be conducted to understand impact and implementation processes. _x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT_x000D_ Patient and caregiver perspectives have informed this research. Mechanisms are in place to continue patient and caregiver involvement throughout the project. _x000D_ _x000D_ ANTICIPATED IMPACT AND DISSEMINATION_x000D_ We will develop the iSWITCHED intervention components (decision aid and training) to be tested within a trial, information resources for healthcare providers and the public, and recommendations to support implementation. Outputs will aim to support substantial public health benefits for people with SMI currently receiving high-risk antipsychotics in England, which accounts for ~300,000 people. Key messages from the research will be shared in a variety of formats including peer-review publications, social media content and a mixed stakeholder conference to reach diverse audiences. We will work with patient and clinical experts and Keele Impact Accelerator Unit to co-develop outputs to support accessibility and identify emerging opportunities to maximise impact.

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