Developing and user testing iSWITCHED (implementing SWITCHing EDucational intervention) to support switching antipsychotics to improve physical health outcomes in people with severe mental Illness

BACKGROUND 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. AIM AND OBJECTIVES 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. METHODS 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. PATIENT AND PUBLIC INVOLVEMENT Patient and caregiver perspectives have informed this research. Mechanisms are in place to continue patient and caregiver involvement throughout the project. ANTICIPATED IMPACT AND DISSEMINATION 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.