Clinical & cost effectiveness and implementation evaluation of the Early Psychosis Informatics Into Care [EPICare] digital psychosis registry and clinical decision support system

Background: Psychotic disorders are amongst the most disabling illnesses globally. They are accompanied by enormous personal, healthcare and societal costs, and disproportionately affect minoritised ethnic groups and those in socioeconomic disadvantage. NHS England has implemented a national network of Early Intervention in Psychosis (EIP) services to deliver evidence-based care to people experiencing their first episode of psychosis (FEP), according to a national Standard. However, only 30-40% of FEP patients make a full recovery. The suboptimal way that routine NHS EIP data is currently collected and used prevents us from identifying, understanding and tackling causes that prevent patient recovery in real-world settings. This could be overcome through a novel learning healthcare system that incorporated digital technologies capable of optimising actionable insights from routine data. To realise this, NIHR and Office for Life Sciences investment has allowed us to co-design and build a prototypic national psychosis registry and embedded clinical decision support system (CDSS), called Early Psychosis Informatics into Care (EPICare). EPICare will collect an enhanced minimum dataset, including existing routine EIP data, and two novel outcomes (symptom severity, cognition) highly-valued by patients and clinicians. We now need to evaluate whether EPICare can provide real-time, causally-robust insights that could unlock our understanding of the real-world effectiveness and equitable delivery of evidence-based treatments to improve patient care and outcomes in EIP services in England. Aim: This programme grant aims to evaluate the implementation, clinical- and cost-effectiveness of EPICare in EIP services covering five NHS Trusts that care for 12% of all people, 14-65 years old, who develop FEP each year in England. Research questions: Does EPICare provide reliable clinical data to support actionable insights? Is EPICare acceptable and liked by patients and clinicians? What are the barriers and facilitators to implementation; how can these be overcome? Can EPICare test the real-world clinical- and cost-effectiveness of treatments associated with patient outcomes; identify, examine and reduce inequities in care, and; improve patient outcomes? Does EPICare provide feasible data to validate FEP-specific risk algorithms in real-world clinical settings to guide tailored preventative care? Methods & timelines: We will pilot EPICare in two Trusts, from 1 June 2024 for 9 months, to examine initial data quality, acceptability, and implementation barriers and facilitators, using an implementation process evaluation to refine the platform. The refined platform will be deployed in five Trusts, for three years, to collect data on over 4,000 people predicted to commence EIP care for the first time. Quasi-experimental causal inference methods (Interrupted Time Series, Difference-in-Difference, Inverse Probability Weighting), and cost-effectiveness analyses will establish clinical- and cost-effectiveness. Further implementation evaluation will synthesise evidence to produce an implementation toolkit and strategic plan for national rollout. Anticipated impact & dissemination: EPICare could transform EIP care to ensure effective, equitable treatment at the right time, to the right people, to improve outcomes that matter most to patients, if acceptable, implementable and effective. With patient, clinician, and policy partner (NICE) involvement throughout the project, we will co-produce appropriate materials to disseminate to the wider audiences our stakeholders represent.