Early Psychosis Informatics into Care [EPICare]: A co-designed protocol for implementing and evaluating a national integrated digital registry and clinical decision support system within early intervention in psychosis services

Introduction: Early Intervention in Psychosis services are nationally mandated in England to provide multidisciplinary care to people experiencing first-episode psychosis, which disproportionately affects deprived and ethnic minority youth. Quality of service provision varies by region, and people from historically underserved populations have unequal access. In other disease areas, including stroke and dementia, national digital registries coupled with clinical decision support systems have revolutionised delivery of equitable, evidence-based interventions to transform patient outcomes and reduce population-level disparities in care and prognosis. Given psychosis is ranked the third most burdensome mental health condition by the World Health Organization, it is essential that we achieve the same parity of health improvements. Here, we provide details of a co-designed protocol to produce an evidence-based, stakeholder-informed framework for the build, implementation, and evaluation of a national integrated digital registry and clinical decision support system for psychosis, known as EPICare (Early Psychosis Informatics for Care). Methods and Analysis: Using a participatory co-design framework, we engaged key stakeholders (N~40-50) across four meetings to establish the parameters and essential features of EPICare and identify factors likely to influence adoption and implementation into routine practice. Stakeholders consisted of organisational, clinical, academic, and patient and public contributors. In collaboration with National Health Service (NHS) informatics teams, we identified how to retrieve key data items from Electronic Health Records and subsequently design the software architecture and data model to create an infrastructure plan for future implementation. Guided by Normalisation Process Theory, data synthesised from observations of stakeholder meetings and individual interviews (n=10) were subject to interpretative qualitative analysis. Finally, a co-designed set of guides were produced to allow for the build, implementation, and evaluation of EPICare in a larger, future study. An inclusive, representative stakeholder group, fully engaged with the future co-development of EPICare, was also established. ### Competing Interest Statement I have read the journal's policy and the authors of this manuscript have the following competing interests: GKM has received consultancy fees from ieso. RU reports speaker fees from Sunovion, Springer Healthcare, Otsuka and Vitaris outside the submitted work and holds unpaid officership with the British Association for Pharmacology - Honorary General Secretary 2021-2024. ### Funding Statement EPICare is fully funded by the NIHR Programme Development Grants: PDG Mental Health Call 2021, grant number [NIHR203669]. Birmingham Women’s and Children’s NHS Foundation Trust agreed to act as sponsor for this study. The work is supported by the NIHR UCLH Biomedical Research Centre and Oxford Health Biomedical Research Centre. The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The EPICare programme was deemed as not needing approval by the NHS Research Ethics Committee and has been granted full approval by the Health Research Authority (Ref:306234). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.