The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement

Abstract

Background Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium–long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. Method The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14–35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. Discussion The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. Trial registration ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.

Translational framework for implementation evaluation and research: a normalisation process theory coding manual for qualitative research and instrument development

“…First, AG coded transcripts of interviews ( n =55 with managers, practitioners, and patients) conducted for an evaluation of the accelerated implementation of remote clinician-patient interaction in a tertiary orthopaedic centre during the COVID-19 pandemic. Second, KG coded transcripts of interviews ( n =22, with community mental health professionals) conducted for the process evaluation of the EYE-2 Trial (an engagement intervention for first episodes of psychosis employed in early intervention in the community) [ 26 ]. Further disambiguation .…”

Neglecting the care of people with schizophrenia: here we go again

“…There has been splendid qualitative and quantitative research on factors that may predict disengagement (Doyle et al, 2014;Kim et al, 2019;Mascayano et al, 2020Mascayano et al, , 2021Polillo et al, 2022;Tindall et al, 2018) and an ambitious cluster-RCT of a teambased motivational intervention to improve engagement is well underway in first-episode psychosis teams around England (Greenwood et al, 2021;ISRCTN registry, 2021). The importance of service engagement for this patient group is summarised well in the trial's plain language summary: 'at least a quarter of all young people drop out of services in the first 12 months, leading to greater risk of poor health and more long-term service use.…”

Applying the cultural adaption framework to the Early Youth Engagement (EYE‐2) approach to early intervention in psychosis

“…EYE‐2 is a cluster randomized controlled trial (RCT) comparing the EYE‐2 intervention plus standardized EIP service to standardized EIP service alone, with randomization at team level (Greenwood et al, 2021). The intervention is a team‐based motivational engagement intervention, delivered by EIP clinicians during their normal routine contacts.…”