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

Authors: Christopher Iain Jones, Stephen Bremner, Richard Hooper, Jenny Gu, Gergely Bartl, Kathryn Greenwood

Published in: Trials | Issue 1/2021

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 health services. This study will evaluate the effectiveness of a team-based motivational engagement intervention, the Early Youth Engagement (EYE-2) intervention.

Methods and design

The EYE-2 trial is a cluster randomised controlled trial comparing the EYE-2 intervention plus standardised EIP service to standardised EIP service alone, with randomisation at the clinical team (cluster) level. The study aimed to enrol 950 young people (aged 14–35 years) with first episode psychosis in 10 teams per arm.

Results

The primary outcome is time to disengagement: days from the date of allocation to care coordinator to date of the last contact following either refusal to engage with an EIP team or lack of response to EIP contact for 3 consecutive months which will be analysed using a shared frailty model. Secondary outcomes are Health of the Nation Outcome Scale (HoNOS), Process of Recovery Questionnaire (QPR), DIALOG (a service user-reported measure of quality of life and treatment satisfaction) and service use outcomes which will be analysed using mixed effects regression models.

Discussion

This paper is the detailed statistical analysis plan for the EYE-2 trial. Any changes to, or deviations from, this plan will be described and justified in the final trial report.

Trial registration

ISRCTN 51629746. Prospectively registered on 7 May 2019. Date assigned 10 May 2019.

Available only for authorised users

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Title: Statistical analysis plan for the Early Youth Engagement in first episode psychosis (EYE-2) study: a pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement
Authors: Christopher Iain Jones
Stephen Bremner
Richard Hooper
Jenny Gu
Gergely Bartl
Kathryn Greenwood
Publication date: 01-12-2021
Publisher: BioMed Central
Published in: Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05670-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods and design

Results

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods and design

Results

Discussion

Trial registration

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