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      Evaluation of intensive community care services for young people with psychiatric emergencies: study protocol for a multi-centre parallel-group, single-blinded randomized controlled trial with an internal pilot phase

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          Abstract

          Background

          Over 3000 young people under the age of 18 are admitted to Tier 4 Child and Adolescent Mental Health Services (CAMHS) inpatient units across the UK each year. The average length of hospital stay for young people across all psychiatric units in the UK is 120 days. Research is needed to identify the most effective and efficient ways to care for young people (YP) with psychiatric emergencies. This study aims to evaluate the clinical effectiveness and cost-effectiveness of intensive community care service (ICCS) compared to treatment as usual (TAU) for young people with psychiatric emergencies.

          Methods

          This is a multicentre two-arm randomized controlled trial (RCT) with an internal pilot phase. Young people aged 12 to < 18 considered for admission at participating NHS organizations across the UK will be randomized 1:1 to either TAU or ICCS. The primary outcome is the time to return to or start education, employment, or training (EET) at 6 months post-randomization. Secondary outcomes will include evaluations of mental health and overall well-being and patient satisfaction. Service use and costs and cost-effectiveness will also be explored. Intention-to-treat analysis will be adopted. The trial is expected to be completed within 42 months, with an internal pilot phase in the first 12 months to assess the recruitment feasibility. A process evaluation using visual semi-structured interviews will be conducted with 42 young people and 42 healthcare workers.

          Discussion

          This trial is the first well-powered randomized controlled trial evaluating the clinical and cost-effectiveness of ICCS compared to TAU for young people with psychiatric emergencies in Great Britain.

          Trial registration

          ISRCTN ISRCTN42999542, Registration on April 29, 2020

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          Most cited references31

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          Health equity in England: the Marmot review 10 years on

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            Adolescent Depression and Long-Term Psychosocial Outcomes: A Systematic Review and Meta-Analysis

            Experiencing depression in adolescence can disrupt important developmental processes, which can have longstanding effects on socioeconomic status and relationships. The objective of this article was to systematically review the evidence examining associations between adolescent depression and adult psychosocial outcomes.
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              Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility.

              In trial-based cost-effectiveness analysis baseline mean utility values are invariably imbalanced between treatment arms. A patient's baseline utility is likely to be highly correlated with their quality-adjusted life-years (QALYs) over the follow-up period, not least because it typically contributes to the QALY calculation. Therefore, imbalance in baseline utility needs to be accounted for in the estimation of mean differential QALYs, and failure to control for this imbalance can result in a misleading incremental cost-effectiveness ratio. This paper discusses the approaches that have been used in the cost-effectiveness literature to estimate absolute and differential mean QALYs alongside randomised trials, and illustrates the implications of baseline mean utility imbalance for QALY calculation. Using data from a recently conducted trial-based cost-effectiveness study and a micro-simulation exercise, the relative performance of alternative estimators is compared, showing that widely used methods to calculate differential QALYs provide incorrect results in the presence of baseline mean utility imbalance regardless of whether these differences are formally statistically significant. It is demonstrated that multiple regression methods can be usefully applied to generate appropriate estimates of differential mean QALYs and an associated measure of sampling variability, while controlling for differences in baseline mean utility between treatment arms in the trial. Copyright 2004 John Wiley & Sons, Ltd
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                Author and article information

                Contributors
                thilipan.thaventhiran@kcl.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                22 February 2024
                22 February 2024
                2024
                : 25
                : 141
                Affiliations
                [1 ]GRID grid.4868.2, ISNI 0000 0001 2171 1133, Queen Mary University of London, ; London, UK
                [2 ]East London NHS Foundation Trust, ( https://ror.org/01q0vs094) London, UK
                [3 ]King’s College London, ( https://ror.org/0220mzb33) London, UK
                [4 ]London South Bank University, ( https://ror.org/02vwnat91) London, UK
                [5 ]Oxford Health NHS Foundation Trust, ( https://ror.org/04c8bjx39) Oxford, UK
                [6 ]Central and North-West London NHS Foundation Trust, ( https://ror.org/05drfg619) London, UK
                [7 ]North-East London NHS Foundation Trust, ( https://ror.org/023e5m798) London, UK
                [8 ]NHS Lothian, ( https://ror.org/03q82t418) Edinburgh, UK
                [9 ]Cwm Taf Morgannwg University Health Board, Wales, UK
                [10 ]Cardiff University, ( https://ror.org/03kk7td41) Wales, UK
                [11 ]Berkshire Healthcare NHS Foundation Trust, ( https://ror.org/03t542436) Bracknell, UK
                [12 ]Cambridgeshire and Peterborough Foundation Trust, ( https://ror.org/040ch0e11) Cambridge, UK
                [13 ]South London and Maudsley NHS Foundation Trust, ( https://ror.org/015803449) Beckenham, UK
                Author information
                http://orcid.org/0000-0003-4827-9795
                Article
                7974
                10.1186/s13063-024-07974-5
                10885519
                38389089
                14225a4f-8c97-4389-8b9c-e680552ebcae
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 9 December 2023
                : 6 February 2024
                Categories
                Study Protocol
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2024

                Medicine
                young people,children,community care,intensive community care services,inpatient care,mental health

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