Administrative information
Title {1} | Comparison of effectiveness and cost-effectiveness of intensive community care services versus treatment as usual including inpatient care for young people with psychiatric emergencies (IVY): an internal pilot followed by a randomized controlled trial comprising all Intensive community service care teams in Great Britain. Protocol Short title: Evaluation of Intensive Community Care Services for young people with psychiatric emergencies (IVY). |
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Trial registration {2a and 2b} | ISRCTN: ISRCTN42999542 |
Protocol version {3} | Version 2.7; August 10, 2023 |
Funding {4} | National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme. (Ref: NIHR127408). |
Author details {5a} | 1 Queen Mary University of London, London, UK 2 East London NHS Foundation Trust, London, UK 3 King’s College London, London, UK 4 London South Bank University, London, UK 5 Oxford Health NHS Foundation Trust, Oxford, UK 6 Central and North-West London NHS Foundation Trust, London, UK 7 North-East London NHS Foundation Trust, London, UK 8 NHS Lothian, Edinburgh, UK 9 Cwm Taf Morgannwg University Health Board, Wales, UK 10 Cardiff University, Wales, UK 11 Berkshire Healthcare NHS Foundation Trust, Bracknell, UK 12 Cambridgeshire and Peterborough Foundation Trust, Cambridge, UK 13 South London and Maudsley NHS Foundation Trust, Beckenham, UK |
Name and contact information for the trial sponsor {5b} | King’s College London Name of Sponsor Representative: Professor Bashir Al-Hashimi Address: Room 8.11, 8th Floor Melbourne House, 44-46 Aldwych London WC2B 4LL. Telephone: 02078487306 Email: vpri@kcl.ac.uk South London and Maudsley NHS Foundation Trust Name of Sponsor Representative: Christina Armoogum Address: R&D Department, Room W1.08, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), De Crespigny Park, London SE5 8AF Telephone: 020 784 80339 Email: slam-ioppn.research@kcl.ac.uk |
Role of sponsor {5c} | Role of sponsor includes local Research and Development approval, institutional indemnity insurance for the trial, but does not include funding or trial conduct |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
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Green (go): progression to definitive trial if 80–100% of projected target is achieved.
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Amber (amend): review/amend recruitment strategies if 60–80% of the projected target is achieved.
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Red (stop): the study should not process as planned if < 60% of the projected target is achieved.
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion | Exclusion |
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1. Young people aged 12 years 0 months to 17 years 11 months (exclude if 18 at randomization) 2. Young people who can consent* and who are being considered for in-patient psychiatric admission or ICCS in the participating NHS Trusts. * Eligible participants under 16 years of age will require the consent of at least one person with parental responsibility | 1. Local ICCS or TAU teams unable to accept new referrals due to their full capacity being reached. 2. Young people unable to consent due to their mental state. 3. The young person’s risk profile is incompatible with ensuring their safety and/or the safety of others in the community, as indicated by a Children’s Global Assessment Scale (CGAS) score of < 20 |
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
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Small caseload: ICCS teams will have a service user/provider ratio of no more than 10:1.
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Team approach: ICCS providers will function as a team rather than as individual practitioners, and clinicians will know and work with all clients.
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ICCS team meeting: ICCS teams will meet frequently to plan and review services for each service user.
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Practicing team leader: The supervisor of front-line clinicians will provide direct services.
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Continuity of staffing: ICCS teams will aim to maintain the same staffing over time.
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Staff capacity: ICCS teams will operate at full staffing.
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Psychiatrist/psychiatric prescriber on staff: There will be at least one full-time psychiatrist per 100 service users assigned to work with the ICCS team.
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Nurse (RMN) on staff: There will be at least two full-time nurses (RMNs) assigned to work with a 100-client ICCS team.
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ICCS team size: ICCS teams will be of sufficient absolute size to consistently provide the necessary staffing diversity and coverage.
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Explicit admission criteria: ICCS teams will have a clearly identified mission to serve a particular population and will have and use measurable and operationally defined criteria to screen out inappropriate referrals.
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Intake rate: ICCS teams will take clients in at a low rate to maintain a stable service environment.
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Responsibility for hospital admissions: ICCS teams will be involved in hospital admissions.
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Community-based services: ICCS teams will work to monitor status and develop skills in the community rather than function as office-based teams.
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No dropout policy: ICCS teams will engage and retain service users at a mutually satisfactory level.
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Assertive engagement mechanisms: ICCS teams will use community outreach, motivational/engagement techniques, as well as legal mechanisms or other techniques to ensure ongoing engagement.
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Intensity of service: ICCS teams will provide a high amount of face-to-face service time as needed.
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Frequency of contact: ICCS teams will provide a high number of face-to-face service contacts as needed.
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Work with informal support system: With or without service users present, ICCS teams will provide support and skills for service users’ support networks, such as family, school, and extracurricular activities coordinators.
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Role of service users on treatment team: Service users will be involved in the functioning of the team (e.g. as members of interview panels).
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Provision of a day service: ICCS teams will provide a form of day service, such as a day school or partial hospitalization, to those service users who need it.