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ISRCTN
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ISRCTN73110773
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ClinicalTrials.gov identifier
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Public title
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Oxford Community Treatment Order Evaluation Trial
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Scientific title
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A single centre randomised controlled trial of Community Treatment Order versus treatment on leave in patients with psychosis
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Acronym
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OCTET
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Serial number at source
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NIHR: RP-PG-0606-1006
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Study hypothesis
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The overall hypothesis is that the use of Community Treatment Orders (CTOs) in patients with psychosis and a history of compulsory admissions will result in a reduction in readmissions to hospital compared to treatment on leave. To test the hypothesis, the primary outcome measure is psychiatric hospitalisation in the 12-month follow-up period.
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Ethics approval
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North and South Staffordshire Research Ethics Committee awarded full ethical approval on 30th October 2008 (ref: 08/H1204/131)
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Study design
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Single centre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Psychosis
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Participants - inclusion criteria
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1. Aged 18 - 65 years (reflecting national service configurations), either sex
2. Diagnosed with psychosis
3. Currently admitted under a treatment section (section 3 or 37) of the Mental Health Act
4. Judged by their clinicians (psychiatrist and Approved Mental Health Professional) to need ongoing community treatment under compulsion
5. Able give written and informed consent
6. Not already participating in the study
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Participants - exclusion criteria
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Subject to additional legal restrictions on treatment
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Anticipated start date
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03/11/2008
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Anticipated end date
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31/10/2010
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Status of trial
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Ongoing |
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Patient information material
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Can be found at http://www.psychiatry.ox.ac.uk/research/researchunits/socpsych/research/octetinfo/participantinfo
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Target number of participants
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300
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Interventions
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Eligible patients will be identified from current involuntary inpatients under the care of Community Mental Health Teams (CMHTs) and Assertive Outreach Teams (AOTs) who have agreed to collaborate. Teams must be able, and agree, to offer contact with the patient approximately weekly in either arm.
Access to patients is through a member of the care team. An independent researcher will assess and record the patient's capacity before seeking written informed consent. Participants will be interviewed at baseline and at 6 and 12 months, using appropriate validated and standardised questionnaires. Data related to the primary outcome measure (plus several secondary measures) will be collected from patients' medical records. After 12 months in the trial, care returns to normal.
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Primary outcome measure(s)
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Rate of readmission to hospital in a 12-month follow-up period
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Secondary outcome measure(s)
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Measured at baseline, 6 and 12 months:
1. Number of days in psychiatric hospital
2. Time to readmissions
3. Engagement with clinical services and loss to care
4. Adherence to prescribed medication
5. Satisfaction with services
6. Clinical and social outcomes
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Sources of funding
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National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1006)
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Trial website
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Publications
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Contact name
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Prof
Tom
Burns
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Address
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University Department of Psychiatry
Warneford Hospital
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City/town
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Oxford
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Zip/Postcode
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OX3 7JX
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Country
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United Kingdom
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Tel
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+44 (0)1865 226 474
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Email
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tom.burns@psych.ox.ac.uk
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Sponsor
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Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)
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Address
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Littlemore Mental Health Centre
Sandford Road
Littlemore
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City/town
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Oxford
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Zip/Postcode
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OX4 4XN
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Country
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United Kingdom
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Sponsor website:
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http://www.obmh.nhs.uk/
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Date applied
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11/12/2009
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Last edited
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20/01/2010
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Date ISRCTN assigned
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20/01/2010
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