10PRT/0496: Oxford Community Treatment Order Evaluation Trial (OCTET): a single-outcome randomised controlled trial of compulsory outpatient treatment in psychosis (ISRCTN73110773)
Burns, Tom, Rugkasa, Jorun, Dawson, John, Doll, Helen, Molodynski, Andrew, Priebe, Stefan and Sinclair, Julia (2010) 10PRT/0496: Oxford Community Treatment Order Evaluation Trial (OCTET): a single-outcome randomised controlled trial of compulsory outpatient treatment in psychosis (ISRCTN73110773). London, GB, The Lancet, 1pp. (Oxford Community Treatment Order Evaluation Trial (OCTET), ISRCTN73110773).
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Background: different forms of compulsory supervision and treatment of outpatients with severe mental illness have developed internationally in the wake of widespread deinstitutionalisation. Community Treatment Orders (CTOs) for patients with psychiatric illness became available in 2008 as a treatment option in England and Wales under the amended Mental Health Act 2007. There is no convincing experimental evidence for the efficacy of compulsory outpatient treatment, so current clinical guidance and decision making is not based on firm evidence. Section 17 leave remains a lawful option for supervision of patients in the community.
Aims: OCTET is designed as a single-outcome randomised trial to test the hypothesis that CTOs reduce readmissions to hospital in patients compared with patients not subject to CTOs.
Design and population: patients will be randomised on a 1:1 basis to a CTO or section 17 leave. Outcome data will be collected from patients’ interviews and medical notes at baseline, and at 6 and 12 months. Eligible patients are those considered suitable for CTO by their clinical team, diagnosed with psychosis, aged 18-65 years, and not subject to any other legal restrictions.
Outcomes: the single primary outcome is rate of readmission to hospital in a 12-month follow-up. Secondary outcomes are: number of days in psychiatric hospital, time to readmission, engagement with clinical services and loss to care, adherence to prescribed medication, satisfaction with services, and clinical and social outcomes.
Sample size: the proposed sample size is 300, based on the North Carolina trial, the only rigorous randomised trial of compulsory outpatient treatment published. That study found a difference of 16% in the proportion readmitted to psychiatric hospital between the two groups. Assuming similar rates of readmission in our control group (48%), we require 288 patients to detect a similar difference with a significance level of 5% and power of 80%. Attrition is anticipated to be negligible because primary outcome data are available from medical records.
Analysis plan: analysis will be on an intention-to-treat basis. The primary analysis will be a test of the difference in the proportion of patients readmitted during follow-up between the two groups. If the data can be transformed into a normal distribution, a t test will be used to compare the difference between the two groups. If normality cannot be achieved, Wilcoxon's rank-sum test will be used. Two-sided significance tests will be used. If the proportion of patients with missing data for the primary outcome exceeds 20% in either group, a sensitivity analysis will be done
|Item Type:||Monograph (Project Report)|
|Subjects:||R Medicine > R Medicine (General)|
|Divisions:||University Structure - Pre August 2011 > School of Medicine > Clinical Neurosciences
|Date Deposited:||19 Jul 2011 14:31|
|Last Modified:||02 Mar 2012 12:56|
|Contributors:||Burns, Tom (Author)
Rugkasa, Jorun (Author)
Dawson, John (Author)
Doll, Helen (Author)
Molodynski, Andrew (Author)
Priebe, Stefan (Author)
Sinclair, Julia (Author)
|Funder:||National Institute of Health Research (RP-PG-0606-1006)|
|RDF:||RDF+N-Triples, RDF+N3, RDF+XML, Browse.|
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