1 Randomisation of section 3 psychosis patients to CTO or section 17 leave (not CTO)

2 UK Compulsory care from November 2008 Two possibilities: CTOs or Section 17 leave of absence –CTO six months, renewable twelve months –Can be discharged at any time –Section 17 reviewed weekly Sec 17 provisions have not been changed –(other than to ‘consider’ the appropriateness of CTOs)

3 Legal issues Anticipation is that CTOs will be more enduring than sec 17 leave – months not weeks but not sure Legal opinion is that CTO not more restrictive than section 17 Is ‘increased deprivation of liberty’ (CTO) balanced by better clinical outcomes?

4 Research questions and aims Do CTOs reduce the rate and duration of readmission to hospital for ‘revolving door’ psychotic patients’? –(Are CTOs more enduring than section 17 leave?) Do CTOs improve compliance with anti-psychotic medication? Do CTOs improve clinical and social outcomes, reported quality of life and satisfaction with services? Baseline patient characteristics associated with outcome Treatment patterns associated with outcome In-depth experiences of patients and families Ethical and practical challenges experienced by staff Cost effectiveness of CTOs

5 Inclusion criteria Psychotic diagnosis Current involuntary inpatient –on treatment section (‘section’ 3 or 37) –Not on section 17 leave > 4 weeks No restrictions on section Considered suitable for CTO by team Able to give informed consent to research (semi-structured assessment of capacity)

6 North Carolina secondary analyses Swartz et al, 1999 No CTO, 180 days CTO green. clinical contacts per month Results Mean admissions down 57%, occupancy down 20 days (73% and 28 days for schizophrenia)

7 Clinical requirements Remain in the allocated treatment arm for 12 months –Not on CTO for 12 months in control arm (‘inoculated’) –I.E same management even after readmission. Section 17 as transition to voluntary care –not ersatz CTO ‘long-leash’ Offer weekly clinical contact/support –(minimum X2 per month) Good standard clinical practice Confirmed by North Carolina Principle of reciprocity Clinical decision making otherwise unconstrained

8 How it works in practice: OCTET Team R&D approval, research passports and honorary contracts etc for Research Assistants We identify patients –keep contact with you or organise ‘Ward sweeps’ (us or local CSOs) Patients assessed,randomised and followed up by us Clinical team Understand the study, acknowledge equipoise Want to co-operate and agree to randomisation of (all) CTO candidates.

Study structure Team agrees to be involved We identify involuntary inpatients (ongoing) –(considered suitable for CTO) Patient assessed and consented Concealed, stratified Randomisation (50/50) Follow-up at 7/12 and 13/12 Primary outcome readmission One hour interview with structured assessments –Clinical, social, satisfaction, Health Economics data 9

10 Equipoise Clinical uncertainty Uncertainty lies in the evidence not in the individual clinical decision –We do not know with any certainty although we may ‘feel’ certain in an individual case A rational, not an emotional, condition Needs to be sustained throughout the trial –Not reduced by individual relapses

11 The Damascene conversion

The conversion Hardly a single word in favour of CTOs in evidence from psychiatrists to Parliamentary scrutiny committee Now “it clearly works”, “I’ve seen it with my own eyes”, “It would be unethical to randomise” 12

Can you see it with your own eyes? Of course you can’t. The outcomes are distal and probabilistic! 13

Edwin Smith Surgical Papyrus (c BCE). Instruction for a dislocation of the mandible. “ If you examine a man having a dislocation [wenekh] in his mandible [aret] and you find his mouth open and his mouth does not close for him, you then place your finger[s] [? thumb] on the back of the two rami of the mandible inside his mouth, your two claws [groups of fingers] under his chin, you cause them [i.e. the two mandibles] to fall so they lie in their [correct] place! Thou shalt then say, concerning him, one suffering from a dislocation of his two mandibles, an ailment which I will treat. You should then bind it with imru and honey every day until he recovers.” 14

Psychiatry has nothing to be compacent about here We’ve made lots of mistakes when we ‘saw with our own eyes’ 15

Active aversion treatment for homosexuality into the 1960s 16

Aversion therapy ‘shock box’ 17

Insulin coma treatment Continued into the 1970s First medical treatment convincingly disproved by an RCT and then eventually abandoned. 18

8 from 4 trusts in the East Midlands 2 from 1 trust in the East of England 38 from 8 trusts in London 31 from 5 trusts in the South East 5 from 1 trust in the South West 15 from 3 trusts in the West Midlands 1 from 1 trust in the North West Current N = 186 (target 300) 19

20 Meet the team OCTET hotline: Claire, Helen, Sarah, Naomi Lindsey and Caroline Goodbye Sarah and Naomi Hello Riti, Lisa and Aingus

Final conclusion A well conducted RCT of CTOs is still needed OCTET is carefully thought through and an opportunity unlikely to be repeated May generate the evidence and help restore psychiatry’s image. 21

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