Randomisation of section 3
psychosis patients to
CTO or section 17 leave (not CTO)
1
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)
2
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?
3
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
4
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)
5
North Carolina secondary analyses
Swartz et al, 1999
• No CTO,
<180 days blue,
• < 3 > clinical contacts per month
>180 days CTO green.
Results
• Mean admissions down 57%, occupancy down 20 days
• (73% and 28 days for schizophrenia)
6
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
7
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.
8
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
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
10
The Damascene conversion
11
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. 2000 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
1 from 1 trust in
the North West
2 from 1
trust in the
East of
England
15 from 3 trusts in
the West Midlands
Current N = 186
(target 300)
38 from 8
trusts in
London
5 from 1 trust in the
South West
31 from 5 trusts in
the South East
19
Meet the team
Goodbye
Sarah and Naomi
Hello
Riti, Lisa and Aingus
Lindsey and Caroline
Claire, Helen, Sarah, Naomi
OCTET hotline: 01865 613171
Email: [email protected]
20
• 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.
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