Transcript ANDREA LD

ANDREA LD
ANti-psychotic Drug REduction in primary
care for Adults with Learning Disabilities
(ANDREA-LD): A Randomised Double-blind
Placebo Controlled Trial
The Key points
Funded by the Health
Technology Assessment
Programme
Aims to investigate the
impact of antipsychotic drug
withdrawal in people with a
learning disability
Aims to inform on risk of
behaviour disturbance so as
to aid in reducing the
personal and societal
burden of antipsychotic use
in those without psychosis
What will ANDREA LD do?
Identify people
Apply the intervention
Identify people with a
Communicate findings
learning disability on Randomise and
antipsychotics
either withdraw over High quality evidence
without psychosis
6 months or stay on to support practice
same drug-but
blinded
Participants and process
• Adults with learning disabilities (LD) identified through
practice LD registers prescribed one of two anti-psychotic
drugs, haloperidol or risperidone, for treatment of
challenging behaviour with no known current psychosis or
previous recurrence of psychosis following prior drug
reduction
• A 2 arm randomised double-blind placebo-controlled noninferiority withdrawal trial. Treatment will be primary care
led and will be supported by a specially designed trial
specific treatment and safety package. During the trial,
those in the intervention arm will proceed through 4
monthly approximately 25% reduction stages within a 6
month period (although blinded, the GP has discretion to
delay progression to the next step)
Why should we do this?
• The age-specific rate of registered learning disability in
people 16 years and over in Wales is 0.47% and adult users
of learning disability services in England are also estimated
to constitute 0.47% of the adult population; making about
200,000 adults in the two countries combined.
• An audit of adults with learning disabilities in primary care
in Wales (n=9,947) found that 29% were prescribed antipsychotic medication. An earlier and smaller primary care
trial in England found that 21% of 357 adults with learning
disabilities were prescribed anti-psychotic medication.
Applying the average of the two estimates to the number
of people above suggests that there are 50,000 adults with
learning disabilities in England and Wales who are
prescribed anti-psychotic drugs.
Who is doing this?
Why should we do this?
• The rate of prescription of anti-psychotic
medication in this population far exceeds the
estimated prevalence of psychosis (3-4%). The
discrepancy may be accounted for by the use of
anti-psychotic medications for the treatment of
behavioural problems, the commonest reason for
their prescription
• The effectiveness of anti-psychotic medications
in treating or controlling challenging behaviour
has not been demonstrated
The small print……
Recruitment of practices and patients (+ R&D approvals) – trial briefing, consent/assent
Recruitment pilot
Continued recruitment – Wave 1, Wave 2, Wave 3
Screening – age, gender, current medication, ABS, Mini PAS-ADD
Baseline assessment –medication, MOAS, ABC, PAS-ADD Checklist, UKU, DISCUS, CSRI
Baseline contact with GP – establish CRF
Blinded randomisation
Intervention Arm
Control Arm
Stage 1
GP visit 1 month post baseline
st
1 batch of blinded medication released
(reduction to 75% of starting dose)
1st
Stage 1
GP visit 1 month post baseline
batch of blinded medication released
(maintain starting dose)
Stage 2
GP visit 2 months post baseline
2nd batch of blinded medication released
(reduction to 50% of starting dose)
Stage 2
GP visit 2 months post baseline
2nd batch of blinded medication released
(maintain starting dose)
Stage 3
GP visit 3 months post baseline
3rd batch of blinded medication released
(reduction to 25% of starting dose)
Stage 3
GP visit 3 months post baseline
3rd batch of blinded medication released
(maintain starting dose)
4th
Stage 4
GP visit 4 months post baseline
batch of blinded medication released
(reduction to 0% of starting dose)
4th
Stage 4
GP visit 4 months post baseline
batch of blinded medication released
(maintain starting dose)
6 month assessment
(MOAS, ABC, PAS-ADD, CSRI
9 month assessment
(MOAS, ABC, PAS-ADD, CSRI
Unblinding
Drug changes and qualitative
interviews: reasons for change
12 month assessment
(medication, MOAS, ABC, PAS-ADD, CSRI)
A call for support from LDAN
• Please support recruitment
• Please spread the word that this is a unique
opportunity to address the science needed to
impact on one of the largest negative impacts
on the health of people with a learning
disability
• THANK YOU