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Dr Dorothy Wade
Lead clinical investigator
Principal health psychologist
Debbie Smyth
Co-Investigator
Senior nurse, research
Funder:
NIHR
HS&DR Programme
Funder reference:
12/64/124
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In ICU
Anxiety, stress, panic, low mood,
insomnia,
Agitation, hallucinations, delusions
Risk factors for future psychological
morbidity
After ICU
Posttraumatic stress disorder 20%
depression 30% anxiety 40%
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Nicole: thought nurses were tryingto kill her and her baby
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Nicole – ICU flashbacks
ICU post emergency caesarean, nearly died
‘Imprisoned in a blue room’ for 12 days
Stayed awake to stop nurses murdering her baby
Home at 4 weeks – couldn’t stop crying or sleep
“My daughter forces me to get on with life, but I can’t forget”
Constant vivid flashbacks of ICU experience
Five years on flashbacks less frequent but still vivid
Recently triggered by need for hip operation – she cancelled
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Psychosocial outcomes
Psychological morbidity
Data from numerous systematic reviews and meta-analyses suggest
o Around 20% have PTSD symptoms
o 30% depression symptoms
o Up to 40% anxiety symptoms
Cognitive impairment (CI)
o 1 in 3 with new or accelerated CI post-ICU Wilson et al 2018
Return to work
o 29% unable to return to work post-ICU Hodgson et al 2018
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Risk factors for post-ICU
psychological morbidity
Acute stress in ICU Wade 2012, Davydow 2013
• Physical stress – life-threatening illness, invasive procedures
• Environmental stress
• Psychoactive drugs
Memories Jones 2007, Wade 2014
• Early intrusive trauma memories of ICU
• Memories of delusions and hallucinations from ICU
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2009 Guideline
Assess patients for
psychological risk
2017 Quality standard
Psychological support key
to rehabilitation
Rehabilitation of body and mind
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Early interventions to reduce stress in ICU
23 studies (15 RCT), 12 showed benefit
o Psychological interventions
o Music, nature sounds
o Mind/body, relaxation practices
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The POPPI intervention
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Rationale for POPPI intervention
Patient view. “Patients in intensive care are terrified for their lives. If there is something we can do about this, we should do it” (Journalist, ICU survivor, David Aaronovitch)
Early interventions to reduce acute stress in ICU look promising
E.g. Introducing psychology service in ICU reduced PTSD among trauma patients Peris 2011
Three sessions of CBT delivered early to address acute stress following a trauma could prevent PTSD NICE 2013
CBT for psychosis – reduces distress caused by hallucinations and delusions
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Few psychologists in NHS ICUs
Trained, non-expert staff delivered psychological interventions effectively in other settings
Hypothesis that given special training, ICU nurses have motivation and understanding to deliver psychological support
Rationale for POPPI intervention
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Patient-public involvement
PPI group formed at UCLH in 2012, 20 patients involved in POPPI intervention development and studies
Nicole Als, Caroline Knight, Kate Baden-Fuller, Rajadurai Sunderalingam, Peter Cross,
David Aaronovitch, Sheila Richards, Chris Whitman, Mags Harvey
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Intervention development team
Senior UCH nurses John Welch, Debbie
Smyth; Psychologists Dorothy Wade and Dr
Vaughan Bell (UCL, Maudesley)
Overseen by an Expert psychology advisory
group (EPAG) chaired by a professor of
clinical psychology specialising in psychosis
Including medical educationalists, and
experts in PTSD and health psychology
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Stage one (development)
1. Identify evidence base
2. Identify or develop theory
3. Model process/outcomes
Stage two (feasibility/piloting)
1. Test procedures
2. Estimate recruitment/retention
3. Determine sample size
Stage three (evaluation)
1. Assess effectiveness
2. Understand change process
3. Assess cost-effectiveness
Stage four (implementation)
1. Dissemination
2. Surveillance/monitoring
3. Long term follow-up
Medical Research Council framework
...for developing and evaluating complex interventions
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A preventative nurse-led
intervention
Three elements
1. Promoting a therapeutic environment in ICU
2. Three stress support sessions for patients
assessed as acutely stressed
3. Relaxation and recovery programme for
acutely stressed patients
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Element one of intervention
Interactive online training for all staff
Improve staff-patient communication and reduce stressors to create a more healing environment
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Element two of intervention
Patients with acute stress identified with
intensive care psychological assessment tool (IPAT)
Three stress support sessions for acutely
stressed patients delivered by nurses
Three-day training course in theory and skills of stress support for ‘POPPI’ nurses
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what goes through
your mind
(words or images)
emotions and
body sensations
you feelwhat you do,
how you react
Stress
support theory
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CBT approaches used
Emotional expression
Normalisation
Psychoeducation
Stress management/coping strategies
Cognitive reappraisal
Behavioural experiments
Homework tasks
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Stress support sessions for
acutely stressed*
Session one (~30 mins) –
helping patients understand and cope with stress
Session two (~30 mins) –
managing frightening thoughts from critical care
Session three (~30 mins)–
creating confidence and hope for a good recovery
Ideally starting in ICU/completed in one week
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Element three: Relaxation and
recovery programme
App on tablet computer (given in session 1 for use
during 3 sessions), DVD and self-help booklet (given in
session 2 for patients to keep)
Calming music
Relaxation practice
Restful nature sounds and
images
Relaxing music
Meditation
Meditation
Patient Recovery Stories
Calming music
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The POPPI study
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Study design
Phase I: 2 feasibility studies completed –
at UCLH, Watford, Bristol, Medway
Phase 2: Cluster-randomised clinical trial
Trial in 24 adult, general, critical care units
– 12 control group
– 12 intervention group
– Allocated geographically in 3 groups of 8
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Aim of the trial
To evaluate the clinical and
cost-effectiveness of a nurse-led preventative psychological intervention
in reducing patient-reported PTSD symptom severity at six months
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Stable criteria
✔ Age 18 years or greater
✔ Receipt of Level 3 critical care
(for any period of time) during first 48 hours
✔ English-speaking
If patient stays in unit greater than 48 hours, screen for:
Pre-existing conditions…
✘ chronic cognitive impairment
✘ chronic post-traumatic stress disorder
✘ psychotic illness
✘ Previously recruited to POPPI
Inclusion criteria
Exclusion criteria
If all stable criteria met, commence daily screening
+
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Transient criteria
✔ Between +1 to -1 on the Richmond Agitation Sedation Scale
✔ Glasgow Coma Scale score of 15
✔ Able to communicate orally
Once stable criteria met, screen daily for:
✘ Receiving end of life care
Inclusion criteria
Exclusion criteria +
Able to consent (approach for consent must be in ICU)
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Control sites
Screen
Consent
Six-month follow-up
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Intervention sites (intervention period)
Screen
Consent
Six-month follow-up
IPAT ≥7
IPAT
IPAT <5IPAT 5-6Repeat IPAT
(max 3 times)
Stress support sessions
Thera
peuti
c e
nvir
onm
ent
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Primary outcome
Mean patient-reported
PTSD symptom severity score at six months
Measured using the PTSD Symptom Scale –
Self Report questionnaire (PSS-SR)
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Secondary outcomes
In hospital
days alive and free from sedation to day 30
duration of critical care unit stay
At six months
PSS-SR threshold for prediction of current or
future PTSD (>18 points)
depression
anxiety
health-related quality of life
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Sample size (power
calculation) Assumed mean of 10.3 points on the PSS-
SR
Treatment effect of a reduction of 4.2 points
Require minimum of 1,378 patients (including refusals/lost to follow-up)
Anticipated 85% power
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Approach to analysisIn
terv
en
tio
n s
ite
sC
on
tro
l site
s
Control sites
Baseline period
Intervention sites
Baseline period
Control sites
Intervention period
Intervention sites
Intervention period
Is the change in intervention sites different from the change in control sites?
Baseline period Intervention period
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POPPI trial results
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Recruitment 1,458 patients recruited
5 withdrew
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Patient follow-up
Baseline period Intervention period
Control Intervention Control Intervention
Returned questionnaire, % of alive at six months
Completed 78.4 78.8 79.8 79.9
Refused 8.5 10.2 7.5 6.1
Lost to follow-up 13.1 11.0 12.8 14.0
• Overall response rate:79.3% of survivors at six months
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Intervention delivery - creating
a therapeutic environment
POPPI online training
Median POPPI online training uptake across intervention group sites (N=12) from transition
month until end of intervention period
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Intervention delivery – the
stress support sessions
Number of stress support sessions received by patients (n=199)
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Primary outcome
Control sites Intervention sites
0
2
4
6
8
10
12
14
Mea
n (
95
% C
I) P
SS
-SR
Baselineperiod
Interventionperiod
Baselineperiod
Interventionperiod
+0.1 −0.3
Adjusted treatment effect (95% CI):−0.03 (−2.58 to 2.52)
Similar results from sensitivity analyses
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• Days alive and free from sedation to day 30
Secondary outcomes
Control sites Intervention sites
0
5
10
15
20
25
30
Me
an
(9
5%
CI)
da
ys a
live
an
d f
ree
of
se
da
tio
n
Baselineperiod
Interventionperiod
Baselineperiod
Interventionperiod
Adjusted treatment effect (95% CI):
0.47 (−1.03 to 1.96)
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• Duration of critical care unit stay
Secondary outcomes
Control sites Intervention sites
0
5
10
15
20
Mea
n (
95
% C
I) d
ura
tion
of
cri
tical care
un
it s
tay
Baselineperiod
Interventionperiod
Baselineperiod
Interventionperiod
Adjusted treatment effect (95% CI):
−0.28 (−3.45 to 2.88)
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• PSS-SR threshold for prediction of current or future PTSD (>18 points)
Secondary outcomes
Control sites Intervention sites
0
5
10
15
20
25
30
Perc
en
tag
e (
95
% C
I) w
ith P
SS
-SR
> 1
8
Baselineperiod
Interventionperiod
Baselineperiod
Interventionperiod
Adjusted odds ratio (95% CI):
1.32 (0.66 to 2.67)
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• Depression at six months
Secondary outcomes
Control sites Intervention sites
0
2
4
6
8
Mea
n (
95
% C
I) H
AD
S d
epre
ssio
n s
core
Baselineperiod
Interventionperiod
Baselineperiod
Interventionperiod
Adjusted treatment effect (95% CI):
−0.22 (−1.40 to 0.95)
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• Anxiety at six months
Secondary outcomes
Control sites Intervention sites
0
2
4
6
8
Mea
n (
95
% C
I) H
AD
S a
nxie
ty s
core
Baselineperiod
Interventionperiod
Baselineperiod
Interventionperiod
Adjusted treatment effect (95% CI):
−0.24 (−1.50 to 1.01)
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• Health-related quality of life at six
months
Secondary outcomes
Control sites Intervention sites
0.0
0.2
0.4
0.6
0.8
1.0
Mea
n (
95
% C
I) E
Q-5
D-5
L
Baselineperiod
Interventionperiod
Baselineperiod
Interventionperiod
Adjusted treatment effect (95% CI):
−0.007 (−0.063 to 0.076)
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State anxiety (STAI-6)score
For those patients who received three
sessions, post-hoc analysis observed a
reduction in the mean (SD) STAI-6 score of
49.3 (16.9) at the time of consent to
40.3(13.5) at the end of their third session
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Summary
The POPPI intervention did not significantly
reduce PTSD symptom severity
No significant difference in any secondary outcomes
No significant variation across subgroups
Secondary/sensitivity analyses all consistent
with primary analysis
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Process evaluation
Variation in delivery 50% sites engaged/50% passive
Fidelity of intervention Unknown
Complexity Intervention/patients
Patient group Some too ‘muddled’ to give consent or
participate in sessions
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What’s next
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“The staff were going to eat me alive” David Aaronovitch, journalist
“I will never forget those days
and nights of terror and
delusion”
ICU patients are terrified out of
their minds. If there is
something we can do about
this, we should do it”
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Discussion
Patient groupWere patients who may benefit discharged earlier than expected?
Timing of the interventionWas ‘early’ the right timing?
Implementation of the creation of the therapeutic environmentTranslate sufficiently into practice?
Dose of the stress support sessions receivedDid they need all three sessions?
Non-expert delivery of the interventionSufficient training and support provided?
Was the POPPI nurse selection process adequate?
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Acknowledgements
John Welch, David Howell, Monty Mythen - UCLH
Nicole Als, Mags Harvey, Chris Whitman, David Aaronovitch and the PPI group
John Weinman, Vaughan Bell, Chris Brewin, Daniel Freeman – psychology experts
Kathy Rowan, chief investigator, David Harrison, head statistician, Paul Mouncey, trial manager, Alvin Richards-Belle, ICNARC
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Cluster-randomised RCT in 24
sites
Sites
University College Hospital Watford General Hospital