The document discusses multiple interventions in the ICU and whether they are worthwhile. It summarizes several randomized controlled trials that tested interventions like physiotherapy and recovery programs in the ICU. While some individual studies found benefits, the results were mixed overall. A qualitative study within one RCT found that patients valued the confirmation and information provided by follow-up consultations, despite the RCT finding no differences in quality of life scores between groups. There are challenges in measuring outcomes that are most important to patients, as their experiences did not always align with generic quality of life scales used.

1. Multiple interventions in the ICU
- are they worthwhile?
Janet Froulund Jensen,
Post.doc., PHD
Department of Anesthesiology
Holbæk Hospital

2. What do we know?
- Mixed results from a RCT
Challenges
Perspectives
Presentation

3. What do we know
Trial n Population Intervention Compari
son
Primary
outcomes
Effect
Schweickert et al
(2009)
104 ICU admission (Ventilatory
support >72 h)
Physiotherapy in the ICU SC Functional status, at
hospital discharge (28
days)
+
Elliot et al (2011) 195 ICU admission (Ventilatory
support >24 h)
Physiotherapy SC Physical function, SF-
36, 6M -
Denehy et al
(2013)
150 ICU admission Physiotherapy SC Physical function, 6
min walk test, 12M -
Moss et al (2016) 120 ICU admission (Ventilatory
support, no time)
Physiotherapy SC Physical function, 1M
-
Morris et al (2016) 300 ICU admission (Ventilatory
support, No time)
Physiotherapy SC LOS - Hospital
-
McDowell et al
(2017)
60 ICU admission (ventilatory
support >96 h)
Physiotherapy SC Physical function, SF-
36, 2,5M -
Jones et al (2010) 352 ICU admission (ventilatory
support >72 h)
ICU diary in the ICU SC Not reported, 3M
+
Cuthbertson et al
(2009)
286 ICU admission (Ventilatory
support, No time)
Complex intervention
(Physical and psychological
program)
SC HRQOL, SF-36, 12M
-
Walsh et al (2015) 240 ICU admission (Ventilatory
support >48 h)
Complex intervention
(Rehabilitation professionals)
SC Physical function, 3M
-
Jensen et al
(2016)
386 ICU admission (Ventilatory
support >48 h)
Complex intervention
(Recovery program)
SC Mental health, SF-36,
12M -

4. What about patient experience
Study n Population/aim Design/Data
Source
Themes Effectiveness
Jonasdóttir
at al (2016)
17 Post-ICU
To synthesize the
advantages of nurse-led
ICU follow-up
Integrative
review
The availability of the
ICU follow-up service might be
helpful <6 M ICU discharge
Strong
implications for
patients’
satisfaction
Prinhja et al
(2009), UK
34 Patients
Explore experiences of
ICU follow-up care from
the perspective of former
patients
Qual
Interviews
1. Continuity of care
2. Receiving information
3. Importance of expert reassurance
4. Giving feedback to ICU staff
Valued
Without access
to ICU follow-up ->
often felt
disappointed
Harraldson
et al (2015)
11 Patients
Describe how ICU-
patients experience a
follow-up session
Qual
Interviews
Clarified and confirmed experiences
Without access to follow-up -> Some
patients showed a greater need for a
follow-up session
Without access
to ICU follow-up
-> some showed a
greater need
Ramsay et al
(2016), UK
22 14 Patients/8 carers
To explore and compare
patient/carer experiences
of rehabilitation in both
arms of the RECOVER
study
Mixed
methods
Experience
questionnaire
and focus group
discussions
(n=4)
The case management approach might
improve patient satisfaction by means
as individualization of care
Highly valued
Concordance
between Quan/qual
data on patients’
satisfaction

5. RAPIT – A RCT
•To test the effectiveness of a post-ICU recovery program on physical and
psychological HRQOL, sense of coherence (SOC), anxiety, depression, and PTSD, and
healthcare service utilization compared to SC 12 months after ICU discharge
Aim
•Non-blinded, two-armed, parallel-group, pragmatic randomized controlled trial
•10 (level II–III) ICUs
•Patients, who received mechanical ventilatory support for a minimum of 48 hours
(n=386)
Setting
•Patients photographs during ICU-stay, three follow-up consultations
•Standard careIntervention
•Health-related quality of life (HRQOL) at 12 months
Primary
Outcome

6. Results primary outcomes
0
10
20
30
40
50
60
70
80
PHYSICAL FUNCTIONING
SCALE
ROLE PHYSICAL SCALE
BODILY PAIN SCALE
GENERAL HEALTH
PERCEPTIONS
VITALITY SCALE
SOCIAL FUNCTIONING
SCALE
ROLE EMOTIONAL SCALE
MENTAL HEALTH SCALE
Complete data, ITT, HRQOL
I 3M
I 12M
SC 3M
SC 12M

7. Conclusion
Overall, no beneficial or detrimental effectiveness were found on
either primary or secondary outcomes.
Danish patients surviving intensive care have a relatively decent life
after 12 months with high scores on the mental component score on
HRQOL, a strong SOC, and with less anxiety and depression
compared with other studies

8. QUANTITATIVE STUDY – A RCT
Design: Qualitative study embedded in RCT
QUALITATIVE STUDY
- A part of the RCT
Aim: To describe the patient experience of
ICU-recovery from a longitudinal
perspective by analyzing follow-up
consultations at three time-points
Data collection:
Patient photographs, Semi-structured
Interviews in three follow-up consultations
(n=12, 36 consultations)

9. Results

10. Conclusion
Provides an understanding of the process of recovery
after intensive care from a longitudinal patient
perspective

11. Mixed results from RCT – The RAPIT-study
RQ Quantitative Qualitative Conclusion
What is the
effects of the
intervention?
Quotes
Third consultation:
- All I needed was someone, who took care of me in
the processes. Nobody else has contacted me.
Actually I think it helped me because I had to
reflect on things I would not have thought about.
I've had a feeling of a caring person who took me
seriously. That has been good (P1)
- I have gained an insight into many things, and
recognized my values that I didn’t before (P2)
- I was very happy at the first consultation at the
hospital when I got my pictures and all that (P6)
- It was comforting and nice to know that some
people do come back after such an experience (P8)
- It was a strong experience to be so far out and
come back again; especially when I got back so
well. It's been good talking to you (P11)
Quan:
No difference
Qual:
Confirmation
and information
was valued
Resolving the
jigsaw puzzle
gave a sense of
coherence and
understanding
Beneficial to
share the
experience
Discordance
between Quan
and Qual
0
10
20
30
40
50
60
70
80
AL
FUNCTI
ONING
SCALE
ROLE
PHYSIC
AL
SCALE
BODILY
PAIN
SCALE
GENERA
L
HEALTH
PERCEP
TIONS
VITALIT
Y SCALE
SOCIAL
FUNCTI
ONING
SCALE
ROLE
EMOTIO
NAL
SCALE
MENTA
L
HEALTH
SCALE
MI Intention-to-treat
I 3M I 12M
SC 3M SC 12M
Preliminary analysis of a Joint display: Discordance?

12. Mixed results from RCT – The RAPIT-study
RS Qualitative Quantitative Conclusion
What is most
important for
patients after
intensive care? Intervention:
- To live and be happy for one's
life, I’m alive still (P2)
- When you have been seriously ill,
you have some good days, and for
a few days you’re all down. If you
feel bad, I'm up again anyway
(P12)
Control:
- It was close I know that. The fact
that I'm sitting here today and I do
have back pain, but it doesn’t
matter because I'm alive - I'm
happy for it
- My health could be better. I was
readmitted at the hospital again.
Otherwise, it's very good, some
days are significantly better than
others. There are different days
Both groups seem to
appreciate life, even
though some days are
better than others
Confirmation of “no
differences between
groups”
But did we measure
what was most
important for patients
in the two data
sources? Discordance
between patient
experiences and the
SF-36 scores
0
10
20
30
40
50
60
70
80
PHYSIC
AL
FUNCTI
ONING
SCALE
ROLE
PHYSIC
AL
SCALE
BODILY
PAIN
SCALE
GENER
AL
HEALT
H
PERCE
PTIONS
VITALI
TY
SCALE
SOCIAL
FUNCTI
ONING
SCALE
ROLE
EMOTI
ONAL
SCALE
MENTA
L
HEALT
H
SCALE
MI Intention-to-treat
I 3M
I 12M
SC 3M
Preliminary analysis of a joint display: Discordance?

13. Challenges - measurements
OQL*
Consensus
Indicators
Dimensions
in general*
General health
Physical health
Psychological health
Sexual function
Social function
Indicators:
Symptoms
Existential questions
(Why me?)
Wellbeing
Satisfaction
ICU
population in
RAPIT
SF-36:
Two component scores
Indicators:
SOC
Symptoms
ICU population in
conceptualizing
HRQOL**
Survivors’ health status and
the impact of this on QOL
Physical status
Emotional/psychological
status
Cognitive status
= life changing experience
Conclusion:
Significant gaps between
generic measures and patient-
based conceptualizing HRQOL
Adapted from *Fayers, 2016 and **Lim et al. 2016

14. Challenges of measuring QOL
Natural development?
- Response shift theory
Adapted from Spranger and Scwartz 1999
Catalyst Mechanism
Response
shift
Perceived
QOL
Antecedent
Antecedents
Socio-demographics
Personality
Expectations
Associated symptoms
Catalysts
Health status (progression)
Events
Experiences
Interventions
Mechanism
Coping
Social comparison
Goal reordering
Reframing expectations
Adherence
Response shift
Changes in
internal standards
Values
Conceptualization

15. - Conceptualization
- Consensus on important outcomes
and instruments
- Development
- Validation
- Itembank – PROMIS
(http://www.healthmeasures.net/explore-
measurement-systems/promis)
- Computer adaptive test
- Improving long-term Outcomes
(www.improvelto.com)
- Core outcome measurement sets?
- Specific QOL/follow-up
measurement
Perspectives

16. Multiple
interventions in
the ICU
- are they
worthwhile?

17. Acknowledgements
Research Foundation, Nordsjællands Hospital, University of Copenhagen
The Danish Nursing Organization
The Novo Nordisk Foundation
Department of Anaesthesiology, Nordsjællands Hospital, University of
Copenhagen
All collaborators, The RAPIT-group and patients
Graphics: Farmhouse design
Photos: AV-Media, Nordsjællands Hospital, Stockphoto, and Colourbox

18. Thank you for your attention
Contact: Jfje@regionsjaelland.dk

19. Looking beyond the ICU to survivorship
Cost-benefits analysis
Experiences from staff
Telemedicine
Big data –databases?
Post-ICU data to direct treatment and
prognosis, and inform and engage
patients in establishing a choice of goals
of care
Optimize healthcare utilization
Communication strategies
Identify high-risk survivors
Re-evaluate measurements/develop new
Test new strategies/interventions
Early ICU-based interventions
Including sub-group analysis
Perspectives

20. Health-related quality of life after Intensive care
Prospective studies after 2010 have investigated HRQOL with at least three
points in time using the Medical Outcome Study 36-Item Short-Form
General Health Survey (SF-36) divided into the PCS and MCS after ICU
discharge

22. Other secondary outcomes