604
J. Wu et al.
Sample size determination
Using LOS as the primary outcome and the observed
variability in our pilot data, a future adequately powe-
red trial (with 80% power) would require 943 partici-
pants in each group to detect a 10% relative reduction
in total LOS; or 604 participants in each group to detect
a 10% relative reduction in acute LOS.
DISCUSSION
This pilot randomized controlled trial demonstrated
that it is feasible to provide an intensive coordinated
multidisciplinary rehabilitation programme using an
in-reach team for ICU survivors on the acute ward. To
our knowledge, this is the first trial to explore the deli-
very of a multidisciplinary rehabilitation intervention
in this patient population, combining medical, nursing,
physiotherapy and occupational therapy expertise.
Significant improvements in physical function over
the course of admission were observed for patients
receiving both in-reach rehabilitation, and usual care.
There was a non-significant difference in total LOS
between the intervention and control groups (median
difference 10 days), but given this pilot was not po-
wered to detect significant differences in LOS, the
reported p-values should be interpreted with caution.
Since the time of conception of this pilot study,
there have been 3 other trials of early rehabilitation
programmes in this patient population, each explo-
ring a different intervention, but focused mainly on
physiotherapy. Gruther and colleagues (28) showed,
in a randomized controlled trial (n = 53), that an early
rehabilitation programme using additional physioth-
erapy on the acute ward for intensive care survivors
led to earlier discharge from hospital. This study found
a median 7-day reduction in hospital LOS, although
long-term follow-up outcomes were not assessed. Their
cohort had a much longer LOS in ICU (mean = 20 days)
compared with our cohort (mean = 10 days). They also
used a number of criteria to select patients who were
more likely to benefit from an early rehabilitation pro-
gramme. Gruther et al.’s trial (28) was able to deliver a
mean of 114 ± 58 min/day of therapy in the intervention
group compared with 21 ± 46 min/day of therapy in the
standard-care group, representing a 543% increase in
therapy dose. Our study achieved less than a 2-fold
increase in combined physiotherapy and occupational
therapy compared with standard care, which probably
contributed to our divergent results.
The study by Walsh et al. (29), conducted at 2 hospi-
tals in Scotland, was more similar in methodology and
outcomes to the present study. Their participant cohort
closely resembled that of the present study (median
time in ICU 11 days), as did the intervention timing
www.medicaljournals.se/jrm
and intensity, starting 2 days post ICU-discharge and
offering a similar increase in therapy intensity with
an allied health assistant seeing patients once daily.
Walsh et al. (29) reported that using an allied health
assistant to deliver a 2- to 3-fold increase in therapy in
the intervention group did not confer a benefit for LOS
in their randomized controlled trial. This is congruent
with our findings, and suggests that a greater increase in
therapy intensity (over and above a 2–3-fold increase)
may be needed to achieve significant benefits.
In a trial by Denehy et al. (30), the investigators ai-
med to provide 2 additional sessions of physiotherapy
per day, but were unable to show an effect over usual
care on LOS, physical function and quality of life. In
this Australian trial, the dose of therapy provided was
not measured, and limited information was available
regarding what therapy was delivered to the interven-
tion group compared with the usual care group. An
insufficient dose of therapy may again be a possible
explanation for the negative results of this trial.
The current study has shown that it is feasible to
provide a higher level of rehabilitation in the acute care
setting compared with standard ward practice, and to
achieve patient participation even among patients who
remain medically unwell. However, process measures
revealed that the dose of therapy actually delivered as
part of our experimental intervention was less than
intended. A median of 8.2 therapy sessions per week
in the intervention group, compared with 4.9 therapy
sessions for the control group, meant that the 2-fold
increase target was not achieved with our staffing
levels. Therapy dosage was also demonstrated to be
a problem in a similar, but adequately powered, early
rehabilitation trial in multi-trauma patients (31). These
results, together with those of similar trials (28–30),
emphasize that therapy dose is an important consi-
deration that needs to be further characterized in the
early/acute rehabilitation setting. They also highlight
the importance of monitoring intervention fidelity and
evaluating the real-world dose of therapy delivered in
rehabilitation trials, in order to draw valid and mea-
ningful conclusions about the dose of therapy required
to improve outcomes (32).
Rehabilitation standards can vary between hospitals.
Our hospital provides physiotherapy up to 7 days per
week as standard care. Many published rehabilitation
trials have been conducted in different “usual care”
settings, often with lower levels of usual care rehabili-
tation (33) (e.g. a median of 2.6 physiotherapy sessions
per week was reported as standard care in a hospital in
Scotland (34)). Furthermore, in the present study 52%
of patients in both arms were discharged home to their
usual place of residence upon leaving hospital. This
compares with 24% of usual-care patients and 43%