Outcomes after in-reach multidisciplinary rehabilitation in the acute ward
of intervention patients in the study by Schweickert
et al. (3). These differences in usual care practice,
including the provision of relatively intensive usual
care rehabilitation services at our study site, may have
contributed in part to the lack of significant between-
group differences observed.
Patient selection is another important consideration
for future rehabilitation trials that was not explicitly
addressed in the present study. Gruther et al. (28) utili-
zed a rehabilitation physician (physiatrist) to clinically
assess patients in order to identify those most likely to
benefit from their intervention and subsequently report
the only positive findings published to date. Thus, de-
veloping a screening process to enable identification
of those patients most likely to benefit from a targeted
early rehabilitation programme is worthy of further
investigation. This may improve patient selection to
maximize the benefit from resource- and time-intensive
rehabilitation interventions.
The use of an activity monitor highlighted an over-
all lack of physical activity on hospital wards. This is
consistent with other research using activity monitors,
which have found similarly low levels of activity in
hospitalized patients (35–37). Evidence is emerging to
suggest that hospitalized physical activity has effects on
readmission rates (38) and mortality (39). This finding
has important implications for both clinical practice and
researchers to explore innovative strategies to increase
physical activity during the acute hospital stay.
Experience gained from conducting this trial and
another similar early rehabilitation trial in multi-trauma
(31) calls into question the use of LOS as the primary
outcome measure for assessing the efficiency and ef-
fectiveness of early rehabilitation. LOS can be signi-
ficantly influenced by medical complications, which
may be unrelated to mobility, functional independence,
as well as numerous non-clinical factors (40). Our
forecasted sample size calculations using LOS as a
primary outcome measure indicate that very large
numbers of participants would be required in future
trials, which would make them costly and logistically
complex. Alternative outcome measures may need to
be considered, such as the time taken for participants
to achieve functional milestones or discharge readiness
from a functional perspective.
Strengths of this study include its high follow-up rate,
comprehensive measurement protocol, including the
collection of long-term longitudinal follow-up data, and
the use of a consecutive cohort of patients. The findings
of this pilot study can be used to inform the design of
larger definitive trials in this area. We have learnt from
this pilot study that it is important to collect data directly
quantifying therapy dose; have a method of selecting
patients most likely to benefit from early rehabilitation;
and use a randomization scheme that stratifies for age,
605
diagnostic categories and functional disability to avoid
the influence of cofactors on the LOS. In-reach teams
may need to reconsider their model of care and staffing
ratios so that adequate levels of therapy intensity can
be provided. It may be pertinent for trials to mandate a
minimum level of intensity in order for an intervention
to be classified as an early rehabilitation intervention.
Limitations of this study include its small sample
size, pilot nature and intervention infidelity. Because
of the considerable variability in LOS, our prospective
power calculations have shown that large numbers of
patients would be required to replicate a powered trial
using the same methodology. “Contamination” was a
significant problem in the present study, which led to
6 patients allocated to the control arm receiving early
in-reach rehabilitation. It was considered unethical not
to provide additional rehabilitation services to patients.
Their acute teams were blinded to the randomization
in the study, and, therefore, if their acute team made
a referral for in-reach rehabilitation based on clinical
need, then that referral was considered part of usual
treatment. These events, however, confound the inter-
pretation of our results. Future studies may need to be
conducted in hospital sites that do not offer in-reach
rehabilitation as part of standard clinical care. Alterna-
tively, a cluster randomized trial design may be used
to circumvent this issue in future trials, but this may
not reduce total sample size, given that cluster trials
appear to be more efficient only where contamination
exceeds 30% (41).
In conclusion, this study found that it is feasible to
deliver a coordinated, multidisciplinary rehabilitation
programme, using an in-reach rehabilitation team, to
critical care survivors soon after discharge from the
ICU. Significantly more sessions of physiotherapy and
occupational therapy were delivered via the interven-
tion, compared with usual care. Median values for total
LOS were 31 [20–56] days for the intervention group
and 41 [17–54] days for those receiving usual care.
Although this did not represent a significant reduction
in this pilot study, a larger definitive trial, which can
deliver more than a 2-fold increase in therapy dose
compared with usual care, may be worth exploring.
Intervention dose, fidelity, outcome measurement and
patient selection should be key considerations in the
design of future trials.
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