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Both intervention and control groups had the same access to
weekend physiotherapy as part of usual care, which prioritizes
patients discharging home. No routine occupational therapy was
available to any participants on the acute ward over weekends.
Participants were not blinded to group allocation.
Outcome measures
A baseline assessment was completed with all participants by
a blinded assessor within 72 hours of transfer from the ICU.
Baseline measures included: premorbid Lawton’s Instrumental
Activities of Daily Living Scale (15); the Functional Indepen-
dence Measure (FIM) (16); the Confusion Assessment Method
for the ICU (CAM-ICU) to assess for the presence/absence of
delirium (17); and the Medical Research Council (MRC) muscle
scale (18) to assess for the presence/absence of ICU-acquired
weakness (defined as MRC sum score < 48 (19)). Additional data
were extracted from participants’ medical records, including
principal diagnosis of admission, the Charlson Comorbidity
Index (20) (a global measure of illness severity), and duration
of delirium (based on daily CAM-ICU assessment (17)).
LOS was collected from the medical records. ICU LOS re-
fers to the first admission to ICU (if there was more than one
admission to ICU). Acute LOS refers to all acute care days (in-
cluding ICU readmission(s)) before acute discharge or transfer
to inpatient rehabilitation. Total LOS refers to all admitted bed
days including transfers back to acute care from rehabilitation
and subsequent acute care days if they were transferred to
another hospital.
In order to monitor fidelity and describe the rehabilitation treat-
ments received by each participant, therapy dosage was collected
from each participant’s medical record and quantified as the
number of therapy occasions of service undertaken by discipline.
During their acute ward admission, the physical activity of
each participant was quantified using a physical activity monitor,
the activPAL™ (AP; Physical Activity Technologies, Glasgow,
UK), worn on the thigh. This device has been validated and
shown to accurately differentiate between time spent sitting/
lying, standing and stepping, even in sedentary populations (21).
Research staff applied the activity monitors to participants and
collected activity data for a 24-hour period once per week on
a weekday, over the course of their acute hospital admission.
All participants were assessed on the ward by an unblinded
assessor at the time of discharge from the acute hospital (re-
gardless of whether they were discharged home or transferred
to inpatient rehabilitation). Discharge assessments included the
FIM; ICU-acquired weakness (via MRC sum score); Timed
Up and Go Test (22) and 6-minutes walk test (23) for physical
function; and the Depression Anxiety Stress Scale 21 (24)
(DASS-21) for psychological status. Discharge destination and
LOS were also collected.
Longer term outcomes were measured at 6 and 12 months.
Assessments were conducted via phone by a blinded assessor,
and included: the DASS-21; Lawton’s Instrumental Activities
of Daily Living Scale (15); and 2 quality of life scales, the
Short Form-12 (SF-12 v2) (25) and the Assessment of Quality
of Life (AQoL-4D) (26) questionnaire. The principal study
investigator (JW) provided staff training, a written assessment
protocol, standard equipment and regular monitoring to ensure
measurement accuracy and consistency between assessors.
Data analyses
The primary outcome for this trial was total hospital LOS (days),
including days in the acute hospital admission, and any inpatient
www.medicaljournals.se/jrm
rehabilitation (where it was required). Secondary outcomes
included: change between baseline and discharge FIM; ICU-
acquired weakness, discharge Timed-Up and Go; discharge
6-minute walk; discharge DASS-21; and discharge destination.
Analyses of follow-up data at 6 and 12 months were used to
supplement those at the primary endpoint of hospital discharge.
Process measures quantifying therapy delivery, intensity and
physical activity were used to enable accurate description of
the intervention that was delivered to each group.
Groups were compared at hospital discharge and at follow-
up using Mann–Whitney U tests for non-normally distributed
variables, and χ 2 analyses for categorical variables. Analyses of
outcome data were by intention-to-treat. Longitudinal changes
in continuous data (e.g. FIM, DASS-21) were analysed using
repeated measures analyses of variance (ANOVAs), with factors
of time and group. Analyses were performed using SPSS v21
(IBM Corp., Armonk, NY, USA), and results were considered
significant where p < 0.05.
Given that this was a feasibility pilot study, no formal power
calculation was performed for this trial. Rather, the aim was to
recruit all eligible participants over a 12-month period in order
to generate the preliminary data required to perform formal
power analyses for a subsequent larger trial. Power calcula-
tions were performed using our pilot data to model sample size
requirements for a future randomized controlled trial of in-reach
rehabilitation using LOS as a primary outcome. Calculations
were performed in GPower (accessed via http: //www.gpower.
hhu.de/), using a non-parametric 2-sample t-test model, with a
power of 80% and a significance threshold of α < 0.05.
RESULTS
Flow of participants through the trial
Between May 2015 and August 2016, a total of 209
ICU survivors with a LOS of at least 5 days were
screened (Fig. 1). Of the 89 patients who were eligible
for the study, 66 (74.2%) consented to participate. Four
patients subsequently died in acute care, and were not
included in the analyses. Follow-up assessments were
completed for all participants by October 2017.
Baseline characteristics
The study cohort was comprised 43 males and 23
females, mean age 55 (standard deviation (SD) 13)
years. Baseline comparisons between the intervention
and control groups are presented in Table I. There
were no significant between-group differences for any
demographic or clinical variables at baseline. Prior to
enrolment, the pooled cohort spent a mean of 9.7 (SD
5.0) days in ICU.
Dose of therapy and activity levels
The mean number of days from ICU discharge to
commencement of the in-reach rehabilitation team
was 2.0 (SD 1.4) days. The in-reach team was invol-
ved in patient care for a mean of 11.3 (SD 8.7) days.
Participants receiving in-reach rehabilitation stayed