Occupational Therapy for Delirium Management in Elderly Patients without
mechanical ventilation in an Intensive Care Unit. A Pilot Randomized Clinical
Trial

Evelyn A. Álvarez, Maricel A. Garrido, Eduardo A. Tobar, Stephanie

A. Prieto, Sebastian O. Vergara, Constanza D. Briceño, Francisco J. González

PII: S0883-9441(16)30487-7
DOI: doi: 10.1016/j.jcrc.2016.09.002
Reference: YJCRC 52268

To appear in: Journal of Critical Care

Please cite this article as: Álvarez Evelyn A., Garrido Maricel A., Tobar Eduardo A.,
Prieto Stephanie A., Vergara Sebastian O., Briceño Constanza D., González Francisco J.,
Occupational Therapy for Delirium Management in Elderly Patients without mechanical
ventilation in an Intensive Care Unit. A Pilot Randomized Clinical Trial, Journal of
Critical Care (2016), doi: 10.1016/j.jcrc.2016.09.002

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Occupational Therapy for Delirium Management in Elderly Patients without mechanical

ventilation in an Intensive Care Unit. A Pilot Randomized Clinical Trial.

Corresponding Author: Evelyn A. Álvarez, Master of Neuroscience1.

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Lord Cochrane # 417, Santiago Centro-Chile, Postal Code: 8330507

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1
School of Occupational Therapy, Universidad Central de Chile, Address: Lord Cochrane #

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417, Santiago Centro-Chile, Postal Code: 8330507; Occupational Therapy Department,
University of Chile, Address: Avenida Independencia # 1027, Independencia-Chile, Postal

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Code: 8380453.
Phone: +(56)997413610. alvarezevelyna@gmail.com

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Maricel A. Garrido, Master of Neurorehabilitation2.
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Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.
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Physical Medicine and Rehabilitation Service, Clinical Hospital of University of Chile,
Address: Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.
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Phone: + (56) 942502855. maricel.garrido.m@gmail.com

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Eduardo A. Tobar, Intensivist3.

Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.
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3
Critical Care Unit, Clinical Hospital of University of Chile, Address: Santos Dumont # 999,
Independencia-Chile, Postal Code: 8380456.
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Phone: +(56) 992368717. mailto:edotobar@gmail.com

Stephanie A. Prieto, Occupational Therapist4

Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.
4
Physical Medicine and Rehabilitation, Clinical Hospital of University of Chile, Address:
Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456; School of Occupational
Therapy, Universidad Central de Chile, Address: Lord Cochrane # 417, Santiago Centro-
Chile, Postal Code: 8330507.
Phone: +(56) 976426366. prietostephanie@gmail.com
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Sebastian O. Vergara, Master of Neurorehabilitation5.

Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.
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Physical Medicine and Rehabilitation Service, Clinical Hospital of University of Chile,
Address: Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.

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Phone: +(56) 998560683 . sebastian.vergara.ruiz@gmail.com

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Constanza D. Briceño, Occupational Therapist6.
Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.

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Physical Medicine and Rehabilitation Service, Clinical Hospital of University of Chile,
Address: Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456; Occupational

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Therapy Department, University of Chile, Address: Avenida Independencia # 1027,
Independencia-Chile, Postal Code: 8380453.
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Phone: +(56) 994997156. constanza.briceno.ribot@gmail.com

Francisco J. González, Internist7.

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Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.

Internal Medicine Service, Department of Medicine, Clinical Hospital of University of Chile,
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Address: Santos Dumont # 999, Independencia-Chile, Postal Code: 8380456.

Phone: +(56) 998735936. fgonzalezandrade@gmail.com
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Introduction

Delirium is a frequent complication in the intensive care unit (ICU), with an incidence of 45-

87% [1]. In non-ventilated elderly ICU patients, the incidence of delirium is 20-56% [2, 3].

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Delirium's negative impact has been widely documented in the medical literature. It has been

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associated with increased mortality and morbidity, longer hospital stays, as well as motor,

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cognitive and functional decline [2,4-7]. Some studies suggest that the duration of delirium

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affects patients’ survival, increasing mortality by 11% for every 48 h that delirium persists

[7]. Therefore, preventing and managing delirium is fundamental to reducing its negative

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impact, and it has been estimated that up to 40% of cases are preventable in non-ICU patients
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[8]. Pharmacological protocols were proposed, including low doses of haloperidol, but they

did not show categorical evidence to support delirium prevention [9]. Non-pharmacological

strategies have been recommended in the ICU, including measures for improving sleep
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(reducing noise and night procedures), developing protocols for bundles of sedation
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interruption, spontaneous breathing trials, early mobilization and delirium monitoring [8,

10,11].
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Occupational therapy (OT) promotes good health and welfare by keeping patients active in

their activities of daily living [12], with demonstrable benefits in diverse pathologies [13].

There is evidence that early physical and occupational therapy in mechanically ventilated ICU

patients improves function at discharge and shortens episodes of delirium and length of the

patients’ stay [14,15]. However, to our knowledge, there is no research on OT interventions

for elderly non-ventilated patients in the ICU. We designed a pilot randomized clinical trial

(RCT) in non-mechanically ventilated patients hospitalized in the ICU, to evaluate the impact

of early and intensive OT in delirium management (duration, incidence, severity) and the

patients’ functional outcomes at hospital discharge (functional independence, cognition and

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grip strength). For this, we compared two strategies: standard non-pharmacological

prevention (nPP) based on evidence versus early and intensive OT plus standard nPP.

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Materials and methods

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Selection and description of participants

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The study was a pilot randomized controlled trial that included elderly non-intubated patients

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at the ICU of the University of Chile Clinical Hospital. Patients were recruited between April

2011 and December 2012 from the Medical and Surgical Intermediate Care Units. Patients

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met the following study inclusion criteria: 60 years old or older, hospitalized within 24 h in
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the ICU for post-surgical observation or for acute or chronic decompensated illness and

signed informed consent forms. Researchers excluded patients with cognitive decline (defined

with score >3,3 in the Informant Questionnaire on Cognitive Decline in the Elderly
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(IQCODE)[16] and > 6 points in Spanish version of Functional Activity Questionnaire

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(FAQ))[17], severe communication disorders, delirium before ICU admission or a

requirement for invasive mechanical ventilation. The hospital's Ethics Committee approved
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the research, including patients’ consent.

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Procedures and randomization

Control group: Patients received standard nPP for delirium, consisting of the following

interventions: a) reorientation by nursing staff twice daily, which included delivering

information about time, date, location and reason for hospitalization; b) early mobilization

three times daily by a physiotherapist, that included: passive and active mobilization of limbs,

rolling and supine activation, supine to sitting transference, sitting, sitting to standing

transference, walking in place, ambulation; c) correction of sensory deficits (encouraging

patients to use glasses and hearing aids); d) management of the environment, which included
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avoiding physical restraints (replaced by supervision from a medical professional or relative)

and installing a clock and calendar in the patient's room to avoid disorientation; e) sleep

protocols that included dimmed lights, promotion of quiet and calm environments, and

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avoidance of medicating at night; and f) avoidance, when feasible, of medications with the

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potential to cause delirium (anticholinergic drugs and benzodiazepines) [8-11]. Treatment of

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the control group was supervised on a daily basis. The intervention began during the first 24 h

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of the patient's admission into the ICU.

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Experimental group: Patients received standard nPP plus early and intensive OT, beginning
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in the first 24 h of the patient's admission into the ICU and was delivered twice a day with

sessions of 40 minutes each, one am and other pm, for five consecutive days. OT techniques

were as follows:
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a) Polysensory stimulation: intense external stimulation which objective is to increase the

patient's level of alertness, in case of patients with SAS (Sedation-Agitation Scale) 2 and 3
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[18]; b) Positioning: use of devices and adaptations to prevent edema and bedsores on
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vulnerable body areas. It has to be performed in all sessions (twice a day) [19]; c) Cognitive

stimulation: pool of exercises which objective is to activate mental functions, that include the

following areas among others: alertness, visual perception, memory, calculus, problem

solving, praxis, and language. Each patient received a notebook for cognitive exercises, as

well as tools such as sequencing cards and games (cards, dominoes and memory and

visuospatial construction games). This task has to be performed in all sessions (twice a day);

d) Basic activities of daily living (BADL): Group of activities that promotes independent

living based on BADL that include hygiene, personal grooming and eating, in all morning

sessions; e) Stimulation of upper extremity motor function: exercises to keep the patient's
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upper extremities active and functional[20]. It was performed in all afternoon sessions; and f)

Family participation: daily visits by trained family members [21].

During the intervention phase, occupational therapists used a checklist to confirm that at least

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five of the six areas of the intervention protocol were applied on a daily basis with each

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patient. More detail on both intervention protocols can be found in the Electronic Material

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Supplementary (EMS).

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Randomization and blinding

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Patients were recruited continually for 22 months during mornings by a team internal
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medicine physicians, which obtained the informed consent for each patient. An intensivist

then assigned the patients to one of the two groups. Randomization was performed with

computer-generated random permuted blocks using a centralized, secure web-based

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randomization service. Enrollers, randomizers, evaluators, physiotherapist and statisticians

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were blinded [22]. The professionals of experimental group (occupational therapist), nurses

(due to clinical responsibilities) and the supervisor for verifying the status of interventions,
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could not be blinded.

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More detail on the randomization and blinding procedures is provided in the EMS.

Measuring results

The primary outcome measure was management of delirium, which included duration,

incidence and severity. The secondary outcome was functional outcomes, which included

functional independence, grip strength and cognitive status.

Prior to enrollment and during the first 24 h of the patient's admission into the ICU, staff

collected information using the following measures: a) Sequential Organ Failure Assessment
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(SOFA) [23], b) Acute Physiology and Chronic Health Evaluation (APACHE II) [24], c)

IQCODE [16] and d) FAQ [17]; the last two measures are used to assess cognitive

impairment. Once the patient was enrolled, demographic information and e) Functional

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Independence Measure (FIM) scores were collected. The FIM evaluates independence in 18

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activities of daily living (13 motor and five cognitive items). The scale has seven levels (1 to

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7, from lower to higher levels of independence). The motor FIM score ranges from 13 to 91,

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cognitive FIM from 5 to 35 points and total FIM from 18 to 126 points; higher scores indicate

greater independence [25]. If the total FIM score was ≥75 points, to the patient was

considered to be an independent [26].

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The duration of delirium was evaluated twice daily using the Confusion Assessment Method

(CAM) for the first five consecutive days [26]. The CAM has a sensitivity of 94-100%,
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specificity of 90-95%, positive predictive accuracy of 91-94%, negative predictive accuracy

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of 90-100% and inter rater reliability of 0.81-1.00 [28]. If the CAM test was positive for

delirium, the Delirium Rating Scale (DRS) was applied to determine severity [29].
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Secondary outcomes were assessed 48 h before hospital discharge, using the following

measures: FIM, Jamar® Hydraulic Hand Dynamometer [30] and Mini-Mental State

Examination (MMSE) [31].

Statistical analysis

The duration of delirium is important in critically ill patients [7, 15, 32]. For this reason, the

sample size was calculated in relation to the duration of delirium in ICU non-intubated

patients. Considering the mean duration of 6 ± 4 days [14, 31], and expecting a reduction of

33% with a power of 80% to decrease 4 ± 3 days, the sample size was 398 patients (more
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information, see EMS). The analysis was conducted on an intent-to-treat basis.

The Kolmogorov-Smirnov test was used to determine the distribution of the variables.

Descriptive statistics including median and p25-p75, mean and standard deviation or

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frequencies and percentage, were applied depending of the characteristics to each variable.

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The primary outcome was expressed as density of delirium, understood as the ratio between

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the duration of the event and the exposure time (time spent in the protocol), for this Poisson

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regression was used, therefore, the IRR (Risk incidence Ratio) was the measure used to

compare the groups. Mann-Whitney U test for numerical variables, chi-squared test (χ2) for

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categorical variables, with a two-tailed significance level of p<0.05. Post-hoc analysis
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included a logistic regression analysis with the main predictors of age, APACHE II, sepsis

and the intervention itself; calculus patient-days with delirium (defined as the ratio between

the number of days with a positive result for delirium and the total days when the protocol
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was performed); and pre-DELIRIC score [33]. Statistical analysis was performed using SPSS
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19.0 software.
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This trial is registered in ClinicalTrials.gov, number NCT01555996.

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Results

Patient characteristics and interventions

From April 2011 to December 2012, the research team assessed a total number of 3768

patients were eligible for the trial. 140 were chosen, recruited and randomized. The initial

analysis, which included demographic data and the primary outcome of the assessment,

included 70 individuals in the control group and 70 patients in the experimental group.

Analysis of the secondary outcome at discharge included 65 patients in the control group and

65 patients in the experimental group (Figure 1). Reasons that patients were lost to follow-up
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in the control group were transfer to another medical center or unexpected discharge (three

patients) and passing away (two patients, one from respiratory failure and one from metastatic

cancer). In the experimental group, the reasons were transfer to another medical center or

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unexpected discharge (three patients) and passing away (two patients, one from respiratory

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failure and one from metastatic cancer).

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The patients enrolled were included in the intent-to-treat analysis. There were no significant

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differences in demographics aspects, clinical characteristics including pre-DELIRIC scale

(these data were collected retrospectively) between groups (Table 1).

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There were no changes to the study protocol during intervention. Compliance of the standard

protocol was similar in both group, with high level of implementation (Table 2). The most

common reason for not receiving the intervention was that the patient was unavailable due to
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other procedures; in these cases, the staff attempted to perform the intervention at another
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time. Delirium was assessed for a median of five days [5-5] (an equivalent of 10 CAM

questionnaires) in the control group. In the experimental group, delirium was also assessed for
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a median of five days [4-5], with an overall adherence rate 95% (322.5 of 339 patient-days),
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without significant differences.

Primary Outcome: Management of Delirium

The density of delirium was significantly lower in the experimental group (IRR 0.15 p=0.000,

CI 0.12-0.19 versus IRR 6.6 p=0.000, CI 5.23-8.3) (Table 3). With these results it was

obtained power 82%. The most common day of delirium onset for patients was the second

day in the control group (36%) and the third day in the experimental group (100%).

The incidence of delirium in the control group was 20% (n=14), while the OT group had an
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incidence of 3% (n=2, p=0.001). Delirium severity did not differ significantly between

groups. The mean score was 10 points for the control group [8-13] and 9 for the experimental

group [6-12] (p=0.7).

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Post-hoc analysis included patient-days with delirium, defined as days with delirium while

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patients were receiving the protocol. Of 335 patient-days in the control group, delirium was

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present on 27.5 days (8.2%), and of 339 patient-days in the experimental group, delirium was

present on 3.5 days (1%). Furthermore, the control group had higher risk of delirium than

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experimental group, OR 8.5 (95% CI, 1.853-38.90). Other variable associated with increased
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delirium rates were older over 80 compared with older between 60-79 (OR 2.5, 0.784-8.05,

95% CI).
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Secondary Outcomes: Functional outcomes at hospital discharge

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Patients' functional independence was evaluated using discharge FIM scores. Defining a score

of ≥75 as a cut-off value, 81.5% of the experimental group was functionally independent,
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compared with 47.7% of the control group (p<0.0001, Table 4). The experimental group had a
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median score of 59 on the Motor FIM [44-82.5], which was significantly higher than the

control group, which had a median score of 40 [25-56.5] (p<0.0001, Table 4). The

experimental group also scored higher on the Motor FIM items than the control group

(p<0.0001, Figure 2). For the Cognitive FIM, the experimental group had a median score of

35 [34-35], while the control group scored 33 [31.5-35], representing a significant difference

(p=0.001, Table 4). Grip strength was significantly greater in the OT group for both hands

(p<0.05, Table 4). Finally, the median MMSE at discharge was 28 [25-29] for the

experimental group and 26 [24-28] for the control group (p<0.05, Table 4).

There were significant differences between the results in patients with and without delirium
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for Motor FIM, Cognitive FIM, grip strength, MMSE and length of hospital stay, in favor of

patients without delirium (p<0.001, p<0.001, p<0.001, p<0.039 and p=0.001, respectively)

(see Table EMS_1 in online Resource 2).

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Discussion

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This is the first pilot RCT to assess the intervention of early and intensive OT in elderly

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patients without mechanical ventilation in the management of delirium in ICU. In relation to

the duration of delirium, OT intervention had beneficial effects (positive impact) because

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patients had significantly fewer hours of delirium, compared with the control group that used
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validated interventions in hospitalized elderly patients. Furthermore, it was found that the

recruited sample size obtained a high statistical power (82%) for the primary outcome, giving

greater strength to the founds results.

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Our research has relevant findings in the overall burden of delirium, where the experimental
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group had a significantly lower risk of developing delirium, demonstrated through a

decreasing on patients’ days of delirium contrasted to the control group. This suggests the
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importance of implementing non-pharmacological strategies in delirium in non-intubated

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patients [9, 34].

The experimental group had a significantly lower incidence of delirium, being the lowest

incidence reported in studies in that included non-ventilated patients [7, 8, 32] and elderly

patients in general medical, where a 11-14% [34] of incidence is reached. A lower incidence

of delirium is associated with improved functional outcomes and shorter hospital stays [14,

15].

In relation to the severity of delirium, there is scarcity of evidence to date. A study which

considered elderly patients recovering from surgery found that low doses of haloperidol were
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associated with less severe episodes of delirium [32]. In our study, there were no significant

differences detectable between groups due to the low incidence of delirium in the

experimental group.

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These findings may be attributable to the OT intervention, which gave patients an early and

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intensive routine. The protocol kept the patients alert and active during the day, stimulating

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cognitive function and functional independence. The outcomes of this study, coupled with

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results of other studies, indicate that OT has a role in preventing delirium [14, 15].

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Functional outcomes, are a powerful predictor of health and mortality during and after
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hospitalization. Therefore, creating strategies that include early intervention to minimize the

effects of hospitalization is crucial [35]. A secondary objective of this study, therefore, was to

measure the functional outcomes, defined as ability to participate in activities of daily living,
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as measured by tests of functional independence, cognition and grip strength [36]. Functional
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independence was significantly higher in the experimental group, with higher total scores in

total, motor and cognitive FIM. A total FIM score greater than or equal to 75 points (the sum
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of cognitive and motor items) at discharge has been used as a predictor of functional
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independence at home [26]. In this study, the experimental group showed marked

improvement compared with the control subjects. The results indicate higher independence

levels and are concordant with results published elsewhere in patients recovering from stroke,

hip surgery and mechanical ventilation [14, 15, 37]. In our study, subjects increased their

independence in daily activities such as dressing, self-care, feeding and transfers, but the

scores indicated that they still required supervision in self-care, and minimal assistance for

mobility and locomotion. It is plausible that OT intervention throughout the hospital stay

would have an even greater impact. Improved functionality at hospital discharge not only

impacts on the recovery process of the elderly but also may decrease use of resources in the
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long term and even prevents rehospitalization [38].

Other predictors associated with function are grip strength and cognitive status at discharge.

Evidence shows that patients hospitalized in the ICU lose considerable strength to discharge,

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dropping to mean grip strength of 15.09 kg in the dominant hand and 13.26 in the non-

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dominant hand [35]; these results are similar to those obtained in our control group. Our

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experimental group, however, had significantly higher grip strength, with scores similar to

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those of healthy elderly people [39]. Cognitive FIM and MMSE scores at discharge were

significantly higher in the experimental group, in accordance within normal range of Chilean

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norms by age and education [31]. This might be due to different factors such as early
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mobilization, physical therapy, and an active routine [40].

One of this study's limitations was the exclusion of some predisposing factors such as
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mechanical ventilation, cognitive impairment, dementia or prior episodes of delirium, so the

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results can not be generalized, but it would be interesting to replicate this protocol in these

populations, to determine whether it has similar effects

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There is scarce evidence of the contribution of OT in the ICU; therefore, this work is a
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contribution to develop feasible strategies to implement and replicate in elderly patients

without mechanical ventilation who are cognitively healthy. This protocol allows to identify

procedures that could implement occupational therapists, in order to improve clinical practice.

Therefore, this pilot RCT showed results in decreasing the duration and incidence of delirium.

It may be appropriate, going forward, to extend this work to other medical centers.

Conclusions

This pilot RCT showed that the combination of early and intensive OT plus standard non-

pharmacological strategies is effective to decrease the duration and incidence of delirium in

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elderly without mechanical ventilation in ICU and improve functional outcomes at hospital

discharge.

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Acknowledgments

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 The Physical Medicine and Rehabilitation Service and the Critical Care Unit at the

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Clinical Hospital of University of Chile, for their support of the research team. Special

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thanks to: Elizabeth Guzman, Tatiana Donoso, Claudia Dechent, Consuelo Alzamora,

Camila Bolvaran, Camila Concha, María Fernanda Valencia, Fabiola Villalobos, Atilio

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Gonzalez, Rolando Aranda and Sebastian Gallegos, for participating in the
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implementation phase of the study; Gabriel Cavada, Fernando Quevedo and Sergio

Muñoz, an external collaborator for assistance with analysis: and Rodrigo Cornejo,
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Carlos Romero, Jean Gajardo and Omar Ramirez for checking the manuscript.

 We would like to acknowledge to CONICYT - Chilean National Commission for

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Scientific and Technological Investigation- for funding this research.

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Contributions
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Álvarez Evelyn, Garrido Maricel and Tobar Eduardo participated in the conception, design,

analysis and interpretation of the results; González Francisco, Prieto Stephanie and Briceño

Constanza recruited patients for the study; Prieto Stephanie, Vergara Sebastián and Briceño

Constanza participated in data collection; Álvarez Evelyn and Garrido Maricel wrote and

edited the manuscript; and all of the authors have read and approved the final version of the

manuscript.

Conflicts of Interest

AE, GM, VS, BC, PS and GF received fees by the award of a public fund research and

development in health belonging to a government commission. TE no received fees.

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Source of Funding

The trial was funded by “Fondo Nacional para la Investigacion y Desarrollo en Salud”

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(FONIS – National Fund for Health Research and Development), which belongs to the

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“Comisión Nacional de Investigación Cientifica y Tecnológica de Chile” (CONICYT -

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Chilean National Commission for Scientific and Technological Investigation). The

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commission did not participate in any of the stages pertaining to the study (design,

application, data collection or analysis, interpretation, writing of the present paper or

decisions regarding publishing).

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Informed consent

Informed consent was obtained from all individual participants included in the study.
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This article has an Electronic Supplementary Material.

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Figures

Figure 1. Clinical trial flow chart

Figure 2. Motor FIM Subscale scores at hospital discharge

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Control group Experimental p value

(n=70) group
(n=70)
Age (years), median [P25-75] 71 [63-78.5] 68 [63-75.5] 0.34
Female, n (%) 38 (58.4%) 32 (49.4%) 0.37
Years of education, median [P 25-75] 12 [8.5-14] 12 [6 -15] 0.44

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APACHE II, median [P 25-75] 11 [8-12] 10 [9-12] 0.79

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SOFA, median [P 25-75] 6 [5-6] 6 [4-7] 0.44

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CACI, median [P 25-75] 4 [3-5.25] 4 [3-5] 0.54
IQCODE, median [P 25-75] 3 [3-3,19] 3 [2,96-3,15] 0.66

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FAQ / PFEFFER, median [P 25-75] 1 [0-3] 1 [0 -2] 0.25
Initial Motor FIM, median [P 25-75] 19 [15-22 ] 19 [13-35] 0.83
Initial Cognitive FIM, median [P 25- 33 [30-35] 33 [24- 35] 0.50

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75]
Primary diagnosis on admission, n (%)
Sepsis 34 (48.6%) 29 (41.2%) 0.39
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Renal or Hepatic Failure 13 (18.6%) 15 (21.4%) 0.67
Hemorrhage 7 (10%) 9 (12.9%) 0.59
Acute Respiratory Distress 5 (7.1%) 3 (4.3%) 0.46
Syndrome
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Cardiac Failure 3 (4.3%) 2 (2.9%) 0.6

Decompensated Chronic 1 (1.4%) 1 (1.4%) 1
Obstructive Pulmonary Disease
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Other 7 (10%) 11 (15.7%) 0.31

Comorbidities
Gastrointestinal Disease 17 (24.3%) 19 (27.1%) 0.7
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Hypertension 14 (20%) 12 (17.1%) 0.66

Cancer 12 (17.1%) 11 (15.7) 0.82
Diabetes 10 (14.3%) 11 (15.7%) 0.81
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Hypothyroidism 4 (5.7%) 3 (4.3%) 0.87

Heart Disease 4 (5.7%) 2 (3%) 0.81
Other 9 (12.9%) 12 (17.1%) 0.47
Admission Unit of ICU (%)
IMC 26 (37%) 25 (36%) 0.86
SIU 44 (63%) 45 (64%) 0.86
Baseline Pre-Deliric Score, mean (SD) 16.47 ± 13.3 16.74 ± 13.6 0.83
Length of ICU stay (days) median 5 [3-7] 5 [3-8] 0.44
[P 25-75]
Length of hospital stay (days), median 9 [5-17] 8 [5-15] 0.3
[P 25-75]
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Control Group Experimental Group p-value

(n=65) (n=65)
Total early mobilization (%) 965 (98.9%) 967 (99.17) 0,592
Total reorientation by nursing (%) 640 (98,4%) 638 (98,15%) 0,67
Total Correction Sensory deficits 650 (100%) 650 (100%) 1
(%)

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Management of the environment 650 (100%) 650(100%) 1

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(%)
Medication 12 (18,46%) 13 (20%) 0.88

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 Antipsychotic 2 1
 Antihistamines 2 2

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 Hypnotics (benzodiazepines- 7 5
no benzodiazepines)
 Anticholinergics 1 5

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Sitting (beginning day) 3 [2-4] 2,5 [2-4] 1
Total OT intervention (%) 642 (98,7%)
 Polysensory stimulation 0 (0%)*
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 Positioning 640 (98,46%)
 Cognitive stimulation 642(98,7%)
 BADL 318 (97,8%)
 Stimulation of upper 321(98,7%)
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extremity motor function

 Family participation 286(88%)
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Table 2: Description of implementing interventions

Abbreviations: OT, occupational therapy; BADL, Basic activities of daily living
* No patients had SAS 2 or 3
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Control Group Experimental Group p-value

(n=65) (n=65)
IRR 6,66 0,15 0,000

CI 0,15 0,12-0,19 0,000

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Table 3: Delirium Duration.
Abbreviations: IRR, interval risk ratio; CI, confidence interval.

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Control Group Experimental Group p-value

(n=65) (n=65)
Functional Independence at 31 (47.7%) 53 (81.5%) <0.0001
discharge, nº (%)a
Motor FIM, median [P 25-75] 40 [25-56.5] 59 [44-82.5] <0.0001

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Cognitive FIM, median [P 25-75] 33 [31.5-35] 35 [34-35] 0.001

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Grip strength dominant hand, 18 [10-29.5] 26 [15-36] 0.02

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median [P 25-75], kg
Grip strength non-dominant hand, 14 [9-23] 20 [14-35] 0.01

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median [P 25-75], kg
MMSE, median [P 25-75] 26 [24-28] 28 [25-29] 0.04

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Table 4. Functional outcomes at hospital discharge
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Abbreviations: Motor FIM, Motor Functional Independence Measure (scale 13-91); Cognitive

FIM, Cognitive Functional Independence Measure (scale 5-35); MMSE, Mini-Mental State
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Examination (scale 0-30).a ≥ 75 score Total FIM.

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Figure 1
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Figure 2