Efficacy of Early Enhanced Occupational Therapy in an Intensive Care Unit (EFFORT

Abstract

Importance: This research trial contributes to the evidence for occupational therapy service delivery in intensive care settings.

Objective: To explore the feasibility of a trial to evaluate the impact of early enhanced occupational therapy on mechanically ventilated patients in intensive care.

Design: Single-site assessor-blinded randomized controlled feasibility trial.

Setting: Level 5 8-bed adult medical–surgical intensive care unit (ICU) at Logan Hospital, Brisbane, Australia.

Participants: Participants were 30 mechanically ventilated patients randomly allocated to two groups.

Outcomes and Measures: We compared standard care with enhanced occupational therapy with outcomes measured at discharge from the ICU, hospital discharge, and 90 days post randomization. The primary outcome measure was the FIM^®. Secondary outcomes included the Modified Barthel Index (MBI); Montreal Cognitive Assessment; grip strength, measured using a dynamometer; Hospital Anxiety and Depression Scale; and the 36-Item Short-Form Health Survey (Version 2). The intervention group received daily occupational therapy, including cognitive stimulation, upper limb retraining, and activities of daily living. Data were analyzed using independent groups t tests and effect sizes.

Results: Measures and procedures were feasible. A significant difference was found between groups on FIM Motor score at 90 days with a large effect size (p = .05, d = 0.76), and MBI scores for the intervention group approached significance (p = .051) with a large effect size (d = 0.75) at 90 days. Further moderate to large effect sizes were obtained for the intervention group for cognitive status, functional ability, and quality of life.

Conclusions and Relevance: This trial demonstrated that occupational therapy is feasible and beneficial in the ICU. Criteria to progress to a full-scale randomized controlled trial were met. This study contributes to embedding ongoing consistency of practice and scope of service delivery for occupational therapy in this field.

What This Article Adds: Occupational therapists should be considered core team members in the critical care–ICU, with funding to support ongoing service provision and optimization of patient outcomes based on effective and feasible service delivery.

This article highlights the evidence for and efficacy of occupational therapy service delivery in intensive care units.

Admissions to intensive care units (ICUs) worldwide have increased exponentially as a result of the coronavirus disease 2019 (COVID-19) pandemic (Tyrrell et al., 2021), prompting calls for a review of current practices to optimize patients’ survival outcomes and inform future service provision planning (Shankar-Hari et al., 2021). Those who survive an ICU admission are likely to experience a combination of long-term sequelae known as postintensive care syndrome (PICS)—a collection of deficits in areas linked with cognition, mental health, and physical functioning, including weakness and fatigue (Mikkelsen et al., 2020; Ramnarain et al., 2021), that may be exacerbated by COVID-19 (Parotto et al., 2021). An additional factor that negatively influences outcome is the presence of delirium (Brummel et al., 2014; Cavallazzi et al., 2012), a reversible condition, for which treatment can enhance the return to higher levels of functional independence (Alvarez et al., 2017).

Early multidisciplinary rehabilitation has become a validated practice within ICUs to improve functional outcomes (Castro-Avila et al., 2015; Schweickert et al., 2009; Sigler et al., 2016) with the associated financial savings (Corcoran et al., 2017; Lord et al., 2013), yet the composition of the core ICU rehabilitation team still varies (Faculty of Intensive Care Medicine and Society, 2022). Occupational therapists have been recognized as key members of the multidisciplinary team and provide therapeutic input into other acute care services (Britton et al., 2015) and contribute to cost savings (Rogers et al., 2017). Occupational therapy has the potential to address or prevent the onset of symptoms of delirium (Alvarez et al., 2017) and PICS. Yet the evidence regarding the effect of occupational therapy on long-term functional gains in the intensive care setting is limited (Weinreich et al., 2017).

Schweickert et al. (2009) evaluated the first early rehabilitation protocol for 104 mechanically ventilated patients. The intervention group received multidisciplinary rehabilitation, with improvements seen in functional outcomes compared with those receiving standard care. The investigators showed that occupational therapy could be safely initiated with patients during sedation breaks, with a session duration of on average 28 mins (Pohlman et al., 2010); however, the majority of therapy focused on movement and mobility, with less engagement in cognitive activities or self-care practices (Pohlman et al., 2010).

Within the ICU, occupational therapists provide occupation-based rehabilitation, such as self-care practice including grooming, showering, and upper limb activities, as well as cognitive stimulation activities that address memory, orientation, and attention through conversation and leisure activities (Bayona et al., 2005; Costigan et al., 2019; French et al., 2008). Engagement in meaningful occupation is a nonpharmacological method of managing delirium that has demonstrated effectiveness in nonventilated patients (Alvarez et al., 2017; Rains & Chee, 2017). Alvarez et al. (2017) conducted a randomized controlled trial (RCT; n = 140) focused on delirium management in the ICU, comparing intensive occupational therapy with customized cognitive and functional activities of up to 80 min per day over two sessions with standard care (reorientation, mobilization, and environmental management) for elderly, nonmechanically ventilated patients. The intervention group had a significantly lower rate of delirium than the standard-care group (Alvarez et al., 2017).

In the United States, the proportion of patients receiving occupational therapy during ICU admissions is low (30%–40%; Jolley et al., 2017; Prohaska et al., 2019). In Australia, staffing has been identified as a barrier to occupational therapy service provision in ICU (Rapolthy-Beck et al., 2022). However, the timing of intervention may be affected by medical acuity and stability. Not all patients may be medically appropriate for occupational therapy at all times, although some occupational therapy intervention and follow-up may arguably help to minimize the development of PICS. Thus, because standard occupational therapy varies across units (Algeo & Aitken, 2019; Foreman, 2005; Rapolthy-Beck et al., 2022; Weinreich et al., 2017), questions remain regarding whether the full scope of occupational therapy can be safely and consistently included on a daily basis in the ICU routine for mechanically ventilated patients and whether a focus on activities of daily living (ADLs) and cognitive stimulation influences longer-term functional outcomes and PICS.

This feasibility trial explored the safety and efficacy of delivering occupational therapy to mechanically ventilated patients in a medical–surgical ICU. The aims of the study were as follows: (1) to determine the utility of a selection of physical, cognitive, and functional outcome measures in capturing the effect of the intervention on outcomes at various time points; (2) to identify recruitment, consent, and retention rates of eligible participants; and (3) to evaluate the occupational therapy intervention in terms of effect size, therapist compliance, ability to provide consistent intervention (fidelity), and differentiation from usual practice to inform a full-scale RCT.

Method

Study Design and Setting

The study was a randomized controlled assessor-blinded feasibility trial comparing standard occupational therapy with an enhanced occupation-based therapy condition for mechanically ventilated patients in an ICU. Outcomes were assessed at three timepoints: ICU discharge, hospital discharge, and 90 days postrandomization (follow-up). The trial protocol has previously been published (Rapolthy-Beck et al., 2021). The trial occurred in a Level 5, eight-bed medical–surgical ICU in Logan Hospital, Brisbane, Queensland, Australia. Ethical approval was gained from the local health service and university ethics committees, and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618000374268). The trial received grant funding from the Metro South Health and Hospital Postgraduate Scholarship Scheme for a period of 3 yr (2018–2020).

Participants

Participants were consecutive admissions to the unit between August 2018 and October 2019. Inclusion criteria were (1) age 18 or older and (2) requiring mechanical ventilation for longer than 48 hr. Exclusion criteria were (1) readmission to the ICU from a current hospitalization, (2) unlikely to survive the current ICU admission or a withdrawal of treatment was expected to occur within the next 24 hr, (3) very low functional ability as indicated by a score of <40 on the Modified Barthel Index (MBI), (4) preexisting cognitive decline as defined by a score of >3.3 on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), (5) a preexisting significant mental health disorder affecting participation in daily life, (6) interstate residence and unable to attend the follow-up interview in person, and (7) unable to communicate in English. All data collection was completed by March 2020.

Consent

Participants were invited to provide informed consent and were given an opportunity to continue or withdraw from the trial at any timepoint. If unable to consent, the person responsible for them could provide informed consent on their behalf.

Randomization and Blinding

Participants were randomly allocated to either the control or the intervention group using a computer-generated number sequence (http://www.randomization.com/) and sealed, consecutively numbered opaque envelopes produced by staff who were not involved in the clinical aspects of the trial. It was not possible to blind the research therapy team or participants to group assignment; however, the assessors, who were general ward-based occupational therapists, were blinded to group assignment.

Measures

The primary outcome measure was the FIM^®, 1 which is validated in the critically ill population (Schweickert et al., 2004; Zanni et al., 2010). The FIM consists of 13 motor and 5 cognitive tasks rated on a 7-point scale ranging from 1 (total assist) and 7 (complete independence). Total scores range from 18, indicating total dependency, to 126, indicating independence.

Secondary outcome measures were as follows:

▪ The Modified Barthel Index (MBI; Shah et al., 1989), an additional measure of functional ability often used in critical care (Davis et al., 2013)

▪ The Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005), a screening measure of cognition commonly used in critical care clinical trials (Needham et al., 2017). Alternate versions were administered at each time point.

▪ Grip strength, measured with a Jamar dynamometer (Samosawala et al., 2016), as an indicator of ICU-acquired weakness, which may affect functional ability (Ali et al., 2008)

▪ The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983), a validated self-report measure of symptoms of anxiety and depression in the critical care population (Jutte et al., 2015). Statements are scored on a scale ranging from 0 to 3, with 3 indicating higher symptom frequency, and totaled to give scores for two subscales (anxiety and depression), with higher scores indicating more symptoms and normal scores ranging between 0 and 7.

▪ The 36-Item Short-Form Health Survey, Version 2 (SF–36v2^®) measures health-related quality of life (Brazier et al., 1992) and is validated in the critical care setting (Chrispin et al., 1997). It consists of 36 questions covering eight domains of health, including physical and mental dimensions.

Severity of illness was measured using the Acute Physiology and Chronic Health Evaluation II (APACHE II) scoring system (Knaus et al., 1985) on admission to the trial. The following preintervention measures were administered on a daily basis before any interaction with participants in either group to identify their ability to participate in therapy that day and adjust therapy content based on response level:

▪ The Richmond Agitation and Sedation Scale (RASS; Ely et al., 2003), which measures level of sedation and agitation. The scale ranges from −5 to 4, with patients scoring −2 to 2 deemed suitable for participation in the intervention.

▪ The Glasgow Coma Scale (GCS; Teasdale & Jennett, 1974), which measures patients’ arousal and response level. Scores range from 15 (fully oriented and alert) to 3 (unresponsive).

▪ The Confusion Assessment Measure ICU (CAM–ICU; Ely et al., 2001), which assesses confusion to aid in the early identification of ICU patients with delirium.

▪ The Short Portable Mental Status Questionnaire (SPMSQ; Pfeiffer, 1975), a 10-item brief questionnaire that indicates the ability to follow questions and engage in therapy and is easily administered at the bedside.

Process

Primary and secondary measures were administered by the blinded assessor at the three time points. The SF–36 v2was only administered twice, at ICU discharge and at follow-up. Daily preintervention measures were administered by a blinded bedside nurse to determine the treatment approach and enable adaptation of therapy for intervention group participants, such that a lower GCS led to sensory stimulation and facilitated grooming (hand over hand) using various tactile stimuli. A manualized intervention guide was developed to support decision-making regarding treatment approach. If a patient’s scores fell outside of the agreed-upon protocol scores for intervention, the session would not be completed at that point, and the scores would be reviewed later in the day to optimize intervention delivery on a daily basis.

A precautions checklist was completed before the delivery of any therapy to the intervention group participants, to ensure medical clearance for therapy participation. All interventions provided by an occupational therapist to participants in the intervention or control group were documented after each session.

Intervention Group

Participants randomized to the intervention group received enhanced occupational therapy, which covered a range of activities that were individualized on the basis of the preintervention measures to enhance their participation. Activities were adapted through use of equipment, set-up, positioning, and number of subtasks planned:

▪ ADLs, such as grooming activities in bed, at the bedside, or in the ICU bathroom; strip-washing in bed; or showering

▪ Leisure tasks as identified by next of kin, including games, technology, and iPad use for cognitive and communication activities, adult mindfulness tasks, and premorbid interest or leisure tasks.

▪ Cognitive stimulation tasks, including reality orientation; choice and decision making; task sequencing and direction following; use of familiar objects, faces, smells, and music; visual challenges (locate or seek games); recall and reminiscence games; and recording a video message or planning a conversation or visit. Strategies such as errorless learning, backward and forward chaining, vanishing cues, and auditory priming were used (Barman et al., 2016).

▪ Polysensory stimulation, carried out with patients with lower GCS scores, included environmental adaptations (varying use of texture and temperature) to increase arousal and elicit responses (Oh & Seo, 2003).

A manualized intervention guide is available from Andrea Rapolthy-Beck on request. The mobilization limits were based on expert consensus guidelines for safety in an ICU setting (Hodgson et al., 2014). Cardiovascular and respiratory monitoring was completed by the bedside ICU nurse throughout the intervention provision. Session termination guidelines were established in the event of an adverse incident. Patients underwent sedation breaks in which the targeted occupational therapy was delivered. Intervention was for a maximum of 60 min/day on weekdays and graded and adapted according to response level (e.g., sessions could be carried out twice a day for 30 min).

Control Group

Patients allocated to the control group received standard occupational therapy intervention according to service provision agreements local to Logan Hospital. An occupational therapist attended daily clinical ward rounds in the ICU and saw patients for urgent splinting and pressure care management. This limited amount of occupational therapy is typical in Australian ICUs (Rapolthy-Beck et al., 2022).

Statistical Analysis

Data were entered into an Excel database and imported into IBM SPSS Statistics (Version 28.0) for analysis. Data were summarized descriptively and screened to determine whether statistical assumptions for parametric tests were met. Imputation (carry-forward method) was used to correct for missing data on outcome measures. Data were analyzed via intention to treat and per protocol methods. Continuous variables were compared between the groups at each follow-up using independent groups t tests with adjustment, if indicated, by Levine’s test for equal variance and χ² tests for categorical variables. Effect sizes were calculated using Cohen’s d and interpreted as small (d = 0.2), medium (d = 0.5), or large (d = 0.8) effects (Cohen, 1988). A p value of .05 (one-sided) was considered significant for group comparisons on outcome measures. Data on occupational therapy treatment delivered in the ICU were summarized descriptively.

Feasibility Analyses

The evaluation of trial feasibility followed the guidelines proposed by Avery et al. (2017) to support the progression of a feasibility trial to a full-scale RCT. Targets for recruitment (n = 30), retention (75%), outcome measure administration (80%), and intervention completion (50%) were identified. Evaluation of the trial against these outcomes considered mortality rates for the cohort. A power calculation was performed to determine the sample size for a fully powered trial.

Results

Patient Characteristics

All patients admitted to the ICU between August 8, 2018, and October 3, 2019, were screened. Of the 139 patients who met the inclusion criteria, 109 were excluded (Figure 1). Thirty patients were recruited and randomly allocated into the intervention and control groups. Participants were 16 men and 14 women with a mean age of 54.73 yr (SD = 15.43). Sample characteristics in Table 1 suggest the groups were similar. No participants requested to withdraw, no adverse events occurred, and no changes were made to the study protocol during the trial. Detailed analysis of intervention provision and documented case notes showed no protocol deviations or cross-over.

Figure 1.

Trial Flowchart

Table 1.

Baseline Characteristics of Study Sample and Treatment Characteristics

Characteristic	M (SD)		t or χ²	df	p	95% CI
Characteristic	Control (n = 15)	Intervention (n = 15)	t or χ²	df	p	95% CI
Age	49.87 (18.03)	59.60 (10.82)	−1.79	28	.84	[−1.38, 0.09]
Gender, male	7	6	1.4	1	.71
Severity, APACHE II	20.07 (6.75)	19.67 (5.54)	0.18	28	.86	[−0.65, 0.78]
Baseline MBI	99.33 (0.98)	96.87 (7.63)	1.24	14.46	.23	[−0.28, 1.18]
IQCODE	2.83 (0.41)	3.05 (0.11)	−2.06	16.04	.06	[−1.4, 0.00]
Diagnosis, f (%)			0.47	6	.59
Sepsis	6 (40)	4 (26.7)
Gastrointestinal	4 (26.7)	3 (20)
Respiratory	4 (26.7)	5 (33.3)
Liver	0	1 (6.7)
Cardiac	0	1 (6.7)
Neurological	0	1 (6.7)
Discharge support level from hospital, f (%)			2.94	4	.57
Dependent	3 (20)	4 (26.7)
Family assistance	3 (20)	7 (46.7)
Independent	5 (33.3)	3 (20)
Died or interhospital transfer	4 (26.7)	1 (6.7)
Treatment variables
ICU LOS	13.07 (8.76)	12.00 (11.41)	0.29	28	.78	[−0.61, 0.82]
Hospital LOS	19.93 (10.12)	22.80 (18.25)	−0.53	21.87	.60	[−0.91, 0.53]
Hours of intubation	231.09 (145.60)	158.25 (118.48)	1.50	28	.14	[−0.19, 1.27]
Hours of intubation (survivors)	235.45 (148.02)	161.51 (122.25)	1.37	23	.18	[−0.26, 1.35]
Days recorded as delirious in ICU	2.4 (3.94)	1.13 (1.60)	1.15	28	.26	[−0.31, 1.14]
Days eligible for treatment	8.07 (6.15)	7.00 (7.88)	0.41	28	.68	[−0.57, 0.87]
Days on which treatment was received	0.40 (0.74)	6.23 (6.97)	−3.24	14.31	.006*	[−1.95, −0.40]
% of eligible days on which treatment provided	4.42 (8.67)	82.65 (34.36)	−8.55	15.78	<.001*	[−4.19, −2.03]
Days contraindication was met	2.27 (3.24)	1.93 (2.87)	0.30	28	.77	[−0.61, 0.82]
Days sedated	3.13 (3.00)	2.47 (3.66)	0.55	28	.59	[−0.52, 0.92]
Treatment time per session (minutes)	6.70 (4.49)	40.35 (18.00)	−7.02	15.73	<.001*	[−3.53, −1.57]
Total treatment time in ICU (minutes)	54.33 (52.50)	289.00 (318.82)	−2.82	14.76	.013*	[−1.79, −0.26]

Note. APACHE II = Acute Physiology and Chronic Health Evaluation; CI = confidence interval; ICU = intensive care unit; IQCODE = Informant Questionnaire of Cognitive Decline in the Elderly; LOS = length of stay; MBI = Modified Barthel Index.

Utility of Outcome Measures

All outcome measures were able to be administered at the three time points. Administration time was influenced by cognitive ability and ranged from 30 min to 60 min. Feedback from blinded assessors was that the number of outcome measures made it difficult for patients to remain cognitively engaged during assessment at each time point.

Intervention Effect

Groups were compared on outcome measures at each time point using independent groups t tests. Table 2 reports the results of the intention-to-treat analyses with all cases analyzed in the group to which they were assigned and with missing data carried forward from the last available data point.

Table 2.

Intention-to-Treat Analysis Comparing Groups on Outcome Measures

Outcome Measures	M (SD)		t	df	p	95% CI	d
Outcome Measures	Control	Intervention	t	df	p	95% CI	d
ICU Discharge
n	15	15
FIM
Total	50.53 (30.82)	59.40 (29.72)	0.80	28	0.42	[−1.01, 0.43]	0.29
Motor	30.47 (21.00)	33.40 (23.68)	−0.37	28	0.72	[−0.85, 0.59]	0.13
Cognitive	20.07 (12.56)	26.00 (10.86)	−1.38	28	0.187	[−1.23, 0.23]	0.51
MBI	25.93 (27.0)	32.60 (28.62)	−0.66	28	0.52	[−0.96, 0.48]	0.24
Grip strength
Left	9.96 (11.16)	12.38 (10.20)	−0.62	28	0.54	[−0.94, 0.49]	0.23
Right	10.00 (11.22)	13.27 (10.92)	−0.81	28	0.43	[−1.01, 0.43]	0.30
MoCA	12.47 (10.20)	17.13 (9.98)	−1.27	28	0.22	[−1.18, 0.27]	0.46
HADS
Anxiety	6.07 (6.27)	8.07 (5.69)	−0.92	28	0.37	[−1.05, 0.39]	0.33
Depression	5.13 (5.34)	7.13 (5.66)	−0.10	28	0.33	[−1.08, 0.36]	0.36
SF–36v2
PCS	19.78 (16.35)	25.19 (16.98)	−0.89	28	0.38	[−1.04, 0.40]	0.33
MCS	28.39 (23.84)	33.07 (21.78)	−0.57	28	0.58	[−0.92, 0.51]	0.21
Hospital Discharge
n	15	15
FIM
Total	79.93 (45.61)	102.07 (26.52)	−1.63	22.50	0.12	[−1.32, 0.14]	0.59
Motor	57.87 (32.58)	71.93 (20.45)	−1.42	23.55	0.17	[−1.24, 0.22]	0.52
Cognitive	22.07 (13.26)	30.13 (8.41)	−1.99	23.69	0.06	[−1.46, 0.02]	0.73
MBI	58.67 (43.85)	80.67 (27.41)	−1.65	23.49	0.11	[−1.33, 0.14]	0.60
Grip strength
Left	13.71 (14.42)	17.98 (8.88)	−0.98	28	0.34	[−1.08, 0.37]	0.36
Right	14.00 (14.26)	18.02 (10.09)	−0.89	28	0.38	[−1.04, 0.4]	0.33
MoCA	15.80 (12.27)	21.00 (7.48)	−1.40	23.15	0.17	[−1.24, 0.22]	0.51
HADS
Anxiety	4.27 (4.25)	7.40 (4.85)	−1.88	28	0.07	[−1.42, 0.06]	0.69
Depression	3.53 (4.52)	5.80 (4.75)	−1.34	28	0.19	[−1.21, 0.24]	0.49
90 Days Postrandomization
n	15	15
FIM
Total	85.40 (43.00)	111.07 (26.94)	−1.96	23.52	0.06	[−1.45, 0.30]	0.72
Motor	60.20 (31.64)	80.13 (19.69)	−2.07	23.43	0.05*	[−1.49, 0.01]	0.76
Cognitive	28.13 (23.33)	30.93 (7.99)	−0.44	28	0.66	[−0.88, 0.56]	0.16
MBI	60.60 (44.63)	88.00 (25.85)	−2.06	22.44	0.051	[−1.49, 0.00]	0.75
Grip strength
Left	15.73 (16.27)	20.44 (9.89)	−0.96	28	0.35	[−1.07, 0.38]	0.35
Right	14.84 (14.78)	18.40 (11.19)	−0.74	28	0.46	[−0.99, 0.45]	0.27
MoCA	16.33 (11.96)	22.67 (8.25)	−1.69	24.87	0.10	[−1.35, 0.12]	0.62
HADS
Anxiety	4.07 (4.17)	6.60 (5.62)	−1.40	28	0.17	[−1.24, 0.22]	0.51
Depression	3.13 (3.23)	5.00 (4.96)	−1.22	28	0.23	[−1.17, 0.28]	0.45
SF–36v2, M (SD), n
PCS	31.51 (10.07), 11	38.06 (8.98), 14	−1.72	23	0.10	[−1.50, 0.13]	0.69
MCS	47.42 (13.23), 11	51.60 (12.86), 14	−0.80	23	0.43	[−1.11, 0.48]	0.32

Note. CI = confidence interval; df = degrees of freedom; HADS = Hospital Anxiety and Depression Scale; ICU = intensive care unit; MBI = Modified Barthel Index; MCS = Mental Component score; MoCA = Montreal Cognitive Assessment; PCS = Physical Component score; SF–36 = 36-Item Short Form Survey.

No significant between-groups differences were found on primary and secondary measures at ICU or hospital discharge. Moderate effect sizes were noted for FIM Cognitive (d = 0.51) and the MoCA (d = 0.46), with the intervention group having better scores at ICU discharge. At hospital discharge, moderate to large effect sizes were noted for FIM Total (d = 0.59), FIM Motor (d = 0.52), FIM Cognitive (d = 0.73), MBI (d = 0.60), and MoCA (d = 0.51) scores in the direction of the intervention group having better scores, and for the HADS Anxiety (d = 0.69) and Depression (d = 0.49) Scales in the direction of the intervention group having higher levels of anxiety and depression; however, mean scores for the intervention group were in the normal range (0–7).

At follow-up, a significant difference was found between groups on FIM Motor (p = .05) with a moderate to large effect size (d = 0.76). The between-groups difference on the MBI approached significance (p = .051) with a moderate to large effect size (d = 0.75), with the intervention group having better scores. Further moderate to large effect sizes were found for the FIM Total (d = 0.72), MoCA (d = 0.62), and the SF–36 v2 Physical Component Scores (d = 0.69).

Data analyzed via the per-protocol method yielded no statistically significant results at any timepoint and mostly small effect sizes. A moderate effect size was found in the ICU Discharge SF–36v2 Physical Component Score (d = 0.55), with the intervention group reporting higher physical abilities. At follow-up, moderate effect sizes were found for the MoCA (d = 0.51) and the SF–36v2 PCS (d = 0.78) in the direction of the intervention group having higher scores and better outcomes. Results of the per protocol method can be found in the supplementary file.

Intervention Provision

Table 1 also details the results of comparison of the intervention provided to the groups. There were no significant difference between groups in ICU or hospital length of stay. The mean occupational therapy treatment time (minutes) per session was significantly greater for the intervention group than for the control group (p ≤ .001), as was the number of days on which treatment was received (p = .006). Eligible days were defined as those days when a patient was well enough to participate in treatment and no contraindications were present. Treatment was provided on a significantly greater percentage of eligible days for the intervention group compared with the control group (p < .001). There were no significant between-groups differences for the number of days eligible for treatment (p = .68), days a contraindication was met (p = .77) or days sedated (p = .59). There were nonsignificant differences but moderate effect sizes in hours of intubation (d = 0.55) and days recorded as delirious in ICU (d = 0.42), with the intervention group having less time in both. The intervention group received a mean of 40.35 min per session (SD = 18.0) with the control group having a mean of 6.70 mins (SD = 4.49), which was a significant difference (p < .001, d = 2.56).

Analysis of Session Content

Analysis of the types of intervention delivered showed that the most common therapy for the intervention group was cognitive stimulation, occurring on 96.05% of eligible treatment days; followed by functional upper limb training (61.84%), grooming (55.26%), family engagement (27.63%), self-care and showering (25.00%), interest checklists (19.74%), leisure activities (17.11%), splinting (15.79%), iPad or technology use (10.53%), pressure care (10.53%), education (6.58%), and interview (3.95%). The intervention group received no occupational therapy intervention on 14.47% of eligible treatment days. In comparison, the control group received no occupational therapy intervention on 88.43% of eligible treatment days, followed by splinting on 7.44%, pressure care on 2.48%, and other treatment on 0.83% of eligible treatment days.

Progression to RCT

Review of the criteria indicating feasibility for progression to a full-scale RCT showed that the rate of recruitment was slow because of the number meeting the exclusion criteria (n = 109). The main reasons for exclusion were a significant mental health history (n = 32) and living out of the area (n = 17), which influenced the ability to attend follow-up in person. Only 60% completed the study; however, a retention of 75% (n = 18) was achieved at follow-up (90 days postrandomization) among those who survived their ICU admission. All other factors, including completion of the intervention, outcome measure acceptability, and adverse events, indicated that the protocol was suitable for progression to a full-scale RCT (Table 3). According to G* Power, using the obtained effect size of 0.29 for the primary outcome variable (FIM Total score) at ICU discharge, with power set at 0.80 and α set at 0.05 (one-tailed), a total sample size of 290 is required for an adequately powered trial.

Table 3.

Criteria for Progression to RCT

Domain	Criteria to Proceed^a		EFFORT–ICU Results and Recommendations
Domain	Proceed With RCT	Proceed With Changes to Protocol	EFFORT–ICU Results and Recommendations
Recruitment	Recruitment of 30 eligible patients ≤6 mo	Recruitment of eligible patients ≤6–12 mo	30 patients recruited during 14 mo. Consider adapting exclusion criteria to include out-of-area residents and mental health for comprehensive data capturing.
Retention	Minimum of 75% retention to follow-up	Minimum of 50% retention to follow-up	60% follow-up achieved (18/30 at 90 days postrandomization; excluding deaths, 18/24 = 75%). Consider offering telehealth administration of outcome measures.
Completion of intervention	At least 50% complete intervention for 60 min/day	At least 50% complete intervention for 20–40 min/day	Criteria met; no changes recommended. Therapy administered an average of 82.65% (SD = 34.36) of eligible days.
Outcome measure acceptability	Able to administer 80% of the outcome measures at each time point	Able to administer 80% of the outcome measures at each time point	Administered to eligible patients at ▪ ICU discharge: 25/25 (100%) ▪ Hospital discharge: 23/23 (100%) ▪ 90 days postrandomization: 18/18 (100%)
Adverse events	No serious therapy-related adverse events during trial	<5 serious therapy-related adverse events during trial	No adverse events recorded

Note. Bold type indicates which criteria this trial met. EFFORT–ICU = Early Enhanced Occupational Therapy in an Intensive Care Unit; ICU = intensive care unit; RCT = randomized controlled trial.

^aCriteria according to Avery et al. (2017).

Discussion

Our trial is the first to explore the specific contribution of participation in early enhanced occupational therapy in the ICU to longer-term recovery. First, this feasibility trial aimed to determine the utility of administering outcome measures for an ICU trial and demonstrated that the chosen outcome measures were able to be successfully administered to participants. Most outcome measures demonstrated improvement over time, suggesting sensitivity to improvements.

Second, the trial demonstrated that occupational therapy in the ICU is safe and that this intervention approach may have benefits, based on a single statistically significant finding and moderate to large effect sizes, on a background of an insufficiently powered trial. Differences were noted between the intention-to-treat analysis and the per-protocol method, and this may be attributed to carrying forward scores of patients who died during the intention-to-treat analysis. We clarified the ability to provide occupational therapy in intensive care by documenting the content and duration of therapy intervention. This trial provided on average 40 min/day per patient (ventilated or extubated), with intervention patients receiving therapy on more than 80% of days during their ICU stay. Larger studies exploring the utilization patterns of occupational therapy service provision over a 5-yr period have reported a lack of occupational therapy input, with patients who are mechanically ventilated receiving only therapy 29.7% of their ICU stay (Jolley et al., 2017; Prohaska et al., 2019). We do, however, acknowledge that practices differ in other countries. This trial enhanced the content of usual occupational therapy by introducing a focus on cognition and ADLs, with the knowledge that increased activity and active cognitive stimulation have an impact on long-term cognitive outcomes (Hopkins & Jackson, 2006).

The results met the criteria for progression to a full-scale RCT with minor modifications to the protocol required to deliver distance-based follow-ups. We recommend the protocol be modified by using a briefer QOL measure to reduce the length of the assessment battery and consider conducting post discharge assessments by telehealth and adapting the exclusion criteria to include patients who live outside of the direct health service funding catchment area and people with mental health conditions. A much larger sample of 290 participants is required for the trial to be adequately powered.

We enhanced the usual content of occupational therapy by introducing a focus on cognition and ADLs, previously demonstrated to improve long-term cognitive outcomes (Hopkins et al., 2012). Cognitive stimulation is an active approach to delirium management that can occur in functional activities and is gaining support as a nonpharmacological intervention method (Deemer et al., 2020). The intervention group received cognitive stimulation on 96% of the days they were eligible for treatment and thus may have contributed to the outcomes achieved by this group. Keeping patients alert during the day through active engagement has beneficial impacts (Hashem et al., 2016; Needham et al., 2010; Schweickert et al., 2009) that ultimately also influence cognitive arousal (Hopkins et al., 2012) and subsequent improvement in delirium presentation or indices (Alvarez et al., 2017; Herling et al., 2018). Delirium is a key indicator of long-term cognitive impairment after critical care illness (Brummel et al., 2014; Girard et al., 2010) and therefore provides an opportunity to embed the critical role of occupational therapy in managing delirium in the ICU (Alvarez et al., 2017).

One of the feasibility criteria in our trial was for participants to be actively engaged with more than 50% of therapy sessions, including components of occupation-based upper limb retraining and grooming practice. Grip strength has been linked to functional outcomes and quality of life (Nakamura et al., 2021) through the concept that increased hand use may lead to increases in independence in ADLs. Although the effect size in this trial was small, future research on the physical effects of participation in upper limb tasks with increased repetitions may be indicated. It is interesting that the intervention group got more splinting and pressure care than the control group even though this is considered standard care. It suggests that doing other activities with the patients alerted the occupational therapists to splinting and pressure needs that otherwise could have been missed.

Our intervention addressed participation in functional activities such as self-care and grooming to build capacity for remaining ADLs, acknowledging that an increase in functional independence is linked with reduced risk of readmission (Franchi et al., 2013). Our intervention produced moderate to large effect sizes in FIM and MBI scores, lending further support to starting rehabilitation earlier to prevent longer-term dependency. Although this trial was completed before the pandemic, it lends support for early rehabilitation in a respiratory population and, alongside other studies (Kara et al., 2021; Malik et al., 2022; Martillo et al., 2021) suggests that this may improve long-term outcomes of ICU patients with COVID-19.

Limitations

This feasibility trial was not intended to be adequately powered, yet a review of the effect sizes indicates a medium to large effect of the treatment on the primary and secondary measures. Given the importance of the individualized nature of the intervention, patients required individual adaptation to optimize participation, and therefore variations in interventions existed, despite being manualized. This reflects real-life therapy and the need for individualized person-centered care. The study team was unable to account for any rehabilitation provided after ICU discharge; however, usual hospital service provision and discharge policies were not changed. The ICU staff was unable to be blinded because the presence of the occupational therapist may have alerted staff to group allocation. The recruitment rate was slower than anticipated because of the high number of exclusions.

Implications for Occupational Therapy

Occupational therapy intervention in the ICU is safe and feasible and may be delivered for up to 40 min per day. Active engagement of patients in occupations in intensive care may have a beneficial impact on arousal levels and functional and cognitive outcomes. Occupational therapists have the potential to make valuable contributions to the multidisciplinary team in the ICU setting.

Conclusion

This trial demonstrated that an enhanced intervention delivered by an occupational therapist, in an intensive care setting for patients who are mechanically ventilated, is safe and effective. The trial protocol met all requirements to proceed to a full-scale RCT, with minor adjustments required to include mental health and distance-based assessment. It is recommended that further studies be conducted to continue to support the contribution of early occupational therapy in intensive care settings.

Footnotes

¹FIM^® is a trademark of the Uniform Data System for Medical Rehabilitation, a division of UB Foundation Activities, Inc.

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Efficacy of Early Enhanced Occupational Therapy in an Intensive Care Unit (EFFORT–ICU): A Single-Site Feasibility Trial

Abstract

Method

Study Design and Setting

Participants

Consent

Randomization and Blinding

Measures

Process

Intervention Group

Control Group

Statistical Analysis

Feasibility Analyses

Results

Patient Characteristics

Utility of Outcome Measures

Intervention Effect

Intervention Provision

Analysis of Session Content

Progression to RCT

Discussion

Limitations

Implications for Occupational Therapy

Conclusion

Footnotes

References