Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000374268
Ethics application status
Approved
Date submitted
1/03/2018
Date registered
13/03/2018
Date last updated
27/08/2024
Date data sharing statement initially provided
3/12/2018
Date results provided
27/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of early functional occupation-based therapy in a medical / surgical intensive care unit.
Scientific title
The effectiveness of early functional occupation-based therapy in a medical / surgical intensive care unit: a single-site feasibility trial (EFFORT-ICU).
Secondary ID [1] 294199 0
Nil Known
Universal Trial Number (UTN)
U1111-1210-1131
Trial acronym
EFFORT-ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care 306833 0
Critical care illness 306834 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305938 305938 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to explore the feasibility and impact of providing early functional occupation-based therapy, including cognitive stimulation and activities of daily living, to patients in intensive care.

The study is divided into 2 parts: part 1 aims to investigate the feasibility of early functional occupational-based therapy in a medical / surgical intensive care unit. Part 2 aims to explore the perceptions of participants and his/her significant others in relation to therapy completion. Both parts of the study are carried out concurrently.

Part 1:
Intervention Group: Early occupation-based purposeful activity interventions will be administered based on a graded plan (according to the Richmond Agitation and Sedation Scale (RASS) and medical stability). A manualised intervention strategy will be followed to ensure consistency of approaches. The aim of the trial is to implement an early occupational performance-based and cognitive stimulation intervention, focusing in particular on the amount, structure and quality of occupation-based therapy. Interventions will be graded according to functional ability. Patients in the intervention group will receive a maximum total of 60 minutes daily engagement within self-care / grooming tasks adapted to current functional ability where a cognitive component will be incorporated within the functional task. Intervention activity options will be based on a leisure / premorbid lifestyle interview with relevant next-of-kin to enable appropriate activity choices for optimised participation.
Cognitive stimulation tasks incorporated within the functional tasks will be modified according to cognitive level. Cognitive tasks incorporated within functional activities will include sensory stimulation and sensory modulation, daily orientation, engagement and reflection of task performance (using judgement and insight), attention challenges through task set-up, active daily planning and goal setting, and iPad tasks impacting on or enhancing functional participation.
Functional tasks will include hand-over-hand facilitation of grooming tasks, self-care activities in the bed, bedside or bathroom, and leisure related activities.
All interventions will be delivered by the trained specialist ICU occupational therapists based on the intervention manual. Two reserve therapists whose primary caseload is not ICU will be trained to ensure all functional sessions can be completed even in absence of usual ICU staff (annual leave / unexpected absence). All occupational therapists expected to work within the ICU will be trained and familiar with the intervention manual prior to research initiation.

Duration of Intervention: 60 Minutes daily (weekdays) until discharge from ICU.

Part 2 of this study includes the qualitative component and will be guided by interpretive description (Thorne, 2004) to explore the lived experience of participants receiving the intervention and the perception of family members / most involved substitute decision maker. All patients from the occupation-based therapy intervention group, will be invited to undergo in-depth semi-structured interviews targeted at exploring their experience of engaging within the early occupation-based purposeful activity program, at 90 days post randomisation.
Interviews will be conducted in a private, wheelchair accessible room at Logan Hospital. Funding for transport will be provided to facilitate attendance at interviews. Wheelchair accessible transport will be organised for participants who require specialist accessibility options.

Duration of Interview: Maximum of 1 hour at the 90 days post randomisation timepoint.
Intervention code [1] 300488 0
Rehabilitation
Comparator / control treatment
Control Group: The control group will receive usual occupational therapy care. At Logan Hospital an occupational therapist attends daily clinical ward rounds within the intensive care unit. Patients are identified based on clinical needs and daily prioritisation guidelines for operation within an acute hospital. Core non-functional risk remediation activities such as splinting (for example foot drop) and pressure cushion provision are provided on an immediate basis when clinical need is identified. Functional therapy is completed at the discretion of therapists and clinical caseload weighting and may be absent in most units.
Control group
Active

Outcomes
Primary outcome [1] 304974 0
Independence within activities of daily living will be measured using the Functional Independence Measure (FIM™). The FIM will quantify the participant’s functional and cognitive status at ICU and hospital discharge, as well as at 90 days post randomisation. This tool is validated for use in the critically ill population and provides reliable information regarding patient functional change during rehabilitation across various hospital and community settings. The FIM will be conducted within 24 hours of the expected ICU and hospital discharge or on the Friday before the expected discharge if likely to occur over the weekend. It will also be administered during the 90 days post randomisation session.
Timepoint [1] 304974 0
ICU Discharge (Primary timepoint)
Hospital Discharge
90 days post randomisation Follow Up
Secondary outcome [1] 343768 0
The Modified Barthel Index (MBI) is used to measure functional ability and serves as a secondary measure included for its ability to detect change within self-care and functional tasks.
Timepoint [1] 343768 0
Update ICU Discharge (Primary timepoint)
Hospital Discharge
90 days post randomisation Follow Up
Secondary outcome [2] 343769 0
The Montreal Cognitive Assessment (MoCA) is a screening measure of cognition and assesses multiple domains of cognition including attention, memory and visuospatial relations.
Timepoint [2] 343769 0
Update ICU Discharge (Primary timepoint)
Hospital Discharge
90 days post randomisation Follow Up
Secondary outcome [3] 343770 0
Grip strength will be measured using a dynamometer (Jamar)
Timepoint [3] 343770 0
Update ICU Discharge (Primary timepoint)
Hospital Discharge
90 days post randomisation Follow Up
Secondary outcome [4] 343771 0
The Short-Form (36) Health Survey (SF-36v2™) will provide a baseline and post discharge measure of participants’ health related quality of life (HRQOL).
Timepoint [4] 343771 0
Update ICU Discharge (Primary timepoint)
90 days post randomisation Follow Up
Secondary outcome [5] 343772 0
Hospital Anxiety and Depression Scale (HADS) is a measure of emotional distress regarding anxiety and depression.
Timepoint [5] 343772 0
Update ICU Discharge (Primary timepoint)
Hospital Discharge
90 days post randomisation Follow Up
Secondary outcome [6] 343773 0
Sedation status will be measured using the validated Richmond Agitation Sedation Scale (RASS). These scores are regularly administered by nursing staff throughout a 24 hour period.
Timepoint [6] 343773 0
RASS scores immediately prior to and following early occupation based interventions will be collected for additional analysis. RASS scores for the control group participants will be collected daily at 9am.
Secondary outcome [7] 343774 0
The Glasgow Coma Scale (GCS) is used to evaluate the level of consciousness in patients with neurological conditions or severe injury
Timepoint [7] 343774 0
daily at 9am
Secondary outcome [8] 344169 0
Delirium status will be measured using the validated and reliable Confusion Assessment Method for ICU (CAM-ICU) These scores are regularly administered by nursing staff throughout a 24 hour period.

Timepoint [8] 344169 0
CAM-ICU scores immediately prior to and following early occupation based interventions will be collected for additional analysis. CAM-ICU scores for the control group participants will be collected daily at 9am.
Secondary outcome [9] 344170 0
The Short Portable Mental Status Questionnaire (MSQ) is a brief orientation checklist used to demonstrate current and previous memory linked to orientation. It is a 10 statement questionnaire that is easily administered at the bedside.
Timepoint [9] 344170 0
It will be completed pre-and post-intervention group treatment, and at 9am within the control group

Eligibility
Key inclusion criteria
Patients admitted to the ICU will be included if they are aged over 18 years, and are expected to require invasive mechanical ventilation for greater than 48 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the trial if:

1. Admission to ICU not requiring mechanical ventilation
2. They have been readmitted to ICU from current hospitalisation
3. They have a poor level of functional ability prior to admission ( requiring carer assistance / high dependency level in activities of daily living as measured by a Modified Barthel Index score <40)
4. Have a pre-existing severe cognitive deficit (as identified by completion of the short form IQCODE with an average score above 3.31-3.38 )
5. Have a pre-existing significant mental health disorder impacting on participation
6. A withdrawal of treatment is expected to occur within the next 24 hours or they are not expected to survive the current ICU admission
7. They live interstate or are not local to Logan Hospital and would be unable to attend the 90 days post randomisation follow up
8. They are unable to communicate in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
consecutively numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised into the intervention and control groups via computer generated numbers (http://www.randomization.com/)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 30 participants has been chosen, based on recommendations regarding pilot and feasibility trials evaluating outcomes [80]. Fifteen patients from the intervention group will be included within the qualitative component carried out at 90 days post-randomisation.

All data from the case report forms (CRF) will be entered into a purposefully designed Excel database and exported into SPSS version 22.0 for analyses. Descriptive statistics will be used to determine the distributions of the data for the intervention and control groups and to test whether statistical assumptions for parametric tests are achieved. Imputation will be used to correct for missing data. Continuous variables that are normally distributed will be compared between the groups at each follow-up using an independent groups t-test. Effect sizes will be calculated using Cohen’s d. Non-parametric analysis will be conducted for continuous variables that are not normally distributed. Categorical variables will be compared with the chi-square statistic. A p value of 0.05 will be considered statistically significant. Where appropriate, analyses will be reported with mean differences and 95% CI. Previous values from the same patient will be used for missing data.
In particular, objectives will be analysed as follows:
1) The utility of the selection of outcome measures will undergo sensitivity analyses in relation to the ease with which they can be administered and will relate to missing data and the identification of both univariate and multivariate outliers. The effect size for the primary outcome variable will be used to determine the required sample size for a fully powered trial.
2) Recruitment and consent rates will be collected and analysed to determine the feasibility of recruiting form the chosen population. The inclusion and exclusion data (screening log) will be summarised and will influence further protocol changes when considering progression to a full scale randomised controlled trial.
3) Retention rates in response to follow up procedures (attendance at interviews) will be analysed to identify any trends that may influence further trial progression.
4) The intervention data will undergo sensitivity analyses in relation to non-compliance, the intention to treat per protocol in addition to as treated. Protocol violations regarding the intervention manual strategies will be noted.
5) The intervention effect will be analysed through the use of the above outcome measures, and further analysis of case notes will reveal common trends in treatment adaptation or selection, based on the structure of the intervention manual.

Patient experience, satisfaction with treatment and perceived benefit of participation within the rehabilitation group will be gathered through the semi structured interviews. The interview data will be transcribed and analysed using thematic analysis [81] to identify key perceptions, self-reported experience and highlight factors that may contribute to future clinical care design. The data will be analysed inductively as little is known regarding the patient experience therefore deductive categories cannot be imposed on the data. Two members of the research team will independently code a portion of the data.

Analysis of Session Content
All case notes of patients seen by occupational therapy will be audited using a pre-designed data collection form, analysed to categorise common therapeutic interventions used, and determine fidelity with respect to adherence to manualised intervention protocol. Deviations from the protocol will be reviewed. Case notes for patients experiencing usual care will also be analysed to identify if any cross-over of groups occurred. Number of interventions delivered will be recorded for each intervention participant, detailing reasons for missed therapy sessions.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
4/06/2018
Actual
1/08/2018
Date of last participant enrolment
Anticipated
1/06/2020
Actual
6/05/2020
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
30
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10236 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 21901 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 298838 0
Hospital
Name [1] 298838 0
Metro South Health Research Support - Study Education and Research Trust Account (SERTA)
Country [1] 298838 0
Australia
Primary sponsor type
Individual
Name
Andrea Rapolthy-Beck
Address
Occupational Therapy Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook
QLD, 4131
Country
Australia
Secondary sponsor category [1] 298029 0
Individual
Name [1] 298029 0
Prof Jennifer Fleming
Address [1] 298029 0
Professor and Head of Occupational Therapy
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane Qld 4072
Country [1] 298029 0
Australia
Secondary sponsor category [2] 298030 0
Individual
Name [2] 298030 0
Dr Merrill Turpin
Address [2] 298030 0
Senior Lecturer
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane Qld 4072
Country [2] 298030 0
Australia
Secondary sponsor category [3] 298032 0
Individual
Name [3] 298032 0
Dr Hayden White
Address [3] 298032 0
Deputy Director Intensive Care Unit
Logan Hospital
Cnr Armstrong and Loganlea Rd
Meadowbrook, QLD, 4131
Country [3] 298032 0
Australia
Secondary sponsor category [4] 298033 0
Individual
Name [4] 298033 0
Kellie Sosnowski
Address [4] 298033 0
Nurse Unit Manager Intensive Care Unit
Logan Hospital
Cnr Armstrong and Loganlea Rd
Meadowbrook, QLD, 4131
Country [4] 298033 0
Australia
Secondary sponsor category [5] 298036 0
Individual
Name [5] 298036 0
Simone Dullaway
Address [5] 298036 0
Occupational Therapy Department
Logan Hospital
Cnr Armstrong & Loganlea Roads
Meadowbrook QLD 4131
Country [5] 298036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299780 0
Metro South Hospital and Health Service Human Research Ethics Committee (EC00167)
Ethics committee address [1] 299780 0
Ethics committee country [1] 299780 0
Australia
Date submitted for ethics approval [1] 299780 0
16/03/2018
Approval date [1] 299780 0
27/04/2018
Ethics approval number [1] 299780 0
Ethics committee name [2] 299784 0
University of Queensland Ethics Committee
Ethics committee address [2] 299784 0
Ethics committee country [2] 299784 0
Australia
Date submitted for ethics approval [2] 299784 0
27/04/2018
Approval date [2] 299784 0
16/11/2018
Ethics approval number [2] 299784 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2469 2469 0 0
/AnzctrAttachments/374621(v01-03-2018-11-28-30)-Protocol EFFORT-ICU V0 26th Feb 2018.docx (Protocol)

Contacts
Principal investigator
Name 81542 0
Mrs Andrea Rapolthy-Beck
Address 81542 0
Occupational Therapy Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook, QLD 4131
Country 81542 0
Australia
Phone 81542 0
+61 7 3299 8858
Fax 81542 0
+61 7 3299 8280
Email 81542 0
[email protected]
Contact person for public queries
Name 81543 0
Andrea Rapolthy-Beck
Address 81543 0
Occupational Therapy Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook, QLD 4131
Country 81543 0
Australia
Phone 81543 0
+61 7 3299 8858
Fax 81543 0
+61 7 3299 8280
Email 81543 0
[email protected]
Contact person for scientific queries
Name 81544 0
Andrea Rapolthy-Beck
Address 81544 0
Occupational Therapy Department
Logan Hospital
Cnr Armstrong and Loganlea Rds
Meadowbrook, QLD 4131
Country 81544 0
Australia
Phone 81544 0
+61 7 3299 8858
Fax 81544 0
+61 7 3299 8280
Email 81544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Outcome measures
When will data be available (start and end dates)?
Data will be available for 5 years post 2026
Available to whom?
Researchers involved with the study in addition to occupational therapy researchers globally.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
By emailing the principal investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA comparison of standard occupational therapy versus early enhanced occupation-based therapy in a medical/surgical intensive care unit: study protocol for a single site feasibility trial (EFFORT-ICU).2021https://dx.doi.org/10.1186/s40814-021-00795-2
N.B. These documents automatically identified may not have been verified by the study sponsor.