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The effectiveness of early functional occupation-based therapy in a medical / surgical intensive care unit.

The effectiveness of early functional occupation-based therapy in a medical / surgical intensive care unit: a single-site feasibility trial (EFFORT-ICU).

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000374268
Acronym
EFFORT-ICU
Enrollment
30
Registered
2018-03-13
Start date
2018-08-01
Completion date
2020-05-06
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Admissions to intensive care units (ICUs) are increasing due to an aging population. With advances in medical care, patients are surviving an initial stay in critical care; however they are presenting with ongoing health and mental ability limitations following their stay in intensive care. Recent research has focused on the introduction of early rehabilitation within the ICU in an attempt to reduce the long-term complications regarding physical recovery and cognition. To date the exact scope and type of therapeutic care that occupational therapists can provide, as part of the multidisciplinary team, requires further investigation. This research project will investigate how useful and effective certain occupational therapy interventions can be in influencing longer term outcomes relating to physical strength and ability to complete simple daily activities such as self-care and grooming, following an early rehabilitation program within an intensive care unit. It will also interview patients who participated in the early rehabilitation program to understand how they felt about participating and whether there are changes that can be made to make their experience more beneficial. The results of this study will help to redefine how we provide occupational therapy in the intensive care unit and may help to support a clearer and more active role for occupational therapists in future critical care settings.

Interventions

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 com

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.

Sponsors

Andrea Rapolthy-Beck
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026