A 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)

Background: Admissions to intensive care units (ICUs) are increasing due to an ageing population, and rising incidence of cardiac and respiratory disease. With advances in medical care, more patients are surviving an initial stay in critical care; however, they can experience ongoing health and cognitive limitations that may influence return to baseline function up to a year post-admission. Recent research has focused on the introduction of early rehabilitation within the ICU to reduce long-term physical and cognitive complications. The aim of this study is to explore the feasibility and impact of providing early enhanced occupation-based therapy, including cognitive stimulation and activities of daily living, to patients in intensive care.

Methods: This study involves a single site randomised-controlled feasibility trial comparing standard occupational therapy care to an early enhanced occupation-based therapy. Thirty mechanically ventilated ICU patients will be recruited and randomly allocated to the intervention or control group. The primary outcome measure is the Functional Independence Measure (FIM), and secondary measures include the Modified Barthel Index (MBI), Montreal Cognitive Assessment (MoCA), grip strength, Hospital Anxiety and Depression Scale (HADS) and Short-Form 36 Health survey (SF-36). Measures will be collected by a blind assessor at discharge from intensive care, hospital discharge and a 90-day follow-up. Daily outcome measures including the Glasgow Coma Scale (GCS), Richmond Agitation and Sedation Scale (RASS) and Confusion Assessment Measure for intensive care units (CAM-ICU) will be taken prior to treatment. Participants in the intervention group will receive daily a maximum of up to 60-min sessions with an occupational therapist involving cognitive and functional activities such as self-care and grooming. At the follow-up, intervention group participants will be interviewed to gain user perspectives of the intervention. Feasibility data including recruitment and retention rates will be summarised descriptively. Parametric tests will compare outcomes between groups. Interview data will be thematically analysed.

Discussion: This trial will provide information about the feasibility of investigating how occupational therapy interventions in ICU influence longer term outcomes. It seeks to inform the design of a phase III multicentre trial of occupational therapy in critical care general medical intensive care units.

Trial registration: Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618000374268 ; prospectively registered on 13 March 2018/ https://www.anzctr.org.au Trial funding: Metro South Health Research Support Scheme Postgraduate Scholarship.