Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients
Condition: Delirium
MeSH terms: Delirium; Critical Illness
Study type: Interventional

Summary: 
      Title: Guided Occupational Therapist (OT) Cognitive Interventions for Critically Ill Patients

      Short Title: GOTCI

      Methodology: Randomized Control Trial

      Study Duration: 12-15 months

      Study Centre: Single Center - South Health Campus, ICU, Calgary, Alberta, Canada

      Objectives: The aim for this study is to evaluate the effect of specific OT guided cognitive
      interventions on delirium in adult critically ill patients.

      Number of Subjects: 112

      Primary Outcome: Delirium Prevalence and Duration

      Secondary Outcomes: Cognitive function, physical function, quality of life, ICU length of
      stay, hospital length of stay and days of mechanical ventilation.

      Inclusion Criteria: Adult Critically Ill Patients admitted to South Health Campus ICU,
      Calgary, Alberta

      Type of Intervention: OT guided cognitive intervention based on RASS score

      Dose: One on one therapeutic sessions with an OT. Five days a week, Monday to Friday, between
      0800-1600. There will be twice daily sessions for 20 minutes each.

      Duration of administration: Cognitive Therapy to be initiated Monday to Friday, for the
      duration of participant ICU admission.

      Reference therapy: Standard of care within the Department of Critical Care Medicine in
      Calgary is delirium prevention strategies using the ABCDEF bundled approach.

      Statistical Methodology: Descriptive statistics (mean, median, proportion) will be employed
      to describe the study population. The primary outcome of delirium prevalence will be explored
      using multivariable logistic regression, which will provide an estimate of the odds ratio and
      accompanying 95% confidence intervals. Both per protocol and intent to treat analyses will be
      performed.
    


Intervention name(s): OT Guided Cognitive Interventions
Intervention type(s): Other
Intervention description(s): RASS is defined as the level of sedation and agitation of a patient. Cognitive interventions are evidence based strategies that enhance the cognition of patients and include memory training using visual imagery; metacognitive training using self-awareness and self-regulation approaches for recovery of executive functioning; and neuropsychological rehabilitation to help improve cognitive and functional deficits. Interventions will be adjusted according to the RASS score. Cognitive interventions include discussion of patient status and education of family around reorientation, cognitive screening and graded exercises according to patient ability. The deepest levels of sedation and highest levels of agitation will be included in the intervention arm.
Interventions will be provided by the Occupational Therapist; Monday to Friday, BID, 20 minutes per session, for the duration of ICU admission.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment