Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients

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.

Conditions

• Delirium

Interventions

OTHER

OT Guided Cognitive Interventions

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.

Sponsors & Collaborators

• Alberta Health Services, Calgary

  lead OTHER

Principal Investigators

• Stephanie Oviatt, MScPT PT · Alberta Health services

• Michelle Parsons, BHScPT PT · Alberta Health services

• Kirsten Fiest, PhD · University of Calgary, Alberta Health Services

• Karolina Herold, MN RN · Alberta Health services

• Juan Posadas, MD · University of Calgary, Alberta Health Services

• Brittany Myhre, MScOT OT · Alberta Health services

• Andrea Soo, PhD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-15

Primary Completion

2020-11-30

Completion

2020-11-30

Countries

• Canada

Study Locations