Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients

Not Applicable

Completed

• Conditions: Delirium
• Interventions: Other: OT Guided Cognitive Interventions

• Registration Number: NCT03604809
• Lead Sponsor: Alberta Health Services, Calgary

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Study Start: 2019-06-15
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-05
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult medical/surgical critically ill patients admitted to the South Health Campus ICU in Calgary, Alberta during designated 6-month study period.

Exclusion criteria as follows:

1. Primary Direct Brain Injury
2. Prior diagnosis of dementia-related illness
3. Prior diagnosis of developmental disability
4. Pre-existing cognitive impairment
5. Requiring palliative care
6. In ICU for less than 48 hours
7. Non-English speaking
8. Severe communication disorders
9. Non-critically ill Plasma Exchange Therapy patients
10. Severe hearing or visual impairment
11. ICU to ICU transfers
12. COVID-19 positive patients

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OT Guided Cognitive Interventions	OT Guided Cognitive Interventions	Occupational Therapy interventions will be adjusted according to the patient's Richmond Agitation and Sedation Scale (RASS).

Primary Outcome Measures

Name	Time	Method
Delirium Prevalence and Duration	From date of patient enrolment to ICU discharge, an average of 6.7 days.	Ever Delirium: Measured using the Intensive Care Delirium Screening Checklist (ICDSC). If the patient has a positive score in the ICDSC at any point during the patient's ICU stay then the patient is considered to have delirium and qualifies for Ever Delirium.; Delirium Duration: Number of days the patient has a positive score on the ICDSC. This does not have to be consecutive days.

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	ICU admission date to ICU discharge date is the time the patient will be given the treatment which is an average of 6.7 days.	Dates will be obtained from electronic medical charts. I.e. Sunrise Clinical Manager.
Quality of Life using the EQ5D-5L (EuroQual 5 Dimensions-5 Levels). This is a health quality of life measure assessing five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	Measured after the treatment period is completed (within 24 hours of discharge) which is an average of 6.7 days.	The 5 Level EQ 5D version is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal (Van Reenan \& Janssen, 2015). It covers five dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression which are measured with one of five response options (no problems, slight problems, moderate problems, severe problems, and extreme problems). A total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression (Reenan \& Janssen, 2015, p. 9). The EQ5D-5L also includes a visual analog scale to measure health state (0-100).
Cognitive Function	Measured within 24 hours of patient ICU admission and again after the treatment period is completed which is an average of 6.7 days.	Johns Hopkins Adapted Cognitive Exam (ACE); o The Adapted Cognitive Exam is the first valid and reliable examination for the assessment and quantification of cognition in critically ill patients. It provides a useful, objective tool that can be used by any member of the interdisciplinary critical care team to support clinical assessment and research efforts.
Physical Function	Measured within 48 hours of ICU admission and again after the treatment period is completed which is an average of 6.7 days.	The Functional Status Score for the ICU (FSS-ICU). The Functional Status Score for the ICU (FSS-ICU) is an assessment of physical function specifically designed for ICU patients. It is scored based on 5 mobility domains (rolling in bed, lying to sitting, sitting balance, sitting to standing and walking) and the level of assistance the patient requires to complete the task. Each item is out of 7, with total scores ranging from 0-35 and a high score correlating to high function. The FSS-ICU has good validity when compared to other functional measures in the ICU, it has been demonstrated to have good interrater reliability and has minimal floor and ceiling effect.
Days of Mechanical Ventilation	Measured on day 1 of mechanical ventilation through to day of extubation (cessation of mechanical ventilation), an average of 4 days.	Dates will be obtained from electronic medical charts. i.e. Metavision
Length of Hospital Stay	Up to 6 months	Date of hospital admission and discharge will be obtained from electronic medical chart. i.e. Sunrise Clinical Manager.

Trial Locations

Locations (1)

South Health Campus Intensive Care Unit; 🇨🇦 Calgary, Alberta, Canada