Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients (GOTCI)

December 5, 2020 updated by: Kirsten Deemer, NP, Alberta Health Services, Calgary

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M1M4
        • South Health Campus Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OT Guided Cognitive Interventions
Occupational Therapy interventions will be adjusted according to the patient's Richmond Agitation and Sedation Scale (RASS).
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.
No Intervention: Usual Care
This will be the standard of care currently provided for delirium prevention within the Department of Critical Care Medicine in Calgary using the ABCDEF bundled approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium Prevalence and Duration
Time Frame: 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.
From date of patient enrolment to ICU discharge, an average of 6.7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function
Time Frame: 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.
Measured within 24 hours of patient ICU admission and again after the treatment period is completed which is an average of 6.7 days.
ICU length of stay
Time Frame: 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.
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.
Physical Function
Time Frame: 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.
Measured within 48 hours of ICU admission and again after the treatment period is completed which is an average of 6.7 days.
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.
Time Frame: 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).
Measured after the treatment period is completed (within 24 hours of discharge) which is an average of 6.7 days.
Days of Mechanical Ventilation
Time Frame: 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
Measured on day 1 of mechanical ventilation through to day of extubation (cessation of mechanical ventilation), an average of 4 days.
Length of Hospital Stay
Time Frame: Up to 6 months
Date of hospital admission and discharge will be obtained from electronic medical chart. i.e. Sunrise Clinical Manager.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health Services, Calgary

Investigators

  • Principal Investigator: Stephanie Oviatt, MScPT PT, Alberta Health Services
  • Principal Investigator: Michelle Parsons, BHScPT PT, Alberta Health Services
  • Principal Investigator: Kirsten Fiest, PhD, University of Calgary, Alberta Health Services
  • Principal Investigator: Karolina Herold, MN RN, Alberta Health Services
  • Principal Investigator: Juan Posadas, MD, University of Calgary, Alberta Health Services
  • Principal Investigator: Brittany Myhre, MScOT OT, Alberta Health Services
  • Principal Investigator: Andrea Soo, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 5, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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