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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604809
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Kirsten Deemer, NP, 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.


Condition or disease Intervention/treatment Phase
Delirium Other: OT Guided Cognitive Interventions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: All investigators, with the exception of the occupational therapist, will be blinded to participant randomization.
Primary Purpose: Treatment
Official Title: Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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.



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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).

  5. 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

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604809


Contacts
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Contact: Kirsten S Deemer, MN ANP 4033544236 kirsten.deemer@ahs.ca

Locations
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Canada, Alberta
South Health Campus Intensive Care Unit Recruiting
Calgary, Alberta, Canada, T3M1M4
Contact: Kirsten Deemer, MN ANP    4033544236    kirsten.deemer@ahs.ca   
Sponsors and Collaborators
Alberta Health Services, Calgary
Investigators
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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:

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Responsible Party: Kirsten Deemer, NP, Critical Care Nurse Practitioner, Alberta Health Services, Calgary
ClinicalTrials.gov Identifier: NCT03604809    
Other Study ID Numbers: 1
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders