Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients

NCT03604809 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Delirium Prevalence and Duration

  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 Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

OT Guided Cognitive Interventions

EXPERIMENTAL

Occupational Therapy interventions will be adjusted according to the patient's Richmond Agitation and Sedation Scale (RASS).

Other: OT Guided Cognitive Interventions

Usual Care

NO INTERVENTION

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.

Interventions

OT Guided Cognitive Interventions OTHER

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.

OT Guided Cognitive Interventions

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Primary Direct Brain Injury
• Prior diagnosis of dementia-related illness
• Prior diagnosis of developmental disability
• Pre-existing cognitive impairment
• Requiring palliative care
• In ICU for less than 48 hours
• Non-English speaking
• Severe communication disorders
• Non-critically ill Plasma Exchange Therapy patients
• Severe hearing or visual impairment
• ICU to ICU transfers
• COVID-19 positive patients

Sponsors & Collaborators

• Alberta Health Services, Calgary: lead

Study Sites (1)

South Health Campus Intensive Care Unit

Calgary, Alberta, T3M1M4, Canada

Location

Related Publications (8)

• Lewin JJ 3rd, LeDroux SN, Shermock KM, Thompson CB, Goodwin HE, Mirski EA, Gill RS, Mirski MA. Validity and reliability of The Johns Hopkins Adapted Cognitive Exam for critically ill patients. Crit Care Med. 2012 Jan;40(1):139-44. doi: 10.1097/CCM.0b013e31822ef9fc.

  PMID: 21926576 BACKGROUND

• Huang M, Chan KS, Zanni JM, Parry SM, Neto SG, Neto JA, da Silva VZ, Kho ME, Needham DM. Functional Status Score for the ICU: An International Clinimetric Analysis of Validity, Responsiveness, and Minimal Important Difference. Crit Care Med. 2016 Dec;44(12):e1155-e1164. doi: 10.1097/CCM.0000000000001949.

  PMID: 27488220 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909.

  PMID: 11430542 BACKGROUND

• van den Boogaard M, Schoonhoven L, Maseda E, Plowright C, Jones C, Luetz A, Sackey PV, Jorens PG, Aitken LM, van Haren FM, Donders R, van der Hoeven JG, Pickkers P. Recalibration of the delirium prediction model for ICU patients (PRE-DELIRIC): a multinational observational study. Intensive Care Med. 2014 Mar;40(3):361-9. doi: 10.1007/s00134-013-3202-7. Epub 2014 Jan 18.

  PMID: 24441670 BACKGROUND

• Wassenaar A, Rood P, Boelen D, Schoonhoven L, Pickkers P, van den Boogaard M. Feasibility of Cognitive Training in Critically Ill Patients: A Pilot Study. Am J Crit Care. 2018 Mar;27(2):124-135. doi: 10.4037/ajcc2018467.

  PMID: 29496769 BACKGROUND

• Deemer K, Zjadewicz K, Fiest K, Oviatt S, Parsons M, Myhre B, Posadas-Calleja J. Effect of early cognitive interventions on delirium in critically ill patients: a systematic review. Can J Anaesth. 2020 Aug;67(8):1016-1034. doi: 10.1007/s12630-020-01670-z. Epub 2020 Apr 24.

  PMID: 32333291 BACKGROUND

• Deemer K, Myhre B, Oviatt S, Parsons M, Watson M, Zjadewicz K, Soo A, Fiest K, Posadas-Calleja J. Occupational therapist-guided cognitive interventions in critically ill patients: a feasibility randomized controlled trial. Can J Anaesth. 2023 Jan;70(1):139-150. doi: 10.1007/s12630-022-02351-9. Epub 2022 Nov 16.

  PMID: 36385466 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators, with the exception of the occupational therapist, will be blinded to participant randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Nurse Practitioner

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 30, 2018
• Study Start: June 15, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)