Clinical trial NCT03604809: Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients
Official title: Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Lead sponsor: Alberta Health Services, Calgary
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Delirium Prevalence and Duration
timeFrame: From date of patient enrolment to ICU discharge, an average of 6.7 days.
Secondary outcomes:
measure: Cognitive Function
timeFrame: Measured within 24 hours of patient ICU admission and again after the treatment period is completed which is an average of 6.7 days.
measure: ICU length of stay
timeFrame: 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.
measure: Physical Function
timeFrame: Measured within 48 hours of ICU admission and again after the treatment period is completed which is an average of 6.7 days.
measure: 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.
timeFrame: Measured after the treatment period is completed (within 24 hours of discharge) which is an average of 6.7 days.
measure: Days of Mechanical Ventilation
timeFrame: Measured on day 1 of mechanical ventilation through to day of extubation (cessation of mechanical ventilation), an average of 4 days.
measure: Length of Hospital Stay
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: South Health Campus Intensive Care Unit
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Stephanie Oviatt, MScPT PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Michelle Parsons, BHScPT PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary, Alberta Health Services
name: Kirsten Fiest, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Karolina Herold, MN RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary, Alberta Health Services
name: Juan Posadas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Brittany Myhre, MScOT OT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Andrea Soo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.