Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients
NCT ID: NCT03604809
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2019-06-15
2020-11-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OT Guided Cognitive Interventions
Occupational Therapy interventions will be adjusted according to the patient's Richmond Agitation and Sedation Scale (RASS).
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
120 Years
ALL
No
Sponsors
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Alberta Health Services, Calgary
OTHER
Responsible Party
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Kirsten Deemer, NP
Critical Care Nurse Practitioner
Principal Investigators
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Stephanie Oviatt, MScPT PT
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Michelle Parsons, BHScPT PT
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Kirsten Fiest, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary, Alberta Health Services
Karolina Herold, MN RN
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Juan Posadas, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary, Alberta Health Services
Brittany Myhre, MScOT OT
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Andrea Soo, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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South Health Campus Intensive Care Unit
Calgary, Alberta, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id