- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03573479
Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study (PICULiber8)
Early Rehabilitation in Critically Ill Children - The PICU Lliber8 Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle.
The objectives are:
- Primary - Implementation Objectives: to determine the feasibility and resources required to implement PICU Liber8 in 2 PICUs, evaluate strategies for successful bundle adoption. Co-Primary - Process Objectives: to determine the impact of PICU Liber8 on the process of care.
- Secondary Efficacy: impact on PACs and patient reported outcomes The methods consist of a PICU Liber8 Bundle Implementation Plan (Pronovost's 4 E's Framework), and measurement of the impact of Implementation through Orchestrated Testing (OT).
For successful adoption of the PICU Liber8 bundle, the following are necessary:
- A context appropriate implementation framework.
- An implementation team leader.
- Inter-professional team engagement (i.e. RN, RT, MD, pharmacy, allied health and family).
- Ability to customize PICU Liber8 to the needs of each site. We will use the Pronovost's implementation framework, which has been shown to facilitate successful bundle adoption and improve the quality of patient care in adult and pediatric ICUs.17-19 This framework has 4 phases: Engage, Educate, Execute and Evaluate.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital
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London, Ontario, Canada
- Children's Hospital London Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria: All children admitted to the Pediatric Intensive Care Unit with a minimum of 48h stay in the PICU and more than one organ dysfunction.
Exclusion criteria: as this is an assessment of a quality improvement strategy there are no criteria for excluding participants.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre-implementation cohort
This is the pre-implementation phase where a baseline documentation will take place about usual clinical practice, perceptions and attitudes of PICU staff and clinicians
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PICU Liber8 bundle
After the implementation of the bundle (the PICU Liber8 components) same measurements will be captured and analyzed comparatively.
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Bundle of elements for quality improvement
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion rate of daily goals (compliance)
Time Frame: 18 months
|
The total number and percentage of daily goals completed from a pre-established daily goals checklist that assess compliance with the bundle.
This is considered part of the feasibility outcomes group.
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18 months
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Performance of the bundle assessed with qualitative (i.e., narrative) description and comparison between groups.
Time Frame: 18 months
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Evaluation of performance as narrative description and comparison between periods of study, about the impact of the bundle on the process of quality of care.
This also is part of the feasibility outcomes group.
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18 months
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Perceptions about barriers and facilitators for implementation of the bundle
Time Frame: 18 months
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Qualitative (i.e., narrative) assessment, description, and comparison of the perceptions from key stakeholders (i.e., family members, patients, clinicians, administrative personnel, nurse team, etc.) between groups about perceived barriers and facilitators for the adequate bundle's implementation.
This belongs to the acceptability outcome.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Economic analysis
Time Frame: 18 months
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Direct cost (in Canadian dollars) before and after the implementation of the bundle that measures activity-based costs associated with the implementation.
Incremental costs of PICU associated complications will be added to this evaluation.
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18 months
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Incidence of morbidities
Time Frame: 18 months
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Measured as the composite incidence (number of new cases) of either delirium, iatrogenic withdrawal, pressure ulcers, or PICU acquired weakness.
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18 months
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Length of stay
Time Frame: 1 month
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Measured as total days in PICU and hospital, and hospital-free days at 30 days post PICU discharge.
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1 month
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Ventilator-free days at 30 days
Time Frame: 1 month
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This is a clinically important outcome, measured as days using mechanical ventilation and days without it.
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1 month
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30-day mortality
Time Frame: 18 months
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Measured as the total number of deaths (due to any cause) during the PICU and/or hospital stay.
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18 months
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Functionality
Time Frame: 18 months
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Using the Pediatric Evaluation and Disability Inventory-Computer Adaptive Test (PEDI-CAT), which measures abilities in three functional domains: Daily Activities, Mobility, and Social/Cognitive.
The PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks.
A final score per several domains is calculated that ranges from 0 to 100.
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18 months
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Health related quality of life
Time Frame: 18 months
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Using the Peds-QL, which includes four Scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) that are grouped together on the actual questionnaire.
The tool creates a final score from 0 to 100 (higher scores indicates better).
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18 months
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Parental stress
Time Frame: 18 months
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Using the Pediatric Inventory for Parents, a 42 item score across 4 domains.
Higher scores indicate greater frequency and difficulty.
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18 months
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Risk measurement of psychological sequelae.
Time Frame: 18 months
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The risk of psychological sequelae will be measured with the Children's Critical Illness Impact Scale (CCIIS) for children >6 years of age, consisting of 23 items that result on the final scale (where higher scores are worse).
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18 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Choong, MD, MSc, McMaster University
Publications and helpful links
General Publications
- Choong K, Koo KK, Clark H, Chu R, Thabane L, Burns KE, Cook DJ, Herridge MS, Meade MO. Early mobilization in critically ill children: a survey of Canadian practice. Crit Care Med. 2013 Jul;41(7):1745-53. doi: 10.1097/CCM.0b013e318287f592.
- Cameron S, Ball I, Cepinskas G, Choong K, Doherty TJ, Ellis CG, Martin CM, Mele TS, Sharpe M, Shoemaker JK, Fraser DD. Early mobilization in the critical care unit: A review of adult and pediatric literature. J Crit Care. 2015 Aug;30(4):664-72. doi: 10.1016/j.jcrc.2015.03.032. Epub 2015 Apr 8.
- Choong K, Foster G, Fraser DD, Hutchison JS, Joffe AR, Jouvet PA, Menon K, Pullenayegum E, Ward RE; Canadian Critical Care Trials Group. Acute rehabilitation practices in critically ill children: a multicenter study. Pediatr Crit Care Med. 2014 Jul;15(6):e270-9. doi: 10.1097/PCC.0000000000000160.
- Wieczorek B, Ascenzi J, Kim Y, Lenker H, Potter C, Shata NJ, Mitchell L, Haut C, Berkowitz I, Pidcock F, Hoch J, Malamed C, Kravitz T, Kudchadkar SR. PICU Up!: Impact of a Quality Improvement Intervention to Promote Early Mobilization in Critically Ill Children. Pediatr Crit Care Med. 2016 Dec;17(12):e559-e566. doi: 10.1097/PCC.0000000000000983.
- Choong K, Fraser D, Al-Harbi S, Borham A, Cameron J, Cameron S, Cheng J, Clark H, Doherty T, Fayed N, Gorter JW, Herridge M, Khetani M, Menon K, Seabrook J, Simpson R, Thabane L. Functional Recovery in Critically Ill Children, the "WeeCover" Multicenter Study. Pediatr Crit Care Med. 2018 Feb;19(2):145-154. doi: 10.1097/PCC.0000000000001421.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PICULiber8/180409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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