PICU Liber8 Bundle
OtherBundle of elements for quality improvement
Other names: implementation of strategy
NCT Number: NCT03573479
This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest. Advancements in the care provided in Pediatric Intensive Care Units (PICUs) have led to fewer deaths in children. These improvements are unfortunately countered by the emergence of side effects of critical illness, known as PICU-acquired complications (PACs). Delirium, muscle weakness, drug dependency and withdrawal are increasingly common. PACs occur because children are often over-sedated and experience long periods of immobilization. PACs delay recovery, increase disability and worsen long-term function and quality-of-life. Although they are preventable, PACs are very common and frequently overlooked by clinicians. This study aims to "liberate"children from critical illness and improve their recovery and functioning after discharge, through an innovative rehabilitation bundle of 8 complementary steps (PICU Liber8) to reduce sedation, allow children to awaken and breathe comfortably, encourage early mobilization, and engage families in their child's care.
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Notify Me1 month–18 year
All sexes
Observational
McMaster Children's Hospital, Hamilton, Ontario, Canada
This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle.
The objectives are:
For successful adoption of the PICU Liber8 bundle, the following are necessary:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Bundle of elements for quality improvement
Other names: implementation of strategy
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.
Time frame: 18 months
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.
Time frame: 18 months
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.
Time frame: 18 months
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.
Time frame: 18 months
Measured as the composite incidence (number of new cases) of either delirium, iatrogenic withdrawal, pressure ulcers, or PICU acquired weakness.
Time frame: 1 month
Measured as total days in PICU and hospital, and hospital-free days at 30 days post PICU discharge.
Time frame: 1 month
This is a clinically important outcome, measured as days using mechanical ventilation and days without it.
Time frame: 18 months
Measured as the total number of deaths (due to any cause) during the PICU and/or hospital stay.
Time frame: 18 months
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.
Time frame: 18 months
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).
Time frame: 18 months
Using the Pediatric Inventory for Parents, a 42 item score across 4 domains. Higher scores indicate greater frequency and difficulty.
Time frame: 18 months
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).
McMaster University
Other
Early Rehabilitation in Critically Ill Children - The PICU Lliber8 Study
Acronym: PICULiber8
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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