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| Name | Class |
|---|---|
| London Health Sciences Centre | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| PICU Liber8 bundle | After the implementation of the bundle (the PICU Liber8 components) same measurements will be captured and analyzed comparatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICU Liber8 Bundle | Other | Bundle of elements for quality improvement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of daily goals (compliance) | 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. | 18 months |
| Performance of the bundle assessed with qualitative (i.e., narrative) description and comparison between groups. | 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. | 18 months |
| Perceptions about barriers and facilitators for implementation of the bundle | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Economic analysis | 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. | 18 months |
| Incidence of morbidities |
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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.
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All patients admitted to the PICU for the QI intervention. For patient follow-up we will conduct for patients at risk (see eligibility criteria)
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| Name | Affiliation | Role |
|---|---|---|
| Karen Choong, MD, MSc | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Hamilton | Ontario | L8N 3Z5 | Canada | ||
| Children's Hospital London Health Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23507722 | Background | 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. | |
| 25987293 | Background | 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. |
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De-identified individual participant data will be collected from both participating sites and analyzed at the coordinating centre at McMaster.
Data will be available within one month of completing the study.
A Data Access Agreement has been completed and signed among participating centres. Further data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D013375 | Substance Withdrawal Syndrome |
| D007049 | Iatrogenic Disease |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Measured as the composite incidence (number of new cases) of either delirium, iatrogenic withdrawal, pressure ulcers, or PICU acquired weakness. |
| 18 months |
| Length of stay | Measured as total days in PICU and hospital, and hospital-free days at 30 days post PICU discharge. | 1 month |
| Ventilator-free days at 30 days | This is a clinically important outcome, measured as days using mechanical ventilation and days without it. | 1 month |
| 30-day mortality | Measured as the total number of deaths (due to any cause) during the PICU and/or hospital stay. | 18 months |
| Functionality | 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. | 18 months |
| Health related quality of life | 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). | 18 months |
| Parental stress | Using the Pediatric Inventory for Parents, a 42 item score across 4 domains. Higher scores indicate greater frequency and difficulty. | 18 months |
| Risk measurement of psychological sequelae. | 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). | 18 months |
| London |
| Ontario |
| Canada |
| 24777303 | Background | 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. |
| 27759596 | Background | 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. |
| 29394221 | Background | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |