Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study (PICULiber8)

• ClinicalTrials.gov Identifier: NCT03573479
• Recruitment Status: Completed
• First Posted: June 29, 2018
• Last Update Posted: February 24, 2021
• Sponsor: McMaster University
• Collaborator: London Health Sciences Centre
• Information provided by (Responsible Party): Karen Choong, McMaster University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Delirium; Withdrawal Syndrome; Hospital Acquired Condition; Critical Illness Myopathy; Critical Illness	Other: PICU Liber8 Bundle

Detailed Description:

This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle.

The objectives are:

1. 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.
2. 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:

1. A context appropriate implementation framework.
2. An implementation team leader.
3. Inter-professional team engagement (i.e. RN, RT, MD, pharmacy, allied health and family).
4. 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 Design

• Study Type: Observational
• Actual Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Early Rehabilitation in Critically Ill Children - The PICU Lliber8 Study
• Actual Study Start Date: January 3, 2019
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: October 30, 2020

Groups and Cohorts

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
PICU Liber8 bundle; After the implementation of the bundle (the PICU Liber8 components) same measurements will be captured and analyzed comparatively.	Other: PICU Liber8 Bundle; Bundle of elements for quality improvement; Other Name: implementation of strategy

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Performance of the bundle assessed with qualitative (i.e., narrative) description and comparison between groups. [ 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.
3. Perceptions about barriers and facilitators for implementation of the bundle [ 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.

Secondary Outcome Measures :

1. Economic analysis [ 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.
2. Incidence of morbidities [ Time Frame: 18 months ]
   Measured as the composite incidence (number of new cases) of either delirium, iatrogenic withdrawal, pressure ulcers, or PICU acquired weakness.
3. Length of stay [ Time Frame: 1 month ]
   Measured as total days in PICU and hospital, and hospital-free days at 30 days post PICU discharge.
4. Ventilator-free days at 30 days [ Time Frame: 1 month ]
   This is a clinically important outcome, measured as days using mechanical ventilation and days without it.
5. 30-day mortality [ Time Frame: 18 months ]
   Measured as the total number of deaths (due to any cause) during the PICU and/or hospital stay.
6. Functionality [ 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.
7. Health related quality of life [ 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).
8. Parental stress [ Time Frame: 18 months ]
   Using the Pediatric Inventory for Parents, a 42 item score across 4 domains. Higher scores indicate greater frequency and difficulty.
9. Risk measurement of psychological sequelae. [ 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).

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the PICU for the QI intervention. For patient follow-up we will conduct for patients at risk (see eligibility criteria)

Criteria

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.

Contacts and Locations

Locations

Canada, Ontario

McMaster Children's Hospital

Hamilton, Ontario, Canada, L8N 3Z5

Children's Hospital London Health Sciences

London, Ontario, Canada

Sponsors and Collaborators

McMaster University

London Health Sciences Centre

Investigators

• Principal Investigator: Karen Choong, MD, MSc; McMaster University

More Information

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. Review.

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.

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.

• Responsible Party: Karen Choong, Professor, McMaster University
• ClinicalTrials.gov Identifier: NCT03573479
• Other Study ID Numbers: PICULiber8/180409
• First Posted: June 29, 2018
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data will be collected from both participating sites and analyzed at the coordinating centre at McMaster.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Data will be available within one month of completing the study.
• Access Criteria: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Choong, McMaster University:

rehabilitation; critical care; child health; quality improvement

Additional relevant MeSH terms:

Delirium; Critical Illness; Iatrogenic Disease; Substance Withdrawal Syndrome; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Substance-Related Disorders; Chemically-Induced Disorders