Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study

NCT03573479 | Completed

• 1 other identifier: PICULiber8/180409
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Delirium; Withdrawal Syndrome; Hospital Acquired Condition; Critical Illness Myopathy; Critical Illness

Keywords

rehabilitation; critical care; child health; quality improvement

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• Economic analysis

  18 months

• Incidence of morbidities

  18 months

• Length of stay

  1 month

• Ventilator-free days at 30 days

  1 month

• 30-day mortality

  18 months

Study Arms (2)

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

Interventions

PICU Liber8 Bundle OTHER

Bundle of elements for quality improvement

Also known as: implementation of strategy

PICU Liber8 bundle

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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)

Sponsors & Collaborators

• McMaster University: lead
• London Health Sciences Centre: collaborator

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital London Health Sciences

London, Ontario, Canada

Location

Related Publications (5)

• 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.

  PMID: 23507722 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.

  PMID: 25987293 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.

  PMID: 24777303 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.

  PMID: 27759596 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.

  PMID: 29394221 BACKGROUND

MeSH Terms

Conditions

Delirium; Substance Withdrawal Syndrome; Iatrogenic Disease; Critical Illness

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Karen Choong, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 29, 2018
• Study Start: January 3, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

CA (2)