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

Critical Illness Clinical Trial

Official title: Early Rehabilitation in Critically Ill Children - The PICU Lliber8 Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Myopathy
• Delirium
• Hospital Acquired Condition
• Iatrogenic Disease
• Substance Withdrawal Syndrome
• Withdrawal Syndrome

• NCT number: NCT03573479
• Study type: Observational
• Source: McMaster University
• Status: Completed
• Start date: January 3, 2019
• Completion date: October 30, 2020