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

McMaster University

Status: Completed

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

Treatments: Other: PICU Liber8 Bundle

Study type: Observational

Funder types: Other

Identifiers

NCT03573479

PICULiber8/180409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

130 participants in 2 patient groups

Pre-implementation cohort

Description:

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

Description:

After the implementation of the bundle (the PICU Liber8 components) same measurements will be captured and analyzed comparatively.

Treatment:

Other: PICU Liber8 Bundle