Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study

Completed

• Conditions: Critical Illness; Delirium; Hospital Acquired Condition; Critical Illness Myopathy; Withdrawal Syndrome
• Interventions: Other: PICU Liber8 Bundle

• Registration Number: NCT03573479
• Lead Sponsor: McMaster University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Study Start: 2019-01-03
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Perceptions about barriers and facilitators for implementation of the bundle	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.
Completion rate of daily goals (compliance)	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.
Performance of the bundle assessed with qualitative (i.e., narrative) description and comparison between groups.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Children's Hospital London Health Sciences; 🇨🇦 London, Ontario, Canada