Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study

Critical Illness Clinical Trial

— PICULiber8  

Official title:

Early Rehabilitation in Critically Ill Children - The PICU Lliber8 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573479
• Other study ID #: PICULiber8/180409
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• PICU Liber8 Bundle
Bundle of elements for quality improvement

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital London Health Sciences	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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