Clinical trial NCT03573479: Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study
Official title: Early Rehabilitation in Critically Ill Children - The PICU Lliber8 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Withdrawal Syndrome
Hospital Acquired Condition
Critical Illness Myopathy
Critical Illness
Keywords: rehabilitation
critical care
child health
quality improvement
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2018-06-29
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility 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.

Primary outcomes:
measure: Completion rate of daily goals (compliance)
timeFrame: 18 months
measure: Performance of the bundle assessed with qualitative (i.e., narrative) description and comparison between groups.
timeFrame: 18 months
measure: Perceptions about barriers and facilitators for implementation of the bundle
timeFrame: 18 months
Secondary outcomes:
measure: Economic analysis
timeFrame: 18 months
measure: Incidence of morbidities
timeFrame: 18 months
measure: Length of stay
timeFrame: 1 month
measure: Ventilator-free days at 30 days
timeFrame: 1 month
measure: 30-day mortality
timeFrame: 18 months
measure: Functionality
timeFrame: 18 months
measure: Health related quality of life
timeFrame: 18 months
measure: Parental stress
timeFrame: 18 months
measure: Risk measurement of psychological sequelae.
timeFrame: 18 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital London Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Karen Choong, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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. doi: 10.1097/PCC.0000000000000983.
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.