Clinical trial NCT02148081: Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study
Official title: Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Critical Illness
Keywords: pediatrics, critical illness, recovery, function, health
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Children's Hospital
name: London Health Sciences Centre
name: Canadian Critical Care Trials Group
First posted: 2014-05-28
Enrollment: 182
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In order to enrol children at potential risk for the outcomes of interest, and avoid "healthier" participants with short PICU stays, we considered the following: the patient should have: a) a minimum age (when one is expected to be ambulatory/mobilizing), and b) a threshold severity of illness. In order to understand how different subsets of PICU populations are affected by critical illness, we chose not to restrict the selection of patients to a specific diagnosis, nor did we exclude patients with underlying functional or cognitive abnormalities at baseline. This study will evaluate the epidemiology of recovery in a general critically ill pediatric population over time.

Brief summary: When children suffer from a critical-illness, the investigators focus on resuscitating and saving lives. Once these children leave the pediatric intensive care unit, very little is known about what happens to them - how long it takes for them to recover, how families cope, and what factors that impede their recovery. The specific objective of this research project is to evaluate how children and their families recover after a critical illness.

Research Hypotheses: Following a critical illness in children, 1) the rate and degree of health and functional recovery is influenced by the following factors: age, pre-admission co-morbid status, critical illness severity, discharge functional status, and time to initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and health-related quality-of-life (HRQoL).

Detailed description: The Specific Objective of this study is to evaluate the trajectory of health and functional outcomes in children following a critical illness, define poor functional recovery, and evaluate predictors of poor recovery.

The Research Questions for this study are: 1) What are the health and functional outcomes in children affected by a critical illness, at 3 and 6 months following Pediatric Intensive Care Unit (PICU) discharge? 2) What defines poor functional recovery? 3) What are predictors of poor functional recovery in critically ill children? 4) What are the most important and relevant outcomes in critically ill children, from the patient and caregiver's point of view?

Study Design: Prospective Observational Mixed Methods Longitudinal Cohort Study Study Setting: Two Academic Pediatric Centres in Canada - McMaster Children's Hospital and London Health Sciences Centre.

Eligibility criteria: Inclusion Criteria:

* Age over 12 months to 17 years
* Admitted to PICU for at least 48 hours
* ≥ one organ dysfunction on admission
* Informed consent of patient/substitute decision maker, and patient assent were appropriate

Exclusion Criteria:

* Patients transferred directly from a neonatal intensive care unit prior to discharge home
* Patients who are already mobilizing well, or are at baseline functional status at time of screening
* Previous enrolment into this study
* Language barrier (i.e. no access to translation services)

Primary outcomes:
measure: Functional Recovery
timeFrame: In the first 6 months following Pediatric Intensive Care Unit Discharge
measure: Predictors of Functional Recovery
timeFrame: 6 months post PICU discharge
Secondary outcomes:
measure: Additional components of functional health
timeFrame: The first 6 months post PICU discharge
Other outcomes:
measure: Audit of Patient Centeredness of Outcomes
timeFrame: 6 months post PICU discharge
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; Canadian Critical Care Trials Group
name: Karen Choong, MB, BCh, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jarvis JM, Fayed N, Fink EL, Choong K, Khetani MA. Caregiver dissatisfaction with their child's participation in home activities after pediatric critical illness. BMC Pediatr. 2020 Sep 2;20(1):415. doi: 10.1186/s12887-020-02306-3.
citation: Jarvis JM, Gurga AR, Lim H, Cameron J, Gorter JW, Choong K, Khetani MA. Caregiver Strategy Use to Promote Children's Home Participation After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Nov;100(11):2144-2150. doi: 10.1016/j.apmr.2019.05.034. Epub 2019 Jul 3.
citation: Jarvis JM, Choong K, Khetani MA. Associations of Participation-Focused Strategies and Rehabilitation Service Use With Caregiver Stress After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Apr;100(4):703-710. doi: 10.1016/j.apmr.2018.11.017. Epub 2018 Dec 19.
citation: Khetani MA, Albrecht EC, Jarvis JM, Pogorzelski D, Cheng E, Choong K. Determinants of change in home participation among critically ill children. Dev Med Child Neurol. 2018 Aug;60(8):793-800. doi: 10.1111/dmcn.13731. Epub 2018 Mar 25.