Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study

August 16, 2018 updated by: McMaster University

Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study

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).

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital
      • London, Ontario, Canada
        • Children's Hospital London Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Critically ill children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Recovery
Time Frame: In the first 6 months following Pediatric Intensive Care Unit Discharge
Functional Status will be measured at PICU discharge, 3 and 6 months post discharge using the following measurement tools: Pediatric Evaluation of Disability Inventory (PEDI), and the Participation and Environment Measure - children and youth versions (PEM-CY/YC-PEM).
In the first 6 months following Pediatric Intensive Care Unit Discharge
Predictors of Functional Recovery
Time Frame: 6 months post PICU discharge
The following hypothesized determinants of functional recovery will be evaluated: age, critical illness severity, pre-admission co-morbid status, PICU discharge functional status, and time to rehabilitation.
6 months post PICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional components of functional health
Time Frame: The first 6 months post PICU discharge
Functional Health Status will be measured using the International Classification of Functioning, Disability and Health (ICF) framework (www.who.int/icidh/). In addition to the primary outcome measurements, the following will be assessed: Caregiver burden using the Pediatric Inventory for Parents; and Health Related Quality of Life using KIDSCREEN. The following secondary outcomes of interest will also be measured: Short-term PICU outcomes (i.e. duration of ventilation, length of stay, severity of organ dysfunction, morbidities attributable to delayed mobilization); mortality, health care utilization, and Pediatric Cerebral performance category and Pediatric Overall Performance scores in the 6 months post PICU discharge.
The first 6 months post PICU discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audit of Patient Centeredness of Outcomes
Time Frame: 6 months post PICU discharge
Qualitative methodology will be used in this study to understand what is important to patients and families following survival from a critical illness, and if our selected outcomes of interest for this study are aligned with what patients and families consider meaningful and important. Patient and caregiver interviews will be conducted for this purpose in the 6 months following PICU discharge
6 months post PICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen Choong, MB, BCh, MSc, McMaster University; Canadian Critical Care Trials Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 14-214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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