- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961727
Implementation of Bedside Pediatric Early Warning Systems (PEWS)
May 28, 2015 updated by: Christopher Parshuram, The Hospital for Sick Children
Implementation of Bedside PEWS at Credit Valley Hospital
Timely identification, referral and treatment of children who are clinically deteriorating while admitted to hospital wards is a fundamental element of inpatient care.
In community hospitals, advantages including greater continuity of inpatient-outpatient care, improved geographic access for families, and lower healthcare system costs, may be undermined if children with evolving critical illness are not recognized and transferred in a timely manner.
The Bedside Paediatric Early Warning System (Bedside PEWS) is a system of care designed to augment existing expertise and to provide a safety net for children who are clinically deteriorating while admitted to hospital wards.
The Bedside PEWS is comprised of 4 components; [1] an expert derived, multi-centre validated severity of illness score, [2] an inter-professionally developed documentation record into which the severity of illness score is embedded, [3] a series of score-matched care recommendations based on the opinions of over 280 paediatric health care professionals, and [4] an educator-developed education-implementation program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We will be performing a prospective observational study of care outcomes, physician workload and frontline staff perceptions before and after the implementation of Bedside PEWS in a community paediatric hospital.
We plan to evaluate the outcomes of patients who were admitted to the 22-bed paediatric inpatient unit and were less than 18 years of age at hospital admission, and the healthcare professionals caring for them during their inpatient stay.
Study Type
Observational
Enrollment (Actual)
200
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
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Ontario
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Toronto, Ontario, Canada
- The Hospital for Sick Children
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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 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted to the 22-bed paediatric inpatient unit and were less than 18 years of age at hospital admission
Description
Inclusion Criteria:
- All patients admitted to the paediatric inpatient unit at Credit Valley Hospital from June 2008-December 2008
Exclusion Criteria:
- Patients over 18 years of age
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
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PEWS System of Care
|
The Bedside PEWS is comprised of 4 components; [1] an expert derived, multi-centre validated severity of illness score, [2] an inter-professionally developed documentation record into which the severity of illness score is embedded, [3] a series of score-matched care recommendations based on the opinions of over 280 paediatric health care professionals, and [4] an educator-developed education-implementation program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Significant clinical deterioration events
Time Frame: -3 months, +2months, and+5months after implementation
|
-3 months, +2months, and+5months after implementation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
'stat' calls to the paediatrician
Time Frame: 3 months before and 5 months after implementation
|
3 months before and 5 months after implementation
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'stat' calls to the respiratory therapist
Time Frame: 3 months before and 5 months after implementation
|
3 months before and 5 months after implementation
|
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immediate calls to treat near or actual cardiopulmonary arrest - 'code-blue'
Time Frame: 3 months before and 5 months after implementation
|
3 months before and 5 months after implementation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Parshuram, MD, The Hospital for Sick Children
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
June 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
Study Record Updates
Last Update Posted (Estimate)
June 1, 2015
Last Update Submitted That Met QC Criteria
May 28, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1000009778
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.