Clinically Deteriorating Paediatric PatientsNCT00961727
Implementation of Bedside Pediatric Early Warning Systems (PEWS)
An observational study of Clinically Deteriorating Paediatric Patients, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Clinically Deteriorating Paediatric Patients
- What is being tested?
- Bedside Paediatric Early Warning System (Bedside PEWS)
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients admitted to the 22-bed paediatric inpatient unit and were less than 18 years of age at hospital admission
Who may be able to join
- All patients admitted to the paediatric inpatient unit at Credit Valley Hospital from June 2008-December 2008
Who cannot join
- Patients over 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Bedside Paediatric Early Warning System (Bedside PEWS)
- Keywords
- Bedside Pews, Credit Valley Hospital, The Bedside Paediatric Early Warning System, clinically deteriorating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside Paediatric Early Warning System (Bedside PEWS)Other
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 group | Role | What they receive |
|---|---|---|
| PEWS System of Care | Not described Receives: Other: Bedside Paediatric Early Warning System (Bedside PEWS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant clinical deterioration events
Measured: -3 months, +2months, and+5months after implementation
Secondary outcomes (3)
'stat' calls to the paediatrician
Measured: 3 months before and 5 months after implementation
'stat' calls to the respiratory therapist
Measured: 3 months before and 5 months after implementation
immediate calls to treat near or actual cardiopulmonary arrest - 'code-blue'
Measured: 3 months before and 5 months after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Deteriorating Paediatric PatientsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Christopher Parshuram, The Hospital for Sick Children
- Investigators
- Christopher Parshuram, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961727
- Sponsor's protocol ID
- 1000009778
- Status last verified
- May 2015
- First submitted
- 17 Aug 2009
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Bedside PEWS at Credit Valley Hospital
- ClinicalTrials.gov ID
- NCT00961727
- Acronym / sponsor ID
- 1000009778
- Keywords
- Bedside Pews, Credit Valley Hospital, The Bedside Paediatric Early Warning System, clinically deteriorating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEWS System of Care | – | Other: Bedside Paediatric Early Warning System (Bedside PEWS) |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients admitted to the 22-bed paediatric inpatient unit and were less than 18 years of age at hospital admission
Key inclusion criteria (1 listed)
- All patients admitted to the paediatric inpatient unit at Credit Valley Hospital from June 2008-December 2008
Key exclusion criteria (1 listed)
- Patients over 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside Paediatric Early Warning System (Bedside PEWS)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. | Other | PEWS System of Care |
Primary outcome
Significant clinical deterioration events
Time frame: -3 months, +2months, and+5months after implementation
3 secondary outcomes
'stat' calls to the paediatrician
Time frame: 3 months before and 5 months after implementation
'stat' calls to the respiratory therapist
Time frame: 3 months before and 5 months after implementation
immediate calls to treat near or actual cardiopulmonary arrest - 'code-blue'
Time frame: 3 months before and 5 months after implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Parshuram, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Deteriorating Paediatric Patients, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant clinical deterioration events (time frame: -3 months, +2months, and+5months after implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.