Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278759
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2006-01-16
Brief Title:
Unclogging the Pediatric Emergency Room Impact of Rapid Viral Diagnostics
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Unclogging the Pediatric Emergency Room Impact of Rapid Viral Diagnostics A Randomized Controlled Trial of Decision Making Based Upon Early at Triage Rapid Diagnosis of Respiratory Viral Infections VIRAP in Children 3-36 Months of Age Presenting to the Emergency Department ED With a Flu-Like Illness
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute respiratory tract infections are among the most common problems of childhood particularly among infants and children younger than 3 years and account for most antibiotic prescriptions to children Most of these infections are self-limited and do not require medical intervention however the symptoms overlap significantly with those of severe viral or bacterial infections At the hospital Emergency Department ED medical assessment prescription of antibiotics unnecessarily if the infection is viral and a series of investigations eg blood work X-rays often take place before a decision on patient management and possible hospital admission can be made Such procedures lead to intense use of human health resources nursing laboratory and radiology staff and hospital facilities
The literature suggests that a prompt single viral diagnosis improves decision-making To our knowledge no-one has performed a controlled trial to examine the impact of a rapid multi-viral detection test like VIRAP or the impact of the timing of such a test on management of children with flu-like illnesses in the ED
Our objective is to determine if use of our new viral detection program VIRAP for rapid testing for viral respiratory infections right after triage will improve patient management and resource use in the ED We will test the hypothesis that availability of VIRAP at triage to support rapid diagnosis of viral infection in children at BCCH will i reduce the waiting time in the ED ii improve decision making regarding diagnostic investigations and specimen collection and iii decrease antibiotic prescriptions
Study completed and manuscript accepted for publication in the Journal of Pediatrics
The literature suggests that a prompt single viral diagnosis improves decision-making To our knowledge no-one has performed a controlled trial to examine the impact of a rapid multi-viral detection test like VIRAP or the impact of the timing of such a test on management of children with flu-like illnesses in the ED
Our objective is to determine if use of our new viral detection program VIRAP for rapid testing for viral respiratory infections right after triage will improve patient management and resource use in the ED We will test the hypothesis that availability of VIRAP at triage to support rapid diagnosis of viral infection in children at BCCH will i reduce the waiting time in the ED ii improve decision making regarding diagnostic investigations and specimen collection and iii decrease antibiotic prescriptions
Study completed and manuscript accepted for publication in the Journal of Pediatrics
Detailed Description:
Description of Project
Background Acute viral respiratory tract infections are among the most common infectious problems of childhood during the first five years of life particularly among infants younger than 2 years of age Although the majority of these infections does not require medical attention and are self-limited in nature worried parents commonly bring their children to the emergency department ED for evaluation average 2500 childrenwinter EDs are choke points in the health care system especially at the peaks of the annual influenza season and respiratory syncytial virus RSV season Without a prompt specific viral diagnosis in a child presenting to the ED with a febrile respiratory illness after being seen by a physician a child may have to undergo a constellation of precautionary diagnostic tests septic work up CXR and be prescribed antibiotics unnecessarily These interventions lead to prolonged ED stays average 180min -120 min intense use of human health resources nursing laboratory and radiology staff resulting in significant cost both direct and indirect to the health care system as well as time lost to the children and their families and contribute to antimicrobial resistance The precise etiology of these viral infection episodes can be determined through the use of rapid screening program such as VIRAP nasopharyngeal washing for rapid direct viral antigen detection via immunofluorescence At the moment VIRAP is a physician ordered test done only after the child has been seen by the physician usually after the child has already been waiting for a significant length of time then has to wait further for the results of the test
Hypothesis Rapid diagnosis of viral infection through VIRAP initiated by a nurse at triage wit results available for ED physician time of assessment may influence decision making with respect to additional investigations therefore reduce the amount of waiting time in the ED as well as decrease antibiotic prescriptions This would ultimately result in improved effectiveness of service provision for children with febrile respiratory illnesses and in turn shorten waiting time for all children in the ED Health care cost reduction by minimising unnecessary diagnostic tests being performed and antibiotic prescription are also expected
Study design We propose to conduct a single centre open label randomized controlled trial comparing outcomes of patients undergoing VIRAP at triage vs routine ED admission protocol During the months of December 2005 to April and again Dec2006 to April 2007 eligible patients based on our inclusion and exclusion will be enrolled at triage and randomized in a 11 ratio to either undergo NPW for VIRAP and have the result available to the treating physician at time of assessment or routine admitting protocol to the ED and await physician assessment without prior investigation
Criteria Patients age 3-36 months admitted to the BCCH ED with fever385 0C measured in ED or documented by the accompanying parent and at least one of cough runny nose nasal congestion and sore throat will be eligible for enrolment Excluded from the study will be patients who are immuno-compromised who have underlying chronic severe respiratory conditions cystic fibrosis bronchopulmonary dysplasia or chronic heart conditions uncorrected cyanotic heart lesions prosthetic valves who have had prior assessment in our ED department for the current illness Only one child per family can be enrolled
End points The duration of stay in ED from assessment to discharge including time waiting for investigations and review of results by the physician is the primary endpoint Secondary endpoints include whether any investigations following the assessment blood test radiographs or urine tests were ordered and whether study patients were prescribed antibiotics
Background Acute viral respiratory tract infections are among the most common infectious problems of childhood during the first five years of life particularly among infants younger than 2 years of age Although the majority of these infections does not require medical attention and are self-limited in nature worried parents commonly bring their children to the emergency department ED for evaluation average 2500 childrenwinter EDs are choke points in the health care system especially at the peaks of the annual influenza season and respiratory syncytial virus RSV season Without a prompt specific viral diagnosis in a child presenting to the ED with a febrile respiratory illness after being seen by a physician a child may have to undergo a constellation of precautionary diagnostic tests septic work up CXR and be prescribed antibiotics unnecessarily These interventions lead to prolonged ED stays average 180min -120 min intense use of human health resources nursing laboratory and radiology staff resulting in significant cost both direct and indirect to the health care system as well as time lost to the children and their families and contribute to antimicrobial resistance The precise etiology of these viral infection episodes can be determined through the use of rapid screening program such as VIRAP nasopharyngeal washing for rapid direct viral antigen detection via immunofluorescence At the moment VIRAP is a physician ordered test done only after the child has been seen by the physician usually after the child has already been waiting for a significant length of time then has to wait further for the results of the test
Hypothesis Rapid diagnosis of viral infection through VIRAP initiated by a nurse at triage wit results available for ED physician time of assessment may influence decision making with respect to additional investigations therefore reduce the amount of waiting time in the ED as well as decrease antibiotic prescriptions This would ultimately result in improved effectiveness of service provision for children with febrile respiratory illnesses and in turn shorten waiting time for all children in the ED Health care cost reduction by minimising unnecessary diagnostic tests being performed and antibiotic prescription are also expected
Study design We propose to conduct a single centre open label randomized controlled trial comparing outcomes of patients undergoing VIRAP at triage vs routine ED admission protocol During the months of December 2005 to April and again Dec2006 to April 2007 eligible patients based on our inclusion and exclusion will be enrolled at triage and randomized in a 11 ratio to either undergo NPW for VIRAP and have the result available to the treating physician at time of assessment or routine admitting protocol to the ED and await physician assessment without prior investigation
Criteria Patients age 3-36 months admitted to the BCCH ED with fever385 0C measured in ED or documented by the accompanying parent and at least one of cough runny nose nasal congestion and sore throat will be eligible for enrolment Excluded from the study will be patients who are immuno-compromised who have underlying chronic severe respiratory conditions cystic fibrosis bronchopulmonary dysplasia or chronic heart conditions uncorrected cyanotic heart lesions prosthetic valves who have had prior assessment in our ED department for the current illness Only one child per family can be enrolled
End points The duration of stay in ED from assessment to discharge including time waiting for investigations and review of results by the physician is the primary endpoint Secondary endpoints include whether any investigations following the assessment blood test radiographs or urine tests were ordered and whether study patients were prescribed antibiotics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None