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Impact Of A Health Care Protocol For Patients Suffering Symptoms Of Mild Acute Viral Bronchiolitis On Early Release In The Emergency Department

This study has been withdrawn prior to enrollment.
(The study was stopped because it was not approved for funding)
Sponsor:
Information provided by (Responsible Party):
Dre Chantal Guimont, Laval University
ClinicalTrials.gov Identifier:
NCT01091064
First received: March 19, 2010
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

Acute viral bronchiolitis is the principal cause of lower respiratory tract infection in infants worldwide. It is characterized by a first episode of respiratory distress preceded by rhinorrhea, cough and fever. The majority of patients present with mild symptoms which can be treated safely at home by parents. Every year between October thru April emergency departments in North America are overwhelmed with patients waiting to be seen with mild respiratory infections, such as bronchiolitis. Thus new strategies in health care have to be elaborated to reduce costs and waiting time in the emergency department.

The investigators hypothesize that patients liberated from triage with mild acute viral bronchiolitis would have the same rate of office re-visits than those with mild acute bronchiolitis in the emergency department.


Condition Intervention Phase
Bronchiolitis
Other: Randomization
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: IMPACT OF A HEALTH CARE PROTOCOL FOR PATIENTS SUFFERING SYMPTOMS OF MILD ACUTE VIRAL BRONCHIOLITIS ON EARLY DISCHARGE IN THE EMERGENCY DEPARTMENT.

Further study details as provided by Laval University:

Primary Outcome Measures:
  • emergency revisit rate [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    emergency revisit rate in the first 15 days after recruitment


Enrollment: 0
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early depart
Patients who will be liberated at triage with mild acute viral bronchiolitis
Other: Randomization
Patients will be randomized to either an early depart or for being seen by a physician.
No Intervention: Medical visit group
Patients with acute viral bronchiolitis who will wait to be seen by the physician
Other: Randomization
Patients will be randomized to either an early depart or for being seen by a physician.

Detailed Description:

Acute viral bronchiolitis constitutes the principal cause of acute lower respiratory tract infections in infants and children in Nord America. Every year 11% of infants younger than 1 year and 6% of those between 1 and 2 years are affected. Acute viral bronchiolitis is characterized by a first episode of respiratory distress associated to rhinorrhea, cough and fever, other symptoms such as vomiting, use of accessory intercostal muscles and irritability can be present. Mild symptoms presentation in bronchiolitis is very common, these patients do not require treatment or testing, only appropriate information on how to ameliorate respiratory symptoms and a well list of alarm signs for parents are frequently enough to send the patient home.

Increasing workload in the ED is a national worry after the last 20 years. Between October and April, this phenomena is seen each year due to cold and influenza season. From an economic perspective along with a lack in human resources, new strategies have to be implemented to reduce duration and costs in office visits in the emergency department. Since mild bronchiolitis does not require a specific treatment, we hypothesize that patients liberated from triage with mild acute viral bronchiolitis would have the same rate of office re-visits than those with mild acute bronchiolitis in the emergency department.

Our principal objective will be to compare between groups of infants with mild acute viral bronchiolitis the use of hospital resources within the fist 15 days after recruitment. Specific objectives will be to compare between the 2 groups the rate of office re-visit, or to the ED during the fist 15 days after recruitment, the severity of respiratory symptoms during re-visits, on follow up at 2-4 days, 6-8 days and 13-15 days, patient and parent satisfaction of the first visit and of follow up at 2-4 days, 6-8 days and 13-15 days.

This research project will have a rapid and direct effect on quality of health care in infants with acute viral bronchiolitis and their parents, as well as important repercussions on the workload in the waiting rooms of EDs allowing physicians to concentrate on other patients are in need of a rapid attention. This project will be carried on in two high concentration specialized hospitals in the province of Quebec, Canada.

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients of any sex aged 3 to 12 months old with the diagnosis of mild acute viral bronchiolitis.

Exclusion Criteria:

  • Infants aged < 3 months of > 13 months old.
  • Infants born before 30 weeks gestation.
  • Infants' weight < 5 kg.
  • Infants with a dehydration score of more or equal to 1.
  • Yale score > 10.
  • Infants with chronic pulmonary, cardiovascular or neuromuscular disease.
  • Infants with primary or secondary immunodeficiencies.
  • Patients with the antecedent of wheezing.
  • Need of any ventilatory support.
  • Patients in whom the diagnosis of acute viral bronchiolitis is not precise.
  • Patients in whose parents refuse to sign the consent formulary or not willing to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091064

Locations
Canada
Laval University Hospital Center
Quebec, Canada
Sponsors and Collaborators
Laval University
  More Information

No publications provided

Responsible Party: Dre Chantal Guimont, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT01091064     History of Changes
Other Study ID Numbers: 20636
Study First Received: March 19, 2010
Last Updated: January 30, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014