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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02037841
Other study ID # #11/10E
Secondary ID
Status Completed
Phase N/A
First received July 4, 2013
Last updated January 29, 2016
Start date March 2012
Est. completion date October 2015

Study information

Verified date January 2014
Source Children's Hospital of Eastern Ontario
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Asthma is the most common chronic disease of childhood and is responsible for large portion of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways allow for optimal delivery of care and may result in decreased length of stay, leading to important economic benefits. Weaning of asthma medications prescribed for asthma exacerbation is not standardized in the current model of care. Currently, weaning is performed by ward physicians; in a teaching hospital, this most often done by residents staff. Differences in practice between different physicians, delays in patient assessment and adjustment of doctor's orders, likely prolong the hospital stay for children admitted with asthma.

This study's main objective is to determine the effect of a nursing-driven clinical pathway on children's length of stay when admitted to hospital with a diagnosis of acute asthma exacerbation. The pathway will allow nurses to wean a specific type of medication(β2-agonist), as compared to the current standard of care, which dictates that a physician writes an order to wean the medication. Number of administered β2-agonist treatments will be compared between both groups, as well as asthma-related health care utilization within two weeks of hospital discharge. Nursing, physician, and patients' satisfaction with the pathway will be evaluated, and a cost minimization analysis will be performed.

This study has the potential to improve resource use efficiency, increase patient safety by avoiding administration of unnecessary medications, and ameliorate quality of care by standardizing the care of children admitted to the hospital with a diagnosis of acute asthma exacerbation. The results of the study will be disseminated across the Canadian Health Care System with the goal of improving outcomes of children admitted to hospitals with acute asthma exacerbations.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 17 Years
Eligibility Inclusion Criteria:

- Children admitted during the study period with a diagnosis of asthma exacerbation, reactive airway disease, or wheezing

- Children aged 2 to 17 years

Exclusion Criteria:

- Children under the age of 2 years

- Children with congenital heart disease

- Children with chronic lung diseases other than asthma, including cystic fibrosis and bronchopulmonary dysplasia

- Children with severe neurological impairment

- Children with other significant co-morbid disorders

- Children whose caregivers do not understand English or French

- Children whose caregivers cannot be reached by phone for the 14-day follow up

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Nursing-driven clinical pathway for management of inpatient asthma


Locations

Country Name City State
Canada Children's Hospital of Eastern Ontario Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Eastern Ontario CHAMO Innovation Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Cost analysis At study completion, expected within 2-3 years No
Primary Length of hospital admission, in hours The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days. Duration of hospital admission, average 2-3 days No
Secondary The number of inhaled or nebulized ß2-agonist treatments given The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days. Duration of hospital admission, average 2 -3 days Yes
Secondary number of children transferred to the ICU The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days. During admission to hospital, average 2-3 days Yes
Secondary number of families attending asthma teaching sessions The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days. Duration of hospital admission, average 2-3 days Yes
Secondary number of children seeking medical attention for asthma-related issues Follow up will occur to assess all children who seeked medical attention for concerns related to asthma for two weeks post-discharge from hospital Within 2 weeks of hospital discharge date Yes
Secondary Nursing and physician satisfaction with the pathway At study completion, expected within 2 to 3 years No
Secondary patient satisfaction with the care received in hospital Follow up satisfaction questionaire will be completed within two weeks of discharge from hospital Within 2 weeks of hospital discharge date No
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