- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037841
The Impact of Implementing a Nursing-driven Clinical Pathway for Inpatient Management of Children With Asthma (NAP)
The Impact of Implementing a Nursing-driven Clinical Pathway for Inpatient Management of Children Admitted to a Tertiary Care Centre With a Diagnosis of Asthma: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nursing-driven Asthma protocol
Children randomized to the intervention group will have their β2-agonist medication weaned by the nurse, according to the steps outlined in the clinical pathway.
The nurse will ensure that the patient's family is booked for asthma teaching, and will also remind the physicians to fill out an asthma action plan on discharge.
Detailed information as to when to contact physicians in the event of an acute deterioration of the patient is included in the clinical pathway.
|
|
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No Intervention: Physician-driven asthma management
Patients in the control group will continue receiving the current standard of care, which consists of physicians weaning the β2-agonist medication when called to the bedside by the nurse or when deemed necessary by a physician
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital admission, in hours
Time Frame: Duration of hospital admission, average 2-3 days
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of inhaled or nebulized β2-agonist treatments given
Time Frame: Duration of hospital admission, average 2 -3 days
|
The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.
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Duration of hospital admission, average 2 -3 days
|
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number of children transferred to the ICU
Time Frame: During admission to hospital, average 2-3 days
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The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.
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During admission to hospital, average 2-3 days
|
|
number of families attending asthma teaching sessions
Time Frame: Duration of hospital admission, average 2-3 days
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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
|
|
number of children seeking medical attention for asthma-related issues
Time Frame: Within 2 weeks of hospital discharge date
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Follow up will occur to assess all children who seeked medical attention for concerns related to asthma for two weeks post-discharge from hospital
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Within 2 weeks of hospital discharge date
|
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Nursing and physician satisfaction with the pathway
Time Frame: At study completion, expected within 2 to 3 years
|
At study completion, expected within 2 to 3 years
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patient satisfaction with the care received in hospital
Time Frame: Within 2 weeks of hospital discharge date
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Follow up satisfaction questionaire will be completed within two weeks of discharge from hospital
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Within 2 weeks of hospital discharge date
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cost analysis
Time Frame: At study completion, expected within 2-3 years
|
At study completion, expected within 2-3 years
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #11/10E
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