The Impact of Implementing a Nursing-driven Clinical Pathway for Inpatient Management of Children With Asthma (NAP)

January 29, 2016 updated by: Children's Hospital of Eastern Ontario

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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

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.
Duration of hospital admission, average 2 -3 days
number of children transferred to the ICU
Time Frame: During admission to hospital, average 2-3 days
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
number of families attending asthma teaching sessions
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
number of children seeking medical attention for asthma-related issues
Time Frame: Within 2 weeks of hospital discharge date
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
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
patient satisfaction with the care received in hospital
Time Frame: Within 2 weeks of hospital discharge date
Follow up satisfaction questionaire will be completed within two weeks of discharge from hospital
Within 2 weeks of hospital discharge date

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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