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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Children's Hospital of Eastern Ontario
Sponsor:
Collaborator:
CHAMO Innovation Fund
Information provided by (Responsible Party):
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT02037841
First received: July 4, 2013
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Length of hospital admission, in hours [ Time Frame: Duration of hospital admission, average 2-3 days ] [ Designated as safety issue: No ]
    The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.


Secondary Outcome Measures:
  • The number of inhaled or nebulized β2-agonist treatments given [ Time Frame: Duration of hospital admission, average 2 -3 days ] [ Designated as safety issue: Yes ]
    The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.

  • number of children transferred to the ICU [ Time Frame: During admission to hospital, average 2-3 days ] [ Designated as safety issue: Yes ]
    The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.

  • number of families attending asthma teaching sessions [ Time Frame: Duration of hospital admission, average 2-3 days ] [ Designated as safety issue: Yes ]
    The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.

  • number of children seeking medical attention for asthma-related issues [ Time Frame: Within 2 weeks of hospital discharge date ] [ Designated as safety issue: Yes ]
    Follow up will occur to assess all children who seeked medical attention for concerns related to asthma for two weeks post-discharge from hospital

  • Nursing and physician satisfaction with the pathway [ Time Frame: At study completion, expected within 2 to 3 years ] [ Designated as safety issue: No ]
  • patient satisfaction with the care received in hospital [ Time Frame: Within 2 weeks of hospital discharge date ] [ Designated as safety issue: No ]
    Follow up satisfaction questionaire will be completed within two weeks of discharge from hospital


Other Outcome Measures:
  • Cost analysis [ Time Frame: At study completion, expected within 2-3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Nursing-driven clinical pathway for management of inpatient asthma
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

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02037841

Contacts
Contact: Barb Murchinson 613-737-7600 ext 4133 bmurchinson@cheo.on.ca

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Victoria Gelt, MD    613-566-5182    vgelt@cheo.on.ca   
Contact: Barbara Murchison    613-737-7600 ext 4133    bmurchison@cheo.on.ca   
Principal Investigator: Catherine Pound, MD, FRCPC         
Principal Investigator: Victoria Gelt, MD, FRCPC         
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
CHAMO Innovation Fund
  More Information

No publications provided

Responsible Party: Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02037841     History of Changes
Other Study ID Numbers: #11/10E
Study First Received: July 4, 2013
Last Updated: January 14, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:
Asthma
Nursing
Protocol
PRAM
Length of Stay
Weaning
Clinical pathway
Asthma exacerbation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014