NCT02037841

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2014

Enrollment Period

3.6 years

First QC Date

July 4, 2013

Last Update Submit

January 29, 2016

Conditions

Keywords

AsthmaNursingProtocolPRAMLength of StayWeaningClinical pathwayAsthma exacerbation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • The number of inhaled or nebulized β2-agonist treatments given

    Duration of hospital admission, average 2 -3 days

  • number of children transferred to the ICU

    During admission to hospital, average 2-3 days

  • number of families attending asthma teaching sessions

    Duration of hospital admission, average 2-3 days

  • number of children seeking medical attention for asthma-related issues

    Within 2 weeks of hospital discharge date

  • Nursing and physician satisfaction with the pathway

    At study completion, expected within 2 to 3 years

  • +1 more secondary outcomes

Other Outcomes (1)

  • Cost analysis

    At study completion, expected within 2-3 years

Study Arms (2)

Nursing-driven Asthma protocol

EXPERIMENTAL

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

Physician-driven asthma management

NO INTERVENTION

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

Interventions

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children admitted during the study period with a diagnosis of asthma exacerbation, reactive airway disease, or wheezing
  • Children aged 2 to 17 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2013

First Posted

January 16, 2014

Study Start

March 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 1, 2016

Record last verified: 2014-01

Locations