Primary Care Pathway for Childhood Asthma

September 24, 2019 updated by: University of Alberta

At least half of children with asthma have poor disease control, which can result in complications requiring emergency treatment and hospitalization. As asthma is one of the most common reasons for children to visit emergency departments (ED) and be hospitalized, this disease places a heavy burden on the health care system and families. While there is strong evidence that timely treatment with preventative therapies can substantially improve asthma control, reduce sudden worsening of symptoms, and lower rates of ED visits and hospitalizations, a significant proportion of children do not receive these therapies.

The purpose of this study is to improve the prescription and use of evidenced-based preventative therapies for children with asthma with the goal to significantly improve their disease control and quality of life, while reducing unnecessary ED visits and hospitalizations. The investigators will achieve this by: i) installing a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (EMR) to facilitate the use of best-evidence by practitioners, and ii) training chronic disease management (CDM) health professionals to provide targeted and timely asthma education to parents and children with asthma. The investigators will test this pathway and education project in a representative sample of 22 Alberta primary care practices, using a pragmatic cluster controlled trial methodology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta

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

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Validated diagnosis of asthma according to CPCSSN validated definition

Exclusion Criteria:

  • Children under 1 and over 17 years of age
  • Children of parents who have opted out of CPCSSN data collection
  • Children with validated asthma who have not attended practices in the last 2 years, or have not received bronchodilator therapy in the last 12 months

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Embedding a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (EMR) to facilitate practitioners utilizing best-evidence; training these practices' chronic disease management (CDM) professionals to provide asthma education to children with asthma and their parents; and clinicians receiving an EMR embedded dashboard.
Other: Primary care clinical pathway
Installing a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (EMR) to facilitate the use of best-evidence by practitioners.
Other: Asthma education
Physicians will receive web-based education through an interactive learning module regarding best management for childhood asthma and use of the primary care clinical pathway. Chronic disease management (CDM) health professionals in practices will attend asthma education sessions delivered by an asthma educator. This training will be then used by the CDM professional to provide targeted and timely asthma education to parents and children with asthma.
Other: EMR embedded dashboard
An EMR embedded dashboard will deliver real-time feedback to clinicians.
No Intervention: Control group
Practice will continue with routine care. Control group will be offered the intervention at study completion, if successful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prescription of evidenced-based preventative therapies
Time Frame: 12 months after receiving intervention
The proportion of symptomatic children with asthma in the baseline and follow-up periods (separate calculations) who are appropriately treated with a preventer will be the primary outcome. The denominator will be the number of children who meet the case definition of asthma and receive at least one prescription for an inhaled short-acting beta-agonist (e.g. salbutamol) during the applicable time period. The numerator will be, of these children, the number who receive a prescription for inhaled corticosteroid, montelukast, a combined inhaled long-acting beta agonist and corticosteroid, or some combination of these three drugs in the same time period.
12 months after receiving intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dispensed preventative therapies
Time Frame: 12 months after receiving intervention
The proportion of applicable children in baseline and follow-up periods who are appropriately dispensed a preventer by a pharmacy will highlight if there is a significant gap between prescriptions given and filled. The denominator will be the same as for the primary outcome but the numerator will be the number of these children who are dispensed one or more preventer medications from newly available Pharmaceutical Information Network (PIN) data.
12 months after receiving intervention
Emergency department visits and hospitalizations for asthma
Time Frame: 12 months after receiving intervention
The number of asthma emergency department visits or hospitalizations (ICD10 J45 or J46) per child who meets the case definition of asthma during each time period, a measure of health care use.
12 months after receiving intervention
Electronic Medical Record (EMR) data
Time Frame: 12 months after receiving intervention
The research team has worked with TELUS to develop and validate a case definition and case finding algorithm for identifying children with asthma in practices. The TELUS EMR data will provide, for all eligible children, individual categorical and continuous patient level data such as patient demographics, ICD9 codes and medication prescriptions, and for children evaluated in practices randomized to the pathway group, asthma phenotype and provision of asthma action plans.
12 months after receiving intervention

Collaborators and Investigators

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

Sponsor

University of Alberta

Collaborators

Ottawa Hospital Research Institute
University of Calgary
Alberta Innovates Health Solutions
Alberta Health Services, Calgary
Health Quality Council of Alberta (HQCA)
TELUS

Investigators

  • Principal Investigator: Andrew Cave, FCFP, FRCGP, Department of Family Medicine, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201400389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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