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OpenTrials
Completed

NCT Number: NCT02481037

Primary Care Pathway for Childhood Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary care clinical pathway

Other

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.

Asthma Education

Other

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.

EMR embedded dashboard

Other

An EMR embedded dashboard will deliver real-time feedback to clinicians.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 25, 2015
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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