NCT02481037

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Apr 2015

Longer than P75 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

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3.2 years

First QC Date

June 19, 2015

Last Update Submit

September 24, 2019

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Prescription of evidenced-based preventative therapies

    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 Outcomes (3)

  • Dispensed preventative therapies

    12 months after receiving intervention

  • Emergency department visits and hospitalizations for asthma

    12 months after receiving intervention

  • Electronic Medical Record (EMR) data

    12 months after receiving intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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 pathwayOther: Asthma educationOther: EMR embedded dashboard

Control group

NO INTERVENTION

Practice will continue with routine care. Control group will be offered the intervention at study completion, if successful.

Interventions

Primary care clinical pathwayOTHER

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.

Intervention group
Asthma educationOTHER

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.

Intervention group
EMR embedded dashboardOTHER

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

Intervention group

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Validated diagnosis of asthma according to CPCSSN validated definition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (3)

  • Potestio ML, Sharpe H, Johnson DW, Grimshaw JM, Faris P, Duan QM, Pow J, Cave A. A cluster randomized controlled trial of an electronic medical record-based pathway for pediatric asthma in primary care in Alberta. CMAJ. 2025 Nov 23;197(40):E1330-E1336. doi: 10.1503/cmaj.241694.

    PMID: 41285460DERIVED

  • Sharpe H, Potestio M, Cave A, Johnson DW, Scott SD. Facilitators and barriers to the implementation of the Primary Care Asthma Paediatric Pathway: a qualitative analysis. BMJ Open. 2022 May 12;12(5):e058950. doi: 10.1136/bmjopen-2021-058950.

    PMID: 35551084DERIVED

  • Cave AJ, Sharpe H, Anselmo M, Befus AD, Currie G, Davey C, Drummond N, Graham J, Green LA, Grimshaw J, Kam K, Manca DP, Nettel-Aguirre A, Potestio ML, Rowe BH, Scott SD, Williamson T, Johnson DW. Primary Care Pathway for Childhood Asthma: Protocol for a Randomized Cluster-Controlled Trial. JMIR Res Protoc. 2016 Mar 8;5(1):e37. doi: 10.2196/resprot.5261.

    PMID: 26955763DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andrew Cave, FCFP, FRCGP

    Department of Family Medicine, University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 25, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2018

Study Completion

March 1, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)