AsthmaNCT02481037
Primary Care Pathway for Childhood Asthma
A study testing Primary care clinical pathway, Asthma education and EMR embedded dashboard in people with Asthma, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Primary care clinical pathway, Asthma education and EMR embedded dashboard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Validated diagnosis of asthma according to CPCSSN validated definition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asthma
- Being tested
- Primary care clinical pathway, Asthma education, EMR embedded dashboard
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
EMR embedded dashboardOther
An EMR embedded dashboard will deliver real-time feedback to clinicians.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Primary care clinical pathway; Other: Asthma education; Other: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after receiving intervention
Secondary outcomes (3)
Dispensed preventative therapies
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.
Measured: 12 months after receiving intervention
Emergency department visits and hospitalizations for asthma
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.
Measured: 12 months after receiving intervention
Electronic Medical Record (EMR) data
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.
Measured: 12 months after receiving intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Alberta Health Services, Calgary, Health Quality Council of Alberta (HQCA), University of Calgary, Ottawa Hospital Research Institute, TELUS
- Responsible party
- Sponsor
- Investigators
- Andrew Cave, FCFP, FRCGP, Principal investigator, Department of Family Medicine, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481037
- Sponsor's protocol ID
- 201400389
- Status last verified
- Sep 2019
- First submitted
- 19 Jun 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 41285460Sharpe 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.
PubMed 35551084Cave 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.
PubMed 26955763
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Pathway for Childhood Asthma
- ClinicalTrials.gov ID
- NCT02481037
- Acronym / sponsor ID
- 201400389
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Alberta Health Services, Calgary, Health Quality Council of Alberta (HQCA), University of Calgary, Ottawa Hospital Research Institute, TELUS
- Study start
- Apr 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Primary care clinical pathway, Other: Asthma education, Other: EMR embedded dashboardEmbedding 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. |
| Control group | No intervention | –Practice will continue with routine care. Control group will be offered the intervention at study completion, if successful. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Validated diagnosis of asthma according to CPCSSN validated definition
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary care clinical pathwayInstalling 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 | Intervention group |
| Asthma educationPhysicians 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 | Intervention group |
| EMR embedded dashboardAn EMR embedded dashboard will deliver real-time feedback to clinicians. | Other | Intervention group |
Primary outcome
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.
3 secondary outcomes
Dispensed preventative therapies
Time frame: 12 months after receiving intervention
Emergency department visits and hospitalizations for asthma
Time frame: 12 months after receiving intervention
Electronic Medical Record (EMR) data
Time frame: 12 months after receiving intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 41285460Potestio 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.
- Derived from this study: PubMed 35551084Sharpe 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.
- Derived from this study: PubMed 26955763Cave 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Cave, FCFP, FRCGP principal investigator
Department of Family Medicine, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary care clinical pathway, Asthma education and EMR embedded dashboard in people with Asthma, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription of evidenced-based preventative therapies (time frame: 12 months after receiving intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481037, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.