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Primary Care Pathway for Childhood Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Primary care clinical pathway
Asthma education
EMR embedded dashboard
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 19, 2015
Last Updated
September 24, 2019
Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, Alberta Health Services, Calgary, Health Quality Council of Alberta (HQCA), University of Calgary, Ottawa Hospital Research Institute, TELUS
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1. Study Identification

Unique Protocol Identification Number
NCT02481037
Brief Title
Primary Care Pathway for Childhood Asthma
Official Title
Primary Care Pathway for Childhood Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, Alberta Health Services, Calgary, Health Quality Council of Alberta (HQCA), University of Calgary, Ottawa Hospital Research Institute, TELUS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Practice will continue with routine care. Control group will be offered the intervention at study completion, if successful.
Intervention Type
Other
Intervention Name(s)
Primary care clinical pathway
Intervention Description
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 Type
Other
Intervention Name(s)
Asthma education
Intervention Description
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 Type
Other
Intervention Name(s)
EMR embedded dashboard
Intervention Description
An EMR embedded dashboard will deliver real-time feedback to clinicians.
Primary Outcome Measure Information:
Title
Prescription of evidenced-based preventative therapies
Description
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.
Time Frame
12 months after receiving intervention
Secondary Outcome Measure Information:
Title
Dispensed preventative therapies
Description
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.
Time Frame
12 months after receiving intervention
Title
Emergency department visits and hospitalizations for asthma
Description
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.
Time Frame
12 months after receiving intervention
Title
Electronic Medical Record (EMR) data
Description
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.
Time Frame
12 months after receiving intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Cave, FCFP, FRCGP
Organizational Affiliation
Department of Family Medicine, University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35551084
Citation
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.
Results Reference
derived
PubMed Identifier
26955763
Citation
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.
Results Reference
derived

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Primary Care Pathway for Childhood Asthma

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