- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766544
Asthma & COPD Guideline Implementation
Asthma and COPD Guideline Implementation: Lessons Learned on Recruitment of Primary Care Physicians to a Knowledge Translation Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Asthma and chronic obstructive pulmonary disease (COPD) are the two most common chronic pulmonary ailments in Canada, affecting about 2.5 million and 750 thousand individuals, respectively. In the last two decades, the Canadian Thoracic Society (CTS) has successfully developed and disseminated evidence-based asthma and COPD clinical practice guidelines. However, evidence suggests that guideline implementation in these diseases remains inadequate.
Successful guideline implementation requires tailoring of selected strategies to settings and population-specific barriers, based on established theories and principles. In 2004, the CTS and its collaborators organized a symposium in Quebec City, to discuss existing barriers to respiratory guideline implementation and possible knowledge translation (KT) strategies. This was followed in the fall of 2007 by an expert-led workshop on guideline implementation strategies.
Herein, the investigators report the planned methods and outcome of a project which resulted from these meetings. This study sought to explore the effectiveness of a multi-faceted KT strategy in improving concordance with COPD and asthma guidelines among primary care physicians (PCPs) in Canada, but was aborted due to inadequate PCP recruitment. The investigators discuss the difficulties encountered in recruiting PCPs, factors which may have influenced recruitment, and alternative strategies. The goal of the investigators is to provide practical lessons to inform the design of future KT initiatives with similar interventions and/or a similar target audience.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Primary care physicians were eligible if they: 1) managed at least 15 patients with asthma and 15 patients with COPD per month in an office setting; and 2) agreed to designate an appropriately trained person at his/her site to identify eligible study patients, collect consent, and provide a questionnaire to patients.
Patients were eligible if they: 1) spoke French or English; and 2) had a diagnosis of asthma or COPD (as per their participating PCP). Furthermore, patients with asthma had to be between 18 and 45 years of age, and patients with COPD had to be between 40 and 75 years of age and have a smoking history of >10 pack-years.
Exclusion Criteria:
Physicians were excluded if they: 1) had presented at a continuing medical education (CME) event on asthma or COPD in last year; 2) had completed any specialty training in respiratory diseases; or 3) practiced primarily at walk-in clinics, with children, or in emergency departments.
Patients were excluded if they: 1) had any condition which could interfere with study measurements (as per their participating PCP); 2) had any known respiratory disorders other than asthma or COPD; or 3) were currently participating in another clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard practice group (SPG)
Send a copy of the latest Canadian asthma and COPD guidelines to all PCPs.
|
The investigators planned to send a copy of the latest Canadian asthma and COPD guidelines to all PCPs in the Standard Practice (SP) Group at the start of the study period, by mail.
No other intervention would be offered during the study, but upon study completion, all control participants would be offered the educational intervention received by the Targeted Intervention Strategy (TIS) Group.
|
Active Comparator: Targeted Intervention Strategy (TISG)
interactive educational intervention, expert mentorship, practice-based tools.
Consisting of 3 interactive sessions, 2 of which would be live meetings of 3h each and the third a one-hour teleconference.
|
interactive educational interventions, expert mentorship and practice-based tools.
3 interactive sessions, 2 of which would be live meetings of 3h each, and the third hour teleconference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician Assessment Questionnaire-Asthma
Time Frame: First visit
|
The co-primary outcomes (for asthma and COPD) were defined as the change in patient-reported physician conformity to each of the following key guideline recommendations, measured through a questionnaire (Appendix 1): A) For asthma, assessment of asthma control, defined as ascertainment of at least 2 of the 5 asthma control questions recommended by the Canadian Asthma Guidelines. Stratified physician randomization would randomize 75% of PCPs to the TIS group and 25% to the SP group. |
First visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Physician Practice Assessment Questionnaire
Time Frame: First visit
|
Secondary outcomes collected through the patient questionnaires included other guideline-recommended physician behaviours.
For asthma, these included spirometry performance, asthma action plan provision and review, inhaler technique review, and maintenance anti-inflammatory medication prescription when indicated.
For COPD, these included spirometry performance, inhaler technique review, exacerbation screening, long-acting bronchodilator prescription when indicated, and smoking cessation efforts in smokers.
A separate questionnaire measured physician self-reported changes in knowledge and adherence to guideline-recommended behaviours (the "Physician Practice Assessment Questionnaire") (PPAQ)
|
First visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louis-Philippe Boulet, MD, FRCPC, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIPC
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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