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Asthma & COPD Guideline Implementation

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Standard Practice Group (SPG)
TISG
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Asthma focused on measuring asthma, COPD, guidelines, knowledge transfer, medical education, care gaps

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard practice group (SPG)

Targeted Intervention Strategy (TISG)

Arm Description

Send a copy of the latest Canadian asthma and COPD guidelines to all PCPs.

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.

Outcomes

Primary Outcome Measures

Physician Assessment Questionnaire-Asthma
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.

Secondary Outcome Measures

The Physician Practice Assessment Questionnaire
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)

Full Information

First Posted
January 7, 2013
Last Updated
January 9, 2013
Sponsor
Laval University
Collaborators
GlaxoSmithKline, Canadian Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT01766544
Brief Title
Asthma & COPD Guideline Implementation
Official Title
Asthma and COPD Guideline Implementation: Lessons Learned on Recruitment of Primary Care Physicians to a Knowledge Translation Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment of physicians to participate to the study.
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
Collaborators
GlaxoSmithKline, Canadian Lung Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a report of a protocol developed to improve asthma and COPD care in a primary care setting. The study was approved by an Ethics Committee and support by the Canadian Thoracic Society through an unrestrictive grant from GlaxoSmithKline. However, the study could not be done and the investigators report why, discussing the difficulties to perform such study. This information should be very useful to investigators planning this sort of study.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease
Keywords
asthma, COPD, guidelines, knowledge transfer, medical education, care gaps

7. Study Design

Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard practice group (SPG)
Arm Type
Active Comparator
Arm Description
Send a copy of the latest Canadian asthma and COPD guidelines to all PCPs.
Arm Title
Targeted Intervention Strategy (TISG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Practice Group (SPG)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TISG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physician Assessment Questionnaire-Asthma
Description
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.
Time Frame
First visit
Secondary Outcome Measure Information:
Title
The Physician Practice Assessment Questionnaire
Description
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)
Time Frame
First visit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis-Philippe Boulet, MD, FRCPC
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

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Asthma & COPD Guideline Implementation

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