Asthma & COPD Guideline Implementation

NCT01766544 | Terminated Early Phase 1

• 1 other identifier: GIPC
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Keywords

asthma; COPD; guidelines; knowledge transfer; medical education; care gaps

Outcome Measures

Primary Outcomes (1)

• 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.

  First visit

Secondary Outcomes (1)

• The Physician Practice Assessment Questionnaire

  First visit

Study Arms (2)

Standard practice group (SPG)

ACTIVE COMPARATOR

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

Other: Standard Practice Group (SPG)

Targeted Intervention Strategy (TISG)

ACTIVE COMPARATOR

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.

Other: TISG

Interventions

Standard Practice Group (SPG) OTHER

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.

Standard practice group (SPG)

TISG OTHER

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.

Targeted Intervention Strategy (TISG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• GlaxoSmithKline: collaborator
• Canadian Lung Association: collaborator

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Louis-Philippe Boulet, MD, FRCPC

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 11, 2013
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

CA (1)