Asthma & COPD Guideline Implementation

NCT ID: NCT01766544

Last Updated: 2013-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-03-31

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard practice group (SPG)

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

Group Type: ACTIVE_COMPARATOR

Standard Practice Group (SPG)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

TISG

Intervention Type: 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.

Interventions

Standard Practice Group (SPG)

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

TISG

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Canadian Lung Association

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis-Philippe Boulet, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

GIPC

Identifier Type: -

Identifier Source: org_study_id