AsthmaEarly Phase 1NCT01766544
Asthma & COPD Guideline Implementation
A Early Phase 1 study testing Standard Practice Group (SPG) and TISG in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Standard Practice Group (SPG) and TISG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Mar 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: Asthma and COPD Guideline Implementation: Lessons Learned on Recruitment of Primary Care Physicians to a Knowledge Translation Study
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.
Read the 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
- Being tested
- Standard Practice Group (SPG), TISG
- Keywords
- asthma, COPD, guidelines, knowledge transfer, medical education, care gaps
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
TISGOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard practice group (SPG) | Active comparator | Send a copy of the latest Canadian asthma and COPD guidelines to all PCPs. Receives: 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. Receives: Other: TISG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- 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.
Measured: First visit
Secondary outcomes (1)
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)
Measured: First visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Insufficient recruitment of physicians to participate to the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Canadian Lung Association
- Responsible party
- Sponsor
- Investigators
- Louis-Philippe Boulet, MD, FRCPC, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766544
- Sponsor's protocol ID
- GIPC
- Status last verified
- Jan 2013
- First submitted
- 7 Jan 2013
- Last updated
- 11 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma and COPD Guideline Implementation: Lessons Learned on Recruitment of Primary Care Physicians to a Knowledge Translation Study
- ClinicalTrials.gov ID
- NCT01766544
- Acronym / sponsor ID
- GIPC
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- asthma, COPD, guidelines, knowledge transfer, medical education, care gaps
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment of physicians to participate to the study.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Canadian Lung Association
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard practice group (SPG) | Active comparator | Other: Standard Practice Group (SPG)Send a copy of the latest Canadian asthma and COPD guidelines to all PCPs. |
| Targeted Intervention Strategy (TISG) | Active comparator | Other: TISGinteractive 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Standard practice group (SPG) |
| TISGinteractive 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. | Other | Targeted Intervention Strategy (TISG) |
Primary outcome
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.
1 secondary outcome
The Physician Practice Assessment Questionnaire
Time frame: First visit
Results and safety
The study was stopped early (reason given: Insufficient recruitment of physicians to participate to the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis-Philippe Boulet, MD, FRCPC principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Standard Practice Group (SPG) and TISG in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment of physicians to participate to the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Assessment Questionnaire-Asthma (time frame: First visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2013.