Chronic Obstructive Pulmonary DiseaseTLALNCT01107613
The Lung Attack Alert Study
A study testing Opinion leader educational letter in people with Chronic Obstructive Pulmonary Disease, run by University of Alberta at 2 sites in Canada.
Trial summary
This study will enroll patients who present to Emergency Departments (EDs) and have an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or asthma at discharged in one Edmonton ED. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Opinion leader educational letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2011to Jan 2013
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Appropriately signed and dated informed consent has been obtained;
- ED patients presenting with an acute exacerbation of COPD requiring treatment in the ED;
- Previous physician-diagnosis of COPD (e.g., emphysema, chronic bronchitis or COPD) either previously or within the ED;
- Age > 40 years of age;
- Current or former smokers of more than 10 pack years (number of packs of cigarettes {or pipe and/or cigars) smoked per day X the number of years of smoking);
- FEV1/FVC ratio < 0.7 for age, sex and height (either known or determined within the ED);
- Patients can read and comprehend English language.
Who cannot join
- Patients presenting for prescription renewal;
- Patients who require hospitalization;
- Patients who do not have a primary care physician or patients for whom a family physician cannot be found;
- Patients who have already been enrolled in the study;
- Patients with a ED physician-diagnosis of primary asthma, pneumonia, HIV/AIDS, immuno-compromise, or life expectance of < 90 days;
- Patients who, in the opinion of the investigator, should be excluded.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital Emergency Department
Edmonton, Alberta, T6G2B7
Northeaset Community Health Clinic
Edmonton, Alberta
About this study
Official title: Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
This study will enroll patients who present to Emergency Departments (EDs) and have an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or asthma at discharged in one Edmonton ED. Patients will all be provided with evidence-based discharge (prednisone and an antibiotic for COPD and prednisone and inhaled corticosteroids for asthma) and will be randomized to receive enhanced education to the primary care provider or standard care. The investigators' goal is to determine if an opinion leaders' advice will improve chronic care in these patients.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of morbidity and mortality worldwide. COPD is now seen as a disease that is both preventable and treatable. In order to better facilitate treatment for these patients, a number of consensus guidelines have been developed to help physicians in the diagnosis and chronic management of these patients. However, a number of studies have shown that implementation and adherence to the guidelines by physicians, both at the primary care and specialist level, remains poor. Similar argument can be made for asthma: its a common disease, its readily treatable, and guideline compliance is low.
Patients who experience an Acute Exacerbation of COPD (AECOPD) or asthma have an increased risk of serious adverse events, and therefore, must have their management optimized to improve outcomes. These patients most often are evaluated and treated in their local emergency departments (EDs) for the acute episode; however, follow up care is often left to their primary care physician (PCP). The national rate of patient compliance for follow up with their PCP within the first month following an AECOPD is unknown, however, locally, it is only 30%. Similar local statistics are available for asthma From this, it could be inferred that there is a poor rate for any adjustment in chronic management after an AECOPD or acute asthma presentation and therefore an increased risk of future exacerbations.
It is our belief that informing the PCP that their patient experienced an acute COPD or asthma ED presentation, with a form that provides details of the acute management along with an update of the current guideline recommendations, will improve follow up, compliance with current guidelines and the quality of life for patients with COPD or asthma.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Opinion leader educational letter
- Keywords
- opinion leader, COPD, Emergency Department, relapse, follow-up, evidence-based guidelines, Exacerbation of COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emergencies, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opinion leader educational letterBehavioural
All patients will receive prednisone X 10 days and antibiotics X 5 days, as well as an opinion leader educational letter sent to the primary care provider outlining the needs of this patient.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Opinion leader educational letter Receives: Behavioral: Opinion leader educational letter |
| Control/Standard Care | No intervention | Regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up with primary care provider
The follow-up of the patient by their primary care provider for review of the acute and chronic management of their COPD or asthma and addressing any issues on the Lung Attack Alert, within the first 90 days after discharge from the ED.
Measured: 90 days
Secondary outcomes (6)
Relapse
An unscheduled visit for worsening COPD or asthma symptoms. relapse will be sub-divided into various categories (relapse- no change in management; relapse- change in management; relapse-ED visit change in management and discharged; relapse-ED visit change in management and admission; relapse-death)
Measured: 90 days
Adjusted management
The TLAL letter will identify patients who need review and adjustment of the management of their COPD or asthma (e.g., medication change, smoking cessation strategies, pulmonary rehabilitation, etc). This assessment will document all of the actions taken by the primary care provider after ED discharge.
Measured: 90 days
Length of ED Stay
The length of stay from the triage to the departure from the ED.
Measured: Up to 24 hours
Quality of life
Change in patients' health-related quality of life, within 90 days of discharge from the ED.
Measured: 90 days
Referrals
The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.
Measured: 90 days
Follow-up with primary care provider
The follow-up of the patient by their primary care provider for review of the acute and chronic management of their COPD and addressing any issues on the Lung Attack Alert, within the first 30 days after discharge from the ED.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Brian H Rowe, MD, MSc, Principal investigator, University of AlbertaMohit Bhutani, MD, FRCPC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107613
- Sponsor's protocol ID
- Pro00011325
- Acronym
- TLAL
- Status last verified
- Nov 2017
- First submitted
- 12 Apr 2010
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
PubMed 35514131
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
- ClinicalTrials.gov ID
- NCT01107613
- Acronym / sponsor ID
- TLAL / Pro00011325
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- opinion leader, COPD, Emergency Department, relapse, follow-up, evidence-based guidelines, Exacerbation of COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Apr 2010 (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 study will enroll patients who present to Emergency Departments (EDs) and have an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or asthma at discharged in one Edmonton ED. Patients will all be provided with evidence-based discharge (prednisone and an antibiotic for COPD and prednisone and inhaled corticosteroids for asthma) and will be randomized to receive enhanced education to the primary care provider or standard care. The investigators' goal is to determine if an opinion leaders' advice will improve chronic care in these patients.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of morbidity and mortality worldwide. COPD is now seen as a disease that is both preventable and treatable. In order to better facilitate treatment for these patients, a number of consensus guidelines have been developed to help physicians in the diagnosis and chronic management of these patients. However, a number of studies have shown that implementation and adherence to the guidelines by physicians, both at the primary care and specialist level, remains poor. Similar argument can be made for asthma: its a common disease, its readily treatable, and guideline compliance is low.
Patients who experience an Acute Exacerbation of COPD (AECOPD) or asthma have an increased risk of serious adverse events, and therefore, must have their management optimized to improve outcomes. These patients most often are evaluated and treated in their local emergency departments (EDs) for the acute episode; however, follow up care is often left to their primary care physician (PCP). The national rate of patient compliance for follow up with their PCP within the first month following an AECOPD is unknown, however, locally, it is only 30%. Similar local statistics are available for asthma From this, it could be inferred that there is a poor rate for any adjustment in chronic management after an AECOPD or acute asthma presentation and therefore an increased risk of future exacerbations.
It is our belief that informing the PCP that their patient experienced an acute COPD or asthma ED presentation, with a form that provides details of the acute management along with an update of the current guideline recommendations, will improve follow up, compliance with current guidelines and the quality of life for patients with COPD or asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Opinion leader educational letterOpinion leader educational letter |
| Control/Standard Care | No intervention | –Regular care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Appropriately signed and dated informed consent has been obtained;
- ED patients presenting with an acute exacerbation of COPD requiring treatment in the ED;
- Previous physician-diagnosis of COPD (e.g., emphysema, chronic bronchitis or COPD) either previously or within the ED;
- Age > 40 years of age;
- Current or former smokers of more than 10 pack years (number of packs of cigarettes {or pipe and/or cigars) smoked per day X the number of years of smoking);
Key exclusion criteria (6 listed)
- Patients presenting for prescription renewal;
- Patients who require hospitalization;
- Patients who do not have a primary care physician or patients for whom a family physician cannot be found;
- Patients who have already been enrolled in the study;
- Patients with a ED physician-diagnosis of primary asthma, pneumonia, HIV/AIDS, immuno-compromise, or life expectance of < 90 days;
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 |
|---|---|---|
| Opinion leader educational letterAll patients will receive prednisone X 10 days and antibiotics X 5 days, as well as an opinion leader educational letter sent to the primary care provider outlining the needs of this patient. | Behavioural | Intervention Arm |
Primary outcome
Follow-up with primary care provider
Time frame: 90 days
The follow-up of the patient by their primary care provider for review of the acute and chronic management of their COPD or asthma and addressing any issues on the Lung Attack Alert, within the first 90 days after discharge from the ED.
6 secondary outcomes
Relapse
Time frame: 90 days
Adjusted management
Time frame: 90 days
Length of ED Stay
Time frame: Up to 24 hours
Quality of life
Time frame: 90 days
Referrals
Time frame: 90 days
Follow-up with primary care provider
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 35514131Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
- CTS COPD GuidelinesLink provided by the sponsor.
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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.
Brian H Rowe, MD, MSc principal investigator
University of Alberta
Mohit Bhutani, MD, FRCPC principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opinion leader educational letter in people with Chronic Obstructive Pulmonary Disease, run by University of Alberta at 2 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Follow-up with primary care provider (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107613, which also lists 1 linked publication.
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 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.