- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107613
The Lung Attack Alert Study (TLAL)
Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G2B7
- University of Alberta Hospital Emergency Department
-
Edmonton, Alberta, Canada
- Northeaset Community Health Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
Opinion leader educational letter
|
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.
|
No Intervention: Control/Standard Care
Regular care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse
Time Frame: 90 days
|
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)
|
90 days
|
Adjusted management
Time Frame: 90 days
|
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.
|
90 days
|
Length of ED Stay
Time Frame: Up to 24 hours
|
The length of stay from the triage to the departure from the ED.
|
Up to 24 hours
|
Quality of life
Time Frame: 90 days
|
Change in patients' health-related quality of life, within 90 days of discharge from the ED.
|
90 days
|
Referrals
Time Frame: 90 days
|
The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.
|
90 days
|
Follow-up with primary care provider
Time Frame: 30 days
|
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.
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian H Rowe, MD, MSc, University of Alberta
- Principal Investigator: Mohit Bhutani, MD, FRCPC, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00011325
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Opinion leader educational letter
-
University of AlbertaCompleted
-
RTI InternationalNational Institute of Mental Health (NIMH)CompletedHIV Infections | Sexually Transmitted DiseasesPeru, Russian Federation, China, India, Zimbabwe
-
Centers for Disease Control and PreventionCompletedHIV InfectionsUnited States
-
University of AlbertaAlberta Health & Wellness; Merck Frosst Canada Ltd.; Canadian Diabetes Association and other collaboratorsCompletedHypertension | Diabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1Canada
-
University of AlbertaAlberta Heritage Foundation for Medical Research; Institute of Health Economics...CompletedHeart Failure | Coronary Disease | Ischemic Heart DiseaseCanada
-
Centers for Disease Control and PreventionUniversity of Alabama at BirminghamCompletedRisk Behavior | Sexually Transmitted DiseasesUnited States
-
Centers for Disease Control and PreventionTexas A&M UniversityCompletedRisk Behavior | Sexually Transmitted DiseasesUnited States
-
Stanford UniversityThe Physicians FoundationCompletedSocial Stigma | Help-Seeking Behavior | Workplace Culture | Education, Medical, ContinuingUnited States
-
Drexel UniversityCompletedCovid19 | Violence | Mental Health IssueUnited States
-
University of AlbertaCanadian Institutes of Health Research (CIHR)Completed