Clinical trial NCT01107613: The Lung Attack Alert Study
Official title: Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: opinion leader
COPD
Emergency Department
relapse
follow-up
evidence-based guidelines
Exacerbation of COPD
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-04-21
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Follow-up with primary care provider
timeFrame: 90 days
Secondary outcomes:
measure: Relapse
timeFrame: 90 days
measure: Adjusted management
timeFrame: 90 days
measure: Length of ED Stay
timeFrame: Up to 24 hours
measure: Quality of life
timeFrame: 90 days
measure: Referrals
timeFrame: 90 days
measure: Follow-up with primary care provider
timeFrame: 30 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital Emergency Department
state: Alberta
city: Edmonton
country: Canada
facility: Northeaset Community Health Clinic
state: Alberta
Study officials:
affiliation: University of Alberta
name: Brian H Rowe, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Mohit Bhutani, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.