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The Lung Attack Alert Study (TLAL)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Opinion leader educational letter
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring opinion leader, COPD, Emergency Department, relapse, follow-up, evidence-based guidelines, Exacerbation of COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alberta Hospital Emergency Department
  • Northeaset Community Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control/Standard Care

Arm Description

Opinion leader educational letter

Regular care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
Length of ED Stay
The length of stay from the triage to the departure from the ED.
Quality of life
Change in patients' health-related quality of life, within 90 days of discharge from the ED.
Referrals
The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.
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.

Full Information

First Posted
April 12, 2010
Last Updated
July 7, 2022
Sponsor
University of Alberta
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01107613
Brief Title
The Lung Attack Alert Study
Acronym
TLAL
Official Title
Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
opinion leader, COPD, Emergency Department, relapse, follow-up, evidence-based guidelines, Exacerbation of COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Opinion leader educational letter
Arm Title
Control/Standard Care
Arm Type
No Intervention
Arm Description
Regular care
Intervention Type
Behavioral
Intervention Name(s)
Opinion leader educational letter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Follow-up with primary care provider
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Relapse
Description
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)
Time Frame
90 days
Title
Adjusted management
Description
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.
Time Frame
90 days
Title
Length of ED Stay
Description
The length of stay from the triage to the departure from the ED.
Time Frame
Up to 24 hours
Title
Quality of life
Description
Change in patients' health-related quality of life, within 90 days of discharge from the ED.
Time Frame
90 days
Title
Referrals
Description
The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.
Time Frame
90 days
Title
Follow-up with primary care provider
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian H Rowe, MD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohit Bhutani, MD, FRCPC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital Emergency Department
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Northeaset Community Health Clinic
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35514131
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.
Results Reference
derived

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The Lung Attack Alert Study

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