The Lung Attack Alert Study (TLAL)
Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G2B7
- University of Alberta Hospital Emergency Department
-
Edmonton, Alberta, Kanada
- Northeaset Community Health Clinic
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Kein Eingriff: Control/Standard Care
Regular care
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Follow-up with primary care provider
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Relapse
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 24 hours
|
The length of stay from the triage to the departure from the ED.
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Up to 24 hours
|
|
Quality of life
Zeitfenster: 90 days
|
Change in patients' health-related quality of life, within 90 days of discharge from the ED.
|
90 days
|
|
Referrals
Zeitfenster: 90 days
|
The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.
|
90 days
|
|
Follow-up with primary care provider
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Brian H Rowe, MD, MSc, University of Alberta
- Hauptermittler: Mohit Bhutani, MD, FRCPC, University of Alberta
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro00011325
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