The Lung Attack Alert Study (TLAL)
Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G2B7
- University of Alberta Hospital Emergency Department
-
Edmonton, Alberta, Kanada
- Northeaset Community Health Clinic
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Žádný zásah: Control/Standard Care
Regular care
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Follow-up with primary care provider
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relapse
Časové okno: 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
Časové okno: 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
Časové okno: Up to 24 hours
|
The length of stay from the triage to the departure from the ED.
|
Up to 24 hours
|
|
Quality of life
Časové okno: 90 days
|
Change in patients' health-related quality of life, within 90 days of discharge from the ED.
|
90 days
|
|
Referrals
Časové okno: 90 days
|
The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.
|
90 days
|
|
Follow-up with primary care provider
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Brian H Rowe, MD, MSc, University of Alberta
- Vrchní vyšetřovatel: Mohit Bhutani, MD, FRCPC, University of Alberta
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro00011325
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .