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The Lung Attack Alert Study (TLAL)

7. juli 2022 opdateret af: University of Alberta

Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

128

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • University of Alberta Hospital Emergency Department
      • Edmonton, Alberta, Canada
        • Northeaset Community Health Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Ingen indgriben: Control/Standard Care
Regular care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Follow-up with primary care provider
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relapse
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 24 hours
The length of stay from the triage to the departure from the ED.
Up to 24 hours
Quality of life
Tidsramme: 90 days
Change in patients' health-related quality of life, within 90 days of discharge from the ED.
90 days
Referrals
Tidsramme: 90 days
The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.
90 days
Follow-up with primary care provider
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Brian H Rowe, MD, MSc, University of Alberta
  • Ledende efterforsker: Mohit Bhutani, MD, FRCPC, University of Alberta

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

12. april 2010

Først indsendt, der opfyldte QC-kriterier

19. april 2010

Først opslået (Skøn)

21. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2022

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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