Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Trial of Spirometry Fundamentals™ in the Primary Care Setting

28 juni 2010 uppdaterad av: University of Washington

Randomized Controlled Trial of Spirometry Fundamentals™ in the Primary Care Setting

Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Misclassification of asthma severity has been reported when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment that may result in increased morbidity and increased healthcare utilization/cost. However, even when spirometry is utilized to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society.

The goal of this study is to evaluate the effectiveness of the Spirometry Fundamentals™ tool in training primary care providers and their staff in producing high-quality flow-volume curves as compared to existing training modalities and to gather information in a 'real-world' setting that can be used to improve Spirometry Fundamentals™.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Currently few self-paced, distance learning programs exist that train staff to perform good quality spirometry tests. This study evaluates the effectiveness of a distance-learning tool for training primary care providers and their medical assistants in the use of spirometry to assist in managing obstructive lung disease (asthma and COPD). This tool is called "Spirometry Fundamentals™: A basic guide to lung function testing". It is a computer-based training program that teaches primary care providers and their staff what spirometry is, how it can be used, the techniques required to perform high-quality spirometry, and clinical interpretation of the spirometric data.

We evaluated the effectiveness of Spirometry Fundamentals in the primary care setting by conducting a randomized controlled trial (RCT). Study participants were primary care physicians (MDs or DOs) and their staff (medical assistants (MAs) or nurses (RNs)) and were recruited as study pairs. The role of the MDs was to utilize spirometry in clinical care by ordering spirometry tests based on their clinical judgment, and the role of the MAs was to perform the spirometry. The patients performed the spirometry as part of their usual care were not considered study subjects.

Studietyp

Interventionell

Inskrivning (Faktisk)

52

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98195
        • University of Washington

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 90 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Subjects must have internet access in order to transmit spirometry curve and survey data.
  • Subjects must have access to a computer with Windows 2000 /Mac OS 10 or higher in order to view Spirometry Fundamentals™.
  • Subjects must have access to a ndd Easyone spirometer.

Exclusion Criteria:

  • Subjects who lack internet access which will be needed to transmit study data
  • Subjects who lack access to a computer with Windows 2000 /Mac OS 10 or higher which will be needed to view Spirometry Fundamentals™.
  • Subjects who lack access to a ndd Easyone spirometer.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Vårdstandard
Experimentell: Intervention
Spirometry Fundamentals™ CD training program
Beteende: Spirometry Fundamentals™ Training CD
MD-MA pairs randomized to the intervention arm of the study received 2 copies of the Spirometry Fundamentals™ CD. Included with the CDs was a letter explaining that each member of the MD-MA pair should view the CD at their convenience within the following 3 weeks. This letter included instructions on how to access the study website in order to complete an evaluation survey after viewing the CD.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Spirometry test quality
Tidsram: Four months for controls; six months for intervention sites
Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
Four months for controls; six months for intervention sites

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effect of frequency of spirometry use on primary outcome
Tidsram: Four months for controls; six months for intervention sites
Examined whether frequency of spirometry use related to the percent of passing testing sessions conducted by the office.
Four months for controls; six months for intervention sites
Effect of practice location on primary outcome
Tidsram: Four months for controls; six months for intervention sites
Examined whether practice location (private/community, hospital/university) related to the percent of passing testing sessions conducted by the office.
Four months for controls; six months for intervention sites
Effect of practice type on primary outcome
Tidsram: Four months for controls; six months for intervention sites
Examined whether practice type (pediatric/non-pediatric) related to the percent of passing testing sessions conducted by the office.
Four months for controls; six months for intervention sites
Effect of practice structure on primary outcome
Tidsram: Four months for controls; six months for intervention sites
Examined whether practice structure related to the percent of passing testing sessions conducted by the office.
Four months for controls; six months for intervention sites
Effect of months of spirometry use on primary outcome
Tidsram: Four months for controls; six months for intervention sites
Examined whether months of spirometry use by practice (prior to participating in study) related to the percent of passing testing sessions conducted by the office.
Four months for controls; six months for intervention sites

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Washington

Utredare

  • Huvudutredare: Rita Mangione-Smith, MD, MPH, University of Washington/Seattle Children's Hospital
  • Huvudutredare: James W Stout, MD, MPH, University of Washington

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2007

Primärt slutförande (Faktisk)

1 maj 2009

Avslutad studie (Faktisk)

1 maj 2009

Studieregistreringsdatum

Först inskickad

25 juni 2010

Först inskickad som uppfyllde QC-kriterierna

28 juni 2010

Första postat (Uppskatta)

29 juni 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 juni 2010

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juni 2010

Senast verifierad

1 juni 2010

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 31552-E/A
  • A26829 (Annat bidrag/finansieringsnummer: American Thoracic Society)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Spirometry Fundamentals™ Training CD

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Uruguay

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera