Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

Spirometry Clinical Trial

Official title:

Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005952
• Other study ID #: 09/078/992
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: December 4, 2013
• Start date: February 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2009
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Still not well resolved access, execution and interpretation of spirometry in primary care medicine. This seriously affects the quality of care of chronic respiratory diseases.

OBJECTIVE: To compare the effectiveness of two methods for quality control in performing spirometry in primary care teams (EAP) participating in the "Healthcare Process Chronic Obstructive Pulmonary Disease (COPD )" (multidisciplinary program between primary care medicine and hospital for improved care COPD).

METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality control of spirometry in each EAP randomize into three branches:

1. Supervision from the pulmonary function laboratory of the Hospital ; computer.

2. Program incorporated into automated spirometer.

3. Spirometric usual practice (control group without any support on the quality ). Spirometry EAP participants include year follow-up study . All sites use the same model spirometer and have received the same previous training . In a 2nd phase results implementing the most effective method shown in the 1st phase was studied.

EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the quality spirometry.

POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early detection (secondary prevention ) , the diagnosis of the severity and developmental control of COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: June 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All patients seen in the participating primary care, requiring spirometry for both the diagnosis and control of any disease will be included.

Exclusion Criteria:

• Patients under 15 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spirometry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of two methods for quality control in primary care spirometry		Basal	No