Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

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.

Study Overview

• Status: Completed
• Conditions: Spirometry

• Study Type: Observational
• Enrollment (Actual): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring spirometry performing a diagnostic or tracking control for respiratory disease

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Spirometry, quality control, Pulmonary Function Laboratory; Performing spirometry, with control over the quality of the same, made from the pulmonary function laboratory of the Hospital de la Santa Creu i Sant Pau.
Spirometry, quality control, software; Performing spirometry, with the support of software self-management quality of spirometry maneuvers incorporated therein
Spirometry, quality control, control group; Performing spirometry in the way that is currently working in primary care (control group without any support).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effectiveness of two methods for quality control in primary care spirometry	Basal

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Jordi Giner, MSc, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 09/078/992