Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

NCT02005952 | Completed

• 1 other identifier: 09/078/992
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Supervision from the pulmonary function laboratory of the Hospital ; computer.
2. 2.Program incorporated into automated spirometer.
3. 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.

Conditions

Spirometry

Outcome Measures

Primary Outcomes (1)

• Effectiveness of two methods for quality control in primary care spirometry

  Basal

Study Arms (3)

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).

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients under 15 years

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Officials

• Jordi Giner, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 9, 2013
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2012
• Last Updated: December 9, 2013

Record last verified: 2009-05