Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT02005952

Collaborator

(none)

3,000

Enrollment

Duration (Months)

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Spirometry

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

Effectiveness of two methods for quality control in primary care spirometry [Basal]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02005952

Other Study ID Numbers:

09/078/992

First Posted:

Dec 9, 2013

Last Update Posted:

Dec 9, 2013

Last Verified:

May 1, 2009

Study Results

No Results Posted as of Dec 9, 2013