Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02005952
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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. 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.


Condition or disease
Spirometry

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Effectiveness of Two Methods for Quality Control in Primary Care Spirometry
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2012

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).



Primary Outcome Measures :
  1. Effectiveness of two methods for quality control in primary care spirometry [ Time Frame: Basal ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring spirometry performing a diagnostic or tracking control for respiratory disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005952


Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Layout table for investigator information
Principal Investigator: Jordi Giner, MSc Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Additional Information:

Layout table for additonal information
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02005952     History of Changes
Other Study ID Numbers: 09/078/992
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: May 2009