Evaluation of Spirometry Expert Support in General Practice

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Boehringer Ingelheim
The Netherlands Asthma Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00131157
First received: August 16, 2005
Last updated: February 28, 2007
Last verified: February 2007
  Purpose

More and more general practitioners (GPs) use spirometry in their practices. At this time, there is sufficient reason to presume that, after a single postgraduate training program without any further support, most GPs have insufficient knowledge and ability to assure valid interpretation of their spirometry tests. Therefore, some kind of continuous diagnostic support with regard to spirometry interpretation by GPs is advisable. The aim of the present study is to assess whether implementation of spirometry expert support (either by a computerised expert system or a working agreement between general practitioners and respiratory consultants with respect to spirometry interpretation) causes changes in diagnosing and appropriateness and efficiency of medical care in subjects with chronic respiratory morbidity managed in general practice.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Asthma
Cough
Dyspnea
Procedure: expert support for interpretation of spirometry

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Study I: between-group difference in the proportion of cases in which the GP opts for the gold standard diagnosis before versus expert/sham information
  • Study II: between-group difference in the proportion of patients with a changed respiratory diagnosis after spirometry interpretation in a random sample (n=20 patients) taken from an index population per practice

Secondary Outcome Measures:
  • Study I: between-group difference in the proportion of cases in which the GP opts for the gold standard treatment (prescription, referrals) before versus after the addition of expert/sham information
  • Study II: between-group difference in the proportion of ordered additional investigations and referrals by GPs

Estimated Enrollment: 39
Study Start Date: January 2003
Estimated Study Completion Date: August 2006
Detailed Description:

More and more general practitioners (GPs) use spirometry in their practices. At this time, there is sufficient reason to presume that, after a single postgraduate training program without any further support, most GPs have insufficient knowledge and ability to assure valid interpretation of their spirometry tests. Therefore, some kind of continuous diagnostic support with regard to spirometry interpretation by GPs is advisable. The problem formulation for the study proposed is: "Does implementation of spirometry expert support (either by a computerized expert system or a local working agreement between GPs and respiratory consultants with respect to spirometry interpretation) cause changes in diagnosing and quality and efficiency of medical care in subjects with chronic respiratory morbidity managed in general practice?”. In order to address this issue, two separate studies with different designs are proposed. Study I (n=62 GPs) is an ‘in-depth’ study of the GPs‘ decision-making process with regard to spirometry, and the impact of a computerized expert system on this process. Study II (n=39 general practices) is a pragmatic randomised-controlled implementation study evaluating two realistic modes of spirometry expert support (i.e., a computerized expert system or a working agreement between GPs and respiratory consultants).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GP practices with a Windows supported electronic Patient Journal System (PJS) in a certain postal region in the Netherlands.

Exclusion Criteria:

  • GP practices without a Windows supported PJS
  • Practices outside a certain postcode region
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131157

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Boehringer Ingelheim
The Netherlands Asthma Foundation
Investigators
Principal Investigator: Chris van Weel, Prof Radboud University Nijmegen Medical Centre, Nijmegen
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131157     History of Changes
Other Study ID Numbers: 95500, NAF-3.4.02.18, ZonMW 920-03-265
Study First Received: August 16, 2005
Last Updated: February 28, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Pulmonary Disease, Chronic Obstructive
Family Practice
Spirometry
Decision Support Systems
Feedback

Additional relevant MeSH terms:
Asthma
Chronic Disease
Dyspnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014