Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Evaluation of Spirometry Expert Support in General Practice
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Boehringer Ingelheim Pharmaceuticals
The Netherlands Asthma Foundation
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00131157
  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

MedlinePlus related topics: Asthma Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Cough
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice

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

Locations
Netherlands, Gelderland
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 Pharmaceuticals
The Netherlands Asthma Foundation
Investigators
Principal Investigator: Chris van Weel, Prof Radboud University Nijmegen Medical Centre, Nijmegen
  More Information

Publications:
Study ID Numbers: 95500, NAF-3.4.02.18, ZonMW 920-03-265
Study First Received: August 16, 2005
Last Updated: February 28, 2007
ClinicalTrials.gov Identifier: NCT00131157  
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

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Cough
Asthma
Chronic Disease
Dyspnea
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009