- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00131157
Evaluation of Spirometry Expert Support in General Practice
February 28, 2007 updated by: Radboud University Medical Center
A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
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Nijmegen, Gelderland, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chris van Weel, Prof, Radboud University Nijmegen Medical Centre, Nijmegen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chavannes N, Schermer T, Akkermans R, Jacobs JE, van de Graaf G, Bollen R, van Schayck O, Bottema B. Impact of spirometry on GPs' diagnostic differentiation and decision-making. Respir Med. 2004 Nov;98(11):1124-30. doi: 10.1016/j.rmed.2004.04.004.
- Schermer TR, Jacobs JE, Chavannes NH, Hartman J, Folgering HT, Bottema BJ, van Weel C. Validity of spirometric testing in a general practice population of patients with chronic obstructive pulmonary disease (COPD). Thorax. 2003 Oct;58(10):861-6. doi: 10.1136/thorax.58.10.861.
- Poels PJ, Schermer TR, Thoonen BP, Jacobs JE, Akkermans RP, de Vries Robbe PF, Quanjer PH, Bottema BJ, van Weel C. Spirometry expert support in family practice: a cluster-randomised trial. Prim Care Respir J. 2009 Sep;18(3):189-97. doi: 10.4104/pcrj.2009.00047.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion
August 1, 2006
Study Registration Dates
First Submitted
August 16, 2005
First Submitted That Met QC Criteria
August 16, 2005
First Posted (ESTIMATE)
August 17, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
March 1, 2007
Last Update Submitted That Met QC Criteria
February 28, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95500
- NAF-3.4.02.18
- ZonMW 920-03-265
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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