Evaluation of Spirometry Expert Support in General Practice
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Asthma, Cough
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
expert support for interpretation of spirometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Family Practice, Spirometry, Decision Support Systems, Feedback
Eligibility 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
Sites / Locations
- Radboud University Nijmegen Medical Centre
Outcomes
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
Full Information
NCT ID
NCT00131157
First Posted
August 16, 2005
Last Updated
February 28, 2007
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Boehringer Ingelheim, The Netherlands Asthma Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00131157
Brief Title
Evaluation of Spirometry Expert Support in General Practice
Official Title
A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Boehringer Ingelheim, The Netherlands Asthma Foundation
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Asthma, Cough, Dyspnea
Keywords
Pulmonary Disease, Chronic Obstructive, Family Practice, Spirometry, Decision Support Systems, Feedback
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
39 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
expert support for interpretation of spirometry
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
Study II: between-group difference in the proportion of ordered additional investigations and referrals by GPs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris van Weel, Prof
Organizational Affiliation
Radboud University Nijmegen Medical Centre, Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
15526814
Citation
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.
Results Reference
background
PubMed Identifier
14514938
Citation
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.
Results Reference
background
PubMed Identifier
19649513
Citation
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.
Results Reference
derived
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Evaluation of Spirometry Expert Support in General Practice
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