Clinical Trial: A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice
This study is currently recruiting patients.
Verified by Radboud University August 2005
| Sponsors and Collaborators: | Radboud University ZonMw: The Netherlands Organisation for Health Research and Development Boehringer Ingelheim Pharmaceuticals St. Radboud University Hospital Netherlands Asthma Foundation | | Information provided by: | Radboud University | | ClinicalTrials.gov Identifier: | NCT00131157 | |
Purpose
More and more general practitioners (GPs) use spirometry in their practice. At this time, there is sufficient reason 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 if 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
Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: 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 diagnose after spirometry interpretation in a random sample (n=20 patients) taken from an index population per practice.
Secondary Outcomes: 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
Expected Total Enrollment: 39
Study start: January 2003; Expected completion: January 2007
Last follow-up: August 2006; Data entry closure: August 2006
More and more general practitioners (GPs) use spirometry in their practice. 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 above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00131157
Patrick Poels, MD ++31243613315 p.j.p.poels@hag.umcn.nl
Tjard Schermer, MSc PhD ++31243614611 t.schermer@hag.umcn.nl
Netherlands, Gelderland Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, 6500 HB, Netherlands; Recruiting
Patrick Poels, MD, Sub-Investigator
Study chairs or principal investigators
Chris van Weel, Prof, Principal Investigator, Radboud University Nijmegen Medical Centre, Nijmegen
More Information
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.
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.
Study ID Numbers: 95500; NAF-3.4.02.18; ZonMW 920-03-265
Last Updated: August 16, 2005
Record first received: August 16, 2005
ClinicalTrials.gov Identifier: NCT00131157
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23
Source: ClinicalTrials.gov
Cache Date: August 24, 2005