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A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice - Article


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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

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Page Updated: October 3, 2005
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