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Clinical Trials/NCT00131157
NCT00131157UnknownNot Applicable

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

Radboud University Medical Center1 site in 1 country39 target enrollmentStarted: January 1, 2003Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
39
Locations
1
Primary Endpoint
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 Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

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 diagnosis 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

Investigators

Sponsor Class
Other

Study Sites (1)

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