NCT00131157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

August 16, 2005

Last Update Submit

February 28, 2007

Conditions

Pulmonary Disease, Chronic ObstructiveAsthmaCoughDyspnea

Keywords

Pulmonary Disease, Chronic ObstructiveFamily PracticeSpirometryDecision Support SystemsFeedback

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • 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

Interventions

expert support for interpretation of spirometryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GP practices with a Windows supported electronic Patient Journal System (PJS) in a certain postal region in the Netherlands.

You may not qualify if:

  • GP practices without a Windows supported PJS
  • Practices outside a certain postcode region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 15526814BACKGROUND

  • 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.

    PMID: 14514938BACKGROUND

  • 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.

    PMID: 19649513DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthmaCoughDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Chris van Weel, Prof

    Radboud University Nijmegen Medical Centre, Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 17, 2005

Study Start

January 1, 2003

Study Completion

August 1, 2006

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

NL(1)