Pulmonary Disease, Chronic ObstructiveNCT00131157
Evaluation of Spirometry Expert Support in General Practice
A study testing expert support for interpretation of spirometry in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Asthma, Cough
- What is being tested?
- expert support for interpretation of spirometry
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GP practices with a Windows supported electronic Patient Journal System (PJS) in a certain postal region in the Netherlands.
Who cannot join
- GP practices without a Windows supported PJS
- Practices outside a certain postcode region
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice
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.
Read the 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).
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma, Cough, Dyspnea
- Being tested
- expert support for interpretation of spirometry
- Keywords
- Pulmonary Disease, Chronic Obstructive, Family Practice, Spirometry, Decision Support Systems, Feedback
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Cough, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expert support for interpretation of spirometryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startJan 2003
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 39 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Boehringer Ingelheim, The Netherlands Asthma Foundation
- Investigators
- Chris van Weel, Prof, Principal investigator, Radboud University Nijmegen Medical Centre, Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131157
- Sponsor's protocol ID
- 95500
- Other IDs
- NAF-3.4.02.18, ZonMW 920-03-265
- Status last verified
- Feb 2007
- First submitted
- 16 Aug 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
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. doi: 10.1016/j.rmed.2004.04.004.
PubMed 15526814Schermer 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.
PubMed 14514938Poels 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.
PubMed 19649513
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice
- ClinicalTrials.gov ID
- NCT00131157
- Acronym / sponsor ID
- 95500
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma, Cough, Dyspnea
- Keywords
- Pulmonary Disease, Chronic Obstructive, Family Practice, Spirometry, Decision Support Systems, Feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Boehringer Ingelheim, The Netherlands Asthma Foundation
- Study start
- Jan 2003
- Study completion
- Aug 2006
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GP practices with a Windows supported electronic Patient Journal System (PJS) in a certain postal region in the Netherlands.
Key exclusion criteria (2 listed)
- GP practices without a Windows supported PJS
- Practices outside a certain postcode region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expert support for interpretation of spirometry | Procedure or surgery | – |
Primary outcome
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
2 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
- Background: PubMed 15526814Chavannes 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.
- Background: PubMed 14514938Schermer 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.
- Derived from this study: PubMed 19649513Poels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris van Weel, Prof principal investigator
Radboud University Nijmegen Medical Centre, Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expert support for interpretation of spirometry in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131157, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2007.