Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 10:08 AM
Study NCT ID:
NCT00131157
Status:
UNKNOWN
Last Update Posted:
2007-03-01
First Post:
2005-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Spirometry Expert Support in General Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 39}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2006-08'}, 'lastUpdateSubmitDate': '2007-02-28', 'studyFirstSubmitDate': '2005-08-16', 'studyFirstSubmitQcDate': '2005-08-16', 'lastUpdatePostDateStruct': {'date': '2007-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}, {'measure': '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'}], 'secondaryOutcomes': [{'measure': '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'}, {'measure': 'Study II: between-group difference in the proportion of ordered additional investigations and referrals by GPs'}]}, 'conditionsModule': {'keywords': ['Pulmonary Disease, Chronic Obstructive', 'Family Practice', 'Spirometry', 'Decision Support Systems', 'Feedback'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Asthma', 'Cough', 'Dyspnea']}, 'referencesModule': {'references': [{'pmid': '15526814', 'type': 'BACKGROUND', 'citation': "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': '14514938', 'type': 'BACKGROUND', 'citation': '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': '19649513', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GP practices with a Windows supported electronic Patient Journal System (PJS) in a certain postal region in the Netherlands.\n\nExclusion Criteria:\n\n* GP practices without a Windows supported PJS\n* Practices outside a certain postcode region'}, 'identificationModule': {'nctId': 'NCT00131157', 'briefTitle': 'Evaluation of Spirometry Expert Support in General Practice', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'A Randomized-Controlled Evaluation of Spirometry Expert Support in General Practice', 'orgStudyIdInfo': {'id': '95500'}, 'secondaryIdInfos': [{'id': 'NAF-3.4.02.18'}, {'id': 'ZonMW 920-03-265'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'expert support for interpretation of spirometry', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Chris van Weel, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Nijmegen Medical Centre, Nijmegen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': 'The Netherlands Asthma Foundation', 'class': 'OTHER'}]}}}