Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-29 @ 1:53 PM
Study NCT ID:
NCT02409251
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-31', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention)', 'timeFrame': 'Pre- and post-intervention (both 12 months)', 'description': 'Number of ANA tests divided by the number of new patients'}, {'measure': 'Change from baseline (pre-intervention) % of positive ANA tests at 12 months (post-intervention)', 'timeFrame': 'Pre- and post-intervention (both 12 months)', 'description': "Percentage of ANA tests reported as positive by the local laboratory. ANA tests reported as 'weakly positive' are regarded as negative."}, {'measure': 'Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention)', 'timeFrame': 'Pre- and post-intervention (both 12 months)', 'description': 'Percentage of patients with ≥1 ANA test in 12 months (pre- or post-intervention period)'}, {'measure': 'Change from baseline (pre-intervention) % of ANA associated diagnoses at 12 months (post-intervention)', 'timeFrame': 'Pre- and post-intervention (both 12 months)', 'description': 'Percentage of patients, in which an ANA is done during the study period, with final diagnosis of SLE, SSc, PM/DM, MCTD or SS'}, {'measure': 'Change from baseline (pre-intervention) APR variation between rheumatologists at 12 months (post-intervention)', 'timeFrame': 'Pre- and post-intervention (both 12 months)', 'description': 'Standard deviation around the mean APR, calculated from the APRs of the individual rheumatologists'}, {'measure': 'Change from baseline (pre-intervention) reaching the of target APR at 12 months (post-intervention)', 'timeFrame': 'Pre- and post-intervention (both 12 months)', 'description': 'Difference (percentage) between the actual APR and the target-APR defined during the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antinuclear antibody (ANA)', 'Overuse', 'Rheumatologists', 'Quality of care'], 'conditions': ['Rheumatic Diseases']}, 'referencesModule': {'references': [{'pmid': '26414008', 'type': 'DERIVED', 'citation': 'Lesuis N, Hulscher ME, Piek E, Demirel H, van der Laan-Baalbergen N, Meek I, van Vollenhoven RF, den Broeder AA. Choosing Wisely in Daily Practice: An Intervention Study on Antinuclear Antibody Testing by Rheumatologists. Arthritis Care Res (Hoboken). 2016 Apr;68(4):562-9. doi: 10.1002/acr.22725.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of a simple intervention (a combination of education and feedback) on Antinuclear Antibody (ANA) testing.\n\nThis aim was chosen because of the known overuse of many laboratory tests, of which ANA testing is one. As overuse of ANA tests can have negative consequences (both for patients and society), the investigators designed an intervention to see how this would influence Antinuclear Antibody testing by rheumatologists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria rheumatologists:\n\n* rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre\n\nExclusion Criteria rheumatologists:\n\n* rheumatologists not working the full study period (pre- and post-intervention) at a participating centre\n* rheumatologists not giving their consent to participate\n\nInclusion Criteria patients - all patients with an ANA test requested by an included rheumatologist during the study period\n\nExclusion Criteria patients\n\n\\- patients with an ANA test requested during a clinical admission'}, 'identificationModule': {'nctId': 'NCT02409251', 'briefTitle': 'Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints', 'organization': {'class': 'OTHER', 'fullName': 'Sint Maartenskliniek'}, 'officialTitle': 'Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints', 'orgStudyIdInfo': {'id': 'RR-103-ANA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education and feedback', 'description': 'The intervention consisted of a one-hour, small group educational session. During this session information on rational ANA testing was provided and feedback on current ANA testing was provided to the rheumatologists. A booster session with the same components was held 6 months after the first session.', 'interventionNames': ['Behavioral: Education and feedback']}], 'interventions': [{'name': 'Education and feedback', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Education and feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 GM', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Sint Maartenskliniek', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Woerden', 'country': 'Netherlands', 'facility': 'Maartenskliniek Woerden', 'geoPoint': {'lat': 52.085, 'lon': 4.88333}}], 'overallOfficials': [{'name': 'Ronald van Vollenhoven, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Marlies Hulscher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scientific Institute for Quality of Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands'}, {'name': 'Alfons den Broeder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sint Maartenskliniek, Nijmegen, the Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sint Maartenskliniek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nienke Lesuis', 'investigatorAffiliation': 'Sint Maartenskliniek'}}}}