Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 3:55 PM
Study NCT ID:
NCT00915304
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evidence-Based Medicine Electronic Decision Support Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-17', 'studyFirstSubmitDate': '2009-06-05', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of reminders triggered (in relation to the number of eligible patients, Ri/Ni) during repeated Virtual Health Checks (VHCs)', 'timeFrame': 'Follow-up time max one and half year', 'description': 'VHC will be performed once a week for the whole study population, beginning at baseline and before randomisation. The main outcome measure is Ri/Ni at follow-up time after commencement of the study where Ri is the total number of reminders triggered by the patient record data in intervention and in control group at the time of analysis, and Ni is the total number of patients.'}], 'secondaryOutcomes': [{'measure': 'Specific clinical measures compared to an intervention and a control group', 'description': 'Clinical measures as mean values of laboratory parameters, for example a mean level of HbA1c, a mean level of total cholesterol.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical Decision Support System', 'Automatic reminder', 'Primary care', 'Evidence-Based Medicine'], 'conditions': ['Decision Support Systems, Clinical']}, 'referencesModule': {'references': [{'pmid': '24444113', 'type': 'DERIVED', 'citation': 'Kortteisto T, Raitanen J, Komulainen J, Kunnamo I, Makela M, Rissanen P, Kaila M; EBMeDS (Evidence-Based Medicine electronic Decision Support) Study Group. Patient-specific computer-based decision support in primary healthcare--a randomized trial. Implement Sci. 2014 Jan 20;9:15. doi: 10.1186/1748-5908-9-15.'}], 'seeAlsoLinks': [{'url': 'http://www.ebmeds.org', 'label': 'Click here for more information about this study and EDMeDS'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze the effect of the Evidence-Based Medicine electronic Decision Support (EBMeDS) automatic reminders in primary health care.\n\nHypothesis (1)is that in the intervention group the total number of EBMeDS reminders will decrease compared to the control group.\n\nHypothesis (2) is that in the intervention group the quality measures will increase faster compared to the control group at follow-up time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All residents of Sipoo who have patient ID number in the Mediatri electronic patient record system in Sipoo Health Centre\n\nExclusion Criteria:\n\n* Those residents who's occupational health care is produced by Sipoo Health Centre"}, 'identificationModule': {'nctId': 'NCT00915304', 'acronym': 'EBMeDS', 'briefTitle': 'Evidence-Based Medicine Electronic Decision Support Study', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'Patient Specific Automatic Reminders in Primary Care - the EBMeDS Randomised Trial', 'orgStudyIdInfo': {'id': 'EBMeDS-40344-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'The EBMeDS reminders', 'type': 'BEHAVIORAL', 'description': 'Phase I: EBMeDS reminders specific to the visiting or caring patient and his/her clinical problem are generated when the practitioner uses the electronic patient record. During visits of intervention group patients the EBMeDS reminders will be shown on screen to the practitioner.\n\nPhase II: As phase I and in addition, results of the Virtual Health Check (VHC) of all the intervention group patients will be shown to the practitioners.Phase II will be fulfilled in Autumn 2010 and follow-up time will be about 3 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Tampere', 'state': 'Finland', 'country': 'Finland', 'facility': 'University of Tampere; School of Health Sciences', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Pekka Rissanen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tampere; School of Health Sciences'}, {'name': 'Tiina Kortteisto, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tampere; School of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Finnish Medical Society Duodecim', 'class': 'UNKNOWN'}, {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, {'name': 'Duodecim Medical Publications Ltd.', 'class': 'INDUSTRY'}, {'name': 'ProWellness Ltd.', 'class': 'UNKNOWN'}, {'name': 'The Finnish Funding Agency for Technology and Innovation (TEKES)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Tiina Kortteisto', 'investigatorAffiliation': 'Tampere University'}}}}