Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 7:48 PM
Study NCT ID:
NCT02413957
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medication Reconciliation in Comparison to an Extensive Medication Safety Check
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059065', 'term': 'Medication Reconciliation'}, {'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D008508', 'term': 'Medication Errors'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019300', 'term': 'Medical Errors'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D008509', 'term': 'Medication Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of adverse drug events', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy', 'timeFrame': '1 year', 'description': 'Severity scale for medication related problems: minor, significative, major, critical, catastrophic'}, {'measure': 'Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy', 'timeFrame': '1 year', 'description': 'Severity scale for discrepancies: minor, significative, major, critical, catastrophic'}, {'measure': 'number of medication related problems', 'timeFrame': '1 year'}, {'measure': 'number of discrepancies', 'timeFrame': '1 year'}, {'measure': 'duration of taking the best possible medication history', 'timeFrame': '1 year', 'description': 'The duration is measured in minutes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Elderly Patients', 'Medication Safety', 'Pharmaceutical Care', 'Medication Reconciliation'], 'conditions': ['Elderly', 'Adverse Drug Event']}, 'referencesModule': {'references': [{'pmid': '24867348', 'type': 'BACKGROUND', 'citation': 'Franzen K, Lenssen R, Jaehde U, Eisert A. [Medication Reconciliation-theory and practice]. Ther Umsch. 2014 Jun;71(6):335-42. doi: 10.1024/0040-5930/a000521. German.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient 65 years and older\n* written informed consent patient or the legal representative\n* existing medication therapy at hospitalization\n* admission to one of the project wards via emergency department (non elective)\n\nExclusion Criteria:\n\n\\- patients included in the study previously'}, 'identificationModule': {'nctId': 'NCT02413957', 'briefTitle': 'Medication Reconciliation in Comparison to an Extensive Medication Safety Check', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Pilot Project to Investigate the Influence of Medication Reconciliation and an Extensive Medication Safety Check on the Number of Adverse Drug Events in the Elderly', 'orgStudyIdInfo': {'id': '14178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Controll-Group', 'description': 'Patient randomized to the Control-Group will receive the traditional care by physician and nurse on the ward.'}, {'type': 'EXPERIMENTAL', 'label': 'MedRec-Group', 'description': 'Patient randomized to the MedRec-Group will receive the traditional care by physician and nurse on the ward and additional pharmacist led medication reconciliation.', 'interventionNames': ['Other: Medication Reconciliation']}, {'type': 'EXPERIMENTAL', 'label': 'AMTS-Group', 'description': 'Patient randomized to the AMTS-Group will receive the traditional care by physician and nurse on the ward and additional pharmaceutical care by a pharmacist.', 'interventionNames': ['Other: Pharmaceutical Care']}], 'interventions': [{'name': 'Medication Reconciliation', 'type': 'OTHER', 'description': 'Pharmacist take the best possible medication history (BPMH), comparison of the BPMH with the admission order (AMO), clarify and solve al discrepancies between the BPMH and the AMO.', 'armGroupLabels': ['MedRec-Group']}, {'name': 'Pharmaceutical Care', 'type': 'OTHER', 'description': 'Checking medication under safety considerations (medication at admission, during hospital stay, at discharge); recommendations for inappropriate medication (e.g. contraindications or interactions) or medication related problems. Pharmaceutical care includes Medication Reconciliation.', 'armGroupLabels': ['AMTS-Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ärztliche Zentrum für Qualität in der Medizin', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Bonn - Institut für Patientensicherheit', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}