Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-26 @ 9:56 AM
Study NCT ID:
NCT00140504
Status:
COMPLETED
Last Update Posted:
2013-02-26
First Post:
2005-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Adverse Drug Events With PatientSite
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-24', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To prevent adverse drug events with PatientSite.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Improve patient satisfaction', 'timeFrame': '3 years'}, {'measure': 'better utilization of services', 'timeFrame': '3 years'}, {'measure': 'improve patient-clinician communication', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adverse drug event', 'Patient safety', 'Internet portal', 'PatientSite', 'Preventive health', 'Primary care'], 'conditions': ['Adverse Drug Event']}, 'referencesModule': {'references': [{'pmid': '23965840', 'type': 'DERIVED', 'citation': 'Weingart SN, Carbo A, Tess A, Chiappetta L, Tutkus S, Morway L, Toth M, Davis RB, Phillips RS, Bates DW. Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. J Patient Saf. 2013 Sep;9(3):169-75. doi: 10.1097/PTS.0b013e31829e4b95.'}]}, 'descriptionModule': {'briefSummary': "This is a study to better understand the nature and extent of adverse drug events (ADEs), defined as injuries due to prescription medications, in primary care. We will study whether PatientSite (an internet-based communication program for patients and health care providers) can improve clinicians' ability to detect adverse drug events among primary care patients and to mitigate the consequences by sending electronic queries to patients after they receive new medication prescriptions.", 'detailedDescription': '* A drug safety module called MedCheck was developed for PatientSite. This allows physicians to query patients automatically 10 days after they receive a new prescription asking them questions about their new prescription. In this study new enhancements will be tested.\n* Participants will be assigned at random to the intervention group or control group. The intervention group will receive a single electronic PatientSite message asking them questions about the new prescription which is then forwarded to their physician. The control group will receive a generic message about medication safety.\n* To identify adverse drug events, a telephone survey and medical record review will be conducted of patients in the intervention group and controls.\n* This study will run for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\>18\n* Patients that receive a new prescription\n* Proficient in spoken and written english\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00140504', 'briefTitle': 'Preventing Adverse Drug Events With PatientSite', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Preventing Adverse Drug Events With PatientSite', 'orgStudyIdInfo': {'id': '05-061'}, 'secondaryIdInfos': [{'id': 'Weingart - K08HS11644'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MedCheck', 'description': 'Electronic medication safety queries via PatientSite portal', 'interventionNames': ['Other: Medcheck message']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'No electronic medication safety messages via PatientSite portal'}], 'interventions': [{'name': 'Medcheck message', 'type': 'OTHER', 'description': 'Participants selected at random will receive one email message asking them questions about their prescription which will be forwarded to their physician', 'armGroupLabels': ['MedCheck']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Saul N Weingart, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': 'Blue Cross Blue Shield', 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'VP for Quality Improvement and Patient Safety', 'investigatorFullName': 'Saul N. Weingart, MD, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}