Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-09 @ 5:01 AM
Study NCT ID:
NCT03475550
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2018-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Side Effects in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported benefit from the drug', 'timeFrame': '3 weeks after the physician visit', 'description': 'Visual Analog Scale of reported benefit from the drug (0-10)'}, {'measure': 'Number of side effects reported from the drug', 'timeFrame': '3 weeks after the physician visit', 'description': 'Checklist of reported side effects from the drug'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Gastrointestinal Disorders']}, 'descriptionModule': {'briefSummary': 'This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).', 'detailedDescription': "The purpose of this study is to evaluate patients' reported experiences with regularly prescribed medications. No medications are prescribed as part of this study. Rather, if a patient are prescribed a new medication during their regularly scheduled clinic visit, he/she may be eligible to participate.\n\nPatients who agree to participate and who are prescribed a medication in clinic will be contacted by telephone or email 3 weeks after their appointment to evaluate positive and negative experiences with the medication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is seen in the Division of Gastroenterology at BIDMC\n* Patient is prescribed a medication for the treatment of functional gastrointestinal disorders that has not previously been tried by the patient\n\nExclusion Criteria:\n\n* Patient is not seen in the Division of Gastroenterology at BIDMC\n* Patient has previously taken the drug that is prescribed'}, 'identificationModule': {'nctId': 'NCT03475550', 'briefTitle': 'Managing Side Effects in Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders', 'orgStudyIdInfo': {'id': '2017P000179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care 1', 'description': 'Patients will receive one of 2 different descriptions of the medication\'s risks and benefits. Both descriptions meet ethical standards of transparency and respect for person and are commonly used but have never been compared. "Standard of Care 1" includes more details than "Standard of Care 2".', 'interventionNames': ['Other: Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care 2', 'description': 'Patients will receive one of 2 different descriptions of the medication\'s risks and benefits. Both descriptions meet ethical standards of transparency and respect for person and are commonly used but have never been compared. "Standard of Care 2" includes fewer details than "Standard of Care 1".', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Standard of Care', 'type': 'OTHER', 'description': 'The intervention involves clinician-provided information to patients receiving a new medication as part of their standard medical care. Intervention 1 includes more detailed information compared to Intervention 2.', 'armGroupLabels': ['Standard of care 1', 'Standard of care 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Anthony Lembo', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}