Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-28 @ 9:24 PM
Study NCT ID:
NCT05622903
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cash Benefits on Health Care Utilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-14', 'size': 176658, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-21T08:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3615}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergency department use', 'timeFrame': '10 months', 'description': 'Count of visits to the emergency department (ED) using the electronic health record'}], 'secondaryOutcomes': [{'measure': 'Behavioral health-related ED visit', 'timeFrame': '10 months', 'description': 'Visits to the ED with a behavioral health-related diagnosis code'}, {'measure': 'Substance use disorder-related ED visit', 'timeFrame': '10 months', 'description': 'Visits to the ED with a substance use disorder-related diagnosis code'}, {'measure': 'Potentially avoidable ED visit', 'timeFrame': '10 months', 'description': 'Visits to the ED that are potentially avoidable, categorized as avoidable according to the previously validated New York University algorithm'}, {'measure': 'ED visit resulting in admission to the hospital', 'timeFrame': '10 months', 'description': 'Visits to the ED that result in a hospitalization'}, {'measure': 'Outpatient service use', 'timeFrame': '10 months', 'description': 'Office visits and visits for other types of outpatient care such as imaging and procedures'}, {'measure': 'COVID vaccination', 'timeFrame': '10 months', 'description': 'Binary variable for having received at least one dose of any COVID vaccine by the end of the trial period'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '10 months', 'description': 'Continuous measure of diabetes, using the latest available reading or result during trial period'}, {'measure': 'Blood pressure', 'timeFrame': '10 months', 'description': 'Continuous measure of blood pressure, using the latest available reading or result during trial period'}, {'measure': 'Weight', 'timeFrame': '10 months', 'description': 'Continuous measure of weight, using the latest available reading or result during trial period'}, {'measure': 'Cholesterol', 'timeFrame': '10 months', 'description': 'Continuous measure of cholesterol, using the latest available reading or result during trial period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Care Utilization']}, 'descriptionModule': {'briefSummary': 'Using data from the Chelsea Eats program, we propose to study a randomized controlled trial in which the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months during the first two years of the COVID-19 pandemic. We will analyze the impact of the cash benefit on health care utilization and health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Resident of Chelsea, Massachusetts\n* Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income\n\nExclusion Criteria:\n\n* See inclusion criteria"}, 'identificationModule': {'nctId': 'NCT05622903', 'briefTitle': 'Effect of Cash Benefits on Health Care Utilization', 'organization': {'class': 'OTHER', 'fullName': 'Harvard Medical School (HMS and HSDM)'}, 'officialTitle': 'Effect of Cash Benefits on Health Care Utilization', 'orgStudyIdInfo': {'id': '2022P000093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Participants in the treatment group received up to $400 per month.', 'interventionNames': ['Other: Cash Benefit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in the control group did not receive monthly cash benefits.', 'interventionNames': ['Other: No Cash Benefit']}], 'interventions': [{'name': 'Cash Benefit', 'type': 'OTHER', 'otherNames': ['Basic Income', 'Debit Card'], 'description': 'Spending from the cards was not restricted to food but could be spent on anything and anywhere Visa was accepted. The debit cards were credited with the first payment on November 18th, 2020 and the second payment on December 18th, 2020. The program continued with monthly credits through August 2021.', 'armGroupLabels': ['Treatment Group']}, {'name': 'No Cash Benefit', 'type': 'OTHER', 'description': 'No monthly cash benefit.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sumit Agarwal, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital and Harvard Medical School"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Cambridge Health Alliance', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Sumit Agarwal', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}