Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 8:14 AM
Study NCT ID:
NCT02345434
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ajs2102@columbia.edu', 'phone': '212 305 7084', 'title': 'Adam Sacarny', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber', 'otherNumAtRisk': 758, 'otherNumAffected': 0, 'seriousNumAtRisk': 758, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.", 'otherNumAtRisk': 760, 'otherNumAffected': 0, 'seriousNumAtRisk': 760, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}, {'value': '760', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'id': 'OG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."}], 'classes': [{'categories': [{'measurements': [{'value': '461.1', 'spread': '443.9', 'groupId': 'OG000'}, {'value': '450.0', 'spread': '450.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.53', 'ciLowerLimit': '-6.35', 'ciUpperLimit': '13.4', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 months', 'description': 'The prescribing of schedule II controlled substances over the 3 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of schedule II controlled substances attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.', 'unitOfMeasure': '30-day equivalent prescription fills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}, {'value': '760', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'id': 'OG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."}], 'classes': [{'categories': [{'measurements': [{'value': '155.5', 'spread': '148.8', 'groupId': 'OG000'}, {'value': '151.1', 'spread': '150.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-3.68', 'ciUpperLimit': '2.1', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 month', 'unitOfMeasure': '30-day equivalent prescription fills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'id': 'OG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."}], 'timeFrame': '6 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure not collected for study'}, {'type': 'SECONDARY', 'title': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'id': 'OG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."}], 'timeFrame': '9 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure not collected for study'}, {'type': 'SECONDARY', 'title': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'id': 'OG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure not collected for study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'id': 'FG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '763'}, {'groupId': 'FG001', 'numSubjects': '762'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '758'}, {'groupId': 'FG001', 'numSubjects': '760'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Deceased (excluded from intervention and analysis)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'There was no recruitment in the traditional sense. High prescribers of Schedule II controlled substances were identified in Medicare administrative data using a Tukey outlier method.', 'preAssignmentDetails': 'Seven of the identified outliers had died by the time of the study and were excluded from the intervention and later analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Informative Letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'id': 'BG001', 'title': 'Informative Letter', 'description': "This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)\n\nInformative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'unitOfMeasure': 'years', 'populationDescription': 'Data for Baseline Measures were not collected'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'populationDescription': 'Data for Baseline Measures were not collected'}, {'title': 'Race and Ethnicity Not Collected', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'This baseline measure data was not collected'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1525}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2014-10-06', 'resultsFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2015-01-19', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-11', 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'timeFrame': '3 months', 'description': 'The prescribing of schedule II controlled substances over the 3 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of schedule II controlled substances attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.'}], 'secondaryOutcomes': [{'measure': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'timeFrame': '1 month'}, {'measure': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'timeFrame': '6 months'}, {'measure': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'timeFrame': '9 months'}, {'measure': '30-day Equivalent Prescribing of Schedule II Controlled Substances', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Economics', 'Fraud', 'Delivery of Health Care', 'Health Expenditures', 'Centers for Medicare and Medicaid Services (U.S.)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.socialscienceregistry.org/trials/525', 'label': 'American Economic Association Randomized Controlled Trials Registry Entry'}]}, 'descriptionModule': {'briefSummary': 'Fraud and waste is estimated to cost the American health care system nearly $200 billion each year, and the public Medicare and Medicaid programs about $60 billion each year. This study will evaluate a new method for fighting fraud: mailing informative letters to outlier providers to notify them of their aberrant behavior. These letters are targeted at high prescribers of schedule II controlled substances in Medicare Part D. The investigators will look at the effects of these letters on the behavior of providers and their patients. These effects are of substantial policy interest as they suggest how to best design anti-fraud policies. They are also of academic interest, shedding light on the behavior of physicians and their patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outlier with respect to the count of schedule II prescription drug events relative to peer group of prescribers in two of the three years 2011, 2012, and 2013\n* Outlier with respect to the 30-day equivalent prescriptions of schedule II substances relative to peer group of prescribers in two of the three years 2011, 2012, and 2013\n\nExclusion Criteria:\n\n\\- Deceased'}, 'identificationModule': {'nctId': 'NCT02345434', 'briefTitle': 'The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances', 'organization': {'class': 'OTHER', 'fullName': 'Abdul Latif Jameel Poverty Action Lab'}, 'officialTitle': 'The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances', 'orgStudyIdInfo': {'id': 'JPAL-LETTERS-SII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No informative letter', 'description': 'This is the control arm and it involves no contact with the prescriber'}, {'type': 'EXPERIMENTAL', 'label': 'Informative letter', 'description': 'This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)', 'interventionNames': ['Other: Informative letter']}], 'interventions': [{'name': 'Informative letter', 'type': 'OTHER', 'otherNames': ['Comparative billing report', 'Peer activity report'], 'description': "The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.", 'armGroupLabels': ['Informative letter']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amy Finkelstein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Institute of Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abdul Latif Jameel Poverty Action Lab', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Medicare and Medicaid Services', 'class': 'FED'}, {'name': 'General Services Administration (GSA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}