Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-03 @ 2:42 PM
Study NCT ID:
NCT02467933
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Informative Letters on the Prescription and Receipt of Seroquel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5055}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-05', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day equivalent prescribing of Seroquel treatments', 'timeFrame': '9 months', 'description': 'The prescribing of Seroquel over the 9 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of Seroquel attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.'}], 'secondaryOutcomes': [{'measure': '30-day equivalent prescribing of Seroquel treatments', 'timeFrame': '3 months'}, {'measure': '30-day equivalent prescribing of Seroquel treatments', 'timeFrame': '6 months'}, {'measure': '30-day equivalent prescribing of Seroquel treatments', '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': {'availIpds': [{'id': '449', 'url': 'https://www.socialscienceregistry.org/trials/729', 'type': 'Study Protocol', 'comment': 'Study protocol archived on American Economic Association Social Science Registry page.'}, {'id': '448', 'url': 'https://www.socialscienceregistry.org/trials/729', 'type': 'Statistical Analysis Plan', 'comment': 'Pre-specified analysis plan archived on American Economic Association Social Science Registry page.\n\nFinal version prior to unblinding: Version 2.0 (March 5, 2016)'}], 'references': [{'pmid': '30073273', 'type': 'DERIVED', 'citation': 'Sacarny A, Barnett ML, Le J, Tetkoski F, Yokum D, Agrawal S. Effect of Peer Comparison Letters for High-Volume Primary Care Prescribers of Quetiapine in Older and Disabled Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):1003-1011. doi: 10.1001/jamapsychiatry.2018.1867.'}], 'seeAlsoLinks': [{'url': 'https://www.socialscienceregistry.org/trials/729', 'label': 'American Economic Association Randomized Controlled Trials Registry Entry'}]}, 'descriptionModule': {'briefSummary': 'Abusive prescribing exposes patients to unnecessary health risks and results in wasteful public expenditures. This study will evaluate an innovative approach to fighting abusive prescription: sending letters to suspected inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the investigators will assess the effect of the letters on prescribing of Seroquel, receipt of Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General care practitioner\n* Outlier with respect to the count of Seroquel prescription drug treatments relative to peer group of prescribers in 2013 and 2014\n* Outlier with respect to the count of Seroquel 30-day equivalent prescription drug treatments relative to peer group of prescribers in 2013 and 2014\n\nExclusion Criteria:\n\n* Deceased'}, 'identificationModule': {'nctId': 'NCT02467933', 'briefTitle': 'The Effect of Informative Letters on the Prescription and Receipt of Seroquel', 'organization': {'class': 'OTHER', 'fullName': 'Abdul Latif Jameel Poverty Action Lab'}, 'officialTitle': 'The Effect of Informative Letters on the Prescription and Receipt of Seroquel', 'orgStudyIdInfo': {'id': 'JPAL-LETTERS-SEROQUEL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo arm receives a placebo letter unrelated to Seroquel', 'interventionNames': ['Other: Placebo letter']}, {'type': 'EXPERIMENTAL', 'label': 'Informative Letter', 'description': 'The interventional arm prescribers receive an initial informative letter (called a comparative billing report or peer activity report) followed by 2 followup informative letters at approximately 3 month intervals.', 'interventionNames': ['Other: Initial Informative letter', 'Other: Followup Informative Letter']}], 'interventions': [{'name': 'Placebo letter', 'type': 'OTHER', 'description': 'The placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare', 'armGroupLabels': ['Placebo']}, {'name': 'Initial Informative letter', 'type': 'OTHER', 'description': "The intervention is a letter that describes the Seroquel 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']}, {'name': 'Followup Informative Letter', 'type': 'OTHER', 'description': 'The followup informative letter is identical to the initial informative letter except it provides an update on more recent prescribing rather than a description of earlier prescribing.', 'armGroupLabels': ['Informative Letter']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Adam Sacarny, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}