Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-31 @ 9:35 AM
Study NCT ID:
NCT00950157
Status:
COMPLETED
Last Update Posted:
2010-06-07
First Post:
2009-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2944}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-04', 'studyFirstSubmitDate': '2009-07-30', 'studyFirstSubmitQcDate': '2009-07-30', 'lastUpdatePostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes', 'timeFrame': '0 weeks (assessed during intervention)'}], 'secondaryOutcomes': [{'measure': "Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes", 'timeFrame': '0 weeks (assessed during intervention)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Risk Communication']}, 'referencesModule': {'references': [{'pmid': '21911629', 'type': 'DERIVED', 'citation': 'Schwartz LM, Woloshin S. Communicating uncertainties about prescription drugs to the public: a national randomized trial. Arch Intern Med. 2011 Sep 12;171(16):1463-8. doi: 10.1001/archinternmed.2011.396.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether cautions about the evidence, in this case an "open questions" statement, decreases enthusiasm for drugs that are approved on surrogate outcomes (compared to patient outcomes) alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).'}, 'identificationModule': {'nctId': 'NCT00950157', 'briefTitle': 'Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone', 'organization': {'class': 'FED', 'fullName': 'White River Junction Veterans Affairs Medical Center'}, 'officialTitle': 'Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone', 'orgStudyIdInfo': {'id': '16785'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Directive "open question" statement', 'description': 'Survey describes the surrogate outcome of the drug along with a directive warning (i.e., stating the issue and why it matters) for drugs shown to improve surrogate outcomes.\n\nThis directive warning mentions that it is not known whether the drug will help patients feel better, and that readers should ask their doctor if there is an available drug shown to improve patient outcomes.', 'interventionNames': ['Other: Presentation of information on approval based on a surrogate outcome and levels of caution']}, {'type': 'EXPERIMENTAL', 'label': 'Non-directive open question statement', 'description': 'Survey describes the surrogate outcome of the drug along with a non-directive warning (i.e., stating the issue only) for drugs shown to improve surrogate outcomes.\n\nThis non-directive warning mentions only that it is not known whether the drug will help patients feel better.', 'interventionNames': ['Other: Presentation of information on approval based on a surrogate outcome and levels of caution']}, {'type': 'EXPERIMENTAL', 'label': 'No open question statement', 'description': 'Survey only describes the surrogate outcome of the drug.', 'interventionNames': ['Other: Presentation of information on approval based on a surrogate outcome and levels of caution']}], 'interventions': [{'name': 'Presentation of information on approval based on a surrogate outcome and levels of caution', 'type': 'OTHER', 'description': 'Presentation of information that one drug is approved on a surrogate outcome only while another drug has clinical outcomes. Participants are randomized to 1 of 3 caution (e.g. open question") statements: no open question statement, non-directive open question statement or directive open question statement.', 'armGroupLabels': ['Directive "open question" statement', 'No open question statement', 'Non-directive open question statement']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lisa M Schwartz, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'White River Junction Veterans Affairs Medical Center'}, {'name': 'Steven Woloshin, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'White River Junction Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'White River Junction Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Attorney General Consumer & Prescriber Education Grant', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Lisa M. Schwartz, MD, MS', 'oldOrganization': 'White River Junction VAMC'}}}}