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Testing the Effect of a Warning About New Drugs

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ClinicalTrials.gov Identifier: NCT00950131
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : April 9, 2010
Sponsor:
Collaborator:
Attorney General Consumer & Prescriber Education Grant
Information provided by:
White River Junction Veterans Affairs Medical Center

Brief Summary:
The purpose of this study is to test whether a new drug warning decreases enthusiasm for new drugs.

Condition or disease Intervention/treatment Phase
Risk Communication Other: Presentation of information about drug approval and level of warning Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2944 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Testing the Effect of a Warning About New Drugs
Study Start Date : August 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: Directive new drug warning

Survey contains information about when the drug was approved by the FDA (2009)and a directive warning (i.e., stating the issue and why it matters) for new drugs.

This directive warning mentions that serious drug side effects may emerge only after the drug is already on the market, and the reader should ask their doctor there is an available drug with a longer track record.

Other: Presentation of information about drug approval and level of warning
Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning
Experimental: Non-directive new drug warning

Survey contains information about when the drug was approved by the FDA (2009) and a non-directive warning (i.e., just stating the issue) for new drugs.

This non-directive warning mentions only that serious drug side effects may emerge only after the drug is already on the market.

Other: Presentation of information about drug approval and level of warning
Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning
Experimental: No new drug warning
Survey contains information about when the drug was approved by the FDA (2009) only.
Other: Presentation of information about drug approval and level of warning
Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning



Primary Outcome Measures :
  1. Hypothetical choice of old (vs. newer) drug [ Time Frame: 0 weeks (assessed during intervention) ]

Secondary Outcome Measures :
  1. Comprehension of the drug warning and drug information [ Time Frame: 0 weeks (assessed during intervention) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950131


Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
Attorney General Consumer & Prescriber Education Grant
Investigators
Principal Investigator: Lisa M Schwartz, MD, MS White River Junction Veterans Affairs Medical Center
Principal Investigator: Steven Woloshin, MD, MS White River Junction Veterans Affairs Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa M. Schwartz, MD, MS, White River Junction VAMC
ClinicalTrials.gov Identifier: NCT00950131     History of Changes
Other Study ID Numbers: 16784
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: July 2009