Testing the Effect of a Warning About New Drugs

This study has been completed.
Sponsor:
Collaborator:
Attorney General Prescriber and Consumer Education Grant Program
Information provided by:
White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT00950131
First received: July 30, 2009
Last updated: April 8, 2010
Last verified: July 2009
  Purpose

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


Condition Intervention
Risk Communication
Other: Presentation of information about drug approval and level of warning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Testing the Effect of a Warning About New Drugs

Further study details as provided by White River Junction VAMC:

Primary Outcome Measures:
  • Hypothetical choice of old (vs. newer) drug [ Time Frame: 0 weeks (assessed during intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comprehension of the drug warning and drug information [ Time Frame: 0 weeks (assessed during intervention) ] [ Designated as safety issue: No ]

Enrollment: 2944
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950131

Sponsors and Collaborators
White River Junction VAMC
Attorney General Prescriber and Consumer Education Grant Program
Investigators
Principal Investigator: Lisa M Schwartz, MD, MS White River Junction VAMC
Principal Investigator: Steven Woloshin, MD, MS White River Junction VAMC
  More Information

No publications provided by White River Junction VAMC

Additional 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
Study First Received: July 30, 2009
Last Updated: April 8, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 30, 2014