Testing the Effect of a Warning About New Drugs

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

Study Overview

• Status: Completed
• Conditions: Risk Communication
• Intervention / Treatment: Other: Presentation of information about drug approval and level of warning

• Study Type: Interventional
• Enrollment (Actual): 2944
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hypothetical choice of old (vs. newer) drug	0 weeks (assessed during intervention)

Secondary Outcome Measures

Outcome Measure	Time Frame
Comprehension of the drug warning and drug information	0 weeks (assessed during intervention)

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Collaborators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): July 31, 2009

Study Record Updates

• Last Update Posted (Estimate): April 9, 2010
• Last Update Submitted That Met QC Criteria: April 8, 2010
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 16784