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Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone

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ClinicalTrials.gov Identifier: NCT00950157
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : June 7, 2010
Sponsor:
Collaborator:
Attorney General Consumer & Prescriber Education Grant
Information provided by:
White River Junction Veterans Affairs Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Risk Communication Other: Presentation of information on approval based on a surrogate outcome and levels of caution Not Applicable

Study Design
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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 Caution for Drugs Approved on Surrogate Outcomes Alone
Study Start Date : August 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Directive "open question" statement

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.

This 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.

 Other: Presentation of information on approval based on a surrogate outcome and levels of caution
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.
Experimental: Non-directive open question statement

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.

This non-directive warning mentions only that it is not known whether the drug will help patients feel better.

 Other: Presentation of information on approval based on a surrogate outcome and levels of caution
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.
Experimental: No open question statement
Survey only describes the surrogate outcome of the drug.
 Other: Presentation of information on approval based on a surrogate outcome and levels of caution
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.


Outcome Measures
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Primary Outcome Measures :
  1. Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes [ Time Frame: 0 weeks (assessed during intervention) ]

Secondary Outcome Measures :
  1. Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes [ Time Frame: 0 weeks (assessed during intervention) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).
Contacts and Locations
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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): NCT00950157


Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
Attorney General Consumer & Prescriber Education Grant
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lisa M. Schwartz, MD, MS, White River Junction VAMC
ClinicalTrials.gov Identifier: NCT00950157    
Other Study ID Numbers: 16785
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2011