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

NCT00950157 | Completed

• 1 other identifier: 16785
• Study Type: interventional
• Target: 2,944
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Risk Communication

Outcome Measures

Primary Outcomes (1)

• Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes

  0 weeks (assessed during intervention)

Secondary Outcomes (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

  0 weeks (assessed during intervention)

Study Arms (3)

Directive "open question" statement

EXPERIMENTAL

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

Non-directive open question statement

EXPERIMENTAL

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

No open question statement

EXPERIMENTAL

Survey only describes the surrogate outcome of the drug.

Other: Presentation of information on approval based on a surrogate outcome and levels of caution

Interventions

Presentation of information on approval based on a surrogate outcome and levels of caution OTHER

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.

Directive "open question" statement; No open question statement; Non-directive open question statement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead
• Attorney General Consumer & Prescriber Education Grant: collaborator

Related Publications (1)

• 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.

  PMID: 21911629 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 7, 2010

Record last verified: 2011-06