Testing the Effect of a Caution for Drugs Approved on Sur... | NCT00950157

NCT00950157

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Attorney General Consumer & Prescriber Education Grant	OTHER

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Measure	Description	Time Frame
Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes		0 weeks (assessed during intervention)

Secondary Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21911629	Derived	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.