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

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:

NCT00950157

First received: July 30, 2009

Last updated: June 4, 2010

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 30, 2009

Last Updated Date

June 4, 2010

Start Date ^ICMJE

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes [ Time Frame: 0 weeks (assessed during intervention) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00950157 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Strength of opinion [ Time Frame: 0 weeks (assessed during intervention) ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)

Condition ^ICMJE

Risk Communication

Intervention ^ICMJE

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.

Study Arm (s)

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.

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

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

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

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2944

Completion Date

September 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00950157

Other Study ID Numbers ^ICMJE

16785

Has Data Monitoring Committee

Responsible Party

Lisa M. Schwartz, MD, MS, White River Junction VAMC

Study Sponsor ^ICMJE

White River Junction VAMC

Collaborators ^ICMJE

Attorney General Prescriber and Consumer Education Grant Program

Investigators ^ICMJE

Principal Investigator:	Lisa M Schwartz, MD, MS	White River Junction VAMC
Principal Investigator:	Steven Woloshin, MD, MS	White River Junction VAMC

Information Provided By

White River Junction VAMC

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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