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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone

Further study details as provided by White River Junction VAMC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2944
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950157

Sponsors and Collaborators
White River Junction VAMC
Attorney General Prescriber and Consumer Education Grant Program
Investigators
Principal Investigator: Lisa M Schwartz, MD, MS White River Junction VAMC
Principal Investigator: Steven Woloshin, MD, MS White River Junction VAMC
  More Information

No publications provided by White River Junction VAMC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa M. Schwartz, MD, MS, White River Junction VAMC
ClinicalTrials.gov Identifier: NCT00950157     History of Changes
Other Study ID Numbers: 16785
Study First Received: July 30, 2009
Last Updated: June 4, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 29, 2014