The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT00753857
First received: September 16, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 16, 2008
September 16, 2008
October 2006
May 2007   (final data collection date for primary outcome measure)
Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events [ Time Frame: Immediate return of patient survey ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Comprehension of information contained in the drug facts box [ Time Frame: Immediate return of patient survey ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

RATIONALE:

The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.

PURPOSE:

This randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors understand medical information.

This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 2 intervention arms.

  • Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug, perceptions of drug efficacy and side effects of each drug
  • Comprehension of information contained in the drug facts box
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Healthy
  • Other: Drug Facts Box
    Educational intervention of 1 page summary of drug efficacy and side effects
  • Other: Standard Brief Summary
    Ads consisted of the standard second page called the brief summary
  • Experimental: 1
    Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages.
    Intervention: Other: Drug Facts Box
  • Active Comparator: 2
    Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary)
    Intervention: Other: Standard Brief Summary
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 35-70 year old in household selected by random digit dialing

Exclusion Criteria:

  • Non-English speaking
Both
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00753857
DMS-15879-2
No
Lisa Schwartz, VA Outcomes Group
White River Junction VAMC
National Cancer Institute (NCI)
Principal Investigator: Steven Woloshin, MD, MS Dartmouth Medical School; VA Medical Center (WRJ)
Principal Investigator: Lisa M Schwartz, MD, MS Dartmouth Medical School, VA Medical Center (WRJ)
White River Junction VAMC
September 2008

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