Health Status Unknown Clinical Trial
Official title:
Helping Patients and Physicians Make Sense of Medical Data
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
standard brief summary in helping patients and doctors understand medical information.
OBJECTIVES:
Primary
- 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.
Secondary
- Comprehension of information contained in the drug facts box and rating of the
usability of the drug information.
OUTLINE: 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 4 intervention arms.
- Arm I: Participants receive 2 advertisements for a drug to treat heartburn with a drug
facts second page.
- Arm II: Participants receive 2 advertisements as in arm I for drugs to treat heatburn
with the standard second page (i.e., brief summary).
Participants in both arms complete the self-reported questionnaire mailed with the
advertisement intervention.
PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.
;
Allocation: Randomized
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