NCT00450931

Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information

Helping Patients and Physicians Make Sense of Medical Data

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: White River Junction Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Health Status Unknown

Interventions

Type	Name	Description
OTHER	counseling intervention
OTHER	educational intervention

Timeline

• First posted: 2007-03-22
• Last updated: 2014-01-06