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

White River Junction Veterans Affairs Medical Center

Status: Unknown

Conditions: Health Status Unknown

Treatments: Other: educational intervention; Other: counseling intervention

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT00450931

VAMC-WRJ-15879

CDR0000513888

DMS-15879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• English-speaking adults
• Must be able to be chosen by Random Digit Dialing

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified