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

Not Applicable

• Conditions: Health Status Unknown

• Registration Number: NCT00450931
• Lead Sponsor: White River Junction Veterans Affairs Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-22
• Status Verified: 2008-09
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of two drugs for the same indication
Knowledge of drug efficacy and side effects of each drug

Secondary Outcome Measures

Name	Time	Method
Comprehension of information contained in the drug facts box and rating of the usability of the drug information