Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information
|ClinicalTrials.gov Identifier: NCT00450931|
Recruitment Status : Unknown
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 22, 2007
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Health Status Unknown||Other: counseling intervention Other: educational intervention||Not Applicable|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Official Title:||Helping Patients and Physicians Make Sense of Medical Data|
- Comparison of two drugs for the same indication
- Knowledge of drug efficacy and side effects of each drug
- Comprehension of information contained in the drug facts box and rating of the usability of the drug information
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450931
|Principal Investigator:||Steven Woloshin, MD, MS||White River Junction Veterans Affairs Medical Center|
|OverallOfficial:||Harold Bae||White River Junction Veterans Affairs Medical Center|