Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|