This trial is active, not recruiting.

Condition health status unknown
Treatments counseling intervention, educational intervention
Sponsor White River Junction VAMC
Collaborator National Cancer Institute (NCI)
Trial size 200 participants
Trial identifier NCT00450931, CDR0000513888, DMS-15879, NCT00386932, VAMC-WRJ-15879


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized

Primary Outcomes

Comparison of two drugs for the same indication
time frame:
Knowledge of drug efficacy and side effects of each drug
time frame:

Secondary Outcomes

Comprehension of information contained in the drug facts box and rating of the usability of the drug information
time frame:

Eligibility Criteria

Male or female participants from 35 years up to 70 years old.

DISEASE CHARACTERISTICS: - English-speaking adults - Must be able to be chosen by Random Digit Dialing PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - Not specified

Additional Information

Official title Helping Patients and Physicians Make Sense of Medical Data
Principal investigator Steven Woloshin, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).