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

Helping Patients and Physicians Make Sense of Medical Data

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00450931
Enrollment
200
Registered
2007-03-22
Start date
Unknown
Completion date
Unknown
Last updated
2014-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Status Unknown

Keywords

health status unknown

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.

Interventions

OTHERcounseling intervention
OTHEReducational intervention

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
White River Junction Veterans Affairs Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026