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

NCT ID: NCT00450931

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Health Status Unknown

Study Design

• Allocation Method: RANDOMIZED

Interventions

counseling intervention

Intervention Type: OTHER

educational intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role: lead

Principal Investigators

Steven Woloshin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

White River Junction Veterans Affairs Medical Center

Harold Bae

Role:

White River Junction Veterans Affairs Medical Center

Other Identifiers

VAMC-WRJ-15879

Identifier Type: -

Identifier Source: secondary_id

DMS-15879

Identifier Type: -

Identifier Source: secondary_id

CDR0000513888

Identifier Type: -

Identifier Source: org_study_id

NCT00386932

Identifier Type: -

Identifier Source: nct_alias