The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

White River Junction Veterans Affairs Medical Center

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Other: Standard Brief Summary; Other: Drug Facts Box

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT00753857

DMS-15879-2

NCT00386932

Details and patient eligibility

About

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 short drug summary in helping patients and doctors understand medical information.

Full description

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 2 intervention arms.

• 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, perceptions of drug efficacy and side effects of each drug
• Comprehension of information contained in the drug facts box

Enrollment: 260 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 35-70 year old in household selected by random digit dialing

Exclusion criteria

• Non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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260 participants in 2 patient groups

1

Experimental group

Description:

Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages.

Treatment:

Other: Drug Facts Box

2

Active Comparator group

Description:

Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary)

Treatment:

Other: Standard Brief Summary