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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Other: Drug Facts Box; Other: Standard Brief Summary

• Registration Number: NCT00753857
• Lead Sponsor: White River Junction Veterans Affairs Medical Center

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

Detailed 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

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-09
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-16
• Last Update Submitted: 2008-09-16
• Study First Posted: 2008-09-17
• Last Update Posted: 2008-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

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

Exclusion Criteria

• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Drug Facts Box	Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages.
2	Standard Brief Summary	Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary)

Primary Outcome Measures

Name	Time	Method
Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events	Immediate return of patient survey

Secondary Outcome Measures

Name	Time	Method
Comprehension of information contained in the drug facts box	Immediate return of patient survey

Trial Locations

Locations (1)

VA Medical Center; 🇺🇸 White River Junction, Vermont, United States