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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Drug Facts Box; Other: Standard Brief Summary

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 Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages.	Other: Drug Facts Box; Educational intervention of 1 page summary of drug efficacy and side effects
Active Comparator: 2; Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary)	Other: Standard Brief Summary; Ads consisted of the standard second page called the brief summary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Comprehension of information contained in the drug facts box	Immediate return of patient survey

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven Woloshin, MD, MS, Dartmouth Medical School; VA Medical Center (WRJ); Principal Investigator: Lisa M Schwartz, MD, MS, Dartmouth Medical School, VA Medical Center (WRJ)

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: September 16, 2008
• First Submitted That Met QC Criteria: September 16, 2008
• First Posted (Estimate): September 17, 2008

Study Record Updates

• Last Update Posted (Estimate): September 17, 2008
• Last Update Submitted That Met QC Criteria: September 16, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: risk communication; probability sample by random digit dialing
• Other Study ID Numbers: DMS-15879-2; NCT00386932