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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT00753857
First received: September 16, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
 Other: Drug Facts Box
Other: Standard Brief Summary
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

Further study details as provided by White River Junction VAMC:

Primary Outcome Measures:
  • Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events [ Time Frame: Immediate return of patient survey ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comprehension of information contained in the drug facts box [ Time Frame: Immediate return of patient survey ] [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: October 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753857

Locations
United States, Vermont
VA Medical Center
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
White River Junction VAMC
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)
  More Information

No publications provided

Responsible Party: Lisa Schwartz, VA Outcomes Group
ClinicalTrials.gov Identifier: NCT00753857     History of Changes
Other Study ID Numbers: DMS-15879-2
Study First Received: September 16, 2008
Last Updated: September 16, 2008
Health Authority: United States: Federal Government

Keywords provided by White River Junction VAMC:
risk communication
probability sample by random digit dialing

ClinicalTrials.gov processed this record on May 23, 2013