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

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ClinicalTrials.gov Identifier: NCT00753857
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : September 17, 2008
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Healthy Other: Drug Facts Box Other: Standard Brief Summary Phase 3

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  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
Study Start Date : October 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Comprehension of information contained in the drug facts box [ Time Frame: Immediate return of patient survey ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753857


Locations
United States, Vermont
VA Medical Center
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
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)

Responsible Party: Lisa Schwartz, VA Outcomes Group
ClinicalTrials.gov Identifier: NCT00753857     History of Changes
Other Study ID Numbers: DMS-15879-2
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: September 17, 2008
Last Verified: September 2008

Keywords provided by White River Junction Veterans Affairs Medical Center:
risk communication
probability sample by random digit dialing