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Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450931
First Posted: March 22, 2007
Last Update Posted: January 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  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 standard brief summary in helping patients and doctors understand medical information.


Condition Intervention
Health Status Unknown Other: counseling intervention Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Helping Patients and Physicians Make Sense of Medical Data

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of two drugs for the same indication
  • Knowledge of drug efficacy and side effects of each drug

Secondary Outcome Measures:
  • Comprehension of information contained in the drug facts box and rating of the usability of the drug information

Estimated Enrollment: 200
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • Comprehension of information contained in the drug facts box and rating of the usability of the drug information.

OUTLINE: 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 4 intervention arms.

  • Arm I: Participants receive 2 advertisements for a drug to treat heartburn with a drug facts second page.
  • Arm II: Participants receive 2 advertisements as in arm I for drugs to treat heatburn with the standard second page (i.e., brief summary).

Participants in both arms complete the self-reported questionnaire mailed with the advertisement intervention.

PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

DISEASE CHARACTERISTICS:

  • English-speaking adults
  • Must be able to be chosen by Random Digit Dialing

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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): NCT00450931


Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Woloshin, MD, MS White River Junction Veterans Affairs Medical Center
OverallOfficial: Harold Bae White River Junction Veterans Affairs Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00450931     History of Changes
Obsolete Identifiers: NCT00386932
Other Study ID Numbers: CDR0000513888
VAMC-WRJ-15879
DMS-15879
First Submitted: March 20, 2007
First Posted: March 22, 2007
Last Update Posted: January 6, 2014
Last Verified: September 2008

Keywords provided by National Cancer Institute (NCI):
health status unknown