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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: March 20, 2007
Last updated: January 3, 2014
Last verified: September 2008

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 [ Designated as safety issue: No ]
  • Knowledge of drug efficacy and side effects of each drug [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comprehension of information contained in the drug facts box and rating of the usability of the drug information [ Designated as safety issue: No ]

Estimated Enrollment: 200
Detailed Description:



  • 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.


  • 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.


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


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


  • Not specified


  • Not specified
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450931

Sponsors and Collaborators
White River Junction VAMC
National Cancer Institute (NCI)
Principal Investigator: Steven Woloshin, MD, MS White River Junction VAMC
Investigator: Harold Bae White River Junction VAMC
  More Information

ClinicalTrials.gov Identifier: NCT00450931     History of Changes
Obsolete Identifiers: NCT00386932
Other Study ID Numbers: CDR0000513888  VAMC-WRJ-15879  DMS-15879 
Study First Received: March 20, 2007
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 27, 2016