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
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450931
First received: March 20, 2007
Last updated: January 3, 2014
Last verified: September 2008

March 20, 2007
January 3, 2014
Not Provided
Not Provided
  • 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 ]
Comparison of knowledge and perception about two drugs for the same indication as assessed by a self-reported questionnaire that asks questions about drug efficacy, which drug has more side effects, and which drug is the overall better drug
Complete list of historical versions of study NCT00450931 on ClinicalTrials.gov Archive Site
Comprehension of information contained in the drug facts box and rating of the usability of the drug information [ Designated as safety issue: No ]
  • Knowledge of drug efficacy and side effects of each drug
  • Perceptions of drug efficacy and side effects of each drug
  • Consumer satisfaction with the drug information provided (e.g., how easy is it to find the information, ease of understanding and use)
Not Provided
Not Provided
 
Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information
Helping Patients and Physicians Make Sense of Medical Data

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.

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.

Interventional
Not Provided
Allocation: Randomized
Health Status Unknown
  • Other: counseling intervention
  • Other: educational intervention
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00450931
CDR0000513888, VAMC-WRJ-15879, DMS-15879
Not Provided
Not Provided
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
National Cancer Institute (NCI)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP