Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information - Full Text View

Sponsor:	White River Junction VAMC
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00450931

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:	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:

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

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
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

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

Sponsors and Collaborators

White River Junction VAMC

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Steven Woloshin, MD, MS	White River Junction VAMC
Investigator:	Harold Bae	White River Junction VAMC

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000513888, VAMC-WRJ-15879, DMS-15879
Study First Received:	March 20, 2007
Last Updated:	March 7, 2009
ClinicalTrials.gov Identifier:	NCT00450931 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

health status unknown

ClinicalTrials.gov processed this record on November 20, 2009