Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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 |
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 More Information
Additional Information:
No publications provided
| 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: | March 7, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
health status unknown |
ClinicalTrials.gov processed this record on May 21, 2013