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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Helping Patients and Physicians Make Sense of Medical Data

Conditions
-----------------
Health Status Unknown

Intervention / Treatment
-----------------
* Other: counseling intervention
* Other: educational intervention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: counseling intervention|nan|
|Other: educational intervention|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of two drugs for the same indication |  |  | 
| Knowledge of drug efficacy and side effects of each drug |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension of information contained in the drug facts box and rating of the usability of the drug information |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health status unknown