The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

Study Overview
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Brief Summary
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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 short drug summary in helping patients and doctors understand medical information.

Detailed Description
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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 2 intervention arms. 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, perceptions of drug efficacy and side effects of each drug Comprehension of information contained in the drug facts box

Official Title
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The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

Conditions
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Healthy

Intervention / Treatment
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* Other: Drug Facts Box
* Other: Standard Brief Summary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 35-70 year old in household selected by random digit dialing Exclusion Criteria: Non-English speaking

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages. | Other: Drug Facts Box<br>* Educational intervention of 1 page summary of drug efficacy and side effects<br>|
| Active Comparator: 2<br>Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary) | Other: Standard Brief Summary<br>* Ads consisted of the standard second page called the brief summary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events |  | Immediate return of patient survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension of information contained in the drug facts box |  | Immediate return of patient survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk communication, probability sample by random digit dialing