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

January 3, 2014 updated by: White River Junction Veterans Affairs Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison of two drugs for the same indication
Knowledge of drug efficacy and side effects of each drug

Secondary Outcome Measures

Outcome Measure
Comprehension of information contained in the drug facts box and rating of the usability of the drug information

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

White River Junction Veterans Affairs Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Steven Woloshin, MD, MS, White River Junction Veterans Affairs Medical Center
  • Harold Bae, White River Junction Veterans Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDR0000513888
  • VAMC-WRJ-15879
  • DMS-15879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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