Evaluating Effectiveness of Educational Intervention to Help Physicians Address Inappropriate Patient Requests for Direct-to-Consumer Advertised Prescription Medications

June 5, 2009 updated by: American Medical Association

Sound Prescribing Study - Assessing the Impact of Pharmaceutical Marketing and Promotional Practices on Physician Prescribing

The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since changes in FDA regulation direct-to-consumer advertising (DTCA), pharmaceutical companies have expended increasing resources to market their products to the public. This has led to increased awareness of diseases and potential treatments, but it has also created more public demand for medications that may not be appropriate for a patient's clinical presentation. This study aims to provide physicians with the knowledge and skills required to help them address inappropriate DTCA medication requests from patients.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas at Houston Medical School

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resident physicians in internal medicine or family medicine specialties at participating study sites

Exclusion Criteria:

  • Completed less than 10 months of residency

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
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual education
Participants randomized into the "no intervention" arm were not exposed to the web-based educational modules
Experimental: Web-based educational modules
Participants randomized into the intervention arm were exposed to the web-based educational modules
Other: Web-based educational modules
Interactive case-based modules that includes video vignettes of clinical interactions between hypothetical patients interacting with physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Decision to prescribe celecoxib

Collaborators and Investigators

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

Sponsor

American Medical Association

Collaborators

Attorney General Consumer & Prescriber Education Grant

Investigators

  • Principal Investigator: Audiey C Kao, MD, PhD, American Medical Association

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 Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2009

Last Update Submitted That Met QC Criteria

June 5, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMA-ES62

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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