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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00915291
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
Attorney General Consumer & Prescriber Education Grant
Information provided by:
American Medical Association

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lumbosacral Muscle Strain Other: Web-based educational modules Not Applicable

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  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Official Title: Sound Prescribing Study - Assessing the Impact of Pharmaceutical Marketing and Promotional Practices on Physician Prescribing
Study Start Date : May 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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

Primary Outcome Measures :
  1. Decision to prescribe celecoxib

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Completed less than 10 months of residency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00915291

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Nebraska
Creighton University School of Medicine
Omaha, Nebraska, United States, 68131
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas at Houston Medical School
Houston, Texas, United States, 77030
Sponsors and Collaborators
American Medical Association
Attorney General Consumer & Prescriber Education Grant
Principal Investigator: Audiey C Kao, MD, PhD American Medical Association

Responsible Party: Audiey Kao, MD, PhD, American Medical Association Identifier: NCT00915291     History of Changes
Other Study ID Numbers: AMA-ES62
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: June 8, 2009
Last Verified: June 2009

Keywords provided by American Medical Association:
medical education
clinical decisionmaking
pharmaceutical marketing