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Reducing the Unnecessary Use of Heavily Marketed Medications: A Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788346
First Posted: November 10, 2008
Last Update Posted: December 20, 2012
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.
Collaborator:
Oregon
Information provided by:
VA Boston Healthcare System
  Purpose

Prescribing decisions by clinicians are often thought to be simple: a patient's clinical problem leads a prescriber to choose the optimal treatment. However, many factors other than the patient's condition affect prescribing decisions, including the marketing of pharmaceuticals. Clinicians are subjected to direct "detailing" by representatives of the pharmaceutical industry, advertisements in medical journals and requests for specific treatments from patients, who are increasingly exposed to direct-to-consumer (DTC) advertising. These influences, often based on biased or inaccurate information, contribute to a variety of problems in prescribing, including the unnecessary use of expensive, heavily marketed medications.

Overcoming these influences requires innovative approaches. The movement toward widespread adoption of electronic health records (EHRs) and electronic prescribing presents new opportunities to educate both clinicians and patients at the time of medication prescribing. This project, endorsed by the AHRQ-supported Centers for Education and Research on Therapeutics (CERTs; www.certs.hhs.gov) and the U.S. Food and Drug Administration (FDA), aims to test the effectiveness of computerized prescribing alerts and state-of-the-art educational outreach to reduce the unnecessary use of heavily marketed medications. A second goal is to improve clinicians' knowledge of industry marketing practices, so that they can more effectively assess information provided by drug companies. Thus, the study has two specific aims:

Specific Aim 1: To assess whether computerized prescribing alerts linked electronically to patient educational material can reduce prescribing of heavily marketed medications.

Specific Aim 2: To assess whether group academic detailing increases clinicians' knowledge about industry marketing practices and increases the effect of prescribing alerts.


Condition Intervention
Use of Sleep Medications Behavioral: Computerized alerts Behavioral: Alerts Plus Detailing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Unnecessary Use of Heavily Marketed Medicines: A Randomized Controlled Trial of Computerized Prescribing Alerts and Clinician Education

Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • proportion of prescriptions for hypnotic medications that were heavily marketed medications (study medications). Hypnotic medications were defined as the study medications intervention plus zolpidem and trazodone. [ Time Frame: one year ]

Enrollment: 257
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized Alerts
Computerized Clinical Decision Support to clinician at the time of prescribing
Behavioral: Computerized alerts
Computerized Clinical Decision Support to clinician at the time of prescribing
Experimental: Alerts PLUS Detailing
Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session
Behavioral: Alerts Plus Detailing
Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session
No Intervention: Usual Care
Usual Care

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Internal medicine clinicians

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00788346


Locations
United States, Massachusetts
Harvard Pilgrim Health Care
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
VA Boston Healthcare System
Oregon
Investigators
Principal Investigator: Steven R Simon, MD Harvard Medical School and Harvard Pilgrim Health Care
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven R. Simon, MD (Principal Investigator), Harvard Medical School and Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT00788346     History of Changes
Other Study ID Numbers: 5.12.05
First Submitted: November 7, 2008
First Posted: November 10, 2008
Last Update Posted: December 20, 2012
Last Verified: November 2008

Keywords provided by VA Boston Healthcare System:
Heavily marketed medications
Prescribing
Health information technology
Education