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

Sponsor
VA Boston Healthcare System (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00788346
Collaborator
Oregon (Other)
257
1
3
12
21.4

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Computerized alerts
  • Behavioral: Alerts Plus Detailing
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
257 participants
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
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Internal medicine clinicians
Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00788346
Other Study ID Numbers:
  • 5.12.05
First Posted:
Nov 10, 2008
Last Update Posted:
Dec 20, 2012
Last Verified:
Nov 1, 2008

Study Results

No Results Posted as of Dec 20, 2012