Clinical trial NCT00788346: Reducing the Unnecessary Use of Heavily Marketed Medications: A Randomized Controlled Trial
Official title: Reducing Unnecessary Use of Heavily Marketed Medicines: A Randomized Controlled Trial of Computerized Prescribing Alerts and Clinician Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Use of Sleep Medications
Keywords: Heavily marketed medications
Prescribing
Health information technology
Education
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
Collaborators: name: Oregon
First posted: 2008-11-10
Enrollment: 257
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Internal medicine clinicians

Exclusion Criteria:

* none

Primary outcomes:
measure: 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.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Pilgrim Health Care
state: Massachusetts
Study officials:
affiliation: Harvard Medical School and Harvard Pilgrim Health Care
name: Steven R Simon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fortuna RJ, Zhang F, Ross-Degnan D, Campion FX, Finkelstein JA, Kotch JB, Feldstein AC, Smith DH, Simon SR. Reducing the prescribing of heavily marketed medications: a randomized controlled trial. J Gen Intern Med. 2009 Aug;24(8):897-903. doi: 10.1007/s11606-009-1013-x. Epub 2009 May 28.