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

NCT ID: NCT00788346

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Use of Sleep Medications

Keywords

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Heavily marketed medications Prescribing Health information technology Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Computerized Alerts

Computerized Clinical Decision Support to clinician at the time of prescribing

Group Type EXPERIMENTAL

Computerized alerts

Intervention Type BEHAVIORAL

Computerized Clinical Decision Support to clinician at the time of prescribing

Alerts PLUS Detailing

Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session

Group Type EXPERIMENTAL

Alerts Plus Detailing

Intervention Type BEHAVIORAL

Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session

Usual Care

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Computerized alerts

Computerized Clinical Decision Support to clinician at the time of prescribing

Intervention Type BEHAVIORAL

Alerts Plus Detailing

Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Internal medicine clinicians

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon

OTHER

Sponsor Role collaborator

VA Boston Healthcare System

FED

Sponsor Role lead

Responsible Party

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Harvard Medical School and Harvard Pilgrim Health Care

Principal Investigators

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Steven R Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School and Harvard Pilgrim Health Care

Locations

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Harvard Pilgrim Health Care

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19475459 (View on PubMed)

Other Identifiers

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5.12.05

Identifier Type: -

Identifier Source: org_study_id