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

Study Overview
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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.

Official Title
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Reducing Unnecessary Use of Heavily Marketed Medicines: A Randomized Controlled Trial of Computerized Prescribing Alerts and Clinician Education

Conditions
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Use of Sleep Medications

Intervention / Treatment
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* Behavioral: Computerized alerts
* Behavioral: Alerts Plus Detailing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Internal medicine clinicians Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized Alerts<br>Computerized Clinical Decision Support to clinician at the time of prescribing | Behavioral: Computerized alerts<br>* Computerized Clinical Decision Support to clinician at the time of prescribing<br>|
| Experimental: Alerts PLUS Detailing<br>Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session | Behavioral: Alerts Plus Detailing<br>* Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session<br>|
| No Intervention: Usual Care<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heavily marketed medications, Prescribing, Health information technology, Education