- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00788346
Reducing the Unnecessary Use of Heavily Marketed Medications: A Randomized Controlled Trial
Reducing Unnecessary Use of Heavily Marketed Medicines: A Randomized Controlled Trial of Computerized Prescribing Alerts and Clinician Education
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Harvard Pilgrim Health Care
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Internal medicine clinicians
Exclusion Criteria:
- none
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Sædvanlig pleje
|
|
|
Eksperimentel: Computerized Alerts
Computerized Clinical Decision Support to clinician at the time of prescribing
|
Computerized Clinical Decision Support to clinician at the time of prescribing
|
|
Eksperimentel: Alerts PLUS Detailing
Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session
|
Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: one year
|
one year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Steven R Simon, MD, Harvard Medical School and Harvard Pilgrim Health Care
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 5.12.05
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