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Improving Safety By Computerizing Outpatient Prescribing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235027
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 21, 2015
Information provided by (Responsible Party):
david bates, Agency for Healthcare Research and Quality (AHRQ)

Brief Summary:
Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively little, however, is known about the frequency of ADEs in the ambulatory setting, how to monitor for outpatient ADEs, or on the impact of prevention strategies such as computerization of prescribing supplemented by decision-support.

Condition or disease Intervention/treatment Phase
Impact of Electronic Prescribing on Medication Safety Other: Adverse Drug Event Monitoring Not Applicable

Detailed Description:

Specific Aim 1: Increase routine identification of outpatient adverse drug events (ADEs) through development of a computerized ADE detection monitor.

Specific Aim 2: Use basic computerized outpatient prescribing to reduce preventable ADEs in a diverse array of outpatient settings.

Specific Aim 3: Use advanced decision-support within computerized prescribing to reduce the frequency of preventable ADEs, medication errors, and potential ADEs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Improving Safety By Computerizing Outpatient Prescribing
Study Start Date : August 2000
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Adverse Drug Event Monitoring
In this intervention arm, clinicians received medication safety alerts when they prescribed medications in the electronic medical record.
Other: Adverse Drug Event Monitoring
The intervention in this study is the presentation of medication safety alerts in the electronic medical record to improve patient outcomes and safety.

No Intervention: Care as Usual
In this arm, clinicians did not receive the medication safety alerts.

Primary Outcome Measures :
  1. Preventable Adverse drug events [ Time Frame: 8/5/2004 - 1/5/2005 ]
    Data were electronically collected each time a physician entered a prescription that triggered an alert related to medication safety.

Secondary Outcome Measures :
  1. Total adverse drug events, medication errors [ Time Frame: 1/15/2001 - 5/15/2001 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: At Brigham & Women's Hospital, clinics utilizing the electronic medical record will be included. At Regenstrief, any clinic that has access to their electronic medical record will be utilized.

  • For the impact of basic decision support, clinics were not randomized
  • For impact of advanced decision support, clinics were randomized to receive the intervention

Exclusion Criteria:

  • Clinics not using electronic medical records

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235027

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United States, Indiana
Regenstrief/Indiana University
Indianapolis, Indiana, United States
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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Study Director: Tejal K Gandhi, MD, MPH Brigham and Women's Hospital
Principal Investigator: David Bates, MD Brigham and Women's Hospital
Study Director: Marc Overhage, MD Regenstrief Institute, Inc.