Improving Safety By Computerizing Outpatient Prescribing

July 20, 2015 updated by: david bates, Agency for Healthcare Research and Quality (AHRQ)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

701

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States
        • Regenstrief/Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8/5/2004 - 1/5/2005

Secondary Outcome Measures

Outcome Measure
Time Frame
Total adverse drug events, medication errors
Time Frame: 1/15/2001 - 5/15/2001
1/15/2001 - 5/15/2001

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • RO1 HS 11169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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