Improving Safety By Computerizing Outpatient Prescribing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
david bates, Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00235027
First received: October 6, 2005
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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 Intervention
Impact of Electronic Prescribing on Medication Safety
Other: Adverse Drug Event Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Improving Safety By Computerizing Outpatient Prescribing

Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

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


Secondary Outcome Measures:
  • Total adverse drug events, medication errors [ Time Frame: 1/15/2001 - 5/15/2001 ] [ Designated as safety issue: Yes ]

Enrollment: 701
Study Start Date: August 2000
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235027

Locations
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
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, IU Center for Aging Research
  More Information

Additional Information:
Publications:
Responsible Party: david bates, Chief of General Internal Medicine, BWH, Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier: NCT00235027     History of Changes
Other Study ID Numbers: RO1 HS 11169
Study First Received: October 6, 2005
Last Updated: July 12, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 22, 2014