Improving Safety By Computerizing Outpatient Prescribing

NCT ID: NCT00235027

Last Updated: 2015-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

701 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Impact of Electronic Prescribing on Medication Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Adverse Drug Event Monitoring

In this intervention arm, clinicians received medication safety alerts when they prescribed medications in the electronic medical record.

Group Type EXPERIMENTAL

Adverse Drug Event Monitoring

Intervention Type OTHER

The intervention in this study is the presentation of medication safety alerts in the electronic medical record to improve patient outcomes and safety.

Care as Usual

In this arm, clinicians did not receive the medication safety alerts.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role lead

Responsible Party

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david bates

Chief of General Internal Medicine, BWH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tejal K Gandhi, MD, MPH

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

David Bates, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Marc Overhage, MD

Role: STUDY_DIRECTOR

Regenstrief Institute, Inc.

Locations

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Regenstrief/Indiana University

Indianapolis, Indiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Shah NR, Seger AC, Seger DL, Fiskio JM, Kuperman GJ, Blumenfeld B, Recklet EG, Bates DW, Gandhi TK. Improving acceptance of computerized prescribing alerts in ambulatory care. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):5-11. doi: 10.1197/jamia.M1868. Epub 2005 Oct 12.

Reference Type RESULT
PMID: 16221941 (View on PubMed)

Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, Teal E, Bates DW. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010 Jun;6(2):91-6. doi: 10.1097/PTS.0b013e3181dcae06.

Reference Type RESULT
PMID: 22130350 (View on PubMed)

Other Identifiers

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RO1 HS 11169

Identifier Type: -

Identifier Source: org_study_id

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