NCT00243334

Brief Summary

The purpose of this study is to evaluate the impact of integrating ambulatory computerized physician order entry (ACPOE) and advanced clinical decision support systems (CDSS) on safety and quality domains in the ambulatory setting, including: a) medication monitoring, b) preventive care and chronic disease management, and c) test result follow-up. In addition we will evaluate the impact on organizational efficiency, physician workflow and satisfaction, and perform a cost-benefit analysis. We hypothesize that the value of ACPOE integrated with advanced CSDSS lies in improved medication safety and guideline compliance, but also improved efficiencies for the provider and the health-care system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2005

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

2.4 years

First QC Date

October 21, 2005

Last Update Submit

February 14, 2013

Conditions

Keywords

Ambulatory Care Information SystemsClinical Decision Support SystemsMedication SystemsMedication ErrorsReminder SystemsDrug MonitoringPreventive Health ServicesTime and Motion StudiesEfficiencyCost-Benefit Analysis

Outcome Measures

Primary Outcomes (3)

  • Whether an instance that requires ordering of an appropriate laboratory test or medication or other appropriate monitoring action (based on guidelines and electronic clinical data) is associated with appr opriate action.

    Within 14 days of a patient visit or 28 days of the arrival of a test result

  • Whether the incidence of a particular abnormal result (based on guidelines and electronic clinical data) was associated with the appropriate follow-up.

    Varies by major test type

  • Whether a test ordered does not get performed.

    Varies by major test type

Secondary Outcomes (3)

  • The time to appropriate action following the firing of a reminder.

    Within 14 days of the reminder firing

  • The time to appropriate monitoring action following the arrival of the index lab result.

    Within 28 days of lab result

  • The time to appropriate follow-up following a particular abnormal result.

    Within 28 days of the result

Study Arms (2)

1

EXPERIMENTAL

Decision Support integrated with Order Entry

Other: Integration of advanced clinical decision support with ambulatory computerized physician order entry

2

NO INTERVENTION

Decision Support Only (not integrated with order entry)

Interventions

Actiobable Reminders related to medication monitoring, preventive care and chronic disease management, and test result follow-up are administered either during the visit or between visits.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All physicians in on-site and satellite adult outpatient clinics with the Brigham and Women's Hospital and Massachusetts General Hospital

You may not qualify if:

  • Study clinics must have adopted our electronic health record system, the Longitudinal Medical Record, for at least 24 months and must have implemented the basic version of the internally-developed lab order entry module.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partners HealthCare System, Inc.

Boston, Massachusetts, 02481, United States

Location

Study Officials

  • Tejal K Gandhi, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 24, 2005

Study Start

July 1, 2007

Primary Completion

December 1, 2009

Study Completion

June 1, 2013

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations