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Improving Safety and Quality With Outpatient Order Entry
This study is not yet open for participant recruitment.
Verified by Agency for Healthcare Research and Quality (AHRQ), October 2005
First Received: October 21, 2005   No Changes Posted
Sponsored by: Agency for Healthcare Research and Quality (AHRQ)
Information provided by: Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier: NCT00243334
  Purpose

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.


Condition Intervention
Ambulatory Care Information Systems
Clinical Decision Support Systems
Procedure: Integration of advanced clinical decision support with ambulatory computerized physician order entry

U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

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

Primary Outcome Measures:
  • SPECIFIC AIM 1:
  • - Whether an instance that requires medication monitoring (based on guidelines and electronic clinical data) during the visit is associated with appropriate monitoring within 14 days of the visit.
  • - Whether an arrival of a test result that requires medication adjustment or repeat testing (based on guidelines and electronic clinical data) is associated with appropriate monitoring actions within 28 days.
  • - Whether an instance that requires ordering of an appropriate laboratory test or medication (based on guidelines and electronic clinical data) is associated with appropriate action.
  • - Whether the incidence of a particular abnormal result (based on guidelines and electronic clinical data) was associated with the appropriate follow-up.
  • - Whether a test ordered does not get performed.

Secondary Outcome Measures:
  • SPECIFIC AIM 1:
  • - The time to appropriate action following the firing of a reminder.
  • - The time to appropriate monitoring action following the arrival of the index lab result.
  • - The time to appropriate follow-up following a particular abnormal result.

Estimated Enrollment: 800
Study Start Date: January 2006
Estimated Study Completion Date: August 2007
Detailed Description:

Quality gaps that are relevant to the ambulatory setting include a high incidence of adverse drug events and lack of compliance to established guidelines for preventive care, chronic disease management and test result follow-up. Clinical decision support systems (CDSS) and ambulatory computerized physician order entry (ACPOE) have been touted as powerful interventions to address these concerns. However, doubts exist about the efficacy of these systems in the ambulatory setting, especially when they exist in isolation. Also, despite the evidence of the impact of inpatient CPOE, the impact of ACPOE has not been well studied. Moreover, the adoption of CDSS and ACPOE systems is slow, and their value proposition remains uncertain.

Tightly integrating CDSS with ACPOE serves as a promising strategy to improve quality and efficiency in the ambulatory setting by facilitating physician action. When ACPOE is linked with CDSS, clinicians can be prompted at various points during their workflow about the desirable course of action and simultaneously be given the opportunity to execute the action (by ordering it) with minimal effort. 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. We further hypothesize that the value added by these systems overall out weights their costs. This study will evaluate the impact of integrating ACPOE with advanced CDSS on important safety and quality domains in the ambulatory setting using randomized controlled trials. In addition, we will evaluate the impact on organizational efficiency, physician workflow and satisfaction, and perform a cost-benefit analysis.

There are 2 interventions periods. During Intervention Period 1, a randomized selection of clinics (Arm 1) will receive basic order entry without integrated decision support (i.e. no intervention) while another randomized selection of clinics (Arm 2) receive order entry integrated with decision support in the form of delivery of reminders and alerts during a clinical encounter (Intervention A). During Intervention Period 2, Arm 2 clinics will continue to receive Intervention A. However, Arm 1 clinics receive Intervention A plus additional decision support delivered in between clinic encounters (Intervention B).

Comparisons:

We will evaluate the impact of Intervention A (during visit) and intervention B (between visits) in 2 clustered randomized controlled trials, giving us accurate estimates of their individual efficacies. This is particularly important because these findings will highlight the relative value of these 2 different modes of decision support and inform organizations and vendors about how to invest their development resources. We also will be able to evaluate the combined impact of interventions A and B (between visits) by comparing the outcome in Arm 2 across the 2 intervention periods while simultaneously controlling for any secular trends (as observed in Arm 1 across the 2 intervention periods). All clinics, regardless of randomization status, will have access to at least one intervention during study period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243334

Contacts
Contact: Lisa P Newmark 781-416-8551 lpnewmark@partners.org
Contact: Tejal K Gandhi, MD, MPH 617-732-4956 tgandhi@partners.org

Locations
United States, Massachusetts
Partners HealthCare System, Inc.
Boston, Massachusetts, United States, 02481
Sponsors and Collaborators
Investigators
Principal Investigator: Tejal K Gandhi, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Study ID Numbers: 5 R01 HS015226-02
Study First Received: October 21, 2005
Last Updated: October 21, 2005
ClinicalTrials.gov Identifier: NCT00243334     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Ambulatory Care Information Systems
Clinical Decision Support Systems
Medication Systems
Medication Errors
Reminder Systems
Drug Monitoring
Preventive Health Services
Time and Motion Studies
Efficiency
Cost-Benefit Analysis

ClinicalTrials.gov processed this record on May 07, 2009