Improving Safety and Quality With Outpatient Order Entry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tejal Gandhi, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00243334
First received: October 21, 2005
Last updated: February 14, 2013
Last verified: February 2013
  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
Other: Integration of advanced clinical decision support with ambulatory computerized physician order entry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Safety and Quality With Outpatient Order Entry

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: Within 14 days of a patient visit or 28 days of the arrival of a test result ] [ Designated as safety issue: Yes ]
  • Whether the incidence of a particular abnormal result (based on guidelines and electronic clinical data) was associated with the appropriate follow-up. [ Time Frame: Varies by major test type ] [ Designated as safety issue: Yes ]
  • Whether a test ordered does not get performed. [ Time Frame: Varies by major test type ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The time to appropriate action following the firing of a reminder. [ Time Frame: Within 14 days of the reminder firing ] [ Designated as safety issue: Yes ]
  • The time to appropriate monitoring action following the arrival of the index lab result. [ Time Frame: Within 28 days of lab result ] [ Designated as safety issue: Yes ]
  • The time to appropriate follow-up following a particular abnormal result. [ Time Frame: Within 28 days of the result ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: July 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Decision Support integrated with Order Entry
Other: Integration of advanced clinical decision support with ambulatory computerized physician order entry
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.
No Intervention: 2
Decision Support Only (not integrated with order entry)

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
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: NCT00243334

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

No publications provided

Responsible Party: Tejal Gandhi, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00243334     History of Changes
Other Study ID Numbers: 5 R01 HS015226-02
Study First Received: October 21, 2005
Last Updated: February 14, 2013
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
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 September 14, 2014