Improving Safety and Quality With Outpatient Order Entry

NCT ID: NCT00243334

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Ambulatory Care Information Systems; Clinical Decision Support Systems

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1

Decision Support integrated with Order Entry

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

2

Decision Support Only (not integrated with order entry)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tejal Gandhi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tejal K Gandhi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Partners HealthCare System, Inc.

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5R01HS015226-02

Identifier Type: AHRQ

Identifier Source: org_study_id

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