Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243334
Status:
UNKNOWN
Last Update Posted:
2013-02-18
First Post:
2005-10-21
Brief Title:
Improving Safety and Quality With Outpatient Order Entry
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Improving Safety and Quality With Outpatient Order Entry
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None