Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355986
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-27
Brief Title:
Computerized Decision Support to Prevent Stroke in Atrial Fibrillation
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Community-Based Cluster-Randomized Trial of Electronic Alert-Based Computerized Decision Support to Prevent Stroke in High-Risk Ambulatory Patients With Atrial Fibrillation AF-ALERT3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
AF-ALERT3
Brief Summary:
Atrial fibrillation AF is the most preventable cause of stroke However despite widely available risk stratification tools numerous options for oral anticoagulation and evidence-based practice guidelines anticoagulation for stroke prevention in AF is consistently under-prescribed In a pair of observational cohort analyses within the Mass General Brigham MGB health system prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment 469 vs 572 Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF To address the feasibility and impact of a computerized decision support CDS strategy in the non-tertiary care community medical center setting this study will involve a multicenter cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management
Detailed Description:
Atrial fibrillation AF is the most preventable cause of stroke However despite widely available risk stratification tools numerous options for oral anticoagulation and evidence-based practice guidelines anticoagulation for stroke prevention in AF is consistently under-prescribed In a pair of observational cohort analyses within the MGB health system prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment 469 vs 572 Implementation science strategies including computerized decision support CDS have been proposed as solutions to improve adherence to guideline recommendations A previously conducted randomized controlled trial of alert-based CDS in 458 high-risk hospitalized patients with AF who were not being anticoagulated showed that the alert nearly tripled the proportion of hospitalized patients with AF and high-risk of stroke who were prescribed anticoagulation during the hospitalization at discharge and at 90 days compared with the control group CDS in this trial was associated with an 88 reduction in the frequency of stroke or systemic embolic event and 87 reduction in the frequency of myocardial infarction MI at 90 days A subsequent trial demonstrated that clinician-directed alert-based CDS doubled prescription of antithrombotic therapy in high-risk ambulatory care patients with AF who were not prescribed anticoagulation at the time of randomization A major lesson from the second trial was the importance that perceived bleeding risk played in the shared decision-making process between clinician and patient These two trials demonstrated that bleeding risk is the predominant consideration when omitting anticoagulation or choosing to bypass a CDS alert Clinicians often overestimate bleeding risk compared with objective bleeding risk scores HAS-BLED
Both prior trials were executed at a large tertiary-care center in Boston Massachusetts The feasibility and impact of an alert-based CDS strategy to improve stroke prevention in AF among ambulatory care patients in the community setting and outside of major tertiary-care centers remains to be determined To address the feasibility and impact of a CDS strategy in the non-tertiary care community medical center setting this study will involve a multicenter community-based cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management
Both prior trials were executed at a large tertiary-care center in Boston Massachusetts The feasibility and impact of an alert-based CDS strategy to improve stroke prevention in AF among ambulatory care patients in the community setting and outside of major tertiary-care centers remains to be determined To address the feasibility and impact of a CDS strategy in the non-tertiary care community medical center setting this study will involve a multicenter community-based cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None