Computerized Decision Support to Prevent Stroke in Atrial Fibrillation
Part of paid clinical trials in Edgewood, Kentucky.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06355986
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Alert-based computerized decision support — BEHAVIORALAn on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the provider that his or her patient is at risk for stroke due to AF, and that there is no order for anticoagulation. Clinicians who receive the computer alert will have three options: 1) access an order template of FDA-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence-based clinical practice guidelines to learn more about stroke prevention in AF, or 3) continue with order entry after providing an explanation for why anticoagulation was not prescribed.
Study Details
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 (46.9% vs. 57.2%). 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.
Key Dates
- Start date
- Dec 30, 2026
- Status verified
- Feb 2026
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2027
Study Design
- Enrollment
- 2,500 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: AlertFor Alert cluster sites, an on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the provider that his or her patient is at risk for stroke due to AF, and that there is no order for anticoagulation. Clinicians who receive the computer alert will have three options: 1) access an order template of United States (US) Food and Drug Administration (FDA)-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence-based clinical practice guidelines to learn more about stroke prevention in AF, or 3) continue with order entry after providing an explanation for why anticoagulation was not prescribed.
- No Intervention: No AlertFor No Alert cluster sites, no computerized alert notification will be issued to providers.
Primary Outcome Measure
Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment [ Time Frame: 90 days ]
Central Contacts
- Gregory Piazza, MD, MS7819565525
- Benjamin Peterson, MD6179871046
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Elizabeth Health | Edgewood | Kentucky | 41017 | |
| Mass General Brigham | Boston | Massachusetts | 02115 |
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