Clinical trial NCT06355986: Computerized Decision Support to Prevent Stroke in Atrial Fibrillation
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Keywords: atrial fibrillation
stroke
prevention
computerized decision support
anticoagulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2024-04-10
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2500-patient U.S. multicenter, community-based Quality Improvement Initiative in the form of a cluster-randomized controlled trial.
Primary purpose: PREVENTION

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 (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.

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 (46.9% vs. 57.2%). 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.

Eligibility criteria: Inclusion Criteria:

* Male and Female
* Age ≥ 18 years
* Problem list entry of atrial fibrillation or atrial flutter
* CHA2DS2VASc score ≥ 2 for males
* CHA2DS2VASc score ≥ 3 for females
* No prescription for anticoagulant therapy

Exclusion Criteria:

* Active prescription for anticoagulant therapy
* CHA2DS2VASc score \< 2 for males
* CHA2DS2VASc score ≤ 2 for females

Primary outcomes:
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
timeFrame: 90 days
measure: Frequency of major bleeding at 6 months from enrollment.
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of failure to prescribe anticoagulation because of perceived risk of bleeding in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation at the time of study enrollment and are assigned to the alert group
timeFrame: At 48 hours
measure: Frequency of a composite of major adverse cardiovascular events, defined as cerebrovascular accident, systemic embolism, any MI, symptomatic VTE, or all-cause mortality at 6 months from enrollment
timeFrame: 6 months
Other outcomes:
measure: Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported
timeFrame: 6 months
measure: Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months.
timeFrame: 6 months
Locations:
city: Edgewood
country: United States
facility: St. Elizabeth Health
state: Kentucky
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Gregory Piazza, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piazza G, Hurwitz S, Campia U, Bikdeli B, Lou J, Khairani CD, Bejjani A, Snyder JE, Pfeferman M, Barns B, Rizzo S, Glezer A, Goldhaber SZ. Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2). Thromb Res. 2023 Jul;227:1-7. doi: 10.1016/j.thromres.2023.05.006. Epub 2023 May 11.
citation: Piazza G, Hurwitz S, Galvin CE, Harrigan L, Baklla S, Hohlfelder B, Carroll B, Landman AB, Emani S, Goldhaber SZ. Alert-based computerized decision support for high-risk hospitalized patients with atrial fibrillation not prescribed anticoagulation: a randomized, controlled trial (AF-ALERT). Eur Heart J. 2020 Mar 7;41(10):1086-1096. doi: 10.1093/eurheartj/ehz385.