Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter

NCT ID: NCT02339493

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-09-30

Brief Summary

Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial.

Detailed Description

Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial. The investigators have the following specific aims:

Aim #1 (Primary Efficacy Endpoint)- To assess whether an alert-based computerized decision support strategy increases prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.

Hypothesis #1- An alert-based computer decision support (CDS) strategy will increase prescription of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.

Aim #2 (Secondary Efficacy Endpoint)- To determine the potential impact of an alert-based computerized decision support strategy on the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.

Hypothesis #2- This study will provide proof-of-concept data, including event rates, from which to design a larger randomized control trial to assess whether an alert-based CDS strategy will reduce the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.

Conditions

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Alert Group

If the patient is randomized to the alert group, their ordering provider will receive a computer electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy.

Group Type: EXPERIMENTAL

Computer Electronic Alert

Intervention Type: OTHER

A computer program that will issue an on-screen electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. The alert will provide options for anticoagulation for stroke prevention in AF as well as additional information in the form of suggested reading.

Control Group

If the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computer Electronic Alert

A computer program that will issue an on-screen electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. The alert will provide options for anticoagulation for stroke prevention in AF as well as additional information in the form of suggested reading.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• High-risk patients ≥ 21 years old with paroxysmal, persistent, or permanent nonvalvular AF or atrial flutter (CHA2DS2VASc score ≥ 1) who are not prescribed anticoagulant therapy for stroke prevention and are hospitalized at BWH will be eligible for randomization.

Exclusion Criteria

• <21 years old
• no diagnosis of AF or atrial flutter
• not hospitalized at BWH

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Samuel Z.Goldhaber, MD

Director, Thrombosis Research Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Z Goldhaber, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Piazza G, Hurwitz S, Carroll B, Goldhaber SZ. Patients with perceived high-bleeding risk and computerized decision support for stroke prevention in atrial fibrillation: an AF-ALERT substudy : Piazza: outcomes of high-bleeding risk AF patients. J Thromb Thrombolysis. 2021 Jul;52(1):281-290. doi: 10.1007/s11239-020-02296-0. Epub 2020 Sep 30.

Reference Type: DERIVED

PMID: 33000390 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31228189 (View on PubMed)

Other Identifiers

2014P002317

Identifier Type: -

Identifier Source: org_study_id