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Electronic Alerts for Stroke Prevention in Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02958943
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital

Brief Summary:

Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, five options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. Data from this center (Brigham and Women's Hospital [BWH]) (1) demonstrate that fewer than 50% of outpatients with AF at high-risk for stroke according to 2012 Focused Update of the European Society of Cardiology Guidelines for the Management of AF (2) receive anticoagulation.

Aim #1: To determine the impact of electronic alert-based computerized decision support (CDS) on prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.

Hypothesis #1: Electronic alert-based CDS will increase prescription of anticoagulation by 80% in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.

Aim #2: To determine the impact of electronic alert-based computerized decision support (CDS) on the frequency of stroke and systemic embolic events in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.

Hypothesis #2: Electronic alert-based CDS will reduce the frequency of stroke and systemic embolism in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention. Data acquired through this study regarding the frequency of stroke and systemic embolism will be used to calculate sample size requirements for a future clinical end-point driven randomized controlled trial of electronic alerts to prevent stroke in high-risk AF patients.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Behavioral: On-screen electronic alert Not Applicable

Detailed Description:

AF is associated with an increased risk of fatal and disabling ischemic stroke. Despite widely accessible evidence-based clinical practice guidelines, risk stratification tools (CHA2DS2-VASc and HAS-BLED) and five effective oral antithrombotic agents for stroke prevention (22), at least 40% of high-risk patients with AF worldwide remain unprotected because of failure to prescribe anticoagulation. The failure to prevent stroke in AF has become a critical international patient safety crisis. The root causes of underutilization include lack of provider and patient education about the importance of stroke prevention in AF, inadequate risk stratification, and concerns regarding the bleeding risk with anticoagulant therapy. The investigators were surprised to learn that even at BWH, underutilization of anticoagulation for stroke prevention in AF continues to be a concern (1).

The failure to prevent stroke in AF is similar to the crisis in VTE prevention among hospitalized patients from a decade ago. To address this critical patient safety problem, investigators evaluated the impact of alert-based CDS on VTE prevention (18). First, investigators designed software linked to our Electronic Health Record (EHR) and provider order entry program to identify hospitalized patients at risk for VTE using a weighted risk score and for whom prophylaxis was not ordered. Patients were randomized to the intervention group, in which the responsible physician received an electronic alert regarding the risk of VTE and recommendation regarding prophylaxis, or to the control group, in which no alert was issued. Compared with the control group, electronic alerts more than doubled the rate of thromboprophylaxis orders (from 14.5% to 33.5%; p<0.0001). The risk of symptomatic VTE was reduced by 41% (hazard ratio, 0.59; 95% confidence interval 0.43-0.81; p=0.001) among patients for whom an electronic alert was issued. Investigators have also shown that "human" (person-to-person) alert-based decision support for the prevention of VTE in at-risk hospitalized patients more than doubled the rate of VTE prophylaxis compared with controls during hospitalization (21) and after discharge (19).

The current study will determine the impact of electronic alert-based CDS on prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention. Because this is a Quality Improvement initiative, investigators will not mandate a specific antithrombotic agent, regimen, or duration. Investigators will provide options for anticoagulation to prevent stroke in AF and allow the provider to make the best choice based on their clinical judgment. If there is a contraindication to anticoagulation or if the risks outweigh the benefits of antithrombotic therapy, the provider can elect to omit anticoagulation but will need to provide the rationale for doing so. The current study will also determine the impact of electronic alert-based CDS on the frequency of stroke and systemic embolic events in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention. Data acquired through this study regarding the frequency of stroke and systemic embolism will be used to calculate sample size requirements for a future clinical end-point driven randomized controlled trial of electronic alerts to prevent stroke in high-risk AF patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Electronic Alert-Based Computerized Decision Support to Increase Prescription of Anticoagulation in High-Risk Atrial Fibrillation Patients in the Outpatient Setting
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electronic Alert
Each provider in the alert group will receive an on-screen notification regarding the patient's increased risk of stroke in AF and the lack of an active order for anticoagulation.
Behavioral: On-screen electronic alert
On-screen notification regarding the patient's increased risk of stroke in AF and the lack of an active order for anticoagulation. Providers may then 1) access a template of FDA-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence based clinical practice guidelines, or 3) proceed onto order entry after providing an explanation for why anticoagulation was not prescribed.

No Intervention: No Alert
Each provider in the non-alert group will receive no such notification.



Primary Outcome Measures :
  1. frequency of prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation [ Time Frame: 48 hours ]
    frequency of prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention before study randomization. The primary efficacy outcome will be determined by review of the EHR medication documentation for prescription of anticoagulation by 48 hours after randomization.


Secondary Outcome Measures :
  1. frequency of stroke/TIA, systemic embolism, myocardial infarction and all-cause mortality [ Time Frame: 3 months ]
    frequency of stroke/TIA, systemic embolism, myocardial infarction and all-cause mortality at 3 months from randomization

  2. frequency of major bleeding (as defined by the ISTH bleeding classification system) [ Time Frame: 3 months ]
    major bleeding (as defined by the ISTH bleeding classification system) at 3 months from randomization


Other Outcome Measures:
  1. frequency of stroke, TIA, systemic embolism [ Time Frame: 3 months ]
    frequency of stroke, TIA, systemic embolism

  2. frequency of myocardial infarction [ Time Frame: 3 months ]
    frequency of myocardial infarction

  3. frequency of all-cause mortality [ Time Frame: 3 months ]
    frequency of all-cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women
  • Age ≥ 18 years
  • Problem list entry of AF or atrial flutter
  • CHA2DS2VASc score ≥2

Exclusion Criteria:

  • Active prescription for anticoagulant therapy
  • CHA2DS2VASc score <2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958943


Contacts
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Contact: Gregory Piazza, MD, MS 617-732-6984 gpiazza@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Samuel Z Goldhaber, MD    617-732-6984    sgoldhaber@partners.org   
Principal Investigator: Samuel Z Goldhaber, MD         
Sub-Investigator: John Fanikos, RPh, MBA         
Principal Investigator: Gregory Piazza, MD, MS         
Sponsors and Collaborators
Brigham and Women's Hospital

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Responsible Party: Samuel Z.Goldhaber, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02958943    
Other Study ID Numbers: 2016D005336
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Z.Goldhaber, MD, Brigham and Women's Hospital:
atrial fibrillation
stroke
computerized decision support
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes