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CompletedNCT02734875IQ-MATCHUpdated Jan 16, 2019

Improving Quality of Care - Managing Atrial Fibrillation Through Care Teams and Health Information Technology

An interventional study of Intervention in Atrial Fibrillation, sponsored by Brigham and Women's Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
432
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This stepped wedge randomized intervention will apply machine learning algorithms in an electronic health record system to identify primary care patients with non-valvular atrial fibrillation (AF) who are at high risk of stroke and not on anticoagulation therapy. An Anticoagulant Management Service (AMS) will offer support to primary care providers regarding treatment for relevant patients (either warfarin and novel oral anticoagulants).

This study seeks to:

  1. increase the proportion of appropriately anticoagulated patients with AF,
  2. understand the reasons for lack of anticoagulation, and
  3. document the proportion of patients with AF who are appropriately not anticoagulated (e.g. patient refusal, contraindication).
Read the detailed description

Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with significant mortality and morbidity from stroke, thromboembolism, and related cardiovascular conditions. While the risk of stroke for AF patients as a whole tends to be greater than the general population; within the AF patient population, the risk of stroke is modified by the presence or absence of additional risk factors such as age, comorbid conditions, and prior stroke history.

There is a wealth of evidence for the effectiveness of anticoagulation therapy to prevent stroke and thromboembolism, but while anticoagulants have been demonstrated to be highly effective at preventing stroke and embolic events among AF patients, they are also known to increase the risk of major bleeding events. Anticoagulation with warfarin and other VKA drugs can be complex to manage. These drugs have narrow therapeutic windows and require close monitoring to stay within the target international normalized ratio (INR). They also have many known food and drug interactions.

In the last few years, several novel oral anticoagulants (NOAC) such as dabigatran, rivaroxaban, and apixaban have entered the market. While each of the NOACs demonstrated non-inferiority to warfarin in a large randomized clinical trial prior to FDA approval, experience with NOACs is limited in practice.

Our intervention will combine the ability of health information technology to filter large volumes of data with human capacity to understand subtleties and barriers for complex clinical decision making. Our intervention will facilitate a connection between patients, treating clinicians, and an established Anticoagulant Management Service (AMS) for coordinated care. We will use information from the EHR to direct additional efforts and resources toward reaching potentially unrecognized or undertreated atrial fibrillation patients with the greatest need for preventive anticoagulation therapy and lowest risk of adverse effects. This electronic safety net will assist with efficient allocation of scarce resources beyond usual care. The proposed clinical decision support/care-coordination process will be designed to address many of these identified barriers to appropriate anticoagulation therapy among AF patients. Here we define "appropriate" anticoagulation as a guideline informed shared decision between individual patients and their care team.

This intervention utilizes a stepped wedge design involving 14 primary care clinics affiliated with the Brigham and Women's Hospital. The timing of clinic entry to the intervention arm will be randomized.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • anticoagulants
  • NOACs
  • warfarin
  • randomized designed delay
  • intervention
  • machine learning algorithm
  • primary care
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 432 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Non-valvular atrial fibrillation as identified by machine learning algorithms
  • Primary care provider within Brigham and Women's Hospital
  • No evidence of a prescription for an anticoagulant in medical record for at least 1 year

Exclusion criteria

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
432 participants (actual)

Study arms

  • Experimental
    Intervention

    Primary care providers in the intervention arm will receive lists of their patients with AF who are identified as being at high risk of stroke but not currently on anticoagulation therapy. Along with this list, which includes information on risks and benefits of anticoagulation, primary care providers will receive an offer of assistance from a respected Anticoagulation Management Service within the hospital network to help manage anticoagulation for referred patients.

    Other: Intervention

  • No intervention
    Usual Care

    Primary care providers will provide usual care.

Interventions

  • OtherIntervention

    The intervention arm offers primary care providers additional information on patient risks and benefits as well as an offer of assistance with managing a patient's anticoagulation from a respected service at BWH.

    Also known as: Anticoagulant

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What researchers measure

Primary outcomes

  1. Anticoagulation therapy

    the proportion of eligible patients who initiate anticoagulation therapy following randomization to intervention or usual care

    Time frame: randomization to 1 month post randomization

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data outside of the staff and participants themselves.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02734875
Lead sponsor
Brigham and Women's Hospital
Responsible party
Shirley Vichy Wang (Assistant Professor of Medicine at Harvard Medical School and Associate Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, Brigham and Women's Hospital) — Principal investigator
First posted
Apr 12, 2016
Start date
May 2016
Primary completion
Aug 2017
Completion
Aug 2017
Last update
Jan 16, 2019

Study contacts

Shirley Wang, PhD, ScM
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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