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NCT Number: NCT02950285

Automated Physician Notifications to Improve Guideline-Based Anticoagulation in Atrial Fibrillation

The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by preventing stroke. The investigators propose to implement an automated algorithm using electronic medical record (EMR) data to alert physicians in a large primary care practice network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated stroke risk that are not taking an anticoagulant for stroke prevention. The investigators hypothesize that interventions to notify physicians of such individuals may prompt reassessment for the need for anticoagulation, and thereby increase guideline-indicated anticoagulation rates. Additionally, in a survey component, physicians will characterize reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by preventing stroke. The investigators propose to implement an automated algorithm using electronic medical record (EMR) data to alert physicians in a large primary care practice network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated stroke risk that are not taking an anticoagulant for stroke prevention. Using a medical record algorithm, there are an estimated 2,000 to 3,000 such patients in the primary care practices at MGH. The investigators hypothesize that interventions to notify physicians of such individuals may prompt reassessment for the need for anticoagulation, and thereby increase guideline-indicated anticoagulation rates.

The investigators define the following three Specific Aims to address the primary study hypothesis:

Specific Aim 1: Implement an automated alerting system within the EMR to notify primary care physicians (PCPs) of patients with AF at elevated stroke risk that are not being treated with anticoagulants. To maximize efficiency of the effort, the alert will not require a concurrent clinic visit, but rather will occur with existing data aggregated from the medical record independent of any clinical encounter.

Specific Aim 2: Test whether the alerting system increases the rate of anticoagulation at 3 months after implementation.

Specific Aim 3: Characterize the reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.

Specific Aim 4: Assess how PCPs want to be alerted about anticoagulation status in the future and what types of support they find helpful

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients 18 and older seen in Massachusetts General Hospital primary care practices in the past 3 years
  • Diagnosed with atrial fibrillation
  • Increased risk of stroke (CHA2DS2VASc score ≥ 2)
  • Not currently taking an anticoagulant

Exclusion criteria

  • Patients who are subsequently identified as having died prior to or during the course of the study intervention using the Social Security Death Index
  • Listed in the Massachusetts General Hospital system as having a PCP outside of the network

Treatment and study plan

Baseline alert

Other

PCP notification at baseline that patient has atrial fibrillation, high stroke risk, and is not anticoagulated.

Primary outcomes

  1. Proportion of patients taking an anticoagulant

    Time frame: 3-months

    Difference in the proportion of patients with AF at high risk of stroke taking an anticoagulant at 3-months in the baseline alert arm , compared to the proportion taking an anticoagulant at 3-months in the 3-month alert arm

Secondary outcomes

  1. Proportion of patients taking direct oral anticoagulants vs. warfarin

    Time frame: 3-months

    Difference in the proportion of patients with AF at high risk of stroke taking an anticoagulant at 3-months in the baseline alert arm , compared to the proportion taking an anticoagulant at 3-months in the 3-month alert arm, stratified by type of anticoagulant (direct oral anticoagulants vs. warfarin)

  2. Reasons for not prescribing an anticoagulant

    Time frame: 3-months

    Documented reasons for not prescribing an anticoagulant

  3. Physician characteristics derived from the questionnaire and hospital databases that are associated with having a low proportion of the physician's panel of atrial fibrillation patients on oral anticoagulants

    Time frame: 3-months

    Physician-level characteristics associated with having anticoagulation rates of the physician's panel of atrial fibrillation patients in the lowest quartile among all eligible physicians.

  4. Patient-level characteristics derived from the questionnaire and the electronic health record that are associated with not being prescribed an anticoagulant

    Time frame: 3-months

    Patient-level characteristics that may influence decision making for a physician to not prescribe an anticoagulant

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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