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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Baseline alert

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 2336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baseline alert; For patients randomly selected for the baseline alert arm, their physicians will be alerted via email that a patient(s) under their care has atrial fibrillation, is at high risk of stroke, and is not currently anticoagulated. Physicians will also be asked to complete a survey related to anticoagulation for each patient and will be provided with educational resources and consultation services.	Other: Baseline alert; PCP notification at baseline that patient has atrial fibrillation, high stroke risk, and is not anticoagulated.
No Intervention: 3-month alert arm; For patients randomly selected for the 3-month alert arm, their physicians will not be notified during the 3-month study follow-up period. Instead, PCPs will be sent alerts after 3-months via email for these patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients taking an anticoagulant	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	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients taking direct oral anticoagulants vs. warfarin	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)	3-months
Reasons for not prescribing an anticoagulant	Documented reasons for not prescribing an anticoagulant	3-months
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	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.	3-months
Patient-level characteristics derived from the questionnaire and the electronic health record that are associated with not being prescribed an anticoagulant	Patient-level characteristics that may influence decision making for a physician to not prescribe an anticoagulant	3-months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Steven A Lubitz, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General Publications

• Ashburner JM, Atlas SJ, Khurshid S, Weng LC, Hulme OL, Chang Y, Singer DE, Ellinor PT, Lubitz SA. Electronic physician notifications to improve guideline-based anticoagulation in atrial fibrillation: a randomized controlled trial. J Gen Intern Med. 2018 Dec;33(12):2070-2077. doi: 10.1007/s11606-018-4612-6. Epub 2018 Aug 3.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): May 7, 2017
• Study Completion (Actual): May 7, 2017

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2016P001828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No