Clinical trial NCT02950285: Automated Physician Notifications to Improve Guideline-Based Anticoagulation in Atrial Fibrillation
Official title: Automated Physician Notifications to Improve Guideline-Based Anticoagulation in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2016-11-01
Enrollment: 2336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients taking an anticoagulant
timeFrame: 3-months
Secondary outcomes:
measure: Proportion of patients taking direct oral anticoagulants vs. warfarin
timeFrame: 3-months
measure: Reasons for not prescribing an anticoagulant
timeFrame: 3-months
measure: 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
timeFrame: 3-months
measure: Patient-level characteristics derived from the questionnaire and the electronic health record that are associated with not being prescribed an anticoagulant
timeFrame: 3-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven A Lubitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.