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

NCT ID: NCT02950285

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2017-05-07

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Baseline alert

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Baseline alert

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven A Lubitz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven A Lubitz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30076573 (View on PubMed)

Other Identifiers

2016P001828

Identifier Type: -

Identifier Source: org_study_id