NCT02950285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,336

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 7, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

October 25, 2016

Last Update Submit

June 12, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Proportion of patients taking direct oral anticoagulants vs. warfarin

    3-months

  • 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

    3-months

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

    3-months

Study Arms (2)

Baseline alert

EXPERIMENTAL

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

3-month alert arm

NO INTERVENTION

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.

Interventions

Baseline alertOTHER

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

Baseline alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 30076573DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven A Lubitz, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 1, 2016

Study Start

February 7, 2017

Primary Completion

May 7, 2017

Study Completion

May 7, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)