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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baseline alert
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Baseline alert

3-month alert arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Reasons for not prescribing an anticoagulant
Documented reasons for not prescribing an anticoagulant
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.
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

Full Information

First Posted
October 25, 2016
Last Updated
June 12, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02950285
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
May 7, 2017 (Actual)
Study Completion Date
May 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline alert
Arm Type
Experimental
Arm Description
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.
Arm Title
3-month alert arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Baseline alert
Intervention Description
PCP notification at baseline that patient has atrial fibrillation, high stroke risk, and is not anticoagulated.
Primary Outcome Measure Information:
Title
Proportion of patients taking an anticoagulant
Description
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
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Proportion of patients taking direct oral anticoagulants vs. warfarin
Description
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)
Time Frame
3-months
Title
Reasons for not prescribing an anticoagulant
Description
Documented reasons for not prescribing an anticoagulant
Time Frame
3-months
Title
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
Description
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.
Time Frame
3-months
Title
Patient-level characteristics derived from the questionnaire and the electronic health record that are associated with not being prescribed an anticoagulant
Description
Patient-level characteristics that may influence decision making for a physician to not prescribe an anticoagulant
Time Frame
3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A Lubitz, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30076573
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.
Results Reference
derived

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

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