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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950285
• Other study ID #: 2016P001828
• Status: Completed
• Phase: N/A
• First received: October 25, 2016
• Last updated: June 12, 2017
• Start date: February 7, 2017
• Est. completion date: May 7, 2017

Study information

• Verified date: June 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2336
• Est. completion date: May 7, 2017
• Est. primary completion date: May 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Baseline alert
PCP notification at baseline that patient has atrial fibrillation, high stroke risk, and is not anticoagulated.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Reasons for not prescribing an anticoagulant	Documented reasons for not prescribing an anticoagulant	3-months
Secondary	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
Secondary	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