Atrial FibrillationNCT02950285
Automated Physician Notifications to Improve Guideline-Based Anticoagulation in Atrial Fibrillation
A study testing Baseline alert in people with Atrial Fibrillation, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Baseline alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,336 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 7 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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
- Being tested
- Baseline alert
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline alertOther
PCP notification at baseline that patient has atrial fibrillation, high stroke risk, and is not anticoagulated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-months
Secondary outcomes (4)
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)
Measured: 3-months
Reasons for not prescribing an anticoagulant
Documented reasons for not prescribing an anticoagulant
Measured: 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
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.
Measured: 3-months
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
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start7 Feb 2017
- Primary completion7 May 2017
- Study completion7 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Steven A Lubitz, Massachusetts General Hospital
- Investigators
- Steven A Lubitz, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950285
- Sponsor's protocol ID
- 2016P001828
- Status last verified
- Jun 2017
- First submitted
- 25 Oct 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30076573
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Physician Notifications to Improve Guideline-Based Anticoagulation in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02950285
- Acronym / sponsor ID
- 2016P001828
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,336 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 7 May 2017 (actual)
- Study completion
- 7 May 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline alert | Experimental | Other: Baseline alertFor 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline alertPCP notification at baseline that patient has atrial fibrillation, high stroke risk, and is not anticoagulated. | Other | Baseline alert |
Primary outcome
Proportion of patients taking an anticoagulant
Time frame: 3-months
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
4 secondary outcomes
Proportion of patients taking direct oral anticoagulants vs. warfarin
Time frame: 3-months
Reasons for not prescribing an anticoagulant
Time frame: 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
Time frame: 3-months
Patient-level characteristics derived from the questionnaire and the electronic health record that are associated with not being prescribed an anticoagulant
Time frame: 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 30076573Ashburner 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.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A Lubitz, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline alert in people with Atrial Fibrillation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients taking an anticoagulant (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.