Atrial FibrillationSUPPORT-AF IVNCT05236556
Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF IV
A study testing Best practice advisory (BPA) in people with Atrial Fibrillation, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
Six million Americans live with atrial fibrillation (AF), a heart rhythm abnormality that is a major risk factor for stroke and only half of those AF patients receive oral anticoagulation (AC). 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?
- Best practice advisory (BPA)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,094 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2022to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Providers caring for patients aged 18 years and older with international classification of disease 10th revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the electronic health record (EHR).
- Patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
Who cannot join
- Left atrial appendage closure
- Hospice status
- Providers who do not care for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
- Patients under the age of 18; patients without a ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR. Patients will also be excluded from this study if they are known to be pregnant or a prisoner.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, 32209
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Six million Americans live with atrial fibrillation (AF), a heart rhythm abnormality that is a major risk factor for stroke and only half of those AF patients receive oral anticoagulation (AC). Within the context of an ongoing collaboration between two large learning health systems, the investigators propose to study the impact of a shared clinical decision support tool embedded within the electronic health record designed to enhance guideline-based AC prescription. The hypothesis the investigators are testing is that the number of AC starts in patients seen by intervention providers will be higher than in patients seen by control providers. Additionally, the investigators are testing the hypothesis that the risk of not persisting on AC will be higher in the patients of control providers compared with patients of intervention providers.
Read the detailed description
The proposed project will examine the impact of a novel anticoagulant (AC) clinical decision support tool within the electronic health record (EHR) on AC prescribing behaviors among healthcare providers from two distinct health systems who receive it. Using a mixed-methods approach, the investigators will also examine how healthcare providers interact with the decision support tool to further refine the tool and measure its impact on anticoagulation prescribing behaviors. The investigators will also examine clinician engagement through provider interviews and detailed study of behaviors using electronic health record access logs. Finally, the investigators will refine the alert, develop a comprehensive dissemination plan, and create an implementation toolkit to widen the use of the alert at other learning health systems nationally.
After identifying a list of all cardiology providers and primary care providers (PCPs), the investigators will send an email to all providers notifying them of our research study and request for participation. The investigators will send this email through our data collection platform- Redcap-with a link to one item survey allowing providers to opt out. This follows the prior SUPPORT-AF II protocol which the investigators' Institutional Review Board (IRB) approved. Based on discussions with the IRB, the investigators do not anticipate requiring informed consent from providers or patients for executing this aim of the proposal. After removing providers who opted out, the investigators will randomize the remaining providers to either intervention or control in a 1:1 ratio, using randomly permuted blocks; randomization will be stratified jointly by provider type (cardiologist / PCP) and study site (University of Massachusetts/University of Florida). The allocation of the provider conducting the first visit for a patient will dictate the allocation for the patient.
- Conditions
- Atrial Fibrillation
- Being tested
- Best practice advisory (BPA)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practice advisory (BPA)Behavioural
For patients who are not on oral anticoagulation (AC) but have elevated stroke risk, the practice advisory will "fire," which is to say it will be active in the providers workflow during outpatient encounters with a patient's primary care provider (PCP) or cardiology provider.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive best practice advisory (BPA) Receives: Behavioral: Best practice advisory (BPA) |
| Control | No intervention | Does not receive best practice advisory (BPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of Oral Anticoagulation (AC) Use
The number of participants who initiate AC will be measured using the first encounter for each participant in the 12 months after randomization of providers and launch of the enhanced alert. To count as an AC initiation, a participant will have to have presence of an anticoagulant on his/her current medication list or an international normalized ratio (INR) lab value 1.5 or greater in the two months following the index encounter.
Measured: 12 months
Length of Duration for Oral Anticoagulation (AC) Use
The number of days participants continue on AC for one year after AC initiation will be tracked. Up to one month off AC such as for bleeding or surgical procedure will be permitted so long as the participant resumes AC prior to the end of the 12 month follow up.
Measured: 12 months
Secondary outcomes (2)
Hospitalization for new Stroke, Transient Ischemic Attack, or Systemic Embolism Ischemic Attack /Systemic Embolism.
The number of new hospitalizations for participants for strokes, transient ischemic attacks, or systemic embolisms that is determined by international classification of disease (ICD) codes in the medical record. The count of new hospitalizations for strokes will be limited to those hospitalizations with the stroke code as the admitting or principal diagnosis code. Verification will be performed through manual chart review.
Measured: 12 months
Incidence of Major Hemorrhage and Clinically Relevant non-major Bleeding
Bleeding events will be quantified using international classification of disease (ICD) codes if a bleeding code is present in the admitting or principal diagnosis fields. Verification will be performed through manual chart review.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start15 Dec 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After removing providers who opted out, the investigators will randomize the remaining providers to either intervention or control in a 1:1 ratio, using randomly permuted blocks; randomization will be stratified jointly by provider type (cardiologist/primary care provider) and study site (University of Massachusetts/University of Florida). The allocation of the provider conducting the first visit for a patient will dictate the allocation for the patient.
- Masking
- None (open label)
- Enrolment
- 5,094 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Principal investigator, Alok Kapoor, University of Massachusetts, Worcester
- Investigators
- Alok Kapoor, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236556
- Sponsor's protocol ID
- HL155343
- Acronym
- SUPPORT-AF IV
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF IV
- ClinicalTrials.gov ID
- NCT05236556
- Acronym / sponsor ID
- SUPPORT-AF IV / HL155343
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,094 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Feb 2022 (actual)
- 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.
Six million Americans live with atrial fibrillation (AF), a heart rhythm abnormality that is a major risk factor for stroke and only half of those AF patients receive oral anticoagulation (AC). Within the context of an ongoing collaboration between two large learning health systems, the investigators propose to study the impact of a shared clinical decision support tool embedded within the electronic health record designed to enhance guideline-based AC prescription. The hypothesis the investigators are testing is that the number of AC starts in patients seen by intervention providers will be higher than in patients seen by control providers. Additionally, the investigators are testing the hypothesis that the risk of not persisting on AC will be higher in the patients of control providers compared with patients of intervention providers.
Detailed description
The proposed project will examine the impact of a novel anticoagulant (AC) clinical decision support tool within the electronic health record (EHR) on AC prescribing behaviors among healthcare providers from two distinct health systems who receive it. Using a mixed-methods approach, the investigators will also examine how healthcare providers interact with the decision support tool to further refine the tool and measure its impact on anticoagulation prescribing behaviors. The investigators will also examine clinician engagement through provider interviews and detailed study of behaviors using electronic health record access logs. Finally, the investigators will refine the alert, develop a comprehensive dissemination plan, and create an implementation toolkit to widen the use of the alert at other learning health systems nationally.
After identifying a list of all cardiology providers and primary care providers (PCPs), the investigators will send an email to all providers notifying them of our research study and request for participation. The investigators will send this email through our data collection platform- Redcap-with a link to one item survey allowing providers to opt out. This follows the prior SUPPORT-AF II protocol which the investigators' Institutional Review Board (IRB) approved. Based on discussions with the IRB, the investigators do not anticipate requiring informed consent from providers or patients for executing this aim of the proposal. After removing providers who opted out, the investigators will randomize the remaining providers to either intervention or control in a 1:1 ratio, using randomly permuted blocks; randomization will be stratified jointly by provider type (cardiologist / PCP) and study site (University of Massachusetts/University of Florida). The allocation of the provider conducting the first visit for a patient will dictate the allocation for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After removing providers who opted out, the investigators will randomize the remaining providers to either intervention or control in a 1:1 ratio, using randomly permuted blocks; randomization will be stratified jointly by provider type (cardiologist/primary care provider) and study site (University of Massachusetts/University of Florida). The allocation of the provider conducting the first visit for a patient will dictate the allocation for the patient.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Best practice advisory (BPA)Receive best practice advisory (BPA) |
| Control | No intervention | –Does not receive best practice advisory (BPA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Providers caring for patients aged 18 years and older with international classification of disease 10th revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the electronic health record (EHR).
- Patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
Key exclusion criteria (4 listed)
- Left atrial appendage closure
- Hospice status
- Providers who do not care for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
- Patients under the age of 18; patients without a ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR. Patients will also be excluded from this study if they are known to be pregnant or a prisoner.
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 |
|---|---|---|
| Best practice advisory (BPA)For patients who are not on oral anticoagulation (AC) but have elevated stroke risk, the practice advisory will "fire," which is to say it will be active in the providers workflow during outpatient encounters with a patient's primary care provider (PCP) or cardiology provider. | Behavioural | Intervention |
Primary outcome
Initiation of Oral Anticoagulation (AC) Use
Time frame: 12 months
The number of participants who initiate AC will be measured using the first encounter for each participant in the 12 months after randomization of providers and launch of the enhanced alert. To count as an AC initiation, a participant will have to have presence of an anticoagulant on his/her current medication list or an international normalized ratio (INR) lab value 1.5 or greater in the two months following the index encounter.
Length of Duration for Oral Anticoagulation (AC) Use
Time frame: 12 months
The number of days participants continue on AC for one year after AC initiation will be tracked. Up to one month off AC such as for bleeding or surgical procedure will be permitted so long as the participant resumes AC prior to the end of the 12 month follow up.
2 secondary outcomes
Hospitalization for new Stroke, Transient Ischemic Attack, or Systemic Embolism Ischemic Attack /Systemic Embolism.
Time frame: 12 months
Incidence of Major Hemorrhage and Clinically Relevant non-major Bleeding
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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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.
Alok Kapoor, MD principal investigator
UMass Chan Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best practice advisory (BPA) in people with Atrial Fibrillation, run by University of Massachusetts, Worcester at 2 sites 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Initiation of Oral Anticoagulation (AC) Use (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.