Atrial FibrillationSUPPORT-AFNCT03583008
Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF
A study testing Anticoagulation (AC) Intervention--Academic Detailing and Anticoagulation (AC) Intervention--Prescribing Practices in people with Atrial Fibrillation and Prescribing Practices, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The SUPPORT-AF study aims to improve rates of anticoagulation (AC) in atrial fibrillation (AF) patients by developing and delivering supportive tools and educational materials to providers treating patients with AF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Prescribing Practices, Anticoagulants
- What is being tested?
- Anticoagulation (AC) Intervention--Academic Detailing and Anticoagulation (AC) Intervention--Prescribing Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 1 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Massachusetts providers caring 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 electronic medical record (EHR).
Who cannot join
- University of Massachusetts 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01566
About this study
The SUPPORT-AF study aims to improve rates of anticoagulation (AC) in atrial fibrillation (AF) patients by developing and delivering supportive tools and educational materials to providers treating patients with AF. The investigators hypothesize that AC percentage will increase among providers receiving tools and educational content.
Read the detailed description
Nearly 1 million patients with atrial fibrillation (AF) who meet guideline criteria for anticoagulation (AC) are being left untreated, often due to providers over-estimating risks of bleeding and falling and under-estimating risks of stroke. The objective of this project is to improve rates of adherence to AC guidelines by creating supportive and educational materials for cardiology as well as primary care providers to evaluate the risks and benefits of prescribing AC to patients with AF. The investigators will email providers individual auto-updating reports containing their AC prescription rate compared to their peers and compared to practice level AC prescription goal. This report will also contain a list of the provider's AF patients who are eligible to receive AC based on their CHA2DS2-VASc stroke risk score ≥ 2 and a list of eligible AF patients with upcoming appointments to focus providers on an actionable group of patients with whom they might review the use of AC. The investigators will also message providers through the EHR prior to an upcoming appointment with an eligible patient reminding them to discuss AC if they deem appropriate. In addition, the investigators will directly engage with providers through academic teledetailing to educate providers on AC and address misconceptions and barriers to initiating or resuming AC in AF patients.
- Conditions
- Atrial Fibrillation, Prescribing Practices, Anticoagulants
- Being tested
- Anticoagulation (AC) Intervention--Academic Detailing, Anticoagulation (AC) Intervention--Prescribing Practices
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation (AC) Intervention--Academic DetailingBehavioural
One hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan.
Anticoagulation (AC) Intervention--Prescribing PracticesBehavioural
Education and support related to anticoagulant prescribing practices.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation (AC) Intervention | Experimental | Providers in this arm will receive supportive tools including Anticoagulation (AC) Intervention--Prescribing Practices and Anticoagulation (AC) Intervention--Academic Detailing to help them assess their Anticoagulant (AC) prescribing practices and will also meet with the study investigators for academic detailing. Receives: Behavioral: Anticoagulation (AC) Intervention--Academic Detailing; Behavioral: Anticoagulation (AC) Intervention--Prescribing Practices |
| Control | No intervention | Providers in this arm will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change to Provider prescription rates
The first primary outcome measure is to determine the impact of the intervention on provider prescribing rates (increase, decrease, same)
Measured: Intervention to three months post intervention.
Change to Individual patient Anticoagulation (AC) status
The effect of the intervention on individual patient anti-coagulation status as demonstrated by random effects logistic regression models for post-intervention AC status (anticoagulated / not anticoagulated) as a function of pre-intervention AC status.
Measured: Intervention to three months post intervention.
Secondary outcomes (1)
Change in provider confidence in applying evidence to balance stroke prevention with harm.
The change in provide confidence as assessed by confidence questions included in the provider survey distributed with the AC Provider Profile. More specifically, the change is calculated with an average score for each item in the confidence survey, using a four-point scale based on four response choices - not confident through very confident.
Measured: Intervention to three months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start11 Jun 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
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 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
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Alok Kapoor, University of Massachusetts, Worcester
- Investigators
- Alok Kapoor, MD, MSca, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583008
- Sponsor's protocol ID
- H00012403
- Acronym
- SUPPORT-AF
- Status last verified
- Mar 2019
- First submitted
- 26 Jun 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kapoor A, Amroze A, Vakil F, Crawford S, Der J, Mathew J, Alper E, Yogaratnam D, Javed S, Elhag R, Lin A, Narayanan S, Bartlett D, Nagy A, Shagoury BK, Fischer MA, Mazor KM, Saczynski JS, Ashburner JM, Lopes R, McManus DD. SUPPORT-AF II: Supporting Use of Anticoagulants Through Provider Profiling of Oral Anticoagulant Therapy for Atrial Fibrillation: A Cluster-Randomized Study of Electronic Profiling and Messaging Combined With Academic Detailing for Providers Making Decisions About Anticoagulation in Patients With Atrial Fibrillation. Circ Cardiovasc Qual Outcomes. 2020 Feb;13(2):e005871. doi: 10.1161/CIRCOUTCOMES.119.005871. Epub 2020 Feb 17.
PubMed 32063041
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. 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
- ClinicalTrials.gov ID
- NCT03583008
- Acronym / sponsor ID
- SUPPORT-AF / H00012403
- Conditions
- Atrial Fibrillation, Prescribing Practices, Anticoagulants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 11 Jul 2018 (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.
The SUPPORT-AF study aims to improve rates of anticoagulation (AC) in atrial fibrillation (AF) patients by developing and delivering supportive tools and educational materials to providers treating patients with AF. The investigators hypothesize that AC percentage will increase among providers receiving tools and educational content.
Detailed description
Nearly 1 million patients with atrial fibrillation (AF) who meet guideline criteria for anticoagulation (AC) are being left untreated, often due to providers over-estimating risks of bleeding and falling and under-estimating risks of stroke. The objective of this project is to improve rates of adherence to AC guidelines by creating supportive and educational materials for cardiology as well as primary care providers to evaluate the risks and benefits of prescribing AC to patients with AF. The investigators will email providers individual auto-updating reports containing their AC prescription rate compared to their peers and compared to practice level AC prescription goal. This report will also contain a list of the provider's AF patients who are eligible to receive AC based on their CHA2DS2-VASc stroke risk score ≥ 2 and a list of eligible AF patients with upcoming appointments to focus providers on an actionable group of patients with whom they might review the use of AC. The investigators will also message providers through the EHR prior to an upcoming appointment with an eligible patient reminding them to discuss AC if they deem appropriate. In addition, the investigators will directly engage with providers through academic teledetailing to educate providers on AC and address misconceptions and barriers to initiating or resuming AC in AF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation (AC) Intervention | Experimental | Behavioral: Anticoagulation (AC) Intervention--Academic Detailing, Behavioral: Anticoagulation (AC) Intervention--Prescribing PracticesProviders in this arm will receive supportive tools including Anticoagulation (AC) Intervention--Prescribing Practices and Anticoagulation (AC) Intervention--Academic Detailing to help them assess their Anticoagulant (AC) prescribing practices and will also meet with the study investigators for academic detailing. |
| Control | No intervention | –Providers in this arm will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- University of Massachusetts providers caring 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 electronic medical record (EHR).
Key exclusion criteria (2 listed)
- University of Massachusetts 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.
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 |
|---|---|---|
| Anticoagulation (AC) Intervention--Academic DetailingOne hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan. | Behavioural | Anticoagulation (AC) Intervention |
| Anticoagulation (AC) Intervention--Prescribing PracticesEducation and support related to anticoagulant prescribing practices. | Behavioural | Anticoagulation (AC) Intervention |
Primary outcome
Change to Provider prescription rates
Time frame: Intervention to three months post intervention.
The first primary outcome measure is to determine the impact of the intervention on provider prescribing rates (increase, decrease, same)
Change to Individual patient Anticoagulation (AC) status
Time frame: Intervention to three months post intervention.
The effect of the intervention on individual patient anti-coagulation status as demonstrated by random effects logistic regression models for post-intervention AC status (anticoagulated / not anticoagulated) as a function of pre-intervention AC status.
1 secondary outcome
Change in provider confidence in applying evidence to balance stroke prevention with harm.
Time frame: Intervention to three months post intervention.
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 21 Mar 2019.
- Derived from this study: PubMed 32063041Kapoor A, Amroze A, Vakil F, Crawford S, Der J, Mathew J, Alper E, Yogaratnam D, Javed S, Elhag R, Lin A, Narayanan S, Bartlett D, Nagy A, Shagoury BK, Fischer MA, Mazor KM, Saczynski JS, Ashburner JM, Lopes R, McManus DD. SUPPORT-AF II: Supporting Use of Anticoagulants Through Provider Profiling of Oral Anticoagulant Therapy for Atrial Fibrillation: A Cluster-Randomized Study of Electronic Profiling and Messaging Combined With Academic Detailing for Providers Making Decisions About Anticoagulation in Patients With Atrial Fibrillation. Circ Cardiovasc Qual Outcomes. 2020 Feb;13(2):e005871. doi: 10.1161/CIRCOUTCOMES.119.005871. Epub 2020 Feb 17.
- Individual participant dataSharing planned: No
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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.
Alok Kapoor, MD, MSca principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation (AC) Intervention--Academic Detailing and Anticoagulation (AC) Intervention--Prescribing Practices in people with Atrial Fibrillation and Prescribing Practices, run by University of Massachusetts, Worcester 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 2 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 21 Mar 2019. 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?
Change to Provider prescription rates (time frame: Intervention to three months post intervention.). 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?
On the ClinicalTrials.gov record for NCT03583008, 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 21 Mar 2019.