Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF

Atrial Fibrillation Clinical Trial

— SUPPORT-AF  

Official title:

Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583008
• Other study ID #: H00012403
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators hypothesize that AC percentage will increase among providers receiving tools and educational content.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anticoagulants
• Atrial Fibrillation
• Prescribing Practices

Intervention

Behavioral:
• Anticoagulation (AC) Intervention--Academic Detailing
One hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan.
• Anticoagulation (AC) Intervention--Prescribing Practices
Education and support related to anticoagulant prescribing practices.

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Intervention to three months post intervention.
Primary	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.	Intervention to three months post intervention.
Secondary	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.	Intervention to three months post intervention.