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Completed

NCT Number: NCT03583008

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

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.

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Key information

Conditions

Atrial Fibrillation Anticoagulants Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prescribing Practices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Medical School

Worcester, Massachusetts, 01566, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anticoagulation (AC) Intervention--Academic Detailing

Behavioral

One hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan.

Anticoagulation (AC) Intervention--Prescribing Practices

Behavioral

Education and support related to anticoagulant prescribing practices.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Change in provider confidence in applying evidence to balance stroke prevention with harm.

    Time frame: Intervention to three months post intervention.

    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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Acronym: SUPPORT-AF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2018
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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