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Trial record 1 of 1 for:    NCT03583008
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Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF (SUPPORT-AF)

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ClinicalTrials.gov Identifier: NCT03583008
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Alok Kapoor, University of Massachusetts, Worcester

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Prescribing Practices Anticoagulants Behavioral: Anticoagulation (AC) Intervention--Academic Detailing Behavioral: Anticoagulation (AC) Intervention--Prescribing Practices Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : March 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Anticoagulation (AC) Intervention
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.
 Behavioral: Anticoagulation (AC) Intervention--Academic Detailing
One hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan.

Behavioral: Anticoagulation (AC) Intervention--Prescribing Practices
Education and support related to anticoagulant prescribing practices.
No Intervention: Control
Providers in this arm will not receive any intervention.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583008


Locations
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United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01566
Sponsors and Collaborators
University of Massachusetts, Worcester
Bristol-Myers Squibb
Investigators
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Principal Investigator: Alok Kapoor, MD, MSca UMass Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alok Kapoor, Assistant Professor, University of Massachusetts Medical School, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03583008    
Other Study ID Numbers: H00012403
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes