Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF (SUPPORT-AF)

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

United States, Massachusetts

UMass Medical School

Worcester, Massachusetts, United States, 01566

Sponsors and Collaborators

University of Massachusetts, Worcester

Bristol-Myers Squibb

Investigators

• Principal Investigator: Alok Kapoor, MD, MSca; UMass Medical School

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: March 21, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes