NCT03583008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

June 26, 2018

Last Update Submit

March 19, 2019

Conditions

Atrial FibrillationPrescribing PracticesAnticoagulants

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (1)

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

    Intervention to three months post intervention.

Study Arms (2)

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.

Behavioral: Anticoagulation (AC) Intervention--Academic DetailingBehavioral: Anticoagulation (AC) Intervention--Prescribing Practices

Control

NO INTERVENTION

Providers in this arm will not receive any intervention.

Interventions

Anticoagulation (AC) Intervention--Academic DetailingBEHAVIORAL

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

Anticoagulation (AC) Intervention
Anticoagulation (AC) Intervention--Prescribing PracticesBEHAVIORAL

Education and support related to anticoagulant prescribing practices.

Anticoagulation (AC) Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01566, United States

Location

Related Publications (1)

  • 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.

    PMID: 32063041DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alok Kapoor, MD, MSca

    UMass Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, University of Massachusetts Medical School

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 11, 2018

Study Start

June 11, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)