ImplemeNtation oF demOnstration pRoject for Health systeMs: Atrial Fibrillation (INFORM-AF) Part 1

NCT ID: NCT02569528

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-03-02

Brief Summary

The goal of this study is to learn about the patient and provider perceptions, priorities, preferences, and willingness to use/prescribe anticoagulation as a stroke prevention therapy in patients with atrial fibrillation. Qualitative interviews will be performed with atrial fibrillation patients and providers caring for atrial fibrillation patients. The investigators want to understand the factors that influence decision-making about anticoagulation medications, and to gain insight into patients' and providers' knowledge of the risk of stroke and bleeding associated with oral anticoagulation. This feedback will help provide better education to providers caring for patients with atrial fibrillation and better care to patients with atrial fibrillation by developing tools to optimize the appropriate use of oral anticoagulation for patients with atrial fibrillation.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients of consenting providers will complete a short survey and interview.

No interventions assigned to this group

Providers

Physicians treating patients with atrial fibrillation will complete a short survey and interview.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. adult patient age 18 or older;

2. English speaking;

3. diagnosed atrial fibrillation;

4. at least 1 risk factor for congestive heart failure, hypertension, age, diabetes, stroke (CHADS2) or 2 risk factors for CHADS2 with vascular disease, age, and sex (CHADS2-VASc) ;

5. no documented cognitive impairment per the medical record;

6. not being prescribed an oral anticoagulant

1. physician at one of the study sites treating patients diagnosed with atrial fibrillation

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradi B Granger, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00059115

Identifier Type: -

Identifier Source: org_study_id