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

NCT02569528 | Completed

• 1 other identifier: Pro00059115
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

atrial fibrillation; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Perceptions of using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview

  Each telephone interview (data collection time point) will be approximately one hour

  one hour

Secondary Outcomes (3)

• Willingness to use anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview

  one hour

• preferences for using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview

  one hour

• priorities for using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview

  one hour

Study Arms (2)

Patients

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

Providers

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will include 100 patients and 10 physicians, who are caring for those patients in the outpatient setting.

You may qualify if:

• adult patient age 18 or older;
• English speaking;
• diagnosed atrial fibrillation;
• 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) ;
• no documented cognitive impairment per the medical record;
• not being prescribed an oral anticoagulant
• \. physician at one of the study sites treating patients diagnosed with atrial fibrillation

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead
• Boehringer Ingelheim: collaborator
• Daiichi Sankyo: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bradi B Granger, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 6, 2015
• Study Start: October 1, 2015
• Primary Completion: March 2, 2017
• Study Completion: March 2, 2017
• Last Updated: May 4, 2017

Record last verified: 2016-08

Locations

US (1)