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

Atrial Fibrillation Clinical Trial

— INFORM-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569528
• Other study ID #: Pro00059115
• Status: Completed
• Phase: N/A
• First received: October 5, 2015
• Last updated: May 3, 2017
• Start date: October 2015
• Est. completion date: March 2, 2017

Study information

• Verified date: August 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient 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

Provider Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Boehringer Ingelheim, Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Willingness to use 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	preferences for 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	priorities for 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