Clinical trial NCT02569528: ImplemeNtation oF demOnstration pRoject for Health systeMs: Atrial Fibrillation (INFORM-AF) Part 1
Official title: ImplemeNtation oF demOnstration pRoject for Health systeMs: Atrial Fibrillation (INFORM-AF) Part 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
anticoagulation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Daiichi Sankyo
First posted: 2015-10-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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:

* None

Primary outcomes:
measure: Perceptions of using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview
timeFrame: one hour
Secondary outcomes:
measure: Willingness to use anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview
timeFrame: one hour
measure: preferences for using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview
timeFrame: one hour
measure: priorities for using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview
timeFrame: one hour
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Bradi B Granger, PhD
role: PRINCIPAL_INVESTIGATOR
References: