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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02569528
First Posted: October 6, 2015
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boehringer Ingelheim
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: ImplemeNtation oF demOnstration pRoject for Health systeMs: Atrial Fibrillation (INFORM-AF) Part 1

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Perceptions of using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview [ Time Frame: one hour ]
    Each telephone interview (data collection time point) will be approximately one hour


Secondary Outcome Measures:
  • Willingness to use anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview [ Time Frame: one hour ]
    Each telephone interview (data collection time point) will be approximately one hour

  • preferences for using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview [ Time Frame: one hour ]
    Each telephone interview (data collection time point) will be approximately one hour

  • priorities for using anticoagulation as a stroke prevention therapy in atrial fibrillation, as measured by survey and interview [ Time Frame: one hour ]
    Each telephone interview (data collection time point) will be approximately one hour


Enrollment: 52
Study Start Date: October 2015
Study Completion Date: March 2, 2017
Primary Completion Date: March 2, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569528


Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
Daiichi Sankyo, Inc.
Investigators
Principal Investigator: Bradi B Granger, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02569528     History of Changes
Other Study ID Numbers: Pro00059115
First Submitted: October 5, 2015
First Posted: October 6, 2015
Last Update Posted: May 4, 2017
Last Verified: August 2016

Keywords provided by Duke University:
atrial fibrillation
anticoagulation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes