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Completed

NCT Number: NCT02569528

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • 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

Provider Inclusion Criteria:

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Boehringer Ingelheim
  • Daiichi Sankyo

Registry information

Acronym: INFORM-AF

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2015
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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