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Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation (ARISTA)

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.
 
ClinicalTrials.gov Identifier: NCT03719144
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
This study will survey atrial fibrillation patients to better understand patient perspective of DOAC treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for AF.

Condition or disease
Atrial Fibrillation

Study Design
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Study Type : Observational
Actual Enrollment : 581 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Optimizing Anticoagulation Dosing and Adherence for Patients With Non-valvular Atrial Fibrillation
Actual Study Start Date : April 8, 2019
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients
Patients registered on ResearchMatch.org with Atrial Fibrillation as a medical condition; or who participate in afib-related social media platforms and confirm a diagnosis of afib, will be invited to participate in this study. Patients will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions.
Providers
Providers who have contributed at least 25 Atrial Fibrillation patients to the Symphony pharmacy claims dataset will be contacted to participate. Interested providers will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions.


Outcome Measures
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Primary Outcome Measures :
  1. The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation. [ Time Frame: up to 12 months ]
    The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, the 12-month DOAC discontinuation rates will be examined. DOAC discontinuation will be defined as a gap in fill ≥30 days following the run-out date of the last observed claim for the index therapy. Twelve-month DOAC discontinuation will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.

  2. The co-primary outcome for the retrospective analysis is 12-month adherence rates. [ Time Frame: up to 12 months ]
    The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, medication adherence rates will be examined. DOAC adherence, defined as the proportion of days covered ≥80%, is calculated by the number of days any anticoagulant is available divided by the number of days in the follow-up period. Twelve-month adherence rates will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.


Other Outcome Measures:
  1. Prevalence of under-dosing [ Time Frame: up to 12 months ]
    Providers who contributed at least 25 NVAF patients on DOACs to the pharmacy claims dataset will be grouped into tertiles based on the frequency of under-dosing: high, intermediate, and low. We will examine the association of provider factors with the likelihood of under-dosing.


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is targeting AF patients and providers.
Criteria

Inclusion Criteria:

Retrospective Analysis:

  1. NVAF documented in at least 2 claims between January 2015 and December 2016
  2. CHA2DS2-VASc scores of 2 or higher

Prospective Analysis:

  1. Patient Analysis: All patients in ResearchMatch with diagnosed AF.
  2. Provider Analysis: All providers who contributed at least 25 AF patients treated with DOACs to the Symphony claims dataset. All provider specialties (i.e. cardiology, primary care, and other), as well as provider types (i.e. physician, physician extender, and nurse practitioner) will be included.

Exclusion Criteria:

Retrospective Analysis:

  1. Patients with bioprosthetic or mechanical valves in the mitral position.
  2. Patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for DOAC dosing.
  3. Patients with mitral stenosis.
  4. Patients without 12-month follow-up data.

Prospective Analysis:

  1. Provider Analysis: All providers who contributed less than 25 AF patients treated with DOACs to the Symphony claims dataset.
  2. Patient Analysis: Patients unwilling or unable to consent.
Contacts and Locations
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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): NCT03719144


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Bristol-Myers Squibb
Investigators
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Principal Investigator: Tracy Y Wang, MD Duke Clinical Research Institute, Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03719144    
Other Study ID Numbers: Pro00088597
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes