Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation

NCT03719144 | Completed

• 1 other identifier: Pro00088597
• Study Type: observational
• Target: 581
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation.

  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.

  up to 12 months

• The co-primary outcome for the retrospective analysis is 12-month adherence rates.

  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.

  up to 12 months

Other Outcomes (1)

• Prevalence of under-dosing

  up to 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is targeting AF patients and providers.

You may qualify if:

• Retrospective Analysis:
• NVAF documented in at least 2 claims between January 2015 and December 2016
• CHA2DS2-VASc scores of 2 or higher
• Prospective Analysis:
• Patient Analysis: All patients in ResearchMatch with diagnosed AF.
• 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.

You may not qualify if:

• Retrospective Analysis:
• Patients with bioprosthetic or mechanical valves in the mitral position.
• Patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for DOAC dosing.
• Patients with mitral stenosis.
• Patients without 12-month follow-up data.
• Prospective Analysis:
• Provider Analysis: All providers who contributed less than 25 AF patients treated with DOACs to the Symphony claims dataset.
• Patient Analysis: Patients unwilling or unable to consent.

Sponsors & Collaborators

• Duke University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27701, United States

Location

Related Links

• Analysis of Oral Anticoagulant Dosing and Adherence to Therapy Among Patients With Nonvalvular Atrial Fibrillation
• Differences in Preferences Between Clinicians and Patients for the Use and Dosing of Direct Oral Anticoagulants for Atrial Fibrillation

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tracy Y Wang, MD

  Duke Clinical Research Institute, Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: April 8, 2019
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)