Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03719144
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Study Start: 2019-04-08
• Primary Completion: 2020-03-24
• Study Completion: 2020-03-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 581

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The co-primary outcome for the retrospective analysis is 12-month adherence rates.	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.
The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation.	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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States