Atrial Fibrillation
Conditions
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Duke University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of under-dosing | 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. |
Countries
United States
Outcome results
None listed