Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02427516

Enrollment

1144

Registered

2015-04-28

Start date

2009-01-31

Completion date

2015-11-30

Last updated

2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation

Brief summary

To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Patients aged 18 or older over the study period * Patients with a diagnosis for NVAF or VTE anytime in their medical records * Patients having at least one year of enrolment in the database prior to the index date * Patients newly initiated with VKA during the study period (index date)

Exclusion criteria

* Patients with a diagnosis for both NVAF and VTE anytime in their medical records

Design outcomes

Primary

Measure	Time frame	Description
Annualized total and per patient cost of patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records	Approximately 60 months	Per patient cost: direct medical costs from hospitalizations, consultations, medications, and tests; Coagulation control status: adequately controlled patients defined by INR between 2-3 and TTR≥ 60%

Secondary

Measure	Time frame	Description
Demographic and clinical characteristics for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records	Approximately 60 months	Variables measured: age, gender, employment status, smoking status, BMI, major co-morbidities (including CHARLSON index), CHA2DS2-VASc score, presence and frequency of INR measurement, and INR therapeutic range.
Healthcare resource rates for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records	Approximately 60 months	Healthcare resources used (i.e. hospitalizations, consultations, medication, and tests) by patients will be measured according to coagulation control status. For each healthcare resource the number and percentage of patients using it and the mean, SD, median min, max and valid n will be reported; as well as the number of times that each patient uses the resource.

Outcome results