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Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

2016年9月19日更新者：Bristol-Myers Squibb

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.

研究概览

地位

完全的

条件

抗凝

研究类型

观察性的

注册 (实际的)

1144

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients diagnosed with NVAF or VTE and treated with VKA

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
NVAF-VKA cohort NVAF patients who initiate a VKA treatment
VTE-VKA cohort VTE patients who initiate a VKA treatment

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
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 大体时间：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%	Approximately 60 months

次要结果测量

结果测量	措施说明	大体时间
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 大体时间：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.	Approximately 60 months
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 大体时间：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.	Approximately 60 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bristol-Myers Squibb

合作者

Badalona Serveis Assistencials

IMS Health

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

BMS clinical trial educational resource

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年1月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年11月1日

研究注册日期

首次提交

2015年4月23日

首先提交符合 QC 标准的