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临床试验/NCT04409613
NCT04409613已完成不适用

Cost-Effectiveness Study on Establishing a Warfarin Counseling Clinic for Egyptian Patients With Mitral Valve Prostheses

Ain Shams University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Quality-adjusted life-years (QALYs)

研究概览

简要总结

The outcome of poor adherence to medications can be life threatening with certain drugs like warfarin. For each 10% increase in non-adherence to warfarin, there was a 14% increase in the risk of under-anticoagulation with significantly higher rates of morbidity and mortality. Furthermore, warfarin therapy is fraught with several inherent problems. These include a wide variation in dose requirement, delayed onset of anticoagulant effect, prolonged continuation after cessation of therapy, serious interactions with a wide range of medications and food items, risk of major hemorrhage related to overdosing, unpredictable control in presence of co-morbidities such as hepatic and renal impairment.

There is ongoing evidence that better outcomes are achieved when anticoagulation is managed by a pharmacist with expertise in anticoagulation management rather than usual care by physicians. Pharmacists can contribute to positive outcomes of therapy by educating and counseling patients to prepare and motivate them to follow their therapeutic regimens and monitoring plans, which will result substantially in improving the quality of care, reducing complications, and lowering hospitalization rates. Thus, beneficial effects of the pharmacist-managed counseling clinic have been repeatedly reported in terms of cost-effectiveness, patients' adherence to and knowledge about pharmacotherapy, and the outcome of treatment.

The objective of this study is to evaluate the cost-effectiveness of establishing a Medication Counseling Clinic for outpatients with mitral valve prostheses taking warfarin therapy in an Egyptian Teaching Hospital setting. Availability of this information could be used to target further quality improvement efforts, which may significantly improve outcomes for patients and cost containment efforts in an era when cost-effectiveness is at the forefront of healthcare policy initiatives.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (18-70) years.
  • Post mitral valve surgery patients.
  • Patients with a prescription of warfarin.

排除标准

  • Pregnant patients.
  • Patients with double and aortic valve replacement surgery.
  • Patients with biological prostheses.
  • Patients with congenital blood disorders.

结局指标

主要结局

Quality-adjusted life-years (QALYs)

时间窗: 1 year

The outcome of the two strategies will be measured in terms of quality-adjusted life-years (QALYs).This measurement weighs the length of life by the quality of life a patient experiences while in a specific health state. QALYs combine both morbidity and mortality into a single parameter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radwa Ahmed Batran

Doctor

Ain Shams University

研究点 (2)

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