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临床试验/NCT03575936
NCT03575936已完成不适用

Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic

University of South Florida0 个研究点目标入组 42 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
主要终点
INR

研究概览

简要总结

Introduction:

The ambulatory care pharmacist service is a vision that is supported by several national pharmacy associations and expected by many clinical environments. However, pharmacists practicing in such settings often lack the data to demonstrate their value for the services they provide. Consequently, clinical services provided by pharmacists are not viewed as a billable expense and reimbursements are bundled with drug dispensing. Thus, if a pharmacy service is to sustain for the long-term, it is imperative to develop a value model to support monetary compensation for the cognitive services provided.

Background and Significance:

Anticoagulation with warfarin is a high risk therapy involving complex dosing, monitoring, and ensuring adherence to outpatient therapy. Monitoring anticoagulation intensity utilizing the prothrombin time (PT) and the international normalized ratio (INR) is used to determine the effectiveness of anticoagulation therapy. The proportion of time the INR is within the therapeutic range (TTR) is considered a surrogate measure of anticoagulation control and is associated with lower rates of major bleeds and thromboembolism.

Pharmacist managed anticoagulation clinics eliminate the waiting period between lab work from an external facility and decisions from physicians. Pharmacists practicing in anticoagulation clinics with point-of-care INR testing usually practice under a collaborative agreement, which allows them to adjust and reverse warfarin dosing based on established protocols. This reduces the wait time and is expected to increase patient satisfaction. Despite the wide acceptance of pharmacist-managed anticoagulation clinics, there is inconsistent evidence to support prevention of major bleeding.

Methods:

This is an IRB-approved prospective, unblinded randomized controlled trial of the clinical impact of home anticoagulation monitoring. The study will enroll all patients (who meet eligibility criteria) who require long-term anticoagulation therapy from a pharmacist-managed anticoagulation clinic.

Expected Outcomes:

The purpose of this study is to evaluate if self- monitoring in addition to pharmacist review will increase the TTR. This will allow university- based pharmacists to provide care for more patients effectively in addition to their academic duties.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Established patients within the USF Morsani Center Family Medicine department
  • Adults over the age of 18 years
  • Long-term (> 12 months) warfarin therapy
  • Taking warfarin for at least 90 days prior to enrollment
  • Willing and able to perform home INR monitoring with correct technique (or caregiver)

排除标准

  • Failure by either the patient or caregiver to demonstrate successful INR monitoring technique
  • Issues with mental and/or physical dexterity as evaluated and determined by the pharmacist
  • Unwillingness to take full financial responsibility for costs not covered (by patient's insurance and/or grant money) incurred with home INR monitoring

结局指标

主要结局

INR

时间窗: 12 months

INR obtained weekly via home monitoring arm. INR obtained every 4 weeks or sooner for patients seen in clinic. Two arms compared to determine time within therapeutic range.

次要结局

  • Patient Satisfaction and Quality of Life with Anticoagulation utilizing the Duke Anticoagulation Satisfaction Scale (DASS)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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