Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients
Effects of Pharmacist on Medication-related Problems in Hemodialysis Patients: a Randomized,Controlled, Double-blind Study
The investigators propose that pharmacist interventions would reduce the amount of unresolved medication-related problems in hemodialysis patients.
Condition:Hemodialysis patients
Intervention:Behavioral,Pharmacist intervention
Study Design:Randomized Allocation
Control: Active Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
研究概览
详细说明
Introduction:
End stage renal disease (ESRD) incidence in Taiwan ranked first and prevalence ranked second in the world from 2002 to 2005. Several foreign researches had reported that hemodialysis (HD) patients often require 12 medications to treat 5 to 6 comorbid conditions. Besides, ESRD is a lifelong disease and rates of compliance may diminish overtime. Thus, HD patients may be at particular risk for drug related problems, durg-drug interactions and noncompliance. Our aim is to analysis the effect of pharmacist in medication-related problems in ambulatory hemodialysis patients.
Methods:
This study is a randomized double-blind, active controlled trial. The investigators will invite and communicate with HD patients to find medication -related problems. After pharmacist evaluation, pharmacist will do pharmaceutical interventions to resolve medication-related problems, drug-drug interactions etc. in experimental group. In the active control group, pharmacist in this study will not do pharmaceutical interventions. The investigators will monitor each patient in a two-week period for medication-related problems.
Our primary outcome is the amount of unresolved medication-related problems in each group after two weeks. Blind outcome assessor will evaluate the amount of unresolved medication-related problems in each case as well as compliance in these patients after two weeks.
The investigators suppose that clinical pharmaceutical intervention will reduce the amount of unresolved medication-related problem in experimental group. On the other hand, patients without clinical pharmaceutical intervention will have more unresolved medication-related problems.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Tainan、台湾、701
- 尚未招聘
- Sin-Lau hospital
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接触：
- Hung-Yi Chen, MS
- 电话号码：1040 06-2748316
- 邮箱：lawrence_chern@yahoo.com.tw
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接触：
- Li-Pin Chou, MD
- 电话号码：5175 06-2748316
- 邮箱：slh10@sinlau.org.tw
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首席研究员：
- Hung-Yi Chen, MS
-
Tainan city、台湾
- 招聘中
- Tainan Sin-Lau Hospital
-
接触：
- Hung-Yi Chen, MS
- 电话号码：1040 06-2748316
- 邮箱：lawrence_chern@yahoo.com.tw
-
接触：
- Li-Pin Chou, MD
- 电话号码：5175 06-2748316
- 邮箱：slh10@sinlau.org.tw
-
首席研究员：
- Hung-Yi Chen, MS
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 20-96 years old hemodialysis patient taking medications prescribed by nephrologists.
Exclusion Criteria:
- Patients who refused informed consent
- Cognitive impaired
- unable to talk or hearing disability
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：clinical pharmacist intervention
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Hemodialysis patients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including personal interview, medication review, medication reconciliation, patient education and recommended actions
|
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无干预：usual care
Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.
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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 |
|---|---|---|
|
amount of unsolved medication-related problems in each group
大体时间：14 days
|
Clinical pharmacist provide pharmaceutical care in experimental group in order to reduce medication-related problems.
With pharmaceutical care, we suppose that amount of unsolved medication-related problems will less than the control group.
|
14 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient self-reported medication compliance
大体时间：14 days after recruitment
|
14 days after recruitment, outcome assessor will record patient self-reported medication compliance. 1 score means almost noncompliance,while 5 score means that patient takes almost every medication.
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14 days after recruitment
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pharmaceutical care satisfaction
大体时间：14 days after recruitment
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From 1 score to 5 scores, 1 score means that patient is very unsatisfied with pharmaceutical care in the past 14 days.
5 scores means that patient is very satisfied with pharmaceutical care in the past 14 days.
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14 days after recruitment
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adverse events
大体时间：14 days after recruitment
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An adverse event is any adverse change in health or side effect that occurs in a person who participates in our clinical trial while the patient is receiving the medications prescribed by physician.
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14 days after recruitment
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knowledge about medication
大体时间：14 days after recruitment
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Patient self-reported knowledge about medication.
From 1 score to 5 scores, as the score increase, it means that patients know more information about his medication.
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14 days after recruitment
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合作者和调查者
调查人员
- 首席研究员：Hung-Yi Chen、Sin-Lau hospital
出版物和有用的链接
一般刊物
- Yang WC, Hwang SJ; Taiwan Society of Nephrology. Incidence, prevalence and mortality trends of dialysis end-stage renal disease in Taiwan from 1990 to 2001: the impact of national health insurance. Nephrol Dial Transplant. 2008 Dec;23(12):3977-82. doi: 10.1093/ndt/gfn406. Epub 2008 Jul 15.
- Schmid H, Schiffl H, Lederer SR. Pharmacotherapy of end-stage renal disease. Expert Opin Pharmacother. 2010 Mar;11(4):597-613. doi: 10.1517/14656560903544494.
- Manley HJ, Bailie GR, Grabe DW. Comparing medication use in two hemodialysis units against national dialysis databases. Am J Health Syst Pharm. 2000 May 1;57(9):902-6. doi: 10.1093/ajhp/57.9.902. No abstract available.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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