Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effects of Pharmacist on Medication-related Problems in Hemodialysis Patients: a Randomized,Controlled, Double-blind Study

Conditions
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Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Behavioral: pharmaceutical care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clinical pharmacist intervention<br> | Behavioral: pharmaceutical care<br>* 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<br>|
| No Intervention: usual care<br>Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of unsolved medication-related problems in each group | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported medication compliance | 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. | 14 days after recruitment | 
| pharmaceutical care satisfaction | 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. | 14 days after recruitment | 
| adverse events | 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. | 14 days after recruitment | 
| knowledge about medication | 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. | 14 days after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, pharmacist, medication-related problems, compliance