Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients
NCT ID: NCT01356563
Last Updated: 2011-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2011-05-31
2012-05-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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clinical pharmacist intervention
pharmaceutical care
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
usual care
Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.
No interventions assigned to this group
Interventions
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pharmaceutical care
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cognitive impaired
* unable to talk or hearing disability
20 Years
90 Years
ALL
No
Sponsors
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Sin-Lau Hospital
OTHER
Responsible Party
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Tainan Sin-Lau Hospital
Principal Investigators
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Hung-Yi Chen
Role: PRINCIPAL_INVESTIGATOR
Sin-Lau Hospital
Locations
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Sin-Lau hospital
Tainan City, Tainan, Taiwan
Tainan Sin-Lau Hospital
Tainan City, , Taiwan
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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SLH-100-05
Identifier Type: -
Identifier Source: org_study_id
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