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

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
pharmaceutical care
Sponsored by
Sin-Lau Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Renal Failure Chronic Requiring Hemodialysis focused on measuring hemodialysis, pharmacist, medication-related problems, compliance

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tainan Sin-Lau HospitalRecruiting
  • Sin-Lau hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

clinical pharmacist intervention

usual care

Arm Description

Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 14, 2011
Last Updated
May 18, 2011
Sponsor
Sin-Lau Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01356563
Brief Title
Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients
Official Title
Effects of Pharmacist on Medication-related Problems in Hemodialysis Patients: a Randomized,Controlled, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sin-Lau Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Requiring Hemodialysis
Keywords
hemodialysis, pharmacist, medication-related problems, compliance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
clinical pharmacist intervention
Arm Type
Experimental
Arm Title
usual care
Arm Type
No Intervention
Arm Description
Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.
Intervention Type
Behavioral
Intervention Name(s)
pharmaceutical care
Intervention Description
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
Primary Outcome Measure Information:
Title
amount of unsolved medication-related problems in each group
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Patient self-reported medication compliance
Description
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.
Time Frame
14 days after recruitment
Title
pharmaceutical care satisfaction
Description
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.
Time Frame
14 days after recruitment
Title
adverse events
Description
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.
Time Frame
14 days after recruitment
Title
knowledge about medication
Description
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.
Time Frame
14 days after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Yi Chen
Organizational Affiliation
Sin-Lau Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tainan Sin-Lau Hospital
City
Tainan city
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Yi Chen, MS
Phone
06-2748316
Ext
1040
Email
lawrence_chern@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Li-Pin Chou, MD
Phone
06-2748316
Ext
5175
Email
slh10@sinlau.org.tw
First Name & Middle Initial & Last Name & Degree
Hung-Yi Chen, MS
Facility Name
Sin-Lau hospital
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Yi Chen, MS
Phone
06-2748316
Ext
1040
Email
lawrence_chern@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Li-Pin Chou, MD
Phone
06-2748316
Ext
5175
Email
slh10@sinlau.org.tw
First Name & Middle Initial & Last Name & Degree
Hung-Yi Chen, MS

12. IPD Sharing Statement

Citations:
PubMed Identifier
18628366
Citation
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.
Results Reference
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PubMed Identifier
20163271
Citation
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.
Results Reference
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PubMed Identifier
10840531
Citation
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.
Results Reference
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Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients

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