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

NCT ID: NCT01356563

Last Updated: 2011-05-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

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.

Conditions

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Renal Failure Chronic Requiring Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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clinical pharmacist intervention

Group Type EXPERIMENTAL

pharmaceutical care

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sin-Lau Hospital

OTHER

Sponsor Role lead

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

Site Status NOT_YET_RECRUITING

Tainan Sin-Lau Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Hung-Yi Chen, MS

Role: primary

06-2748316 ext. 1040

Li-Pin Chou, MD

Role: backup

06-2748316 ext. 5175

Hung-Yi Chen, MS

Role: primary

06-2748316 ext. 1040

Li-Pin Chou, MD

Role: backup

06-2748316 ext. 5175

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.

Reference Type BACKGROUND
PMID: 18628366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20163271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10840531 (View on PubMed)

Other Identifiers

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SLH-100-05

Identifier Type: -

Identifier Source: org_study_id

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