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

May 18, 2011 updated by: Sin-Lau Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 701
        • Not yet recruiting
        • Sin-Lau hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hung-Yi Chen, MS
      • Tainan city, Taiwan
        • Recruiting
        • Tainan Sin-Lau Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hung-Yi Chen, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self-reported medication compliance
Time Frame: 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.
14 days after recruitment
pharmaceutical care satisfaction
Time Frame: 14 days after recruitment
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
Time Frame: 14 days after recruitment
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
Time Frame: 14 days after recruitment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sin-Lau Hospital

Investigators

  • Principal Investigator: Hung-Yi Chen, Sin-Lau hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

May 14, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLH-100-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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