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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Sin-Lau Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sin-Lau Hospital
ClinicalTrials.gov Identifier:
NCT01356563
First received: May 14, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention
Renal Failure Chronic Requiring Hemodialysis
Behavioral: pharmaceutical care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effects of Pharmacist on Medication-related Problems in Hemodialysis Patients: a Randomized,Controlled, Double-blind Study

Resource links provided by NLM:


Further study details as provided by Sin-Lau Hospital:

Primary Outcome Measures:
  • amount of unsolved medication-related problems in each group [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 days after recruitment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 days after recruitment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 days after recruitment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 days after recruitment ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: pharmaceutical care
No Intervention: usual care
Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356563

Locations
Taiwan
Sin-Lau hospital Not yet recruiting
Tainan, Taiwan, 701
Contact: Hung-Yi Chen, MS    06-2748316 ext 1040    lawrence_chern@yahoo.com.tw   
Contact: Li-Pin Chou, MD    06-2748316 ext 5175    slh10@sinlau.org.tw   
Principal Investigator: Hung-Yi Chen, MS         
Tainan Sin-Lau Hospital Recruiting
Tainan city, Taiwan
Contact: Hung-Yi Chen, MS    06-2748316 ext 1040    lawrence_chern@yahoo.com.tw   
Contact: Li-Pin Chou, MD    06-2748316 ext 5175    slh10@sinlau.org.tw   
Principal Investigator: Hung-Yi Chen, MS         
Sponsors and Collaborators
Sin-Lau Hospital
Investigators
Principal Investigator: Hung-Yi Chen Sin-Lau Hospital
  More Information

Publications:
Responsible Party: Chen Hung-Yi, Tainan Sin-Lau Hospital
ClinicalTrials.gov Identifier: NCT01356563     History of Changes
Other Study ID Numbers: SLH-100-05
Study First Received: May 14, 2011
Last Updated: May 18, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Sin-Lau Hospital:
hemodialysis
pharmacist
medication-related problems
compliance

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014