Clinical trial NCT01356563: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: hemodialysis
pharmacist
medication-related problems
compliance
Lead sponsor: Sin-Lau Hospital
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: amount of unsolved medication-related problems in each group
timeFrame: 14 days
Secondary outcomes:
measure: Patient self-reported medication compliance
timeFrame: 14 days after recruitment
measure: pharmaceutical care satisfaction
timeFrame: 14 days after recruitment
measure: adverse events
timeFrame: 14 days after recruitment
measure: knowledge about medication
timeFrame: 14 days after recruitment
Other outcomes:
Locations:
city: Tainan city
country: Taiwan
facility: Tainan Sin-Lau Hospital
city: Tainan
country: Taiwan
facility: Sin-Lau hospital
Study officials:
affiliation: Sin-Lau Hospital
name: Hung-Yi Chen
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.