Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- amount of unsolved medication-related problems in each group [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.
Secondary Outcome Measures
- Patient self-reported medication compliance [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.
- pharmaceutical care satisfaction [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.
- adverse events [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.
- knowledge about medication [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tainan Sin-Lau Hospital | Tainan city | Taiwan | ||
| 2 | Sin-Lau hospital | Tainan | Taiwan | 701 |
Sponsors and Collaborators
- Sin-Lau Hospital
Investigators
- Principal Investigator: Hung-Yi Chen, Sin-Lau Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- 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.
- SLH-100-05