Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients
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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Tainan, Taiwan, 701
- Ainda não está recrutando
- Sin-Lau hospital
-
Contato:
- Hung-Yi Chen, MS
- Número de telefone: 1040 06-2748316
- E-mail: lawrence_chern@yahoo.com.tw
-
Contato:
- Li-Pin Chou, MD
- Número de telefone: 5175 06-2748316
- E-mail: slh10@sinlau.org.tw
-
Investigador principal:
- Hung-Yi Chen, MS
-
Tainan city, Taiwan
- Recrutamento
- Tainan Sin-Lau Hospital
-
Contato:
- Hung-Yi Chen, MS
- Número de telefone: 1040 06-2748316
- E-mail: lawrence_chern@yahoo.com.tw
-
Contato:
- Li-Pin Chou, MD
- Número de telefone: 5175 06-2748316
- E-mail: slh10@sinlau.org.tw
-
Investigador principal:
- Hung-Yi Chen, MS
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: clinical pharmacist intervention
|
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
|
|
Sem intervenção: usual care
Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
amount of unsolved medication-related problems in each group
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient self-reported medication compliance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hung-Yi Chen, Sin-Lau hospital
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SLH-100-05
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em pharmaceutical care
-
JW PharmaceuticalConcluídoSaudávelCoréia do Sul
-
Silke Wiegand-Grefe, Prof. Dr.Charite University, Berlin, Germany; Hannover Medical School; University Hospital... e outros colaboradoresAtivo, não recrutando
-
Shuqun ChengDesconhecidoXihuang Cápsulas Prevenção de Recorrência em Pacientes com Carcinoma Hepatocelular Após HepatectomiaCarcinoma hepatocelularChina
-
University of Kansas Medical CenterBioNexus KC; Blue KC (Blue Cross Blue Shield)ConcluídoGravidez relacionada | Cuidados pré-natais | Doula Care | Saúde materna e infantil negraEstados Unidos
-
Weill Medical College of Cornell UniversityCornell UniversityRetiradoSobrecarga do cuidadorEstados Unidos
-
Southeast University, ChinaChinese Academy of SciencesConcluídoSepse | Choque Séptico | Pneumonia Adquirida na ComunidadeChina
-
The Third Xiangya Hospital of Central South UniversityAinda não está recrutandoDoença de Charcot-Marie-Tooth (CMT)
-
Yongjun WangConcluído
-
Duke UniversityAinda não está recrutandoSatisfação, Paciente | Queda Lesão | Tromboembolismo Venoso (TEV) | Duração da estadia | CLABSI - Infecção da Corrente Sanguínea Associada à Linha Central | Enfermeiras | Infecção do Trato Urinário Associada a Cateter | Taxas de readmissão | Hospital adquiriu lesão por pressãoEstados Unidos
-
Barts & The London NHS TrustKing's College Hospital NHS TrustRetiradoDoenças Inflamatórias Intestinais