- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02047448
Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model
28 de abril de 2017 atualizado por: Judith L. Kristeller, Wilkes University
The purpose of this pilot study is to determine if medication adherence is improved by a transitional care pharmacy practice model designed to integrate hospital and community pharmacists in the care and education of patients with heart failure or COPD who are discharged from a community hospital to home.
The hospital and community pharmacists will collaborate with each other, the patient, and other practitioners including the primary care physician, nurse, and case manager to prevent and correct medication-related problems and attempt to improve patient outcomes especially during the error-prone transition from hospital to home.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
180
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Pennsylvania
-
Scranton, Pennsylvania, Estados Unidos, 18510
- Moses Taylor Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- admitted to hospital with a primary or secondary diagnosis of heart failure or COPD
- anticipated eventual discharge to home
- agreeable to participate in monthly counseling sessions (if randomized to intervention group) from a participating community pharmacist
Exclusion Criteria:
- presence of cognitive impairment or dementia that would significantly prevent effective patient education and counseling
- non English-speaking
- anticipated discharge to a long-term care or skilled nursing facility on a permanent basis
- permanent long-term care facility residents
- surgical patients
- hospice patients
- patients who die within 30 days of initial study hospitalization
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control Group
The control group will receive the current standard of care including medication reconciliation during hospitalization performed by a nurse or physician and education about discharge medications provided by the inpatient nurse.
There will not be a pharmacist discharge care plan developed for this group.
The patients will not be required to choose a participating community pharmacist and no counseling and education appointments will be scheduled.
Any medication-related problems identified by the pharmacists and will be communicated as appropriate and resolved as is the standard of care.
Any other interaction between the patient and their pharmacist will be according to the current standard of care.
|
|
|
Experimental: Pharmacist Counseling
The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems.
The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist.
The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge.
The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education.
The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.
|
The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems.
The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist.
The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge.
The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education.
The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Medication Adherence
Prazo: 6 months
|
The primary endpoint will be medication adherence as measured by the Proportion of Days Covered (PDC) calculation.
This is calculated by dividing the total days' supply dispensed by 180 days.
Medications considered in this calculation will include those used for the treatment of heart failure or COPD and known to improve outcomes.
The composite PDC will be an average of the individual PDC for each drug class.
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Medication related problems
Prazo: 6 months
|
Actual or potential medication-related problems (MRP) that are identified by the hospital and participating community pharmacists will be categorized based on an MRP classification tool.
|
6 months
|
|
Patient Satisfaction
Prazo: 6 months
|
The Care Transitions Measure (CTM-3) is a validated survey to assess the patient's satisfaction with the quality of transitional care during hospitalization and will be completed by the patient following hospital discharge.
The patient's satisfaction with the services provided by the community pharmacies will be assessed with the Consumer Experience with Pharmacy Services survey (© Pharmacy Quality Alliance).
|
6 months
|
|
Hospital readmissions or ED visits
Prazo: 6 months
|
Hospital readmissions are defined as an unplanned and overnight admission to the hospital
|
6 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Judith Kristeller, PharmD, Wilkes University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2014
Conclusão Primária (Real)
28 de abril de 2017
Conclusão do estudo (Real)
28 de abril de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
24 de janeiro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de janeiro de 2014
Primeira postagem (Estimativa)
28 de janeiro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CPF
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 .