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Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

28 de abril de 2017 actualizado 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

180

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Scranton, Pennsylvania, Estados Unidos, 18510
        • Moses Taylor Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medication Adherence
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medication related problems
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
Hospital readmissions are defined as an unplanned and overnight admission to the hospital
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Judith Kristeller, PharmD, Wilkes University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2014

Finalización primaria (Actual)

28 de abril de 2017

Finalización del estudio (Actual)

28 de abril de 2017

Fechas de registro del estudio

Enviado por primera vez

24 de enero de 2014

Primero enviado que cumplió con los criterios de control de calidad

27 de enero de 2014

Publicado por primera vez (Estimar)

28 de enero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de mayo de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

28 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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