Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease

14 de octubre de 2021 actualizado por: Saint Luke's Health System

Facilitating End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease

Heart failure is a chronic and frequently terminal illness associated with poor quality of life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent guideline updates have highlighted the need for improved focus on end-of-life and palliative care of advanced heart failure patients, in whom symptom burden can be high and treatment options are often limited. The aims of this study are to evaluate the feasibility of implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive care intervention concerning multiple domains of end-of-life care not often included in regular, outpatient clinic visits.

Descripción general del estudio

Estado

Retirado

Intervención / Tratamiento

Descripción detallada

This study will be a prospective pilot enrolling 10 patients with advanced disease admitted to the heart failure service at St. Luke's Mid America Heart Institute and who are not candidates for advanced therapies such as heart transplant or mechanical circulatory support (left ventricular assist device). Potential enrollees will be identified using a validated risk model that predicts death or poor quality of life in the six months after discharge from the hospital for heart failure exacerbation. Enrolled patients will complete validated questionnaires while still hospitalized, regarding health-related quality of life, illness acceptance, prioritization of different life goals, and confidence in decision-making regarding their terminal heart failure. Patients will then be given a paper exercise regarding delineation of an end-of-life plan and appointment of a surrogate medical decision-maker, to be completed after discharge. At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.

Outcomes to be measured after the intervention include repeated validated questionnaires and unstructured patient interviews at 1 month and, at 6 months, creation of a formalized end-of-life plan, change in code status, obtainment of an advanced directive, designation of a durable power of attorney, frequency of re-hospitalizations, emergency room visits and unscheduled clinic visits with providers, and death. These will be obtained at the time of regularly scheduled heart failure clinic follow-up visits or over the phone.

Tipo de estudio

Intervencionista

Fase

  • No aplica

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

    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • Saint Luke's 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:

  • advanced heart failure
  • ineligible for advanced therapies
  • 50% risk of death or continued poor heart failure-related health status at 6 months from hospital discharge, based on validated risk score

Exclusion Criteria:

  • Hospice enrollment
  • Previous heart transplant or left ventricular assist device placement

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: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Decision Making Intervention
At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.
At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Periodo de tiempo: 1 month
Heart failure-related quality of life
1 month
Decisional Conflict Scale
Periodo de tiempo: 1 month
Decision-making confidence/readiness
1 month
Peace, Equanimity, and Acceptance in Cancer Experience (PEACE) Scale
Periodo de tiempo: 1 month
Illness Acceptance
1 month
Kaldjian's Goals of Care at End of Life
Periodo de tiempo: 1 month
Patient-ranked importance for different goals of care
1 month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Death
Periodo de tiempo: 6 months
Mortality
6 months
Code Status Change
Periodo de tiempo: 6 months
6 months
Advance Directive creation
Periodo de tiempo: 6 months
6 months
Durable Power of Attorney appointment
Periodo de tiempo: 6 months
6 months
Unscheduled Healthcare Encounter
Periodo de tiempo: 6 months
Composite of re-hospitalizations, emergency department visits, urgent care visits, and unscheduled outpatient heart failure clinic visits
6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: John A Spertus, MD, MPH, Saint Luke's Hospital

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 diciembre de 2014

Finalización primaria (Actual)

1 de junio de 2015

Finalización del estudio (Anticipado)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

20 de febrero de 2015

Primero enviado que cumplió con los criterios de control de calidad

19 de marzo de 2015

Publicado por primera vez (Estimar)

25 de marzo de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de octubre de 2021

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

14 de octubre de 2021

Última verificación

1 de octubre de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 14-192

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. .

Suscribir