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Randomized Evaluation of Default Access to Palliative Services (REDAPS)

10 de septiembre de 2020 actualizado por: University of Pennsylvania

Default Palliative Care Consultation for Seriously Ill Hospitalized Patients

This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The REDAPS trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of inpatient palliative consultative services (IPCS) and to test the incremental effectiveness and costs of a simple, scalable method to increase IPCS utilization among properly selected patients. The REDAPS trial will also compare the effectiveness of different palliative care team structures and services and identify patient subgroups most likely to benefit from IPCS. To achieve these goals, the investigators will conduct a clinical trial at 11 Ascension Health hospitals using the same electronic health record. Participating hospitals first contribute a minimum of 4 months of data under the control paradigm (opt-in model), where physicians must identify patients who may benefit from palliative care consultation and actively order such services. Then, using a stepped-wedge design, the hospitals are randomly assigned to begin the intervention in intervals spaced approximately 2.7 months apart. During the intervention, patients meeting consensus criteria for eligibility for palliative care consultation are identified by the electronic health record, a consultation is ordered by default, physicians may cancel the order after being alerted to it, and patients or family members may decline such services. By the end of the trial, all hospitals will have utilized the intervention paradigm of palliative care consultation for at least 4 months. The REDAPS trial will compare outcomes (clinical, economic, and process measures) before and after implementation within hospitals, as well as comparisons among hospitals at given time points.

Tipo de estudio

Intervencionista

Inscripción (Actual)

34239

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

  • Estados Unidos
    • Connecticut
      • Bridgeport, Connecticut, Estados Unidos, 06606
        • St. Vincent's Medical Center
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32204
        • St. Vincent's Medical Center, Riverside
      • Jacksonville, Florida, Estados Unidos, 32216
        • St. Vincent's Medical Center, Southside
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67214
        • Via Christi Hospital, St. Francis
      • Wichita, Kansas, Estados Unidos, 67218
        • Via Christi Hospital, St. Joseph
    • Michigan
      • Kalamazoo, Michigan, Estados Unidos, 49048
        • Borgess Medical Center
    • New York
      • Binghamton, New York, Estados Unidos, 13905
        • Our Lady of Lourdes Memorial Hospital
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37205
        • St. Thomas West Hospital
    • Texas
      • Austin, Texas, Estados Unidos, 78701
        • University Medical Center Brackenridge
    • Wisconsin
      • Mequon, Wisconsin, Estados Unidos, 53097
        • Columbia St. Mary's, Ozaukee
      • Milwaukee, Wisconsin, Estados Unidos, 53211
        • Columbia St. Mary's, North Lake

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age 65 years or older
  2. Current hospitalization of at least 3 calendar days (modified ITT)

  3. Diagnosis of one or more of the following:

    • End-stage renal disease (ESRD) on dialysis
    • Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months
    • Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months

Exclusion criteria:

1. Patients younger than 65 years old will not receive the intervention

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Default ordering of palliative consult
Hospitals randomized to the intervention arm will adopt a system whereby eligible patients are identified by the electronic health record, a consultation is ordered by default, and physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
Conductual: Default ordering of palliative consult
Sin intervención: Usual care
There will be no trial-driven approach to care. Inpatient palliative care consultative services will be actively requested by physicians as in usual care.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Composite Measure: Length of Stay and In-Hospital Mortality
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
The primary outcome is a composite measure of in-hospital mortality and hospital length-of-stay that ranks deaths along the length-of-stay distribution. Data is extracted from the electronic health record.
Duration of hospital stay, an expected average of 8 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Goals of care assessment
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Documented assessments of patients' goals of care within the electronic health record
Duration of hospital stay, an expected average of 8 days
Pain assessment
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Documented assessments of patients' pain scores within the electronic health record
Duration of hospital stay, an expected average of 8 days
Dyspnea assessment
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Documented assessments of patients' dyspnea within the electronic health record
Duration of hospital stay, an expected average of 8 days
Code status
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Code status documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Mechanical ventilation
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Documented orders for mechanical ventilation within the electronic health record
Duration of hospital stay, an expected average of 8 days
Cardiopulmonary resuscitation
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Documented orders for cardiopulmonary resuscitation within the electronic health record
Duration of hospital stay, an expected average of 8 days
Inpatient dialysis
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Documented orders for dialysis during inpatient stay within the electronic health record
Duration of hospital stay, an expected average of 8 days
ICU admission
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Transferal to an intensive care unit documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Hospital discharge status
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Hospital discharge disposition code documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Discharge planning orders
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Discharge orders for home care services documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Hospital readmission
Periodo de tiempo: 30 days
30-day hospital re-admissions documented within the Premier database
30 days
Direct cost per day
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Direct cost per day documented within the Premier database
Duration of hospital stay, an expected average of 8 days
Direct cost per hospitalization
Periodo de tiempo: Duration of hospital stay, an expected average of 8 days
Direct cost per hospitalization documented within the Premier database
Duration of hospital stay, an expected average of 8 days

Colaboradores e Investigadores

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

Patrocinador

University of Pennsylvania

Colaboradores

National Institute on Aging (NIA)

Investigadores

  • Investigador principal: Scott D Halpern, PhD,MD, University of Pennsylvania

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Actual)

1 de marzo de 2016

Finalización primaria (Actual)

1 de noviembre de 2018

Finalización del estudio (Actual)

1 de septiembre de 2020

Fechas de registro del estudio

Enviado por primera vez

16 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

20 de julio de 2015

Publicado por primera vez (Estimar)

22 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de septiembre de 2020

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

10 de septiembre de 2020

Última verificación

1 de septiembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 822134
  • UH2AG050311 (Subvención/contrato del NIH de EE. UU.)

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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