Default Options in Advance Directives
29 de marzo de 2019 actualizado por: Scott Halpern, University of Pennsylvania
In a multicenter, randomized clinical trial of default options in advance directives among patients with incurable diseases, we will determine whether this simple and readily scalable intervention can improve patients quality of life and reduce resource utilization without reducing the number of days that patients are alive and living outside of an acute-care hospital.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
270
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
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Penn Presbyterian Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Pennsylvania Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Perelman Center for Advance Medicine
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University Of Pittsburgh Medical Center
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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:
- Age 18 or older
- Fluent in English
- Has seen current physician at least once prior to current visit
- Resident of Pennsylvania or New Jersey
- One or more of the following diagnoses:
- Amyotrophic lateral sclerosis
- Stage IIIB or IV non-small cell lung cancer, pancreatic cancer, or cholangiocarcinoma
- Stage IV breast, colon, esophageal, gastric, pancreatic, prostate, uterine, cervical, ovarian, or urothelial cancer; paraganglioma, or pheochromocytoma
- Stage C or D hepatocellular carcinoma
- Stage IV renal cell carcinoma
- Stage IV or V chronic kidney disease
- Mesothelioma or any malignancy metastatic to the pleura
- Other incurable interstitial lung diseases with at least severe restriction on most recent pulmonary function tests or eligible for long-term oxygen therapy
- Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry or eligible for long-term oxygen therapy
- Congestive heart failure with NYHA Class IV status or Class III plus 1 heart failure related hospitalization in the past 12 months or ACC stage D or C classification with 1 heart failure related hospitalization in the past 12 months
Exclusion Criteria:
- Currently listed for or being considered for solid organ transplant
- Patients with a previously signed advance directive or living will.
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 paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Life-extension default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards life extension (vs.
comfort oriented care) unless the subject specifies otherwise.
The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be provided unless patients specifically opt-out from such selections.
It also will state that upon discharge from the hospital, long-term care (vs.
hospice care) will be provided unless the patient chooses otherwise.
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|
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Experimental: Comfort default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards comfort and relief of pain and suffering (vs.
life extension) unless the subject specifies otherwise.
The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be not provided unless patients specifically opts into such selections.
It also will state that upon discharge from the hospital, hospice care (vs.
long-term care) will be provided unless the patient chooses otherwise.
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Sin intervención: Standard advance directive
Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hospital free days
Periodo de tiempo: 6 months
|
The primary outcome is "Hospital-Free Days" (HFDs), a measure that PI Halpern has been developing in collaboration with Dr. Jeffrey Silber at Penn's Center for Outcomes Research.
As the name describes, HFDs represent the number of days alive and not in an acute care facility.
Although this is a simple concept, and provides an outcome measure of obvious importance to patients, the use of HFDs as a primary outcome in an RCT is highly innovative.
To bolster confidence in the results, we will evaluate two key variations on the theme.
First, we will explore "Healthcare Facility-Free Days," which represents the number of days alive where a patient is in neither an acute care facility, a chronic care facility, or a nursing home.
We will also evaluate HFDs within a defined period of follow-up - 6 months in this case.
This is analogous to the established outcome of ventilator-free days used commonly in RCTs among ICU patients
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6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hospital and ICU admissions
Periodo de tiempo: up to 1 year
|
The numbers of admissions will be analyzed as count data.
From the dates of hospital and ICU admissions, we will calculate the proportion of each patient's total survival time during study follow-up that was spent in the hospital or ICU.
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up to 1 year
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Costs of care
Periodo de tiempo: up to 1 year
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We will combine all costs of inpatient and outpatient hospice, hospital stays, and life-sustaining procedures.
The perspective will be that of all potential payers.
Costs will be inflated to the date on which analyses are performed using the U.S. gross domestic product deflator
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up to 1 year
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Hospice utilization
Periodo de tiempo: up to 1 year
|
We will analyze hospice utilization in 2 ways: (a) time from advance directive completion to hospice enrollment; and (b) duration of hospice utilization prior to death.
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up to 1 year
|
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Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received
Periodo de tiempo: up to 1 year
|
We will record selections that patients made on their advance directives about 4 specific life-sustaining interventions.
Utilizing data from the Pennsylvania Healthcare Cost Containment Consortium and the New Jersey Department of Health and Senior Services, we will be able to determine which patients received each intervention.
Thus, we will be able to reliably evaluate the proportions of patients who received unwanted interventions.
Because we cannot determine the denominator of patients with indications for these interventions, we will not evaluate the proportions of patients who went without desired services.
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up to 1 year
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Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
Periodo de tiempo: up to 1 year
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Patients will indicate on their advance directives forms their selections for post-hospitalization care.
We will utilize data from the Pennsylvania Health Care Cost Containment Consortium and New Jersey Department of Health and Senior Services to asses if the care patient indicate is the care they receive.
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up to 1 year
|
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Decision conflict
Periodo de tiempo: up to 1 year
|
The decision conflict scale is a well-validated instrument used to assess patients' certainty in making healthcare decisions.
The DCS will be sent home with consenting patients to complete and return along with their advance directive forms and an instruction sheet explaining to patients that they should complete their advance directive forms first, followed by the DCS, and both should be mailed to the research team in the provided stamped envelope.
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up to 1 year
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Decision satisfaction
Periodo de tiempo: up to 1 year
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Satisfaction will also be measured with the CANHELP instrument's global satisfaction with end-of-life care question.
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up to 1 year
|
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Quality of Life using the McGill Quality of Life (MQOL) instrument.
Periodo de tiempo: up to 1 year
|
The MQOL is a well-Validated and widely used scale designed specifically for patients with serious illnesses.
The MQOL can be completed by family members on behalf of patients who have lost the capacity to complete it themselves.
Thus, we will have surrogates (the individuals identified on patients' advance directive forms as their appointed healthcare agents) complete the MQOL for incapacitated patients to minimize missing data.
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up to 1 year
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Surrogates' Perception of the quality of death and dying
Periodo de tiempo: within 3 months of patient death
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Because we are recruiting patients with serious life-limiting illnesses, we anticipate that some patients will die over the course of this study period.
We will speak with surrogates of deceased patients to assess their perceived quality of death and dying using Prigerson's Quality of Death measure.
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within 3 months of patient death
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Post-traumatic stress in surrogates
Periodo de tiempo: within 3 months of patient death
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The risk of post-traumatic stress disorder in surrogates among deceased patients will be assessed using the Impact of Events Scale.
The IES is a valid and reliable scale that has been used frequently to assess PTSD risk among family members of critically ill patients.
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within 3 months of patient death
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Scott D. Halpern, MD, PhD, 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
- Halpern SD, Small DS, Troxel AB, Cooney E, Bayes B, Chowdhury M, Tomko HE, Angus DC, Arnold RM, Loewenstein G, Volpp KG, White DB, Bryce CL. Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201742. doi: 10.1001/jamanetworkopen.2020.1742.
- Gabler NB, Cooney E, Small DS, Troxel AB, Arnold RM, White DB, Angus DC, Loewenstein G, Volpp KG, Bryce CL, Halpern SD. Default options in advance directives: study protocol for a randomised clinical trial. BMJ Open. 2016 Jun 6;6(6):e010628. doi: 10.1136/bmjopen-2015-010628.
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 enero de 2014
Finalización primaria (Actual)
1 de noviembre de 2016
Finalización del estudio (Actual)
1 de noviembre de 2016
Fechas de registro del estudio
Enviado por primera vez
16 de diciembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
16 de diciembre de 2013
Publicado por primera vez (Estimar)
20 de diciembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
29 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UPenn 819325
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. .
Ensayos clínicos sobre Life-extension default advance directive
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