CFP-RCTChaplain Family Project Randomized Controlled Trial
Spiritual Care Assessment and Intervention (SCAI) framework
Trastornos de Ansiedad+1
+ Trastornos Relacionados con el Estrés y el Trauma
+ Trastornos Mentales
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 28 de agosto de 2018
Fecha en la que se inscribió al primer participante.Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice. The specific aims of this proposed study are: 1. To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress. 2. To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative). 3. To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS). 4. To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital. 5. To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 192 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Cognitive Requirements 1. Patient is not decisional due to: * Intubation (other than surgery- see exclusion criteria below) * Sedation * Unresponsive * otherwise unable to communicate (AMS, dementia, delirium, etc.) Decision Support Requirements 2. Patient has a qualified surrogate decision maker Exclusion Criteria: * Intubated for surgery and expected to be extubated within 24 hours * Imminently dying as evidenced by patient notes * Patient and/or family have a care contract or other restriction due to complicated or volatile situation * Patient is a prisoner * Patient is being followed by Adult Protective Services (APS) * Patient meets cognitive criteria but does not have a qualified surrogate decision maker
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
IU Health Methodist Hospital
Indianapolis, United StatesAbrir IU Health Methodist Hospital en Google MapsIU Health University Hospital
Indianapolis, United States