Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE) (INVOLVE)
A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have transient or persistent cognitive impairment that precludes them from making their own healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a family member. SDMs for the critically ill often describe high states of psychological stress associated with the uncertainty of the patient's condition and their decision making role.
The purpose of this study is to test the effectiveness of two decision support interventions for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test interventions tailored to the unique needs of the SDMs of CCI patients delivered using an interactive avatar based format.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators will conduct a three-arm unblinded clinical trial using pre- and post-tests to evaluate the efficacy of two electronic decision-support interventions, Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE) and Informational Support (IS), compared to each other and to usual care (UC) among 270 SDMs of cognitively impaired CCI patients. This design will allow the investigators to prospectively compare the efficacy of the experiential avatar-based decision support tool (INVOLVE) with both an information-only condition and UC. Subjects assigned to an experimental condition (INVOLVE or IS) will receive two doses of the intervention, at enrollment and 1 day later. After the second dose, these subjects will have access to their assigned condition for subsequent self-administered doses, which will be electronically captured until the patient's ICU discharge or death. Data will be collected at (T1) baseline (Day 3 or 4 of the patient's ICU stay), and then on Days 1, 3, 7 and 90 post-baseline
.
The investigators aim to:
- Identify the essential elements of the graphical user interface and educational content needed to revise the INVOLVE prototype for a set of common end-of-life decisions that occur in the ICU.
- Evaluate if there are differences in the decision making readiness and decision making quality between subjects exposed to INVOLVE, IS, or UC on Days 1, 3, and 7 days post-baseline while accounting for covariates (prior SDM experience, SDM knowledge of the patient's preferences, and SDM's religious beliefs).
- Determine if there are differences in the post-decision outcomes of SDMs and their CCI patient by study condition while accounting for covariates at 90 days post-baseline.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Case Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Eligibility criteria for CCI patients:
- aged 18 years or older
- required mechanical ventilation and ICU stay for greater than or equal to 3 days
- not expected to be transferred out of the ICU within 48 hours
- lacks cognitive capacity, as determined by a Glasgow Coma Scale eye score of less than 3 or the motor score less than 6 and verifying the status by asking the patients's attending physician or advanced practice nurse whether he or she would obtain consent from the patient or a family member
- has an identified SDM (next-of-kin or legal representative for healthcare decision making).
Eligibility criteria for SDMs:
- aged 18 years or older
- identified by the healthcare team as the patient's next of kin or legal representative for healthcare decision making
- able to speak and understand English
- able to view images on an 10-inch computer screen and hear audio through a standard set of headphones.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: INVOLVE
The first study condition, called "Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE)" will consist of exposures to an avatar-based decision support technology that will be administered via tablet computer and allow SDMs opportunities to practice their communication and decision making skills through interactions with avatars that portray a decision coach and various healthcare providers.
|
Interactive content and decision coaching with tailored framing of messages to subject's informational processing style and stage of change to promote participatory decision making behavior.
Consideration of options, consequences, values, and preferences to formulate an informed decision.
|
|
Experimental: Informational Support
The second condition, called Informational Support (IS), will also be administered via tablet computers and expose SDMs to educational resources of INVOLVE without the experiential components.
|
Passive, non-tailored informational support.
Screen-based education (videos) with information content on advance care decisions that occur in the intensive care unit.
|
|
Experimental: Usual Care
The third condition, usual care (UC), will expose SDMs to the routine communication and decisional support practices provided by the healthcare team.
|
Routine decision support practices by the healthcare team.
Family meetings, bedside updates, and access to printed or electronic decision aids.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Repeated Measures
Periodo de tiempo: From (T1) baseline through (T5) 90 days post-baseline
|
ANOVA Model (F-Statistic)
|
From (T1) baseline through (T5) 90 days post-baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Preparation for Decision Making Scale
Periodo de tiempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decision Making Preparedness
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Family Decision Making Self-Efficacy Scale
Periodo de tiempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decision Making Self-Efficacy
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Single item measure of Role Stress
Periodo de tiempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decisional Role Stress
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Decision Conflict Scale
Periodo de tiempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decision Conflict
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Modified Control Preferences Scale
Periodo de tiempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Behavioral Activation
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Decision Regret Scale
Periodo de tiempo: (T1) baseline and (T5) 90 days post-baseline
|
Measure of Decision Regret
|
(T1) baseline and (T5) 90 days post-baseline
|
|
Change in Hospital Anxiety and Depression Scale
Periodo de tiempo: (T1) baseline and (T5) 90 days post-baseline
|
Measure of Anxiety and Depressive Symptoms
|
(T1) baseline and (T5) 90 days post-baseline
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 08-16-25
- 5R01NR015750-02 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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. .