- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04881968
EFFECTIVENESS: Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning by Hospitalists
11 de febrero de 2022 actualizado por: Amber Barnato, Dartmouth-Hitchcock Medical Center
Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning Conversations by Hospitalists With Older Adults
Hopewell Hospitalist is a theory-based adventure video game designed to increase the likelihood that a physician will engage in an advance care planning (ACP) conversation with a patient over the age of 65.
Drawing on the theory of narrative engagement, players assume the persona of a hospitalist physician and navigate a series of clinical encounters with seriously-ill patients over the age of 65.
Players experience the consequences of having (or not having) ACP conversations in a timely fashion.
The planned study is a crossover phase III trial testing the effectiveness of providing physicians with a link to a free version of Hopewell Hospitalist as a means for increasing ACP rates measured by ACP billing frequency.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1261
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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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03766
- Dartmouth Hitchcock 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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Hospitalist Inclusion Criteria:
- Employed by Sound
- Not previously included in the Efficacy Trial Arm of the study.
Hospitalist Exclusion Criteria:
- Not employed by Sound
- Does not provide informed consent
- Previously included in the Efficacy Trial Arm of the study.
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 Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control: Usual Care
The control arm occurs prior to receipt of the video game intervention and reflects usual care.
Each hospitalist 'crosses over' from control to intervention at a single time point.
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Experimental: Video Game Intervention
Each hospitalist 'crosses over' from control to intervention at a single time point by receiving a link to the Hopewell Hospitalist game via email and logging in to play the video game.
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Hopewell Hospitalist es un videojuego de aventuras personalizado basado en la teoría que utiliza el compromiso narrativo para educar a los jugadores médicos sobre la planificación anticipada de la atención para aumentar la probabilidad de que los médicos participen y facturen las conversaciones de ACP.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Billed Advance Care Planning
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Change in physician advance care planning billing for patients over the age of 65 in the three months before and after the roll-out of the video game intervention at their hospital.
Advance care planning billing is defined as the presence/absence of ACP charges (Medicare billing codes 99497 or 99498) during a physician's patient's hospitalization.
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6 months (3 months pre and 3 months post intervention)
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Merit-based Incentive Payment System Advance Care Planning Quality Score
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Change in the Merit-based Incentive Payment System (MIPS) self-report measure of advance care planning by enrolled hospitalists (MiPS-ACP quality score).
The MiPS-ACP quality score is the percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan.
The quality score ranges from 0-100%, with higher scores indicating that a greater proportion of patients with an advance care plan documented in the medical record.
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6 months (3 months pre and 3 months post intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hospitalist-Managed Patient In-Hospital Mortality Rate
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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In-hospital mortality rate for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient 90-Day Mortality Rate
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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90-day mortality rate for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Sum of Resources Utilized by Hospitalist-Managed Patients
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Combined sum of resources utilized by patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
It is a composite measure including: admission to ICU, receipt of life-sustaining treatment(s) including mechanical ventilation, placement of tracheostomy, insertion of gastric feeding tube, new onset dialysis.
This measure ranges from 0 to 5, where higher scores indicate greater utilization of resources during the index hospitalization.
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6 months (3 months pre and 3 months post intervention)
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Incidence of Hospitalist-Managed Patient Admission to ICU
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Incidence of admission to ICU for patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
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6 months (3 months pre and 3 months post intervention)
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Incidence of Hospitalist-Managed Patient Mechanical Ventilation
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Incidence of mechanical ventilation of patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
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6 months (3 months pre and 3 months post intervention)
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Incidence of Hospitalist-Managed Patient Receipt of Life-Sustaining Treatment(s)
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Incidence of placement of tracheostomy, insertion of gastric feeding tube, new onset dialysis for patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient Length of Stay
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Total days between admission and discharge for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient Disposition Status Type
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Type of status upon discharge of patients managed by enrolled hospitalists (e.g., discharged to home, to skilled nursing, to hospice, deceased, etc.).
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient 90-Day Episode-Based Spending
Periodo de tiempo: 6 months (3 months pre and 3 months post intervention)
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Amount of total Medicare payments between index admission and 90-days for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hopewell Hospitalist - Apple App Store and Google Analytics
Periodo de tiempo: 3 months
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Number of unique downloads for the HH game will be provided by the Apple App store.
Using Google Analytics we will be able to discern time spent playing the game for each individual hospitalist using their unique log-in passphrase.
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3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Amber Barnato, MD, MPH, MS, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine�
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)
15 de julio de 2021
Finalización primaria (Actual)
13 de agosto de 2021
Finalización del estudio (Actual)
13 de agosto de 2021
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2021
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2021
Publicado por primera vez (Actual)
11 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
11 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00031186 - B
- P01AG019783 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
We will share de-identified participant data and supporting information with other researchers upon request to the PI.
Marco de tiempo para compartir IPD
Upon publication of the planned manuscripts.
Data will be retained through February 2028.
Criterios de acceso compartido de IPD
Data will require completion of a data use agreement with Dartmouth.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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 Planificación anticipada de la atención
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University of Kansas Medical CenterBioNexus KC; Blue KC (Blue Cross Blue Shield)TerminadoRelacionado con el embarazo | Cuidado prenatal | Doula Care | Salud negra materna e infantilEstados Unidos
Ensayos clínicos sobre Videojuego Hopewell Hospitalist
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Dartmouth-Hitchcock Medical CenterNational Institute on Aging (NIA); Sound PhysiciansTerminadoPlanificación anticipada de la atenciónEstados Unidos