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Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms (PROPECS)

31 de octubre de 2017 actualizado por: University Hospital, Grenoble

Communication in the operating room (OR) is a key factor to prevent deleterious events for the patient. French national health authority made the implementation of safety checklist mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key elements for better patient outcomes. Observational studies in the OR showed low compliance to this checklist, either on the way it is used or on the information implemented.

The primary objective of this project is to assess the efficacy of a simulation-based curriculum involving OR medical and non-medical personnel in order to improve communication in the OR.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Operating theater is a complex system where efficient communication is critical to patient safety. Patient safety check-list are used worldwide as a way to improve communication and teamwork in the operating room in order to decrease perioperative morbidity and mortality. Previous studies have shown that communication failure in the OR may be associated with adverse events. The improvement of safety culture (including communication and team work) may be obtained by simulation based training.

The primary objective of this before-after study is to assess the efficacy of a simulation-based curriculum involving OR medical and non medical personnel in order to improve communication in the OR.

In brief, in a first period, an audit to assess communication efficacy and teamwork will be realized during 125 surgical procedures. Communication failures and consequences will be recorded using a standardized form filled by trained personnel. In a second phase, all the OR personnel (surgeon, anesthesiologist, nurses) will be invited to participate to a special training on communication and teamwork. This curriculum will include formal presentations and also simulation-based training. Scenarios are built to improve the ability to communicate in specific situations (fire in the OR, haemorrhage, wrong side, anaphylaxis).

In a third phase, an audit on communication and teamwork, similar to the first phase will be realized. The primary endpoint is the frequency of surgical interventions having at least one communication failure with a consequence. The investigators expect a significant decrease in the rate of communication failures between phase 1 and 3. A fourth phase will consist in a last audit two years after phase 1 to evaluate long-term effect of this curriculum.

Tipo de estudio

De observación

Inscripción (Actual)

259

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

      • Grenoble, Francia, 38000
        • Operating rooms of Grenoble University Hospital

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

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Surgical interventions in Grenoble University Hospital

Descripción

Inclusion Criteria:

  • All surgical interventions occuring in Grenoble University Hospital, North site, between November and January

Exclusion Criteria:

  • Interventions supposed to last more than 4 hours
  • Interventions in situations of vital emergencies

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Before simulation-based curriculum
125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum
After simulation-based curriculum
125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum
Operating room medical and non-medical members will be asked to carry out a simulation session preceded by an educational maze with videos. Outcomes will be compared and correlated after and before this curriculum

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Frequency of surgical interventions having at least on communication failure with a consequence
Periodo de tiempo: After 3 months of audit
After 3 months of audit

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Compliance to the safety checklist in the operating room
Periodo de tiempo: measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
6 items survey estimating teamwork quality
Periodo de tiempo: measured at the end of each surgical intervention, an average of 2.5 hours
measured at the end of each surgical intervention, an average of 2.5 hours
Number of adverse events occuring in the OR declared to the institution
Periodo de tiempo: After 3 months of audit
After 3 months of audit
Surgical Apgar score
Periodo de tiempo: measured at the end of each surgical intervention, an average of 2.5 hours
measured at the end of each surgical intervention, an average of 2.5 hours
Nature of communication failure and consequences
Periodo de tiempo: measured during each surgical procedure, for an average of 2.5 hours
measured during each surgical procedure, for an average of 2.5 hours
rate of communication failures
Periodo de tiempo: measured during each surgical procedure, for an average of 2.5 hours
measured during each surgical procedure, for an average of 2.5 hours
Survey on safety culture for employees working in the OR
Periodo de tiempo: After 3 months of audit
After 3 months of audit
Count of team members and number of passage in the OR
Periodo de tiempo: measured during each surgical procedure, for an average of 2.5 hours
measured during each surgical procedure, for an average of 2.5 hours

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Pierre Albaladejo, MD, PhD, University Hospital, Grenoble

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

1 de noviembre de 2013

Finalización primaria (Actual)

1 de julio de 2015

Finalización del estudio (Actual)

1 de julio de 2015

Fechas de registro del estudio

Enviado por primera vez

20 de marzo de 2014

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2014

Publicado por primera vez (Estimar)

2 de junio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2017

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

31 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2013-32 (Otro identificador: AP HM)

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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