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Infant Special Program for In Hospital Resuscitation Education in the Delivery Room (INSPIRE-D)

30 de septiembre de 2016 actualizado por: Theresa Mariero Olasveengen, Oslo University Hospital

Infant Special Program for In Hospital Resuscitation Education in the Delivery Room - INSPIRE-D

The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn survival and neurologic outcomes.

Descripción general del estudio

Descripción detallada

This prospective interventional trial will be conducted in the delivery unit at OUS. The planned studies consist of five distinct phases with step-wise interventions; 1) baseline data collection, 2) introducing educational debriefing, 3) intensive run-in/rolling-refresher phase, 4) INSPIRE-D phase and lastly 5) evaluation phase.

Phase 1: The baseline data collection phase

  1. Needs assessment/questionnaires from participating healthcare providers will be collected which include demographic data such as sex, age, education, and work experience, as well as exposure to resuscitation training, simulation, self-perceived confidence and suggestions for further training/educational topics.
  2. Observations of the newborn in the resuscitation bays will be done by video recordings and supplemented by resuscitation records, hospital quality improvement data and medical records. Data points to be collected of the newborn are demographics, gestational age, physiological parameters such as heart rate and respirations/oxygenation, Apgar score, interventions performed, and outcomes during and at discharge from hospital.
  3. The healthcare providers adherence to guidelines in neonatal resuscitation (both technical and non-technical skills like team collaboration) will be evaluated by examining the video recordings and scored by validated scoring systems formerly tested with good intra- and inter-rater reliability. The scoring systems is adapted to guidelines from the Norwegian Council of Resuscitation and retested for intra- and inter-rater reliability.

Phase 2: Intervention Phase with Educational Debriefings

  1. Educational debriefings of healthcare providers involved in clinical situations with newborn resuscitation: Selected resuscitation events will be debriefed facilitated by a study team member with special competence in facilitation and an instructor in neonatal resuscitation. The debriefing will be held depending on clinical schedule and availability, to discuss process of care, performance, and provide education to multidisciplinary staff with advocacy/inquiry debriefing techniques.
  2. For healthcare providers; cont¬inued needs assessment and prospective observations by video-recordings in resuscitation bays to document quality of care.
  3. Baseline skills assessment will be collected using a novel manikin, the Newborn Lung Simulator. Healthcare providers will be presented for a mini-simulation with a compromised newborn and asked to perform high quality resuscitation. The performance and adherence to guidelines will be evaluated and retested after the intervention.

Phase 3 - Intensive run-in of high frequency training and team reflection: "The rolling refresher phase"

  1. In this phase training triggers are identified at the start of each day shift. A careful consideration of perinatal factors of both mother and infant will identify "high risk" deliveries with babies who may need resuscitation. If no risk deliveries are identified, a random Healthcare Provider team among the present staff will be selected.
  2. "Just-in-time" and "just-in-place" training; the novel "Rolling refresher", will be introduced (target >80% of staff) at the beginning of day shifts. Health Care Providers caring for labouring mothers with training triggers will be identified and exposed to "low dose" simulation-based "just-in-time" and "just-in-place" skills training. The short training session (<10 minutes) will take place on-site in the resuscitation bay with relevant topics such as; timely assessment of need for intervention, effective assisted ventilations on a Newborn Lung Simulator. We will use observations from the video-films to target training with focus on rapid evaluation of respiratory distress, correct ventilation technique and use of pulse oximetry.
  3. Continued simulation training will be based on problem areas identified from baseline. Performance during simulation training will be evaluated and registered.
  4. Educational debriefings will continue, as in Phase 2
  5. Continued needs assessment and prospective observations in resuscitation bays to document provider confidence, simulation performance and quality of care during implementation of the INSPIRE-D bundle described above.

Phase 4: Continued INSPIRE-D bundle. After successful implementation defined as >80% of staff having been through at least one "just-in-time and just in place" training session, all interventions above (phase 2 and 3) will continue on routine basis. Continued needs assessment of confidence and performance are repeated as described above.

Phase 5: Evaluation. Evaluation of the INSPIRE-D bundle to identify and define key factors and processes that we prove necessary to ensure timely and effective neonatal resuscitation associated with improved newly born survival and neurologic outcomes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

435

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

      • Oslo, Noruega, 0405
        • Oslo 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

Descripción

Inclusion Criteria:

  • Neonates that require stabilisation and/or resuscitation such as ventilatory support, medications and/or chest compressions.

Exclusion Criteria:

  • Parent or health care provider reserved against study participation.

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: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control period
Assessment of resuscitation quality and clinical outcomes prior to educational intervention
Experimental: Educational intervention
Assessment of resuscitation quality and clinical outcomes after educational intervention consisting of debriefing and rolling refreshers.
Educational Debriefings and High frequency training and team reflection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of neonatal resuscitation (Validated performance score assessed by video analysis)
Periodo de tiempo: 12 months
Validated performance score assessed by video analysis
12 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Clinical outcome - Time to effective respiration
Periodo de tiempo: 12 months
12 months
Clinical outcome - Time to heart rate > 100
Periodo de tiempo: 12 months
12 months
Clinical outcome - Admission to intensive care
Periodo de tiempo: 12 months
12 months
Health care providers adherence to guidelines and behaviour markers - Self-reported score
Periodo de tiempo: 12 months
12 months
Health care providers adherence to guidelines and behaviour markers - Simulation score
Periodo de tiempo: 12 months
12 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Theresa M Olasveengen, MD PhD, Oslo University Hospital

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.

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 enero de 2014

Finalización primaria (Actual)

1 de enero de 2015

Finalización del estudio (Actual)

1 de mayo de 2016

Fechas de registro del estudio

Enviado por primera vez

12 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2015

Publicado por primera vez (Estimar)

27 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

3 de octubre de 2016

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

30 de septiembre de 2016

Última verificación

1 de septiembre de 2016

Más información

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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