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The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia

16 de julio de 2018 actualizado por: Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital

The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia on Clinical Performance and Clinical Outcome

Procedural skills are an important determinant of clinical outcomes for certain patient groups. Training for procedural skills in the medical profession is still largely based on an apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by "practicing" on patients under direct supervision by seniors (consultants or senior registrars/residents). Learning a complex and high risk procedural skill on patients is not ideal.

As medical training moves from apprentice based to competency based training along and as for the number of clinical learning opportunities for trainees is less, it is necessary to develop a comprehensive training programme which enables effective and efficient learning without compromising on patient safety. Metrics-based performance based progression has shown to improve clinical performance not only in novices but also in experts.

We envisage a standard methodology which could address the deficiencies in procedural training currently. This would entail development and validation of a set of metrics for a particular procedure, evaluation of a proficiency based progression training programme based on those metrics to and demonstration of improved clinical performance and clinical outcome associated with that programme. Although elements of this "end -end" approach have been demonstrated previously for various procedures, we propose to apply this methodology in its entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To date we have developed and are validating a set of metrics for this procedure. Proficiency based training leading to better procedural skills leading to better patient outcomes has not been studied so far. Epidural analgesia during labor lends itself as an excellent model for evaluating the whole process. It has a specific procedural skill which is closely linked to patient outcome which is measurable and occurs in finite time interval.

The hypothesis of the study is that in novice anaesthetic trainees, training with metrics based performance based progression in addition to improving the clinical performance will also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved by conventional training.

Descripción general del estudio

Descripción detallada

This will be a prospective, randomized, double blind control study. Ethical committee approval and consent from both participating anaesthetist and patients will be obtained.

Trainees will be recruited from Cork University Hospital. Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has performed less than 50 epidurals in the preceding 2 years (not limited to labor epidurals) will be requested to participate in the study.

The trainees will be randomized in to group 1 and group 2. In group 1, standardized conventional teaching and training for labor epidural analgesia will be used. In group 2, they will be trained by metrics based simulation to predetermined level of proficiency. Each trainee will then perform 10 labor epidural catheter insertions and the procedures will be video recorded with patients consent.

Observers blinded to the groups will be used for the data collection, outcome assessment and analysis. Failure rate of epidural will be assessed based on the occurrence of one or more of the following events,

  1. Inadequate analgesia at 45 minutes from start of epidural needle placement.
  2. Resiting epidural or abandoning the procedure.
  3. Accidental Dural puncture.
  4. Supervisor take over. The primary end point of the study is to compare difference in epidural failure rates between the two groups. Secondary end point will include assessment of clinical performance using metrics based assessment by two blinded reviewers based on video recordings and patient satisfaction with epidural analgesia. In addition to demographic data of the patients, duration of labor, cervical dilation at the time of insertion of the catheter, length of catheter inserted, time of insertion of catheter, experience of the operator and position of the patient during epidural placement will be noted. Age, sex and anaesthesia experience of the trainees will also be collected.

The estimated labor epidural failure rates for year 1 trainees is 25%.6 We hope to reduce the failure rate in interventional group to 5%. 48 procedures per group will be sufficient to show a statistically significant difference between the groups with p value of 0.05% and power of 80%. To allow for dropouts, 8 trainees per group will be recruited and each will perform 10 procedures making it a total of 80 procedures per group.

Tipo de estudio

Intervencionista

Inscripción (Actual)

16

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

    • Cork
      • Cork,Ireland, Cork, Irlanda
        • Cork 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

23 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has performed less than 50 epidurals in the preceding 2 years (not limited to labor epidurals) will be requested to participate in the study.

Exclusion Criteria:

  • No tmeeting inclusion criteria
  • Not consenting for 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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Group C
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.
Experimental: Group M
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be subjected to training to proficiency based on the metrics developed for labor epidural catheter placement in a epidural simulator.
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be trained to proficience based on the metrics developed for labor epidural catheter placement in a epidural simulator.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Epidural failure rate
Periodo de tiempo: within 48 hours after completion of epidural

Failure rate of epidural will be assessed based on the occurrence of one or more of the following events,

  1. Inadequate analgesia at 45 minutes from start of epidural needle placement.
  2. Resiting epidural or abandoning the procedure.
  3. Accidental Dural puncture.
  4. Supervisor take over.
within 48 hours after completion of epidural

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
assessment of clinical performance using metrics based assessment
Periodo de tiempo: within 36 months after aquiring the video of epidrual catheter insertion procedure
assessment of clinical performance using metrics based assessment will be done by two blinded reviewers based on video recordings
within 36 months after aquiring the video of epidrual catheter insertion procedure
patient satisfaction with epidural analgesia
Periodo de tiempo: within 48 hours of completion of insertion of labor epidural catheter
Patient will be asked to rate eidural as (a) satisfied, will want it again (b) Not satisfied - give reason in free text
within 48 hours of completion of insertion of labor epidural catheter

Colaboradores e Investigadores

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

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 diciembre de 2017

Finalización del estudio (Actual)

1 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

5 de julio de 2014

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2014

Publicado por primera vez (Estimar)

9 de julio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2018

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

16 de julio de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ECM4(i)06/05/2014

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

producto fabricado y exportado desde los 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. .

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Ensayos clínicos sobre Conventional training

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