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The Effect of Structured Feedback on Live Surgical Performance (CSATS)

21 de octubre de 2022 actualizado por: George Washington University

The Effect of Structured Feedback on Live Surgical Performance: A Single-Blind Randomized Control Trial

This study seeks to establish the effect of regular structured feedback on surgical performance using crowd sourced video assessments with validated objective performance scores and time to complete a specific surgical procedure through a randomized controlled trial. The working hypothesis is that regular structured assessment will lead to a greater measurable improvement in performance, as defined by objective performance scores, than will traditional feedback methods.

Descripción general del estudio

Estado

Terminado

Descripción detallada

The American Association of Gynecologic Laparoscopists (AAGL) and Accreditation Council of Graduate Medical Education (ACGME) have endeavored to implement structure and standardization for the fellowship in minimally invasive gynecologic surgical programs (FMIGS) and obstetric and gynecology residency programs respectively. Educational objectives are explicitly delineated. Though the fellowship and residency educational objectives are well rounded, and include the development of skills to become leaders and educators in the field of minimally invasive gynecologic surgery (MIGS) and general obstetrics and gynecology, one of the main objective of the fellowship and residency training is the attainment of surgical skill. This is ensured by a requirement for a breadth of surgical exposure including vaginal surgery, hysteroscopy, traditional laparoscopy, management of surgical complications, minimally invasive hysterectomy, urogynecologic procedures, gastrointestinal surgery, urinary tract surgery, reproductive surgery, and the surgical management of common gynecologic conditions such as endometriosis. Minimum case requirements have been implemented to provide guidance for FMIGS and residency programs. In addition, trainees are required to log surgical cases and this information is utilized for FMIGS and residency program site inspections as well as for feedback of surgical competency. Despite standardization efforts by the AAGL and ACGME, the FMIGS and obstetric and gynecology residency curriculums are still in evolution. There is likely still great variation in surgical exposure between programs. In addition, though regular feedback is a requirement of training programs, the process is likely unstructured and subjective; based on case logs, self-assessments, and feedback by faculty surgeons. There is thus a critical need to develop a standardized, objective, timely, and actionable feedback methodology to facilitate program oversight and ensure FMIGS fellows and obstetrics and gynecology residents are achieving surgical competency throughout their training. In the absence of such structured feedback models, it will remain difficult to optimize FMIGS fellowship and obstetrics and gynecology resident training, and provide objective measurements of the impact of such training on surgical performance and patient outcomes. .

The long-term goal of this study is to assist in developing methods for surgical assessment that facilitate program oversight, allow fellows, residents, and program directors to identify specific skill sets in need of improvement, monitor progress in skill acquisition, and clearly and objectively document achievement of milestones throughout training. The study's overall objective is to determine how consistent structured feedback using crowd sourcing impacts time to complete a task as well as surgical performance as measured by GOALS and GEARS scores. The central hypothesis is that fellows and residents who receive consistent structured feedback over a sustained period of time will have shorter task times, overall improved performance, and greater satisfaction than fellows and residents receiving traditional feedback. The rationale for this work is that it will provide focus and supportive data for large-scale studies of surgical skill acquisition and development.

This study seeks to establish the effect of regular structured feedback on surgical performance using crowd sourced video assessments with GOALS and GEARS through a randomized controlled trial. The study hypothesizes regular structured assessment will lead to a greater measurable improvement in performance, as defined by change and GOALS and GEARS scores, than will traditional feedback methods as well as time to complete a specific procedure.

Tipo de estudio

Intervencionista

Inscripción (Actual)

47

Fase

  • No aplica

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

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • current position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
  • participants must be between 18 and 60 years of age

Exclusion Criteria:

  • persons not in a position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- persons not a FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
  • participants younger than 18 and older than 60 years of age

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control Group
Participants randomized to the Control Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the control group will receive traditional feedback methods as determined by each participant's training program. Subjects in the control group will repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
Experimental: Experimental Group
Participants randomized to the Experimental Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the experimental group will then receive feedback within 5 business days of video submission and repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
difference in mean time needed to perform cuff closure during hysterectomy
Periodo de tiempo: 6 weeks post study enrollment
The difference in mean time (measured in minutes) needed to perform vaginal cuff closure during hysterectomy between subjects in the control versus experimental groups.
6 weeks post study enrollment
difference in mean surgical performance score
Periodo de tiempo: 6 weeks post study enrollment
The difference in mean surgical performance score of a vaginal cuff closure at the time of hysterectomy between participants in the control versus experimental groups.
6 weeks post study enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
difference in trainee satisfaction with feedback method
Periodo de tiempo: 6 weeks post study enrollment
the difference in mean satisfaction score between participants in the control versus experimental groups
6 weeks post study enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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 (Actual)

1 de diciembre de 2016

Finalización primaria (Actual)

1 de febrero de 2019

Finalización del estudio (Actual)

1 de febrero de 2019

Fechas de registro del estudio

Enviado por primera vez

6 de diciembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

6 de diciembre de 2016

Publicado por primera vez (Estimar)

8 de diciembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de octubre de 2022

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

21 de octubre de 2022

Última verificación

1 de octubre de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 101614

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

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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