- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04305886
Interprofessional Group Intervention to Promote Faculty Wellbeing and Engagement
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
To test the hypothesis that an intervention involving self-facilitated interprofessional group meetings would result in improvement in wellbeing and to determine whether use of a written curriculum provided increased benefit, the following study is conducted:
Practicing clinical faculty in the Department of Obstetrics and Gynecology at the Massachusetts General Hospital were recruited to participate in three monthly small groups over dinner. Participants were randomized to a control group, which met without any specified guidelines for discussion content, or to receive an intervention which consisted of a one-page discussion guide addressing themes relevant to challenges in the healthcare environment: reframing challenging patient interactions; embracing uncertainty in work; and coping with errors, near misses, and bad outcomes. Outcomes included burnout, empowerment and engagement in work, stress from uncertainty assessed using validated metrics, and perception of of collegiality and community.
All participants were also offered the option of participating in evaluation of biomarkers. To test the hypothesis that an increased sense of bonding and relational connection, and reduced stress levels would be reflected by changes in hormone levels during the meeting and over the course of the study. Faculty who opted into this portion of the study gave the following samples:
Urine Oxytocin before and after the first and third group meetings Salivary Oxytocin before and after the first and third group meetings Salivary Cortisol before and after the first and third group meetings Hair Cortisol at the beginning of the study and at the end of the study (a roughly three month interval).
An optional focus group was conducted after the three monthly sessions.
All participants signed a consent form prior to participating in the study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Physican in the Department of Obstetrics and Gynecology at Massachusetts General Hospital
- Nurse Practitioner in the Department of Obstetrics and Gynecology at Massachusetts General Hospital
- Certified Nurse Midwife in the Department of Obstetrics and Gynecology at Massachusetts General Hospital
Exclusion Criteria:
- None
Plan de estudios
¿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 |
---|---|
Experimental: Intervention
Providers were placed in small groups and given the intervention of a discussion guide to facilitate discussion.
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Written list of prompts to facilitate discussion
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Sin intervención: Control
Providers were placed in small groups and not given a discussion guide to facilitate discussion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Burnout
Periodo de tiempo: Change over the three month study period. Baseline measurement and immediately after final intervention.
|
Change from baseline in 2 item Maslach Burnout Inventory scores before and after the intervention. Minimum score: 2; Maximum score: 14 Higher score = more burnt out (worse outcome) |
Change over the three month study period. Baseline measurement and immediately after final intervention.
|
Stress from Uncertainty
Periodo de tiempo: Change over the three month study period. Baseline measurement and immediately after final intervention.
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Change in scores on Physician Response to Uncertainty Scale before and after intervention Minimum score: 6; Maximum score: 90 Higher score = increased stress due to uncertainty (worse outcome)
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Change over the three month study period. Baseline measurement and immediately after final intervention.
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Work Engagement
Periodo de tiempo: Change over the three month study period. Baseline measurement and immediately after final intervention.
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Change in scores on Utrecht Work Engagement Scale before and after intervention Minimum score: 0; Maximum score: 54 Higher score = higher engagement at work (better outcome)
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Change over the three month study period. Baseline measurement and immediately after final intervention.
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Urine oxytocin
Periodo de tiempo: Two samples were taken one hour apart at baseline, and this was repeated three months later.
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Change from baseline in the level of urine oxytocin before and after each intervention.
This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting.
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Two samples were taken one hour apart at baseline, and this was repeated three months later.
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Salivary Oxytocin
Periodo de tiempo: Two samples were taken one hour apart at baseline, and this was repeated three months later
|
Change from baseline in the level of salivary oxytocin before and after each intervention.
This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting.
|
Two samples were taken one hour apart at baseline, and this was repeated three months later
|
Salivary Cortisol
Periodo de tiempo: Two samples were taken one hour apart at baseline, and this was repeated three months later
|
Change from baseline in the level of salivary cortisol before and after each intervention.
This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting.
|
Two samples were taken one hour apart at baseline, and this was repeated three months later
|
Hair Cortisol
Periodo de tiempo: Change over the three month study period. Baseline measurement and immediately after final intervention.
|
Change from baseline in hair cortisol levels.
Maximum and minimum levels are not known and any change up or down is interesting.
|
Change over the three month study period. Baseline measurement and immediately after final intervention.
|
Work Empowerment Scale
Periodo de tiempo: Change over the three month study period. Baseline measurement and immediately after final intervention.
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Minimum score: 12; Maximum score: 84 Change from baseline on Work Empowerment Scale before and after intervention.
Higher score = higher empowerment at work (better outcome)
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Change over the three month study period. Baseline measurement and immediately after final intervention.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018P000415
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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-
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