- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04305886
Interprofessional Group Intervention to Promote Faculty Wellbeing and Engagement
Обзор исследования
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Massachusetts
-
Boston, Massachusetts, Соединенные Штаты, 02114
- Massachusetts General Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Intervention
Providers were placed in small groups and given the intervention of a discussion guide to facilitate discussion.
|
Written list of prompts to facilitate discussion
|
|
Без вмешательства: Control
Providers were placed in small groups and not given a discussion guide to facilitate discussion.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Burnout
Временное ограничение: 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
Временное ограничение: Change over the three month study period. Baseline measurement and immediately after final intervention.
|
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)
|
Change over the three month study period. Baseline measurement and immediately after final intervention.
|
|
Work Engagement
Временное ограничение: Change over the three month study period. Baseline measurement and immediately after final intervention.
|
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)
|
Change over the three month study period. Baseline measurement and immediately after final intervention.
|
|
Urine oxytocin
Временное ограничение: Two samples were taken one hour apart at baseline, and this was repeated three months later.
|
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.
|
Two samples were taken one hour apart at baseline, and this was repeated three months later.
|
|
Salivary Oxytocin
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Change over the three month study period. Baseline measurement and immediately after final intervention.
|
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)
|
Change over the three month study period. Baseline measurement and immediately after final intervention.
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2018P000415
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .