- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04305886
Interprofessional Group Intervention to Promote Faculty Wellbeing and Engagement
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Žádný zásah: Control
Providers were placed in small groups and not given a discussion guide to facilitate discussion.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Burnout
Časové okno: 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
Časové okno: 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)
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Change over the three month study period. Baseline measurement and immediately after final intervention.
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Work Engagement
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2018P000415
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