- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04305886
Interprofessional Group Intervention to Promote Faculty Wellbeing and Engagement
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Aucune intervention: Control
Providers were placed in small groups and not given a discussion guide to facilitate discussion.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Burnout
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2018P000415
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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