- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04305886
Interprofessional Group Intervention to Promote Faculty Wellbeing and Engagement
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Kein Eingriff: Control
Providers were placed in small groups and not given a discussion guide to facilitate discussion.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Burnout
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2018P000415
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Burnout, Profi
-
Fundacion Arturo Lopez PerezNoch keine RekrutierungBurnout Syndrom | Professioneller Burnout
-
Shengjing HospitalAktiv, nicht rekrutierendKarriere-Burnout | Burnout bei StudentenChina
-
The Fourth Hospital of ShijiazhuangAbgeschlossenProfessioneller BurnoutChina
-
Charite University, Berlin, GermanyBogomolets National Medical UniversityRekrutierung
-
Hasanuddin UniversityAbgeschlossenBurnout Syndrom | SelbstwirksamkeitIndonesien
-
University Hospital, Basel, SwitzerlandAbgeschlossen
-
Ankara Yildirim Beyazıt UniversityAnkara Etlik City HospitalRekrutierungBeruflicher Burnout | Kommunikationsfähigkeit | Emotionales BewusstseinTürkei (türkiye)
-
Second Affiliated Hospital, School of Medicine,...Noch keine RekrutierungBeruflicher Burnout
-
Region SkaneLund University; Swedish Council for Working Life and Social Research; County...Abgeschlossen
-
University of PadovaUniversity of ChileAbgeschlossen