- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03453879
Observation of Emergency Obstetrical Situations. (TeamOBS)
TeamOBS - Focuses on the Association Between Teamwork and Clinical Performance in Emergency Obstetrical Situations
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Background:
In obstetric emergency situations (OES) inadequate non-technical skills (NTS) are the leading causes of substandard care.
Aim:
Based on live audio and video (AV)-recordings of real (OES) the aim is to describes how the NTS and the clinical performance are related.
Method:
- Inclusion of the teams. OES teams from the delivery ward at two Danish hospitals, Aarhus University Hospital and Horsens Regional Hospital are AV-recorded are collected and saved for analyzing with consent from all participant.
- Develop a scoring tool to rate clinical performance in OES. 12 Ekspert Senior Obstetricians from different maternity units in Britain, Norway, Sweden, Denmark and Iceland volunteered to join the Delphi panel and develop a clinical performance tool.
- Rate clinical performance. Using the developed tool in 2) to rate live teams
- Rate NTS Recording of teams will be rated by the validated list: Assessment of Obstetric Team Performance with the validated tool from Pamela Morgan: AOTP. Furthermore important observations will be code. Video assessments is planned for 2016-2018
- Explore the association between clinical performance and NTS in OES. Results from 3) and 4) will be compared.
Discussion:
We expect that this study will add to the knowledge of NTS and the effect on clinical performance in OES.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
DK
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Aarhus, DK, Danmark, 8200
- Aarhus University Hospital Skejby
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Horsens, DK, Danmark, 8700
- Horsens Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Video recordings of emergency situations in simulation aswell live will include management of every day situations as well as rare emergencies, with the inclusion criteria of obstetric teamwork: >2 healthcare personal present and one of them an obstetrician. The five situations in are study are the following:
- Eclampsia,
- Post-partum haemorrhage,
- New -born resuscitation (Apgar ≤ 7/5 min),
- Shoulder dystocia and
- Instrumental delivery. The situation can be included if a video recording is capture of the event and all participant in the video have given informed consent.
Exclusion Criteria:
Absent informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
1: Study population
Participants in this study are working staff (junior and senior doctors, midwifes and other health personal) in the maternity wards of two hospitals in Central Region Denmark: Horsens Regional Hospital and Aarhus University Hospital, Skejby.
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No intervention - only observation of teams delivering acute obstetric care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical performance
Tidsramme: 15. october 2014 - 20. May 2016
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Clinical performance is assessed by video raters, using a checklist TeamOBS-tool
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15. october 2014 - 20. May 2016
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Blood loss
Tidsramme: 15. october 2014 - 20. May 2016
|
Blood loss measured and verbalized by the emergency team.
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15. october 2014 - 20. May 2016
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Niels Uldbjerg, MD.PHD, University of Aarhus
- Ledende efterforsker: Ole Kierkegaard, MD, Horsens Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1 (Mobile Health and Wellness Program)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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