- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03453879
Observation of Emergency Obstetrical Situations. (TeamOBS)
TeamOBS - Focuses on the Association Between Teamwork and Clinical Performance in Emergency Obstetrical Situations
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical performance
Tidsramme: 15. october 2014 - 20. May 2016
|
Clinical performance is assessed by video raters, using a checklist TeamOBS-tool
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15. october 2014 - 20. May 2016
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Niels Uldbjerg, MD.PHD, University of Aarhus
- Hovedetterforsker: Ole Kierkegaard, MD, Horsens Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1 (Mobile Health and Wellness Program)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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