- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646486
Video Debriefing at the Delivery Ward
Video Debriefing at the Delivery Ward - Empowering Obstetric Teams to High Performance
Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality worldwide. Successful management of postpartum hemorrhage requires not only administration of the right medicine, but also a rapid and coordinated response from a multi-professional team. A prerequisite for this is that the individuals are well trained, which the investigators believe can be improved by video debriefing of real-life events.
The purpose of this study is to improve obstetric teams management of postpartum hemorrhage using video recordings of real-life events in post event debriefings.
Cameras are placed in the ceiling of all delivery rooms to record obstetric teams' management of postpartum hemorrhage. Video recording requires informed consent from all participants. After an event, the team will review their own performance on video in a debriefing session to improve future performance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Video review was first introduced in healthcare in the 1980s to improve emergency teams' management of critical situations by having them review their own performance on video in a debriefing session. Video debriefing offers an opportunity to review the care delivered in high-stake, high-risk, and time-critical situations. Video debriefing has been found to improve the performance of neonatal resuscitation teams and trauma teams; however, video debriefing has not generally been accepted in the delivery ward. A recent PhD project developed a method for systematically filming obstetric emergencies, in two Danish hospitals, where informed consent had been obtained from all participants. In addition, the project developed a method for systematically assessing obstetric teams' clinical performance during postpartum hemorrhage
The aim of the study is to examine the effect of real-life video debriefing on obstetric teams' management of major postpartum hemorrhage.
Material and methods:
The study will be conducted at two Danish hospitals, Aarhus University Hospital (5,000 deliveries per year) and Horsens Regional Hospital (2,300 deliveries per year).
All delivery rooms have been equipped with an automatic recording system that enables filming of all postpartum hemorrhage. Video recording requires informed consent from all participants. Women expecting to deliver will be invited to provide informed consent for video recording. If a woman declines the invitation, the cameras will be covered up according to our protocol. If video recording occurs, all participants will be asked to give informed consent again.
Video debriefing will be conducted by educated facilitators of debriefing. Debriefings will follow a protocol and will focus on teams' clinical performance and non-technical skills. The main focus of the debriefing protocol will be clinical debriefing with a main goal of improving clinical performance and patient care.
Videos will be included as follows: 1) Baseline video inclusion, before introducing real-life video debriefings of team performance; 2) During the start-up of the debriefings in an exploratory study; 3) After real-life video debriefings have been introduced as standard procedure.
Perspectives:
This project is the first to evaluate the implementation, feasibility and use of real-life video debriefing in obstetric care. Results from this project can revolutionize the ability to learn from clinical cases and can guide how video can be introduced in ways acceptable to women, relatives and healthcare providers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus N, Denmark, 8200
- Aarhus University Hospital
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Horsens, Denmark, 8700
- Horsens Regional Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women with major postpartum hemorrhage (1.0 liter or more).
Exclusion Criteria:
- Language difficulties requiring an interpreter or translator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention - Video debriefing
Baseline period (year 1): Standard practice.
Intervention period (year 2-3): All teams will be assigned to video debriefing.
|
Obstetric teams will review their own performance on video in a debriefing session to improve future performance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical performance
Time Frame: All videos will be assessed 2.5 years (autumn 2023)
|
Videos will be assessed by raters using the TeamOBS-PPH checklist (Brogaard L et al, Development of the TeamOBS-PPH - targeting clinical performance in postpartum hemorrhage, 2018)
|
All videos will be assessed 2.5 years (autumn 2023)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-technical performance
Time Frame: All videos will be assessed 2.5 years (autumn 2023)
|
Videos will be assessed by raters using the AOTP checklist.
|
All videos will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. Time of day.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Day/Night
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. Blood loss.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Total blood loss (ml)
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. GA.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Gestational age
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. Birth length (>18 hours).
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Yes/No
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. Epidural
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Yes/No
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. Oxytocin.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Yes/No
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. Induction.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Yes/No
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal birth characteristics. Twin pregnancy.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Yes/No
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal characteristics additional. Age.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Years
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal characteristics additional. BMI.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- BMI
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal characteristics additional. Previous postpartum hemorrhage.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Yes/No
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Maternal characteristics additional. Previous births
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Number
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Team characteristics. Team size.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Number of team members involved
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Team characteristics. Hospital.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Regional / University
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Neonatal characteristics. Mean birth weight.
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
- Grams
|
Data will be assessed 2.5 years (autumn 2023)
|
|
Implementation of video debriefing
Time Frame: Data will be assessed 2.5 years (autumn 2023)
|
Number of debriefing sessions performed (in total / per participant / failed attempted sessions).
|
Data will be assessed 2.5 years (autumn 2023)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Brogaard L, Kierkegaard O, Hvidman L, Jensen KR, Musaeus P, Uldbjerg N, Manser T. The importance of non-technical performance for teams managing postpartum haemorrhage: video review of 99 obstetric teams. BJOG. 2019 Jul;126(8):1015-1023. doi: 10.1111/1471-0528.15655. Epub 2019 Mar 27.
- Brogaard L, Hvidman L, Hinshaw K, Kierkegaard O, Manser T, Musaeus P, Arafeh J, Daniels KI, Judy AE, Uldbjerg N. Development of the TeamOBS-PPH - targeting clinical performance in postpartum hemorrhage. Acta Obstet Gynecol Scand. 2018 Jun;97(6):677-687. doi: 10.1111/aogs.13336. Epub 2018 Apr 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEAMOBS Intervention
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Study protocol is available at the projects homepage www.teamobs.dk.
Trial related documents and data will be available when results are published and until three years after publication of the last study results.
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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