Video Debriefing at the Delivery Ward
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Video debriefing
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Women with major postpartum hemorrhage (1.0 liter or more).
Exclusion Criteria:
- Language difficulties requiring an interpreter or translator
Sites / Locations
- Aarhus University Hospital
- Horsens Regional Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention - Video debriefing
Arm Description
Baseline period (year 1): Standard practice. Intervention period (year 2-3): All teams will be assigned to video debriefing.
Outcomes
Primary Outcome Measures
Clinical performance
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)
Secondary Outcome Measures
Non-technical performance
Videos will be assessed by raters using the AOTP checklist.
Maternal birth characteristics. Time of day.
- Day/Night
Maternal birth characteristics. Blood loss.
- Total blood loss (ml)
Maternal birth characteristics. GA.
- Gestational age
Maternal birth characteristics. Birth length (>18 hours).
- Yes/No
Maternal birth characteristics. Epidural
- Yes/No
Maternal birth characteristics. Oxytocin.
- Yes/No
Maternal birth characteristics. Induction.
- Yes/No
Maternal birth characteristics. Twin pregnancy.
- Yes/No
Maternal characteristics additional. Age.
- Years
Maternal characteristics additional. BMI.
- BMI
Maternal characteristics additional. Previous postpartum hemorrhage.
- Yes/No
Maternal characteristics additional. Previous births
- Number
Team characteristics. Team size.
- Number of team members involved
Team characteristics. Hospital.
- Regional / University
Neonatal characteristics. Mean birth weight.
- Grams
Implementation of video debriefing
Number of debriefing sessions performed (in total / per participant / failed attempted sessions).
Full Information
NCT ID
NCT04646486
First Posted
November 12, 2020
Last Updated
May 9, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Horsens Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04646486
Brief Title
Video Debriefing at the Delivery Ward
Official Title
Video Debriefing at the Delivery Ward - Empowering Obstetric Teams to High Performance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Horsens Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Data - videos of team performance - will be included as follows:
Year 1) Baseline. Video inclusion, before introducing real-life video debriefings of team performance (n=200).
Year 2) During the start-up of the debriefings (n=20) which will be evaluated in a feasibility study.
Year 2-3) Intervention. After real-life video debriefings have been introduced as standard procedure (n=200).
Masking
None (Open Label)
Masking Description
Videos from baseline period and intervention period will be mixed and assessed at the end of the study. The raters will be blinded to which period the video originates from
Allocation
N/A
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention - Video debriefing
Arm Type
Experimental
Arm Description
Baseline period (year 1): Standard practice. Intervention period (year 2-3): All teams will be assigned to video debriefing.
Intervention Type
Behavioral
Intervention Name(s)
Video debriefing
Intervention Description
Obstetric teams will review their own performance on video in a debriefing session to improve future performance.
Primary Outcome Measure Information:
Title
Clinical performance
Description
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)
Time Frame
All videos will be assessed 2.5 years (autumn 2023)
Secondary Outcome Measure Information:
Title
Non-technical performance
Description
Videos will be assessed by raters using the AOTP checklist.
Time Frame
All videos will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. Time of day.
Description
- Day/Night
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. Blood loss.
Description
- Total blood loss (ml)
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. GA.
Description
- Gestational age
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. Birth length (>18 hours).
Description
- Yes/No
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. Epidural
Description
- Yes/No
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. Oxytocin.
Description
- Yes/No
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. Induction.
Description
- Yes/No
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal birth characteristics. Twin pregnancy.
Description
- Yes/No
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal characteristics additional. Age.
Description
- Years
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal characteristics additional. BMI.
Description
- BMI
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal characteristics additional. Previous postpartum hemorrhage.
Description
- Yes/No
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Maternal characteristics additional. Previous births
Description
- Number
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Team characteristics. Team size.
Description
- Number of team members involved
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Team characteristics. Hospital.
Description
- Regional / University
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Neonatal characteristics. Mean birth weight.
Description
- Grams
Time Frame
Data will be assessed 2.5 years (autumn 2023)
Title
Implementation of video debriefing
Description
Number of debriefing sessions performed (in total / per participant / failed attempted sessions).
Time Frame
Data will be assessed 2.5 years (autumn 2023)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with major postpartum hemorrhage (1.0 liter or more).
Exclusion Criteria:
Language difficulties requiring an interpreter or translator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Horsens Regional Hospital
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The final dataset will be publicly available in an anonymized form using an open data repository.
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
Interested parties will be able to request the data by contacting the trial sponsor.
Citations:
PubMed Identifier
30771263
Citation
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.
Results Reference
result
PubMed Identifier
29485679
Citation
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.
Results Reference
result
Learn more about this trial
Video Debriefing at the Delivery Ward
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