Does Mednav, a Medical Navigation System, Aid Non-technical and Technical Skills in the Simulated Obstetric Emergency?
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|ClinicalTrials.gov Identifier: NCT02783131|
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : May 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage,||Device: MedNav||Not Applicable|
Potential participants will be identified by those attending mandatory training/teaching. 2 weeks before their mandatory training they will be emailed with the study information leaflet and a link to a video which explains how to use Mednav. On the morning of the mandatory training/teaching they will be approached by the practice development midwife/Chief or Principle investigator who will give them a copy of the consent form and again the study information leaflet and show the Mednav video. Eligibility criteria will be checked and the study explained, before taking written informed consent.
Participants will personally sign and date the consent form, before any study specific procedures are performed.
Once the team is decided, the investigators will then randomise them to use of Mednav or no mednav, The participants will then undertake a simulated management of post partum haemorrhage which will be recorded for later review. Faculty will record the timing of completion of key technical skills.
A team of 8 assessors will review these simulated scenario recordings. Assessors will complete validated questionnaires to assess teamwork. Assessors will be asked to complete a technical skills list, showing timing and completion of various technical aspects of managing post partum Haemorrhage.
The end of the study will be when the required sample size has been recruited or significance found on interim data analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Team getting taught to use mednav, and using mednav in simulation managing Post partum Haemorrhage.
MedNav is a tablet based platform device that acts to help teams manage emergencies. In the way that satellite navigation devices have replaced maps on journeys mednav has replaced paper based checklist and guidelines to give teams real-time guidance as the emergency happens. In supports teams by deligating, prompting and scribing as the emergency unfolds. The intervention arm will be taught how to use this device over 30 minutes and then use it in a simulated scenario managing a post partum haemorrhage.
Other Name: A decision support tool
No Intervention: non MedNav
Team undergoing routine simulation training in Post Partum Haemorrhage.
- Clinical Teamwork Scale [ Time Frame: From date of randomisation to 72 weeks, each video will last 20 minutes. Assessors will review the videos at 12 weekly intervals at a sessions that last for up to 3 hours. ]A 15 point clinical teamwork scale that measures teamwork. This has separate points of: overall team work, communication, situation awareness, decision making, role responsibility, patient friendly. Scores for each section are between 0-10. 0 unacceptable, 1-3 Poor, 4-6 Average, 7-9 Good, 10 perfect. Validated for 3 assessors.
- Global Assessment of Team Performance [ Time Frame: From date of randomisation to 72 weeks, each video will last 20 minutes. Assessors will review the videos at 12 weekly intervals at a sessions that last for up to 3 hours. ]A 6 point scoring system with these subsections: Communication with patient and partner, Task management, Teamwork, Situational Awareness,Communication, Environment of Room. Each section is measured on a 5 point rating scale (1 poor performance, 5 excellent performance).
- Technical Skill Achievement and timing [ Time Frame: From date of randomisation to 72 weeks, each video will last 20 minutes. Assessors will review the videos at 12 weekly intervals at a sessions that last for up to 3 hours. ]A set of 11 key skills for managing a post partum haemorrhage. Massive obstetric haemorrhage call, Explore trauma, Palpate uterus, Examine placenta, IV Fluids started, Uterotonic started, Bloods taken and sent, Foley Cather inserted, Bimanual compression commenced, Blood transfusion commenced, Decision to move to theatre. Completion and time since emergency buzzer completion. This will be in the form of a table, which will include the skill and the time at which each skill is achieved. These timings will be recorded by the faculty of the simulation session.
- System Usability Score [ Time Frame: From date of randomisation to 72 weeks, each simulation participant using mednav will answer the questionaire which will take 10 minutes. ]A validated usability score that gives results that can be interoperated into how 'usable' MedNav is.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783131
|Study Director:||shane p Duffy, MBCHB MRCOG||Chelsea and Westminister NHS Foundation Trust|