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OpenTrials
Completed

NCT Number: NCT02783131

Does Mednav, a Medical Navigation System, Aid Non-technical and Technical Skills in the Simulated Obstetric Emergency?

It is well known that medical errors account for a large amount of patient harm within the hospital setting. This is a significant problem within the emergency context. A system that acts as a prompt, guide and scribe for the obstetric emergency has been developed called 'Mednav'. Mednav is a navigation device for the management of medical emergencies; developed at Chelsea and Westminster Hospital since 2010. This is a device which acts similar to a satellite navigation devices in the automobile industry navigating you from A to B, MedNav navigates the clinician from the unwell patient to the well patient.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Staff undertaking mandatory training at chelsea and westminster hospital

Exclusion criteria

  • Non Consenting.

Treatment and study plan

MedNav

Device

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 names: A decision support tool

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 26, 2016
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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