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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
Sponsor:
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE May 13, 2016
First Posted Date  ICMJE May 26, 2016
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Mednav, a Medical Navigation System, Aid Non-technical and Technical Skills in the Simulated Obstetric Emergency?
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Postpartum Hemorrhage,
Intervention  ICMJE Device: MedNav
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
Study Arms  ICMJE
  • Experimental: MedNav
    Team getting taught to use mednav, and using mednav in simulation managing Post partum Haemorrhage.
    Intervention: Device: MedNav
  • No Intervention: non MedNav
    Team undergoing routine simulation training in Post Partum Haemorrhage.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
266
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Staff undertaking mandatory training at chelsea and westminster hospital

Exclusion Criteria:

  • Non Consenting.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02783131
Other Study ID Numbers  ICMJE C&W14/094
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chelsea and Westminster NHS Foundation Trust
Study Sponsor  ICMJE Chelsea and Westminster NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: shane p Duffy, MBCHB MRCOG Chelsea and Westminister NHS Foundation Trust
PRS Account Chelsea and Westminster NHS Foundation Trust
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP