NCT02783131

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

May 13, 2016

Last Update Submit

May 25, 2016

Conditions

Keywords

inventionsSimulation TrainingPostpartum HaemorrhageNon Technical SkillsteamworkCrew Resource Management, Healthcare

Outcome Measures

Primary Outcomes (3)

  • Clinical Teamwork Scale

    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.

    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.

  • Global Assessment of Team Performance

    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).

    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.

  • Technical Skill Achievement and timing

    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.

    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.

Secondary Outcomes (1)

  • System Usability Score

    From date of randomisation to 72 weeks, each simulation participant using mednav will answer the questionaire which will take 10 minutes.

Study Arms (2)

MedNav

EXPERIMENTAL

Team getting taught to use mednav, and using mednav in simulation managing Post partum Haemorrhage.

Device: MedNav

non MedNav

NO INTERVENTION

Team undergoing routine simulation training in Post Partum Haemorrhage.

Interventions

MedNavDEVICE

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.

Also known as: A decision support tool
MedNav

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Staff undertaking mandatory training at chelsea and westminster hospital

You may not qualify if:

  • Non Consenting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • shane p Duffy, MBCHB MRCOG

    Chelsea and Westminister NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 26, 2016

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 26, 2016

Record last verified: 2016-05