NCT04361084

Brief Summary

The scope of this project is to identify if mixed reality (MR) can support simulating the complexities of differing community environments compared to traditional physical structure simulated environments. Concurrent with this, the aim is to establish if mixed reality can produce a safe learning and reflective environment for community staff to develop their skills. This could potentially improve patient outcome and support healthcare teams to deliver safe effective care. Evidence suggests that simulation based learning improves confidence; although there is limited research available that combines simulation based learning and mixed reality. As mixed reality could provide high fidelity simulations, it is an area which requires much needed research.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

April 7, 2020

Last Update Submit

September 21, 2020

Conditions

Keywords

trainingstaffcommunity care

Outcome Measures

Primary Outcomes (1)

  • Evaluate participant confidence following simulated scenario training

    Any difference in participants level of learning and confidence following traditional classroom based simulation of clinical community scenarios using actors compared with simulation of scenarios using mixed reality (virtual reality) technology. Assessment using semi structured interviews (N.B no measurement scales involved)

    1 year

Secondary Outcomes (1)

  • is mixed reality more adaptable and realistic compared to traditional physical (classroom) based simulation environments

    1 year

Study Arms (2)

traditional training

ACTIVE COMPARATOR

Participants will undertake the Community simulation using traditional methods, physical items to recreate the community environment. Training will be in pairs and will play the role of their own profession when undertaking simulated scenarios. Medium to low fidelity traditional simulation techniques involving scenarios played out using actors as (standardised patients) to participants. Following a briefing, the participants will be asked a series of questions prior to the simulation to establish their profession, age and level of previous training achieved so this can be compared against the results and are anonymous. They will also complete their pre-questionnaire which will anonymous. Afterwards participants undertake a post-questionnaire and then asked if they wish to take part in a semi-structured interview.

Other: traditional simulated training

mixed reality simulation training

EXPERIMENTAL

Participants will undertake a mixed reality (MR) simulation training session set in two home situations; involving immersive virtual reality equipment. Participants will be asked a series of questions prior to the simulation to establish their profession, age and level of previous training achieved so this can be compared against the results. The participants will then undertake the simulation watched via live camera by the simulation technician, simulation fellow and a community specialist. Participants will undertake a post simulation questionnaire and then asked if they wish to take part in a semi-structured interview (optional).

Other: mixed reality simulation

Interventions

traditional simulation using actors as standardised patients playing out scenarios plus pre and post questionnaires and semi structured interviews

traditional training

using immersive technologies to create a virtual reality simulated training scenario's plus pre an post questionnaires and semi structured interview's

mixed reality simulation training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants need to be full or part time healthcare staff that work within the community setting, patients own homes.
  • These participants can be registered or non-registered staff but needs to be clinical members of staff
  • Staff will be from various professions, including nurses, occupational therapists, physiotherapists, assistant practitioners and support workers. Relying on volunteers, the study is unlikely to have an even representation of all professions, especially bearing in mind numbers of staff within each profession (proportionately more healthcare support workers than specialist therapist).
  • Participants need to be employed, whether full time/part time or on the bank by Torbay and South Devon to be able to participate in this study.
  • As this is only for staff employed by the local trust, this will mean no one under the age of 18 will be included in this study and those staff who are over the age of 80 will also be excluded, as the Trust doesn't employ clinical healthcare professions outside of these age limits.
  • Only healthcare professionals who have given implied consent will be included.

You may not qualify if:

  • Any individuals who do not work with patients or services users within a community setting (patient's own homes or residential/nursing homes). This will mean non-clinical staff members will be excluded.
  • Participants under the age of 18 and above 80 years old.
  • Participants who are unable to provide informed consent.
  • Participants who have one of the following health conditions will be excluded: Conjunctivitis, Pregnant (5 months+), Corneal Ulcers, Ear infections/ear disease, Corneal Infections, Influenza, "Dry Eye", Head Cold, Iritis, Respiratory Ailments, Cataracts or Glaucoma, Cochlear Implants or other Inner Ear/Vestibular-Related Conditions (e.g.Labyrinthitis). Also anyone that is under the influence of alcohol or drugs on the simulation day. This is due to the unknown research of MR with participants who have medical conditions that could be affected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This feasibility study involves staff within the host Trust. Staff booking into the training will select available dates. These dates have been randomly assigned (not visible on booking to participants) to do traditional or virtual reality simulation training. Only on attending the actual training day will participants find out which training allocation they will undertake.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 24, 2020

Study Start

November 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share