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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04361084
Other study ID # 264392
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date April 30, 2021

Study information

Verified date September 2020
Source Torbay and South Devon NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. Simulation is a technique for practice and learning to replace and amplify real experiences with guided ones, and are often immersive in nature. Simulation is a safe, learning environment, that encourages participants to reflect on the situation. Mixed reality is the merging of real and virtual worlds to produce new environment and visualisation where physical and digital objects can co-exist and interact in real time.

For sustainability of the health and social care sector, the long term aim is to facilitate people's healthcare needs in the community. Such increased community services will require staff with holistic skills to work as independent practitioners. Simulation in the acute setting is currently provided by the simulation team in the Trust's dedicated simulation suite, and through in-situ simulations within individual departments. The scenarios for these simulations can be created due to the repetitive and clinical nature of the environments required. Since becoming an integrated care organisation, the need to provide simulation based learning to all staff, including those who are out in community settings has arisen. In order to create a realistic learning environment for community based staff, there is a need to recreate an individual's home, accounting for all of the different environments the investigator's patients live in, such as a small residence with tight spaces, differing levels of cleanliness and the addition of pets, which is very difficult using traditional simulation methods. The need to develop an innovative way of delivering community based simulation is therefore important, to allow all staff access to valuable simulation based learning while providing a safe and supportive environment to practice both technical and non-technical skills.

The investigator proposes to run two simulations per week resulting in undertaking a total of 34 simulations. One of these will be using traditional methods of simulation, and the other will be using mixed reality. Using traditional methods, physical items will be used to recreate the community environment. It can be costly, time consuming and difficult to achieve the desired environment. Mixed reality provides the option of quickly immersing participants into different environments,allowing participants to experience all of the features. This makes it a very useful to method to compare to traditional methods of simulation, as the outcomes could be potentially be more realistic. The investigator will use questionnaires to get feedback from participants, both before, and after they have taken part in the simulation. This feedback will be used to determine if participants feel more confident and competent from traditional methods of simulation or mixed reality based simulation. It will also assess which environment they feel creates a more realistic environment to learn in. Qualitative data will be collected by those participants who choose to take part in a semi-structured interview. Alongside collecting data from participants the simulation technicians will also be asked via a face to face approach to attend a semi-structured interview regarding the feasibility and adaptable of both simulations. This is voluntary. As although participants feedback is important it is also essential that the technician feedback is included as they will be the ones that have to assist with running the simulations. The semi-structured interviews will be undertaken similar to participants semi-structured interviews, with written consent forms, recording of interview and confidentiality. However the questions will be different. They will be given a participant information sheet when they are approached. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
traditional simulated training
traditional simulation using actors as standardised patients playing out scenarios plus pre and post questionnaires and semi structured interviews
mixed reality simulation
using immersive technologies to create a virtual reality simulated training scenario's plus pre an post questionnaires and semi structured interview's

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Torbay and South Devon NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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 is mixed reality more adaptable and realistic compared to traditional physical (classroom) based simulation environments Assessment using semi structured interviews (N.B no measurement scales involved) 1 year
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