EducationNCT04361084
Community Simulation Utilising Mixed Reality (MR)
A study testing traditional simulated training and mixed reality simulation in people with Education, run by Torbay and South Devon NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Education
- What is being tested?
- traditional simulated training and mixed reality simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: To Identify if Mixed Reality Can Produce a Realistic and Adaptable Community Environment for Simulation Compared to Traditional Simulation Techniques.
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.
Read the detailed 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.
- Conditions
- Education
- Being tested
- traditional simulated training, mixed reality simulation
- Keywords
- training, staff, community care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional simulated trainingOther
traditional simulation using actors as standardised patients playing out scenarios plus pre and post questionnaires and semi structured interviews
mixed reality simulationOther
using immersive technologies to create a virtual reality simulated training scenario's plus pre an post questionnaires and semi structured interview's
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: mixed reality simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (1)
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Torbay and South Devon NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361084
- Sponsor's protocol ID
- 264392
- Status last verified
- Sep 2020
- First submitted
- 7 Apr 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Identify if Mixed Reality Can Produce a Realistic and Adaptable Community Environment for Simulation Compared to Traditional Simulation Techniques.
- ClinicalTrials.gov ID
- NCT04361084
- Acronym / sponsor ID
- 264392
- Conditions
- Education
- Keywords
- training, staff, community care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Torbay and South Devon NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| traditional training | Active comparator | Other: traditional simulated trainingParticipants 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. |
| mixed reality simulation training | Experimental | Other: mixed reality simulationParticipants 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants need to be full or part time healthcare staff that work within the community setting, patients own homes.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional simulated trainingtraditional simulation using actors as standardised patients playing out scenarios plus pre and post questionnaires and semi structured interviews | Other | traditional training |
| mixed reality simulationusing immersive technologies to create a virtual reality simulated training scenario's plus pre an post questionnaires and semi structured interview's | Other | mixed reality simulation training |
Primary outcome
Evaluate participant confidence following simulated scenario training
Time frame: 1 year
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 secondary outcome
is mixed reality more adaptable and realistic compared to traditional physical (classroom) based simulation environments
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing traditional simulated training and mixed reality simulation in people with Education, run by Torbay and South Devon NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate participant confidence following simulated scenario training (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.