Plain English Summary
Background and study aims
Anaphylactic shock is a severe and potentially life-threatening reaction to a trigger such as an allergy. It is a rare medical situation and primary care doctors do not encounter it often. It needs to be recognised and managed quickly and appropriately, so it is essential that the doctor knows what to do and is confident in their knowledge. The aim of this study is to investigate whether using augmented reality simulation in training doctors how to recognize and manage a patient with anaphylactic shock will improve their confidence in managing these situations.
Who can participate?
Family medicine doctors
What does the study involve?
Participants will be randomly allocated to the test and control group. Both groups will receive one day of training on management of patients with anaphylactic shock. The test group will also receive additional training using augmented reality.
What are the possible benefits and risks of participating?
The benefits are learning in a safe environment to manage a patient with anaphylactic shock, allowing the doctors to recognise their own lack of knowledge, skills and competencies and being able to overcome them, recognise safety risks when managing such patients, learn to work in a team, learning to cope with the stress and perform well also under stress. The risks include exposing their knowledge, skills and competencies before other people. Also the training is potentially time-consuming.
Where is the study run from?
Community Health Centre Ljubljana (Slovenia)
When is the study starting and how long is it expected to run for?
September 2019 to February 2022 (updated 04/11/2020, previously: December 2021)
Who is funding the study?
The researchers are funding the study.
Who is the main contact?
Prof. Zalika Klemenc-Ketis, zalika.klemenc@um.si
Trial website
Contact information
Type
Scientific
Primary contact
Prof Zalika Klemenc-Ketis
ORCID ID
https://orcid.org/0000-0002-0270-1754
Contact details
Metelkova 9
Ljubljana
1000
Slovenia
+38641516067
zalika.klemenc@um.si
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1
Study information
Scientific title
The effect of the use of augmented reality in teaching anaphylactic shock management at the primary health care level: a randomised controlled trial
Acronym
Study hypothesis
Learning of the management of anaphylactic shock with the use of augmented reality is more effective than learning without this method.
Ethics approval
Current ethics approval as of 06/04/2020:
Approved 27/02/2020, Komisija Republike Slovenija za medicinsko etiko [National Ethics Committee of Slovenia] (Štefanova ulica 5, 1000 Ljubljana, Slovenia; +386 01 478 60 01; gp.mz@gov.si), ref: 0120-67/2020/7
Previous ethics approval:
Approval pending, the National Ethics Committee of Slovenia
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Learning the management of anaphylactic shock at the primary health care level
Intervention
The participants (family medicine physicians) will be classified into two groups on the basis of a random selection: test and control. Each participant will receive a consecutive number upon enrolling to the study. These numbers will then be used in a randomisation process using random numbers selection by the computer program.
Both groups will complete a questionnaire on demographic characteristics and coping with stress and manage a patient with anaphylactic shock (drug allergy shock) using a high-fidelity simulator. Thereafter, both groups will receive one-day training following a pre-prepared protocol.
The test team will have additional augmented reality education included in the training.
Immediately after completion of the training, both groups will complete a questionnaire on coping with stress and provide care to the patient with anaphylactic shock using a high-fidelity simulator. 6 and 12 months after the education, both groups will complete a stress response questionnaire and manage a patient with anaphylactic shock using a standardised patient, but this care will be provided in a clinical setting.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The management of a patient with anaphylactic shock. The evaluation will be done using the high-fidelity simulators with a pre-prepared scenario and with the use of a standardised patient with a pre-prepared scenario. The evaluation will be done before the education process, immediately after it, 6 months afterwards and 1 year afterwards.
Secondary outcome measures
Coping with stress assessed using the Ways of Coping Questionnaire (WCQ) before the education process, immediately after it, 6 months afterwards and 1 year afterwards
Overall trial start date
01/09/2019
Overall trial end date
01/02/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Family medicine physician
2. Willing to participate in the study
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
310 (150 in the test group and 160 in the control group).
Participant exclusion criteria
1. Students
2. Not willing to participate in the study
Recruitment start date
01/10/2020
Recruitment end date
01/02/2021
Locations
Countries of recruitment
Slovenia
Trial participating centre
Community Health Centre Ljubljana
Metelkova 9
Ljubljana
1000
Slovenia
Sponsor information
Organisation
Community Health Centre Ljubljana
Sponsor details
Metelkova 9
Ljubljana
1000
Slovenia
+38613003928
taj.irroz@zd-lj.si
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publications:
1. A protocol of the study (JMIR Research Protocols), in 2020.
2. A doctoral thesis in 2021.
3. The effect of using the augmented reality, in 2021.
4. Coping with stress (in 2021).
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
31/12/2022
Participant level data
Available on request
Basic results (scientific)
Publication list