Out-Of-Hospital Cardiac ArrestNCT04085692
Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training
A study testing Low-Dose, High-Frequency Simulation-Based Training in people with Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
Trial summary
Clear, concise, yes, and no answers can be challenging to achieve in the assessment of consciousness and breathing in out-of-hospital cardiac arrest (OHCA) calls. Often callers will provide an unclear response, and this can lead to hesitation on the part of the Emergency Medical Dispatcher (EMD). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Low-Dose, High-Frequency Simulation-Based Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Sep 2019to 25 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- EMD employed at the Copenhagen EMS at the time of enrolment.
Who cannot join
- Mean working time as call taker at Copenhagen EMS < 8 hours/week.
- Planned employment cessation at the Copenhagen EMS during the data collection period.
- Planned leave from work longer than four weeks during the data collection period.
- Starting employment at the Copenhagen EMS during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dispatcher-Assisted Cardiopulmonary Resuscitation: A Randomized Controlled Trial of Low-Dose, High-Frequency Simulation-Based Training and the Impact on Real Out-of-Hospital Cardiac Arrest Calls
Clear, concise, yes, and no answers can be challenging to achieve in the assessment of consciousness and breathing in out-of-hospital cardiac arrest (OHCA) calls. Often callers will provide an unclear response, and this can lead to hesitation on the part of the Emergency Medical Dispatcher (EMD). Further, the relatively small proportion OHCA calls represent might demand the need for simulation training in the dispatcher-assisted cardiopulmonary resuscitation (DA-CPR) guiding itself. Therefore, the investigators investigate whether low-dose, high-frequency (LDHF) simulation-based training of EMDs can increase the quality of DA-CPR in a simulation setting. Additionally, the investigators measure whether the effect of the training will be transferred to real OHCA calls.
The study is a randomised controlled trial comparing LDHF simulation-based training to standard quality improvement of the EMD in a single centre. The study protocol is structured according to the SPIRIT 2013 statement, and the study will be reported in compliance with the CONSORT 2010 Statement. The investigators chose EMDs receiving standard quality improvement as the comparator group, to reflect a representative cohort of the EMDs not exposed to the LDHF simulation-based training program.
Read more
The aims of this study are:
- To measure the effect of LDHF simulation-based training on the quality of DA-CPR in a simulation setting.
- To measure the effect of LDHF simulation-based training on the quality of DA-CPR in real OHCA calls.
The investigators hypothesise that LDHF simulation-based training will increase the quality of DA-CPR in the intervention group in a simulation setting and that this improvement is transferred to real OHCA calls - although the effect in real OHCA calls might be smaller due to the complexity of some calls. The investigators hypothesise that this improvement can be detected as a decrease in time to first bystander compression (TTFC), an increase in clarification of consciousness and breathing without asking additional questions, a decrease in time to recognition of cardiac arrest, and an increase in calls where the EMD provide DA-CPR instructions on patients in cardiac arrest.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Low-Dose, High-Frequency Simulation-Based Training
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose, High-Frequency Simulation-Based TrainingBehavioural
Twelve weeks of LDHF training
The simulation-based training sessions take place at the EMDC, at extra workstations set-up as ordinary EMD workstations in an out-of-the-way area. Before each session, the EMD is informed about the simulation call and receives instructions concerning technical differences from a regular call. The instructor acts as a "standardised caller", guided by a computer program. This program, the Danish version of Resuscitation Quality Improvement for Telecommunicators (Laerdal Medical AS, Stavanger, Norway), is a training program for DA-CPR based on the simulation platform Laerdal Learning Application. This modified version of the RQI-T program has, one test scenario, one data collection scenario and six different cardiac arrests scenarios as well as a feedback checklist based on the Danish dispatcher protocol Danish Index for Emergency Care.
Each simulation session takes approximately 20 minutes, including introduction and feedback
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group begins LDHF dispatcher training with one introduction week followed by twelve weeks of LDHF training.
During the study period, all regular quality improvement (QI) activities, such as self-audits, case reviews, mentor groups, and status meetings will continue for all EMDs. Receives: Behavioral: Low-Dose, High-Frequency Simulation-Based Training |
| Comparison | No intervention | During the study period, all regular quality improvement (QI) activities, such as self-audits, case reviews, mentor groups, and status meetings will continue for all EMDs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from a call is taken by EMD to first bystander compression
(seconds)
Measured: During cardiac arrest calls, up to 1 hour
Secondary outcomes (6)
EMD clarifies status of consciousness and breathing before asking any additional questions
(yes/no)
Measured: During cardiac arrest calls, up to 1 hour
Time from a call is taken by EMD to the recognition of cardiac arrest
(seconds)
Measured: During cardiac arrest calls, up to 1 hour
EMD starts DA-CPR instructions
(yes/no)
Measured: During cardiac arrest calls, up to 1 hour
Time from a call is taken by EMD to EMD starts DA-CPR instructions
(seconds)
Measured: During cardiac arrest calls, up to 1 hour
EMD is assertive when starting CPR instructions
(yes/no)
Measured: During cardiac arrest calls, up to 1 hour
EMD starts DA-CPR instructions on patient without cardiac arrest
(yes/no)
Measured: During cardiac arrest calls, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start12 Sep 2019
- Primary completion25 Dec 2019
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies 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
- After enrolment and consent from the EMDs, the EMDs will be randomly assigned to receive either LDHF simulation-based dispatcher training (intervention arm) or no LDHF simulation-based dispatcher training (comparison arm). The EMDs will be randomly assigned to intervention or comparison group in a 1:1 ratio. Randomisation will be stratified by the EMDs' medical backgrounds (paramedic, approximately 30% of the EMDs, or registered nurse, approximately 70% of the EMDs), to balance the number of EMDs with different medical backgrounds randomly assigned to each arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Freddy Lippert, MD, Principal investigator, Emergency Medical Services, Capital Region, DenmarkOscar Rosenkrantz, Study director, Emergency Medical Services, Capital Region, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085692
- Sponsor's protocol ID
- DTP
- Status last verified
- Jan 2020
- First submitted
- 2 Sep 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispatcher-Assisted Cardiopulmonary Resuscitation: A Randomized Controlled Trial of Low-Dose, High-Frequency Simulation-Based Training and the Impact on Real Out-of-Hospital Cardiac Arrest Calls
- ClinicalTrials.gov ID
- NCT04085692
- Acronym / sponsor ID
- DTP
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Collaborators
- TrygFonden, Denmark
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 11 Sep 2019 (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.
Clear, concise, yes, and no answers can be challenging to achieve in the assessment of consciousness and breathing in out-of-hospital cardiac arrest (OHCA) calls. Often callers will provide an unclear response, and this can lead to hesitation on the part of the Emergency Medical Dispatcher (EMD). Further, the relatively small proportion OHCA calls represent might demand the need for simulation training in the dispatcher-assisted cardiopulmonary resuscitation (DA-CPR) guiding itself. Therefore, the investigators investigate whether low-dose, high-frequency (LDHF) simulation-based training of EMDs can increase the quality of DA-CPR in a simulation setting. Additionally, the investigators measure whether the effect of the training will be transferred to real OHCA calls.
The study is a randomised controlled trial comparing LDHF simulation-based training to standard quality improvement of the EMD in a single centre. The study protocol is structured according to the SPIRIT 2013 statement, and the study will be reported in compliance with the CONSORT 2010 Statement. The investigators chose EMDs receiving standard quality improvement as the comparator group, to reflect a representative cohort of the EMDs not exposed to the LDHF simulation-based training program.
The aims of this study are:
- To measure the effect of LDHF simulation-based training on the quality of DA-CPR in a simulation setting.
- To measure the effect of LDHF simulation-based training on the quality of DA-CPR in real OHCA calls.
The investigators hypothesise that LDHF simulation-based training will increase the quality of DA-CPR in the intervention group in a simulation setting and that this improvement is transferred to real OHCA calls - although the effect in real OHCA calls might be smaller due to the complexity of some calls. The investigators hypothesise that this improvement can be detected as a decrease in time to first bystander compression (TTFC), an increase in clarification of consciousness and breathing without asking additional questions, a decrease in time to recognition of cardiac arrest, and an increase in calls where the EMD provide DA-CPR instructions on patients in cardiac arrest.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After enrolment and consent from the EMDs, the EMDs will be randomly assigned to receive either LDHF simulation-based dispatcher training (intervention arm) or no LDHF simulation-based dispatcher training (comparison arm). The EMDs will be randomly assigned to intervention or comparison group in a 1:1 ratio. Randomisation will be stratified by the EMDs' medical backgrounds (paramedic, approximately 30% of the EMDs, or registered nurse, approximately 70% of the EMDs), to balance the number of EMDs with different medical backgrounds randomly assigned to each arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Low-Dose, High-Frequency Simulation-Based TrainingThe intervention group begins LDHF dispatcher training with one introduction week followed by twelve weeks of LDHF training. During the study period, all regular quality improvement (QI) activities, such as self-audits, case reviews, mentor groups, and status meetings will continue for all EMDs. |
| Comparison | No intervention | –During the study period, all regular quality improvement (QI) activities, such as self-audits, case reviews, mentor groups, and status meetings will continue for all EMDs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- EMD employed at the Copenhagen EMS at the time of enrolment.
Key exclusion criteria (4 listed)
- Mean working time as call taker at Copenhagen EMS < 8 hours/week.
- Planned employment cessation at the Copenhagen EMS during the data collection period.
- Planned leave from work longer than four weeks during the data collection period.
- Starting employment at the Copenhagen EMS during the study period.
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 |
|---|---|---|
| Low-Dose, High-Frequency Simulation-Based TrainingTwelve weeks of LDHF training The simulation-based training sessions take place at the EMDC, at extra workstations set-up as ordinary EMD workstations in an out-of-the-way area. Before each session, the EMD is informed about the simulation call and receives instructions concerning technical differences from a regular call. The instructor acts as a "standardised caller", guided by a computer program. This program, the Danish version of Resuscitation Quality Improvement for Telecommunicators (Laerdal Medical AS, Stavanger, Norway), is a training program for DA-CPR based on the simulation platform Laerdal Learning Application. This modified version of the RQI-T program has, one test scenario, one data collection scenario and six different cardiac arrests scenarios as well as a feedback checklist based on the Danish dispatcher protocol Danish Index for Emergency Care. Each simulation session takes approximately 20 minutes, including introduction and feedback | Behavioural | Intervention |
Primary outcome
Time from a call is taken by EMD to first bystander compression
Time frame: During cardiac arrest calls, up to 1 hour
(seconds)
6 secondary outcomes
EMD clarifies status of consciousness and breathing before asking any additional questions
Time frame: During cardiac arrest calls, up to 1 hour
Time from a call is taken by EMD to the recognition of cardiac arrest
Time frame: During cardiac arrest calls, up to 1 hour
EMD starts DA-CPR instructions
Time frame: During cardiac arrest calls, up to 1 hour
Time from a call is taken by EMD to EMD starts DA-CPR instructions
Time frame: During cardiac arrest calls, up to 1 hour
EMD is assertive when starting CPR instructions
Time frame: During cardiac arrest calls, up to 1 hour
EMD starts DA-CPR instructions on patient without cardiac arrest
Time frame: During cardiac arrest calls, up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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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.
Freddy Lippert, MD principal investigator
Emergency Medical Services, Capital Region, Denmark
Oscar Rosenkrantz study director
Emergency Medical Services, Capital Region, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose, High-Frequency Simulation-Based Training in people with Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time from a call is taken by EMD to first bystander compression (time frame: During cardiac arrest calls, up to 1 hour). 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 23 Jan 2020.