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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04085692
Other study ID # DTP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2019
Est. completion date December 25, 2019

Study information

Verified date January 2020
Source Emergency Medical Services, Capital Region, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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:

1. To measure the effect of LDHF simulation-based training on the quality of DA-CPR in a simulation setting.

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 25, 2019
Est. primary completion date December 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion criteria:

- EMD employed at the Copenhagen EMS at the time of enrolment.

Exclusion criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Low-Dose, High-Frequency Simulation-Based Training
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

Locations

Country Name City State
Denmark Copenhagen Emergency Medical Services Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Emergency Medical Services, Capital Region, Denmark TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from a call is taken by EMD to first bystander compression (seconds) During cardiac arrest calls, up to 1 hour
Secondary EMD clarifies status of consciousness and breathing before asking any additional questions (yes/no) During cardiac arrest calls, up to 1 hour
Secondary Time from a call is taken by EMD to the recognition of cardiac arrest (seconds) During cardiac arrest calls, up to 1 hour
Secondary EMD starts DA-CPR instructions (yes/no) During cardiac arrest calls, up to 1 hour
Secondary Time from a call is taken by EMD to EMD starts DA-CPR instructions (seconds) During cardiac arrest calls, up to 1 hour
Secondary EMD is assertive when starting CPR instructions (yes/no) During cardiac arrest calls, up to 1 hour
Secondary EMD starts DA-CPR instructions on patient without cardiac arrest (yes/no) During cardiac arrest calls, up to 1 hour
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