Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training
Primary Purpose
Out-Of-Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low-Dose, High-Frequency Simulation-Based Training
Sponsored by
About this trial
This is an interventional health services research trial for Out-Of-Hospital Cardiac Arrest
Eligibility Criteria
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.
Sites / Locations
- Copenhagen Emergency Medical Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Comparison
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time from a call is taken by EMD to first bystander compression
(seconds)
Secondary Outcome Measures
EMD clarifies status of consciousness and breathing before asking any additional questions
(yes/no)
Time from a call is taken by EMD to the recognition of cardiac arrest
(seconds)
EMD starts DA-CPR instructions
(yes/no)
Time from a call is taken by EMD to EMD starts DA-CPR instructions
(seconds)
EMD is assertive when starting CPR instructions
(yes/no)
EMD starts DA-CPR instructions on patient without cardiac arrest
(yes/no)
Full Information
NCT ID
NCT04085692
First Posted
September 2, 2019
Last Updated
January 17, 2020
Sponsor
Emergency Medical Services, Capital Region, Denmark
Collaborators
TrygFonden, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04085692
Brief Title
Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
December 25, 2019 (Actual)
Study Completion Date
December 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergency Medical Services, Capital Region, Denmark
Collaborators
TrygFonden, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The research group and the participants will not be blinded to the allocation, except for the study statistician (A.K.E.), who will conduct all analyses blinded to the intervention group. Thus, the study statistician will not have access to the randomisation scheme or the random seed and will receive a dataset with the actual groups replaced with the numbers 0 and 1
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-Dose, High-Frequency Simulation-Based Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Time from a call is taken by EMD to first bystander compression
Description
(seconds)
Time Frame
During cardiac arrest calls, up to 1 hour
Secondary Outcome Measure Information:
Title
EMD clarifies status of consciousness and breathing before asking any additional questions
Description
(yes/no)
Time Frame
During cardiac arrest calls, up to 1 hour
Title
Time from a call is taken by EMD to the recognition of cardiac arrest
Description
(seconds)
Time Frame
During cardiac arrest calls, up to 1 hour
Title
EMD starts DA-CPR instructions
Description
(yes/no)
Time Frame
During cardiac arrest calls, up to 1 hour
Title
Time from a call is taken by EMD to EMD starts DA-CPR instructions
Description
(seconds)
Time Frame
During cardiac arrest calls, up to 1 hour
Title
EMD is assertive when starting CPR instructions
Description
(yes/no)
Time Frame
During cardiac arrest calls, up to 1 hour
Title
EMD starts DA-CPR instructions on patient without cardiac arrest
Description
(yes/no)
Time Frame
During cardiac arrest calls, up to 1 hour
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freddy Lippert, MD
Organizational Affiliation
Emergency Medical Services, Capital Region, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oscar Rosenkrantz
Organizational Affiliation
Emergency Medical Services, Capital Region, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Copenhagen Emergency Medical Services
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Immediately following publication. Until 31st of December 2021
IPD Sharing Access Criteria
Researchers who provide a sound proposal and gets approval from the Danish authorities.
Learn more about this trial
Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training
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