- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04085692
Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- Copenhagen Emergency Medical Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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. |
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 |
No Intervention: Comparison
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time from a call is taken by EMD to first bystander compression
Time Frame: During cardiac arrest calls, up to 1 hour
|
(seconds)
|
During cardiac arrest calls, up to 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EMD clarifies status of consciousness and breathing before asking any additional questions
Time Frame: During cardiac arrest calls, up to 1 hour
|
(yes/no)
|
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
|
(seconds)
|
During cardiac arrest calls, up to 1 hour
|
EMD starts DA-CPR instructions
Time Frame: During cardiac arrest calls, up to 1 hour
|
(yes/no)
|
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
|
(seconds)
|
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
|
(yes/no)
|
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
|
(yes/no)
|
During cardiac arrest calls, up to 1 hour
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Freddy Lippert, MD, Emergency Medical Services, Capital Region, Denmark
- Study Director: Oscar Rosenkrantz, Emergency Medical Services, Capital Region, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Out-Of-Hospital Cardiac Arrest
-
Medical University of ViennaLudwig Boltzmann Institute Digital Health and Patient Safety; Emergency Medical...RecruitingCardiac Arrest, Out-Of-HospitalAustria
-
University Medical Centre MariborOHK Medical DevicesRecruiting"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".Cardiac Arrest | Out of Hospital Cardiac ArrestSlovenia
-
National Taiwan University HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
Far Eastern Memorial HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
King's College LondonKing's College Hospital NHS Trust; London Ambulance Service NHS TrustNot yet recruiting
-
Wroclaw Medical UniversityWroclaw Emergency Medical ServicesRecruiting
-
Sunnybrook Health Sciences CentrePrescott-Russell Paramedic Service; Peterborough Paramedic Service; Bruce County... and other collaboratorsRecruiting
-
Emergency Medical Services, Capital Region, DenmarkTrygFonden, Denmark; Danish Heart Foundation; Zoll Medical CorporationRecruitingOut-Of-Hospital Cardiac ArrestDenmark
-
Guy's and St Thomas' NHS Foundation TrustLondon School of Hygiene and Tropical Medicine; King's College London; King's... and other collaboratorsActive, not recruitingOut-Of-Hospital Cardiac ArrestUnited Kingdom
-
National Taiwan University HospitalCompletedOut-Of-Hospital Cardiac ArrestTaiwan
Clinical Trials on Low-Dose, High-Frequency Simulation-Based Training
-
JhpiegoBill and Melinda Gates FoundationCompletedStillbirth | Neonatal Death
-
Rigshospitalet, DenmarkPublic Health Laboratory Ivo de CarneriUnknownNeonatal Death
-
Mbarara University of Science and TechnologyThe Hospital for Sick ChildrenUnknownNeonatal Death | Birth AsphyxiaUganda
-
University of CalgaryNatural Sciences and Engineering Research Council, CanadaRecruiting
-
Rigshospitalet, DenmarkCompleted
-
Zonguldak Bulent Ecevit UniversityNurten Taşdemir Assoc. Prof. PhD.UnknownCardiopulmonary Resuscitation | Nurse's Role | Simulation TrainingTurkey
-
St. Olavs HospitalNorwegian University of Science and TechnologyRecruiting
-
Universidad Complutense de MadridActive, not recruitingFrailty | Electric Stimulation Therapy | WomenSpain
-
Karolinska InstitutetNeuro+CompletedMultiple Sclerosis | Fatigue | Cytokines | Resistance Training | Exercise TherapySweden