NCT04085692

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 12, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

September 2, 2019

Last Update Submit

January 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time from a call is taken by EMD to first bystander compression

    (seconds)

    During cardiac arrest calls, up to 1 hour

Secondary Outcomes (6)

  • EMD clarifies status of consciousness and breathing before asking any additional questions

    During cardiac arrest calls, up to 1 hour

  • Time from a call is taken by EMD to the recognition of cardiac arrest

    During cardiac arrest calls, up to 1 hour

  • EMD starts DA-CPR instructions

    During cardiac arrest calls, up to 1 hour

  • Time from a call is taken by EMD to EMD starts DA-CPR instructions

    During cardiac arrest calls, up to 1 hour

  • EMD is assertive when starting CPR instructions

    During cardiac arrest calls, up to 1 hour

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Emergency Medical Services

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Freddy Lippert, MD

    Emergency Medical Services, Capital Region, Denmark

    PRINCIPAL INVESTIGATOR
  • Oscar Rosenkrantz

    Emergency Medical Services, Capital Region, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 11, 2019

Study Start

September 12, 2019

Primary Completion

December 25, 2019

Study Completion

December 25, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Immediately following publication. Until 31st of December 2021
Access Criteria
Researchers who provide a sound proposal and gets approval from the Danish authorities.

Locations