Condition category
Not Applicable
Date applied
09/10/2020
Date assigned
13/10/2020
Last edited
12/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The Airway, Breathing, Circulation, Disability, and Exposure (ABCDE) approach is widely recommended and taught in many resuscitation courses. In this study we assess the adherence to the ABCDE algorithm and whether this is affected by the instruction method used to teach this approach in healthcare professionals who work with new born babies (neonates).

Who can participate?
Neonatal healthcare providers (nurses, ward physicians, and consultants) of all ages, employed at the Radboudumc, Nijmegen, the Netherlands.

What does the study involve?
Performing neonatal advanced life support (NALS) scenarios on a manikin and determining to what extent the professionals follow the ABCDE approach during such simulated resuscitations, and whether or not the adherence to the ABCDE structure differs between professionals who are trained regarding the ABCDE structure by means of a lecture or through a video-based instruction.

What are the benefits and risks of participating?
There are no risks involved in this study. The benefit for the partaking professionals may be that they are better trained in the ABCDE approach by one of the two instructional methods.

Where is the study run from?
The simulation facility of the tertiary care perinatal center (Radboudumc, Nijmegen, the Netherlands).

When is the study starting and how long is it expected to run for?
May 2017 to January 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Mathijs Binkhorst, mathijs.binkhorst@radboudumc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mathijs Binkhorst

ORCID ID

http://orcid.org/0000-0002-5824-6121

Contact details

Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands
+31 651225283
mathijs.binkhorst@radboudumc.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Adherence to the ABCDE approach in relation to the method of instruction: a randomized controlled simulation study

Acronym

ABCDE

Study hypothesis

We want to investigate to what extent neonatal healthcare professionals follow or adhere to the ABCDE structure (also referred to as ABCDE approach or algorithm) during simulated neonatal advanced life support (NALS) scenarios. In addition, we want to determine whether this adherence is different between professionals trained in this strcuture by means of a lecture or through video-based instruction (VBI).

Ethics approval

Approved 19/06/2017, Institutional Review Board (IRB) of the Radboud UMC (Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, the Netherlands; +31-24-3613154; commissiemensgebondenonderzoek@radboudumc.nl), ref: 2017-3513

Study design

Single-center single-blinded randomized controlled simulation study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Adherence to guideline among neonatal healthcare professionals during the simulated resuscitation of newborns.

Intervention

Participants are randomly assigned to the two study groups, using sequentially numbered opaque sealed envelopes by an independent third party, with an allocation ratio of 1:1.
One group of professionals receives training/instruction regarding the ABCDE algorithm by means of a conventional (PowerPoint) lecture (20-30 min in duration, provided by an experienced simulation specialist).
The other group receives a video-based instruction (15 min, video specifically recorded for this study, showing peer professionals performing the ABCDE approach, just like the lecture only available on study days, not online or elsewhere).

All participants then perform neonatal advanced life support scenarios in the simulation facility of our tertiary perinatal care center (Radboudumc, Nijmegen, the Netherlands). During these scenarios, they systematically evaluate the condition of simulated, vitally unstable neonatal patients using the ABCDE structure. All scenarios are videotaped for later ananlysis.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Adherence to the ABCDE structure/approach is measured by a specifically trained video observer with an assessment instrument/scoring list, which was specifically developed and validated for this study. This video-based scoring procedure takes place several weeks after the scenarios are performed.

Secondary outcome measures

1. Adherence of each profession category (nurses, ward physicians, fellows/neonatologists) to the ABCDE approach, measured using the abovementioned assessment instrument, at the same time point (several weeks after the actual scenarios)
2. Adherence to the domains (A, B, C, D, E) of the ABCDE approach, measured using the abovementioned assessment instrument, at the same time point (several weeks after the actual scenarios)

Overall trial start date

18/05/2017

Overall trial end date

24/01/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Neonatal healthcare professionals of all ages, working at the neonatal intensive care unit (NICU) and/or high care (HC) of the Radboudumc, Nijmegen, the Netherlands

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Based on a sample size estimation, the target total number of participants was 42 (21 per group)

Total final enrolment

92

Participant exclusion criteria

Participant refuses to give permission to use his/her videotaped scenarios for study purposes

Recruitment start date

12/06/2017

Recruitment end date

24/01/2018

Locations

Countries of recruitment

Netherlands

Trial participating centre

Radboud University Medical Center Amalia Children's Hospital
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands

Sponsor information

Organisation

Amalia Kinderziekenhuis

Sponsor details

Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands
+31 243614430
heidy.verbeet@radboudumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.amaliakinderziekenhuis.nl/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a journal for the target audience (i.e. resuscitation of medical education journal). All data generated in this study will be incorporated in the manuscript.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Not applicable.

Publication citations

Additional files

Editorial Notes

12/10/2020: Trial's existence confirmed by Radboud University Nijmegen Medical Centre Research Ethics Committee.