Research on the training of medical students receiving pediatric basic life support (PBLS) training, provided by either peer-instructors (students) or expert-instructors (pediatrician)

ISRCTN	ISRCTN69038759
DOI	https://doi.org/10.1186/ISRCTN69038759
Secondary identifying numbers	Radboudumc01

Submission date: 26/11/2019
Registration date: 12/12/2019
Last edited: 17/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
It is known that healthcare professionals, who are skilled in resuscitation techniques, may fail to apply these techniques successfully unless they have an adequately strong belief in their own capabilities. The present study was conceptualized with the idea of potentially combining the advantages of peer teaching with improved self-efficacy.
Peer-led basic life support training in medical school may be an effective and valued way of teaching medical students, but yet no research has been conducted to evaluate the effect on the self-efficacy of medical students. High self-efficacy stimulates healthcare professionals to initiate and continue basic life support when necessary despite challenges.

Who can participate?
Students in their clinical rotation before entering the pediatric rotation at Radboud UMC.

What does the study involve?
Medical students receive pediatric basic life support (PBLS) training, provided by either peer-instructors (student instructors) or expert-instructors (pediatricians).

What are the possible benefits and risks of participating?
None

Where is the study run from?
Radboud University Medical Center, The Netherlands

When is the study starting and how long is it expected to run for?
January 2015 to January 2016

Who is funding the study?
Radboud University Medical Center, The Netherlands

Who is the main contact?
Edward Tan
edward.tan@radboudumc.nl

Contact information

Mr Edward Tan
Public

Radboud University Nijmegen Medical Centre
Department of Emergency Medicine internal postal code 619
PO Box 9101
Nijmegen
6500 HB
Netherlands

ORCID ID	0000-0002-9978-249X
Phone	+31 243610492
Email	edward.tan@radboudumc.nl

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available.
Scientific title	Peer-led pediatric resuscitation training: effects on self-efficacy and skill performance
Study objectives	The primary aim of the study is to compare the PBLS-related self-efficacy of medical students who were trained by either expert-instructors (pediatricians) or peer-instructors. We will also compare the skill performance of these two groups by assessing their pass rates on a simulated PBLS exam.
Ethics approval(s)	Confirmation that no ethical approval is required by Radboud UMC, because the study does not fall within the remit of the Medical Research Involving Human Subjects Act (WMO), received 12/12/2019.
Health condition(s) or problem(s) studied	Training of pediatric basic life support
Intervention	Medical students receive pediatric basic life support (PBLS) training, provided by either peer-instructors (student instructors) or expert-instructors (pediatricians). The students are randomly assigned (using an independent statistician) to the peer-instructor group or expert-instructor group. All students receive two hours of PBLS training in groups of maximum 15 students. Directly after this training, self-efficacy is assessed with a newly developed questionnaire, based on a validated scoring tool. A week after each training session, students perform a practical PBLS exam and complete another questionnaire to evaluate skill performance and self-efficacy, respectively.
Intervention type	Behavioural
Primary outcome measure	Score on practical examination in pediatric basic life support, one week after the training session.
Secondary outcome measures	Self-efficacy and skill performance regarding pediatric resuscitation in general and compressions and ventilations in particular, measured by questionnaire directly after the training session.
Overall study start date	01/01/2013
Completion date	31/12/2016

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	Both
Target number of participants	200
Total final enrolment	213
Key inclusion criteria	Students in their clinical rotation before entering the pediatric rotation
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2015
Date of final enrolment	01/01/2016

Locations

Countries of recruitment

Netherlands

Study participating centre

Radboud University Medical Centre

PO Box 9101
Nijmegen
6500 HB
Netherlands

Sponsor information

Radboud University Medical Center
Hospital/treatment centre

Department of Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 243619908
Email	edward.tan@radboudumc.nl
Website	http://www.umcn.nl
"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Hospital/treatment centre

Radboud Universitair Medisch Centrum
Private sector organisation / Universities (academic only)

Alternative name(s): Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
Location: Netherlands

Results and Publications

Intention to publish date	01/01/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Submit for publication in medical journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/11/2020	17/11/2020	Yes	No

Editorial Notes

17/11/2020: Publication reference added.
13/12/2019: Internal review.
12/12/2019: Trial’s existence confirmed by Radboud UMC.