NCT03606278

Brief Summary

Introduction: Training of health professionals in neonatal resuscitation reduces risks and adverse events during this intervention. Simulation-based education with constructive immediate feedback (debriefing) is an effective teaching method for personnel in charge of neonatal resuscitation. Objective: To evaluate two debriefing strategies for the development of neonatal resuscitation skills in professionals specialized in critical newborn care. Materials and Methods: A simple blind randomized clinical trial was conducted. Twenty-four professionals (pediatricians, nurses, and respiratory therapists) were randomly assigned for two interventions; one group received oral debriefing and the other oral debriefing assisted by video. Three standardized clinical scenarios that were recorded on video were executed. A checklist was applied for the evaluation, administered by a reviewer blinded to the assignment of the type of debriefing. Null hypothesis: The improved in the skills of neonatal resuscitation is the same for both strategies of debriefing. Alternative hypothesis: The improved in the skills of neonatal resuscitation is different for both strategies of debriefing

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

July 13, 2018

Last Update Submit

July 27, 2018

Conditions

Keywords

Debriefing

Outcome Measures

Primary Outcomes (1)

  • Compliance percentage of the activities

    For the performance and evaluation score of the adherence of the teams to the resuscitation protocols, a review of the literature was performed for constructed a checklist that included cognitive/technical and behavioral aspects of individual performance and performance by profession in each of the scenarios. Each item of the tool was assigned a score of 1 if the evaluated activity was correctly performed, 0 if it was not performed correctly, and N/A if it did not apply for the scenario and/or for the profession. A compliance percentage (range 0% to 100%) of the activities evaluated by participant in the tool was obtained, summed the points obtained onto the possible total score. The higher percentage indicate better outcome.

    The checklist was applied by a reviewer blinded to the assignment of the type of debriefing by reviewing the video, on average 1 week after of the participation of the groups in the scenarios.

Study Arms (2)

Structured debriefing assisted by video

EXPERIMENTAL

In the structured debriefing assisted by video, the process was based on the immediate review of the video, stopping and rewinding the recording as required.

Other: Structured debriefing assisted by video

Structured oral debriefing

ACTIVE COMPARATOR

In the structured oral debriefing, the process was based by the mental search of their memories of what occurred.

Other: Structured oral debriefing

Interventions

In the structured debriefing assisted by video, the process was based on the immediate review of the video, stopping and rewinding the recording as required. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life.

Structured debriefing assisted by video

In the structured oral debriefing, the process was based by the mental search of their memories of what occurred. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life.

Structured oral debriefing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The specialized health professionals (Professional nurses, respiratory therapists, and pediatricians) in charge of newborn care that working in the Neonatal Unit areas, maternity wards, surgery rooms responsible for the care of caesarean sections, and those of pediatric emergencies of University Hospital of La Sabana

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Sawyer T, Sierocka-Castaneda A, Chan D, Berg B, Lustik M, Thompson M. Deliberate practice using simulation improves neonatal resuscitation performance. Simul Healthc. 2011 Dec;6(6):327-36. doi: 10.1097/SIH.0b013e31822b1307.

    PMID: 21937960BACKGROUND
  • Gamboa OA, Agudelo SI, Maldonado MJ, Leguizamon DC, Cala SM. Evaluation of two strategies for debriefing simulation in the development of skills for neonatal resuscitation: a randomized clinical trial. BMC Res Notes. 2018 Oct 17;11(1):739. doi: 10.1186/s13104-018-3831-6.

MeSH Terms

Conditions

Asphyxia NeonatorumBirth Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
For the performance and evaluation score of the adherence of the teams to the resuscitation protocols, a review of the literature was performed, and the modified version of the validated Neonatal Resuscitation Performance Evaluation (NRPE) tool was considered (1). Given that this instrument did not consider behavioral and leadership aspects, a checklist of individual performance and performance by profession was constructed in each of the scenarios that included cognitive/technical and behavioral aspects. This checklist was applied by a reviewer blinded to the assignment of the type of debriefing by reviewing the video of the participation of the groups in the scenarios.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study participants were randomly assigned to the type of debriefing (oral or video), stratified by the type of health professional. For this randomization, the random function of Excel was used, sorting the participants in a random number order and assigning the first half to the oral group and the other half to the video-assisted group. For the conformation of the teams, a second randomization was performed, in which the professionals within an assigned group (oral or video-assisted) were randomized to form a resuscitation team. In this randomization, Excel's random function was also used, sorting the patients in a random number order and assigning the one that was ordered first to team 1, the second to team 2, and so on, each team had three professions: pediatrician, professional nurse, and respiratory therapist. The same team was maintained during the participation of each scenario.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 30, 2018

Study Start

February 1, 2016

Primary Completion

June 15, 2016

Study Completion

June 15, 2017

Last Updated

July 30, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.