Evaluation of Two Strategies for Debriefing in the Development of Skills for Neonatal Resuscitation
Primary Purpose
Asphyxia Neonatorum, Birth Injuries, Cardiopulmonary Resuscitation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structured debriefing assisted by video
Structured oral debriefing
Sponsored by
About this trial
This is an interventional other trial for Asphyxia Neonatorum focused on measuring Debriefing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Structured debriefing assisted by video
Structured oral debriefing
Arm Description
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.
In the structured oral debriefing, the process was based by the mental search of their memories of what occurred.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03606278
Brief Title
Evaluation of Two Strategies for Debriefing in the Development of Skills for Neonatal Resuscitation
Official Title
Evaluation of Two Strategies for Constructive Immediate Feedback in the Development of Skills for Neonatal Resuscitation: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
June 15, 2016 (Actual)
Study Completion Date
June 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de la Sabana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum, Birth Injuries, Cardiopulmonary Resuscitation
Keywords
Debriefing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured debriefing assisted by video
Arm Type
Experimental
Arm Description
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.
Arm Title
Structured oral debriefing
Arm Type
Active Comparator
Arm Description
In the structured oral debriefing, the process was based by the mental search of their memories of what occurred.
Intervention Type
Other
Intervention Name(s)
Structured debriefing assisted by video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Structured oral debriefing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance percentage of the activities
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
None
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
21937960
Citation
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.
Results Reference
background
PubMed Identifier
30333050
Citation
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.
Results Reference
derived
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Evaluation of Two Strategies for Debriefing in the Development of Skills for Neonatal Resuscitation
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