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Evaluation of Two Strategies for Debriefing in the Development of Skills for Neonatal Resuscitation

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ClinicalTrials.gov Identifier: NCT03606278
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Universidad de la Sabana

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


Condition or disease Intervention/treatment Phase
Asphyxia Neonatorum Birth Injuries Cardiopulmonary Resuscitation Other: Structured debriefing assisted by video Other: Structured oral debriefing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Other
Official Title: Evaluation of Two Strategies for Constructive Immediate Feedback in the Development of Skills for Neonatal Resuscitation: a Randomized Clinical Trial
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : June 15, 2016
Actual Study Completion Date : June 15, 2017

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Arm Intervention/treatment
Experimental: Structured debriefing assisted by video
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
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.

Active Comparator: Structured oral debriefing
In the structured oral debriefing, the process was based by the mental search of their memories of what occurred.
Other: Structured oral debriefing
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 Measures :
  1. Compliance percentage of the activities [ 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. ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad de la Sabana
ClinicalTrials.gov Identifier: NCT03606278    
Other Study ID Numbers: Acta 366 11-Dic-2015
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de la Sabana:
Debriefing
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Birth Injuries
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases