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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
Universidad de la Sabana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asphyxia Neonatorum focused on measuring Debriefing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 13, 2018
    Last Updated
    July 27, 2018
    Sponsor
    Universidad de la Sabana
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    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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