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

July 27, 2018 updated by: Universidad de la Sabana

Evaluation of Two Strategies for Constructive Immediate Feedback in the Development of Skills for Neonatal Resuscitation: a Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de la Sabana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

June 15, 2016

Study Completion (ACTUAL)

June 15, 2017

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (ACTUAL)

July 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acta 366 11-Dic-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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