Improving Teamwork for Neonatal Resuscitation

September 19, 2017 updated by: Eric Thomas, The University of Texas Health Science Center, Houston

The Neonatal Resuscitation Program (NRP) is the curriculum used to teach providers how to care for newborns in the delivery room. Breakdowns in teamwork and communication contribute to NRP quality problems. Adding teamwork instruction to NRP may be a method to improve communication, teamwork, and the overall quality of neonatal resuscitation. This study uses simulation to incorporate team training into NRP and to evaluate both the effectiveness and duration of the team training. Furthermore, because high fidelity simulation is very expensive and not widely available, we will compare NRP with low fidelity team training to NRP with high fidelity team training.

Our hypotheses are:

  1. NRP with low fidelity team training results in a) better teamwork, and b) better quality of care compared with standard NRP.
  2. NRP with high fidelity team training does not result in better teamwork or better quality of care than NRP with low fidelity simulation.
  3. NRP with high fidelity team training does not produce a longer lasting effect on teamwork than NRP with low fidelity simulation.

Study Overview

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center, Houston

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New interns that enter pediatrics, family medicine, obstetrics/gynecology, and emergency medicine.

Exclusion Criteria:

-

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control (NRP Curriculum with LFT and no team training)
Standard Neonatal Resuscitation Program (NRP) curriculum with no team training; simulated resuscitation using low-fidelity simulators for low-fidelity training (LFT)
The existing NRP course, taught to most caregivers in the United States who care for newborns, focuses on teaching the technical aspects of neonatal resuscitation with little attention paid to communication and teamwork.
Experimental: NRP with LFT and team training
Standard Neonatal Resuscitation Program (NRP) curriculum + team training; simulated resuscitation using low-fidelity simulators for low-fidelity training (LFT)
The existing NRP course, taught to most caregivers in the United States who care for newborns, focuses on teaching the technical aspects of neonatal resuscitation with little attention paid to communication and teamwork.
Crew Resource Management (CRM) is an aviation training program mandated for all crew members that teaches human factors concepts, communication skills, and teamwork behaviors that can prevent and manage error. Over the last six years the study team has translated these behaviors to neonatal resuscitation and demonstrated that they can be reliably measured. Adding teamwork instruction to the existing NRP, based upon CRM, may be a method to improve communication, teamwork, and the overall quality of neonatal resuscitation.
Experimental: NRP with HFT and team training
Standard Neonatal Resuscitation Program (NRP) curriculum + team training; simulated resuscitations using high-fidelity simulators for high-fidelity training (HFT)
The existing NRP course, taught to most caregivers in the United States who care for newborns, focuses on teaching the technical aspects of neonatal resuscitation with little attention paid to communication and teamwork.
Crew Resource Management (CRM) is an aviation training program mandated for all crew members that teaches human factors concepts, communication skills, and teamwork behaviors that can prevent and manage error. Over the last six years the study team has translated these behaviors to neonatal resuscitation and demonstrated that they can be reliably measured. Adding teamwork instruction to the existing NRP, based upon CRM, may be a method to improve communication, teamwork, and the overall quality of neonatal resuscitation.
SimBaby mannequins (Laerdal Medical Corp, Stavanger, Norway) were used in the high-fidelity skills stations. These mannequins have simulated heart tones, breath sounds, pulses, and cries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Teamwork Event Rate
Time Frame: During the megacode, which was performed about 1 hour after the training
The teamwork event rate was calculated by summing the number of scored teamwork events (sharing information, inquiry, assertion, teaching/advising, and evaluation of plans) and dividing by the total resuscitation time (in minutes).
During the megacode, which was performed about 1 hour after the training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Time Spent on Workload Management
Time Frame: During the megacode, which was performed about 1 hour after the training
Workload management percentage was calculated by summing the total time the team demonstrated workload management behavior and dividing by the total resuscitation time.
During the megacode, which was performed about 1 hour after the training
Percentage of Time Spent on Vigilance
Time Frame: During the megacode, which was performed about 1 hour after the training
Vigilance percentage was calculated by summing the total time the team demonstrated vigilance behavior and dividing by the total resuscitation time.
During the megacode, which was performed about 1 hour after the training
Neonatal Resuscitation Program (NRP) Quality as Assessed by NRP Performance Score
Time Frame: During the megacode, which was performed about 1 hour after the training
We analyzed 2 measures of NRP quality: performance score and resuscitation duration. The performance score was calculated by averaging the scores (ranging from 0 to 2 - higher values represent a better outcome) for each NRP step (some of which occurred multiple times). Those scores were summed and divided by the total possible score (2 times the number of steps that should have been performed). When a step was not indicated for the specific resuscitation scenario (e.g., meconium aspiration), that step was not scored by the observers and it was not included in the denominator for performance calculation. This produced a measure of performance percentage ranging from 0 percent to 100 percent (higher values represent a better outcome) for each resuscitation.
During the megacode, which was performed about 1 hour after the training
Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration
Time Frame: During the megacode, which was performed about 1 hour after the training
Resuscitation duration is time required to complete the resuscitation. The total duration for each resuscitation was calculated from the start of the instructor's reading of the scenario to the team's statement that the infant should be transferred to the NICU. When any teaching moments occurred during the simulation, the total teaching time was subtracted from the resuscitation duration.
During the megacode, which was performed about 1 hour after the training

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Eric J Thomas, MD, MPH, The University of Texas Health Science Center, Houston

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.

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

June 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • UL1RR024148-01 (U.S. NIH Grant/Contract)

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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