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Improving Teamwork for Neonatal Resuscitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651794
First Posted: April 3, 2008
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric Thomas, The University of Texas Health Science Center, Houston
March 31, 2008
April 3, 2008
December 8, 2015
October 19, 2017
October 19, 2017
June 2007
May 2012   (Final data collection date for primary outcome measure)
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).
  • Teamwork rate (events per minute) [ Time Frame: measured during the simulated resuscitation ]
  • NRP Compliance rate (% compliance) [ Time Frame: measured during simulated resuscitation ]
Complete list of historical versions of study NCT00651794 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
Not Provided
Not Provided
Not Provided
 
Improving Teamwork for Neonatal Resuscitation
Improving Teamwork for Neonatal Resuscitation

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Teamwork During Neonatal Resuscitation
  • Behavioral: Teamwork training
    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.
  • Behavioral: Standard NRP curriculum
    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.
  • Behavioral: Skills practice with low-fidelity mannequin
  • Behavioral: Skills practice with high-fidelity mannequin
    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.
  • 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)
    Interventions:
    • Behavioral: Standard NRP curriculum
    • Behavioral: Skills practice with low-fidelity mannequin
  • 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)
    Interventions:
    • Behavioral: Teamwork training
    • Behavioral: Standard NRP curriculum
    • Behavioral: Skills practice with low-fidelity mannequin
  • 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)
    Interventions:
    • Behavioral: Teamwork training
    • Behavioral: Standard NRP curriculum
    • Behavioral: Skills practice with high-fidelity mannequin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00651794
UL1RR024148-01( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Eric Thomas, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Eric J Thomas, MD, MPH The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP