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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
  Purpose

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.

Condition Intervention
Teamwork During Neonatal Resuscitation Behavioral: Teamwork training Behavioral: Standard NRP curriculum Behavioral: Skills practice with low-fidelity mannequin Behavioral: Skills practice with high-fidelity mannequin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Teamwork for Neonatal Resuscitation

Further study details as provided by Eric Thomas, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: June 2007
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
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)
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
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)
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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651794


Locations
United States, Texas
University of Texas Health Science Center, Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Eric J Thomas, MD, MPH The University of Texas Health Science Center, Houston
  More Information