- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00651794
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:
- NRP with low fidelity team training results in a) better teamwork, and b) better quality of care compared with standard NRP.
- NRP with high fidelity team training does not result in better teamwork or better quality of care than NRP with low fidelity simulation.
- NRP with high fidelity team training does not produce a longer lasting effect on teamwork than NRP with low fidelity simulation.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center, Houston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- New interns that enter pediatrics, family medicine, obstetrics/gynecology, and emergency medicine.
Exclusion Criteria:
-
Study Plan
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 |
|---|---|
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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)
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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.
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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.
|
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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.
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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).
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During the megacode, which was performed about 1 hour after the training
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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
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Workload management percentage was calculated by summing the total time the team demonstrated workload management behavior and dividing by the total resuscitation time.
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During the megacode, which was performed about 1 hour after the training
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Percentage of Time Spent on Vigilance
Time Frame: During the megacode, which was performed about 1 hour after the training
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Vigilance percentage was calculated by summing the total time the team demonstrated vigilance behavior and dividing by the total resuscitation time.
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During the megacode, which was performed about 1 hour after the training
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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.
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During the megacode, which was performed about 1 hour after the training
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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.
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During the megacode, which was performed about 1 hour after the training
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Collaborators and Investigators
Investigators
- Principal Investigator: Eric J Thomas, MD, MPH, The University of Texas Health Science Center, Houston
Publications and helpful links
General Publications
- Thomas EJ, Sexton JB, Helmreich RL. Translating teamwork behaviours from aviation to healthcare: development of behavioural markers for neonatal resuscitation. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i57-64. doi: 10.1136/qhc.13.suppl_1.i57.
- Thomas EJ, Sexton JB, Lasky RE, Helmreich RL, Crandell DS, Tyson J. Teamwork and quality during neonatal care in the delivery room. J Perinatol. 2006 Mar;26(3):163-9. doi: 10.1038/sj.jp.7211451.
- Thomas EJ, Taggart B, Crandell S, Lasky RE, Williams AL, Love LJ, Sexton JB, Tyson JE, Helmreich RL. Teaching teamwork during the Neonatal Resuscitation Program: a randomized trial. J Perinatol. 2007 Jul;27(7):409-14. doi: 10.1038/sj.jp.7211771. Epub 2007 Jun 7.
- Thomas EJ, Williams AL, Reichman EF, Lasky RE, Crandell S, Taggart WR. Team training in the neonatal resuscitation program for interns: teamwork and quality of resuscitations. Pediatrics. 2010 Mar;125(3):539-46. doi: 10.1542/peds.2009-1635. Epub 2010 Feb 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UL1RR024148-01 (U.S. NIH Grant/Contract)
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