Teamwork During Neonatal ResuscitationNCT00651794

Improving Teamwork for Neonatal Resuscitation

A study testing Teamwork training, Standard NRP curriculum and Skills practice with low-fidelity mannequin in people with Teamwork During Neonatal Resuscitation, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Teamwork During Neonatal Resuscitation
What is being tested?: Teamwork training, Standard NRP curriculum and Skills practice with low-fidelity mannequin
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Science Center, Houston
Houston, Texas, 77030

Other trials in United States

About this study

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.

Conditions: Teamwork During Neonatal Resuscitation
Being tested: Teamwork training, Standard NRP curriculum, Skills practice with low-fidelity mannequin, Skills practice with high-fidelity mannequin
Keywords: Neonatal Resuscitation, Patient Care Team, Medical Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Teamwork trainingBehavioural
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.
Standard NRP curriculumBehavioural
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.
Skills practice with low-fidelity mannequinBehavioural
Skills practice with high-fidelity mannequinBehavioural
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.

Study groups in NCT00651794
Study group	Role	What they receive
Control (NRP Curriculum with LFT and no team training)	Active comparator	Standard Neonatal Resuscitation Program (NRP) curriculum with no team training; simulated resuscitation using low-fidelity simulators for low-fidelity training (LFT) Receives: Behavioral: Standard NRP curriculum; Behavioral: Skills practice with low-fidelity mannequin
NRP with LFT and team training	Experimental	Standard Neonatal Resuscitation Program (NRP) curriculum + team training; simulated resuscitation using low-fidelity simulators for low-fidelity training (LFT) Receives: Behavioral: Teamwork training; Behavioral: Standard NRP curriculum; Behavioral: Skills practice with low-fidelity mannequin
NRP with HFT and team training	Experimental	Standard Neonatal Resuscitation Program (NRP) curriculum + team training; simulated resuscitations using high-fidelity simulators for high-fidelity training (HFT) Receives: Behavioral: Teamwork training; Behavioral: Standard NRP curriculum; Behavioral: Skills practice with high-fidelity mannequin

What is being measured

The primary outcome is the main question the study is designed to answer.

Teamwork Event Rate
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).
Measured: During the megacode, which was performed about 1 hour after the training

Secondary outcomes (4)

Percentage of Time Spent on Workload Management
Workload management percentage was calculated by summing the total time the team demonstrated workload management behavior and dividing by the total resuscitation time.
Measured: During the megacode, which was performed about 1 hour after the training
Percentage of Time Spent on Vigilance
Vigilance percentage was calculated by summing the total time the team demonstrated vigilance behavior and dividing by the total resuscitation time.
Measured: During the megacode, which was performed about 1 hour after the training
Neonatal Resuscitation Program (NRP) Quality as Assessed by NRP Performance Score
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.
Measured: During the megacode, which was performed about 1 hour after the training
Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration
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.
Measured: During the megacode, which was performed about 1 hour after the training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Jun 2012

First posted3 Apr 2008 (estimated)
Study startJun 2007
Primary completionMay 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Teamwork During Neonatal ResuscitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00651794
Sponsor's protocol ID: UL1RR024148-01
Status last verified: Sep 2017
First submitted: 31 Mar 2008
Last updated: 19 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 15465957
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.
PubMed 16493432
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.
PubMed 17538634
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.
PubMed 20156896

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Teamwork for Neonatal Resuscitation
ClinicalTrials.gov ID: NCT00651794
Acronym / sponsor ID: UL1RR024148-01
Conditions: Teamwork During Neonatal Resuscitation
Keywords: Neonatal Resuscitation, Patient Care Team, Medical Errors
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Jun 2007
Primary completion: May 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 3 Apr 2008 (estimated)
Results: Posted 19 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Control (NRP Curriculum with LFT and no team training)	Active comparator	Behavioral: Standard NRP curriculum, Behavioral: Skills practice with low-fidelity mannequinStandard Neonatal Resuscitation Program (NRP) curriculum with no team training; simulated resuscitation using low-fidelity simulators for low-fidelity training (LFT)
NRP with LFT and team training	Experimental	Behavioral: Teamwork training, Behavioral: Standard NRP curriculum, Behavioral: Skills practice with low-fidelity mannequinStandard Neonatal Resuscitation Program (NRP) curriculum + team training; simulated resuscitation using low-fidelity simulators for low-fidelity training (LFT)
NRP with HFT and team training	Experimental	Behavioral: Teamwork training, Behavioral: Standard NRP curriculum, Behavioral: Skills practice with high-fidelity mannequinStandard Neonatal Resuscitation Program (NRP) curriculum + team training; simulated resuscitations using high-fidelity simulators for high-fidelity training (HFT)

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Teamwork trainingCrew 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.	Behavioural	NRP with HFT and team training, NRP with LFT and team training
Standard NRP curriculumThe 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.	Behavioural	Control (NRP Curriculum with LFT and no team training), NRP with HFT and team training, NRP with LFT and team training
Skills practice with low-fidelity mannequin	Behavioural	Control (NRP Curriculum with LFT and no team training), NRP with LFT and team training
Skills practice with high-fidelity mannequinSimBaby 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.	Behavioural	NRP with HFT and team training

Primary outcome

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).

4 secondary outcomes

Percentage of Time Spent on Workload Management
Time frame: 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
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
Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration
Time frame: During the megacode, which was performed about 1 hour after the training

Results and safety

Results posted to the registry on 19 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control (NRP Curriculum With LFT and no Team Training)	36	15
NRP With LFT and Team Training	31	9
NRP With HFT and Team Training	31	10

Primary outcome: Teamwork Event Rate

Time frame: During the megacode, which was performed about 1 hour after the training. Mean (Standard Deviation). Unit: teamwork events per minute

Measure	Control (NRP Curriculum With LFT and no Team Training) n = 36	NRP With LFT and Team Training n = 31	NRP With HFT and Team Training n = 31
Value	9 (2.10)	10.3 (3.30)	12.8 (3.40)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control (NRP Curriculum With LFT and no Team Training)	0 of 36 (0%)	0 of 36 (0%)	Not reported
NRP With LFT and Team Training	0 of 31 (0%)	0 of 31 (0%)	Not reported
NRP With HFT and Team Training	0 of 31 (0%)	0 of 31 (0%)	Not reported

Limitations and caveats (from the sponsor): Questions remain about whether similar training will be effective for other types of caregivers. Generalizability might be limited if other sites were not able to re-create the team training content.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15465957Thomas 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.
Background: PubMed 16493432Thomas 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.
Background: PubMed 17538634Thomas 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.
Results publication: PubMed 20156896Thomas 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric J Thomas, MD, MPH principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Teamwork Event Rate (time frame: During the megacode, which was performed about 1 hour after the training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00651794, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017; AzTrials last refreshed its copy on 28 Oct 2026.