Improving Teamwork for Neonatal Resuscitation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651794

Enrollment

100

Registered

2008-04-03

Start date

2007-06-30

Completion date

2012-06-30

Last updated

2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teamwork During Neonatal Resuscitation

Keywords

Neonatal Resuscitation, Patient Care Team, Medical Errors

Brief summary

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.

Interventions

BEHAVIORALTeamwork 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.

BEHAVIORALStandard 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.

BEHAVIORALSkills practice with low-fidelity mannequin

BEHAVIORALSkills 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Teamwork Event Rate	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

Measure	Time frame	Description
Percentage of Time Spent on Workload Management	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	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	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	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.

Countries

United States

Participant flow

Recruitment details

All incoming interns for pediatrics, combined pediatrics and internal medicine, family medicine, emergency medicine, and obstetrics and gynecology who began training in June 2007 or June 2008 and had not previously completed NRP certification were eligible for participation in the study.

Pre-assignment details

100 interns were consented, and 98 completed the initial megacode (that is, the initial simulation with a mannequin that was observed and scored). Baseline characteristics are reported for the 98 who completed the initial megacode.

Participants by arm

Arm	Count
Control (NRP Curriculum With LFT and no Team Training) Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators	36
NRP With LFT and Team Training Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators	31
NRP With HFT and Team Training Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators	31
Total	98

Baseline characteristics

Characteristic	Control (NRP Curriculum With LFT and no Team Training)	NRP With LFT and Team Training	NRP With HFT and Team Training	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	36 Participants	31 Participants	31 Participants	98 Participants
Region of Enrollment United States	31 participants	31 participants	31 participants	93 participants
Sex/Gender, Customized Unknown	36 participants	31 participants	31 participants	98 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 36	0 / 31	0 / 31
serious Total, serious adverse events	0 / 36	0 / 31	0 / 31

Outcome results

Primary

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).