Trial Outcomes & Findings for Improving Teamwork for Neonatal Resuscitation (NCT NCT00651794)
NCT ID: NCT00651794
Last Updated: 2017-10-19
Results Overview
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).
COMPLETED
NA
100 participants
During the megacode, which was performed about 1 hour after the training
2017-10-19
Participant Flow
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.
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.
Participant milestones
| Measure |
Control (NRP Curriculum With LFT and no Team Training)
Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
|
NRP With LFT and Team Training
Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
|
NRP With HFT and Team Training
Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
31
|
31
|
|
Overall Study
COMPLETED
|
15
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Teamwork for Neonatal Resuscitation
Baseline characteristics by cohort
| Measure |
Control (NRP Curriculum With LFT and no Team Training)
n=36 Participants
Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
|
NRP With LFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
|
NRP With HFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown
|
36 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
98 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
93 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the megacode, which was performed about 1 hour after the trainingThe 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).
Outcome measures
| Measure |
Control (NRP Curriculum With LFT and no Team Training)
n=36 Participants
Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
|
NRP With LFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
|
NRP With HFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
|
|---|---|---|---|
|
Teamwork Event Rate
|
9 teamwork events per minute
Standard Deviation 2.10
|
10.3 teamwork events per minute
Standard Deviation 3.30
|
12.8 teamwork events per minute
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: During the megacode, which was performed about 1 hour after the trainingWorkload management percentage was calculated by summing the total time the team demonstrated workload management behavior and dividing by the total resuscitation time.
Outcome measures
| Measure |
Control (NRP Curriculum With LFT and no Team Training)
n=36 Participants
Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
|
NRP With LFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
|
NRP With HFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
|
|---|---|---|---|
|
Percentage of Time Spent on Workload Management
|
89.4 percentage of time
Standard Deviation 15
|
98.0 percentage of time
Standard Deviation 5.7
|
98.8 percentage of time
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: During the megacode, which was performed about 1 hour after the trainingVigilance percentage was calculated by summing the total time the team demonstrated vigilance behavior and dividing by the total resuscitation time.
Outcome measures
| Measure |
Control (NRP Curriculum With LFT and no Team Training)
n=36 Participants
Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
|
NRP With LFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
|
NRP With HFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
|
|---|---|---|---|
|
Percentage of Time Spent on Vigilance
|
99.6 percentage of time
Standard Deviation 0.8
|
99.7 percentage of time
Standard Deviation 1.0
|
99.9 percentage of time
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: During the megacode, which was performed about 1 hour after the trainingWe 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.
Outcome measures
| Measure |
Control (NRP Curriculum With LFT and no Team Training)
n=36 Participants
Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
|
NRP With LFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
|
NRP With HFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
|
|---|---|---|---|
|
Neonatal Resuscitation Program (NRP) Quality as Assessed by NRP Performance Score
|
71.5 performance percentage
Standard Deviation 8.3
|
73.4 performance percentage
Standard Deviation 7.6
|
72.4 performance percentage
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: During the megacode, which was performed about 1 hour after the trainingResuscitation 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.
Outcome measures
| Measure |
Control (NRP Curriculum With LFT and no Team Training)
n=36 Participants
Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
|
NRP With LFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
|
NRP With HFT and Team Training
n=31 Participants
Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
|
|---|---|---|---|
|
Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration
|
634 seconds
Standard Deviation 259
|
514 seconds
Standard Deviation 139
|
443 seconds
Standard Deviation 142
|
Adverse Events
Control (NRP Curriculum With LFT and no Team Training)
NRP With LFT and Team Training
NRP With HFT and Team Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place