Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02756195 |
| Other study ID # |
050488 |
| Secondary ID |
1R01HD086792-01 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2016 |
| Est. completion date |
January 31, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Vanderbilt University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The study objective is to decrease neonatal mortality and morbidity by elucidating the
etiology of system failures during perioperative care.
In Aim 1 the investigators will use a novel event discovery method, based on the construct of
the nonroutine event (NRE), to efficiently capture dysfunctional clinical microsystem
attributes and potentially dangerous conditions. A NRE is defined as any event that is
perceived by care providers or skilled observers as a deviation from optimal care based on
the clinical situation.
In Aim 2, the investigators will perform a comparative analysis of prospectively collected
NRE data to the data collected by conventional event reporting methodologies.
In Aim 3 the investigators will collaborate with Primary Children's Hospital (PCH) in Salt
Lake City, UT to conduct practical pilot testing of tools and measures developed and refined
in the first two Aims.
Products from Aims 1 & 2 will include:
1. a taxonomy of NREs and outcomes for perioperative neonates;
2. neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection
tool;
3. comparisons of 5 established event reporting systems, including their rates, costs and
benefits; and
4. a guide to prototype neonatal safety surveillance and risk prediction for hospitals and
NICUs.
Aim 3 will capitalize on PCH's robust network of NICUs, neonatologists, and patient-level
outcome data to conduct a pilot implementation evaluation of the methods and tools developed
and refined in Aims 1-2.
Description:
Neonates are highly vulnerable to iatrogenic events due to their size, fragility, and severe
sensitivity to environmental stressors. Patient safety research in neonatal intensive care
units (NICU) has shown that these attributes increase care complexity and reduce the capacity
of the neonates to endure even small care deviations. As a result, neonates experience
adverse events at rates as high as 8 times of those reported for hospitalized adults. Adverse
events are estimated to occur at a rate of 74 events per every 100 NICU patients (0-11
Adverse Event(AE)/patient), with a third being severe events. The vulnerabilities of neonates
are most exposed in the perioperative environment, in which little patient safety research
has been conducted. In addition to the prevailing risks to all surgical patients (e.g.,
misidentification, positioning errors, wrong site or side, retained foreign bodies, etc.),
neonates are at increased risk to handover (e.g., NICU nurse to Operating Room team),
transport (e.g., monitoring), and intraoperative events (e.g., weight-based dosing,
temperature control, etc.).
The objective of this multi-site study is to improve neonatal safety by applying a novel
event discovery methodology to determine the etiology of system failures in the perioperative
environment. The investigators will use the construct of the non-routine event (NRE) to more
efficiently capture dysfunctional clinical microsystem attributes and potentially dangerous
conditions. A NRE is defined as any event that is perceived by care providers or skilled
observers as a deviation from optimal care based on the clinical situation. NREs encompass a
substantially larger class of events than conventional patient safety metrics, including
sentinel events, medical errors, or "near misses". In prior studies, minimizing the number of
deviations from standard care, minor problems, and disruptions during a case has been shown
to result in smoother, safer, and shorter surgeries. Moreover, in preliminary studies by
members of the research team, intraoperative NREs appeared to be associated with 30-day
surgical mortality and morbidity. The Investigators propose a comprehensive 4-year study of
neonatal patient safety in the perioperative environment to produce the knowledge base
required to inform high-impact intervention studies and guide rapid cycle quality
improvement.
The study's Aims are to:
1a) Determine the prevalence and characteristics of NREs during the perioperative care of
neonates;
1b) Delineate the relationship(s) between NREs, contributory factors, and surgical mortality
and major morbidity during neonatal perioperative care;
2) Perform a comparative analysis of prospective NRE data collection with conventional event
reporting methodologies within the same clinical environment; and
3) Collaborate with Primary Children's Hospital (PCH) in Salt Lake City, UT to conduct
practical pilot testing of tools and measures refined in Aims 1-3.
The investigators anticipate that knowledge gained from a neonatal safety model developed
from data collected prospectively at three children's hospitals and tested within PCH will
guide future intervention studies.
A product of the project will be a patient safety registry for surgical neonates. The
registry will include a sample of approximately 500 neonatal patients receiving first-time
non-cardiac surgical intervention at Monroe Carell Jr. Children's Hospital at Vanderbilt.
Neonates who receive NICU care both pre- and post-operatively will be eligible for this
study. The registry will include the following data elements: NRE data captured prospectively
in the NICU pre-operatively, intraoperatively, and post-operatively, respectively, by trained
observers; contributory factors including factors related to patients, clinicians, equipment,
logistics, and work environment; and 30-day National Surgical Quality Improvement
Project-Pediatric (NSQIP-P) morbidity and mortality outcomes. NRE severity will be
categorized and coded as:
1. Serious Safety Event (SSE);
2. Precursor Safety Event (PSE), or
3. Near Miss Safety Event (NME) based on the Safety Event Classification (SEC) system
taxonomy.
Surgical morbidity will be categorized using the NSQIP-P taxonomy and classified as Serious
(Moderate Temporary Harm to Severe Permanent Harm) or Not Serious (No Harm to Minimal
Permanent Harm) using the SEC definitions of levels of harm.
