Clinical trial NCT02756195: The Impact of Non-Routine Events on Neonatal Safety
Official title: The Impact of Non-Routine Events on Neonatal Safety in the Perioperative Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatology
Keywords: Patient safety
adverse events
pediatric surgery
quality improvement
health systems
observational study
non-routine event
National Surgical Improvement Program
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Utah
First posted: 2016-04-29
Enrollment: 395
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates undergoing first-time non-cardiac surgeries and who are treated in the neonatal intensive care unit both pre-operatively and post-operatively.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Surgical neonates
* Pre- and post-operative care provided in the NICU

Exclusion Criteria:

* neonates having cardiac surgery

Primary outcomes:
measure: National Surgical Quality Improvement Pediatric Mortality
timeFrame: 30-day
Secondary outcomes:
measure: National Surgical Quality Improvement Pediatric Morbidity
timeFrame: 30-day
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel J France, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: