The Impact of Non-Routine Events on Neonatal Safety

NCT ID: NCT02756195

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 395 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-01-31

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.

Conditions

Neonatology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neonates receiving first-time non-cardiac surgery

No intervention will be administered. This is a prospective observational patient safety study focusing on the safety of care delivered to neonates in perioperative care settings. Neonates who receive NICU care both pre- and post-operatively will be eligible for this study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• neonates having cardiac surgery

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Dan France

Research Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J France, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

1R01HD086792-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

050488

Identifier Type: -

Identifier Source: org_study_id