The Impact of Non-Routine Events on Neonatal Safety

NCT02756195 | Completed DMC

• 2 other identifiers: 0504881R01HD086792-01
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 1

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. 1.a taxonomy of NREs and outcomes for perioperative neonates;
2. 2.neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection tool;
3. 3.comparisons of 5 established event reporting systems, including their rates, costs and benefits; and
4. 4.a guide to prototype neonatal safety surveillance and risk prediction for hospitals and NICUs.

Conditions

Neonatology

Keywords

Patient safety; adverse events; pediatric surgery; quality improvement; health systems; observational study; non-routine event; National Surgical Improvement Program

Outcome Measures

Primary Outcomes (1)

• National Surgical Quality Improvement Pediatric Mortality

  American College of Surgeons (ACS) NSQIP Pediatric is a nationally validated, risk-adjusted, outcomes-based approach to measure and improve the quality of surgical care for pediatric patients. It employs a prospective, peer-controlled, validated database to quantify 30-day, risk-adjusted surgical outcomes, which provide a valid comparison of outcomes among all hospitals in the program.

  30-day

Secondary Outcomes (1)

• National Surgical Quality Improvement Pediatric Morbidity

  30-day

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• neonates having cardiac surgery

Sponsors & Collaborators

• Vanderbilt University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Utah: collaborator

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Daniel J France, PhD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Anesthesiology

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 29, 2016
• Study Start: November 1, 2016
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)