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The Impact of Non-Routine Events on Neonatal Safety

NCT02756195 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 395

Last updated 2022-04-26

No results posted yet for this study

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.

Conditions

  • Neonatology

Sponsors & Collaborators

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

    collaborator NIH

  • University of Utah

    collaborator OTHER

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Daniel J France, PhD, MPH · Vanderbilt University Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02756195 on ClinicalTrials.gov