The Impact of Non-Routine Events on Neonatal Safety
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|ClinicalTrials.gov Identifier: NCT02756195|
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : May 3, 2018
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:
- a taxonomy of NREs and outcomes for perioperative neonates;
- neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection tool;
- comparisons of 5 established event reporting systems, including their rates, costs and benefits; and
- 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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||The Impact of Non-Routine Events on Neonatal Safety in the Perioperative Environment|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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.
- National Surgical Quality Improvement Pediatric Mortality [ Time Frame: 30-day ]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.
- National Surgical Quality Improvement Pediatric Morbidity [ Time Frame: 30-day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756195
|Contact: Daniel J France, PhD, MPHfirstname.lastname@example.org|
|Contact: Martin L Blakely, MDemail@example.com|
|United States, Tennessee|
|Monroe Carell Jr. Children's Hospital at Vanderbilt||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Martin Blakely, MD|
|Principal Investigator:||Daniel J France, PhD, MPH||Vanderbilt University Medical Center|