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Trial record 22 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Patient Safety"

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
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Utah
Information provided by (Responsible Party):
Dan France, Vanderbilt University

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.


Condition or disease
Neonatology

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • neonates having cardiac surgery

Information from the National Library of Medicine

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


Contacts
Contact: Daniel J France, PhD, MPH 615-322-1407 dan.france@vanderbilt.edu
Contact: Martin L Blakely, MD 615-936-1050 martin.blakely@vanderbilt.edu

Locations
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: Martin Blakely, MD         
Sponsors and Collaborators
Vanderbilt University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Utah
Investigators
Principal Investigator: Daniel J France, PhD, MPH Vanderbilt University Medical Center

Responsible Party: Dan France, Research Professor of Anesthesiology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02756195     History of Changes
Other Study ID Numbers: 050488
1R01HD086792-01 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared. Only aggregate de-identified data will be disseminated.

Keywords provided by Dan France, Vanderbilt University:
Patient safety
adverse events
pediatric surgery
quality improvement
health systems
observational study
non-routine event
National Surgical Improvement Program