Recruiting

Observational Study

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT02574104

Conditions

Patient Safety

Organizational Change

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Simulate a functional NICU prior to moving patients

Study Details

Brief summary:

Complex service interventions are neither smooth nor easy in any transitioning healthcare facility. Simulations performed in the new environment reinforce patient safety by uncovering safety threats, enabling their correction, and orienting hospital staff. This study expands upon patient safety successes at several institutions to measurably enhance patient safety at upcoming new inpatient facilities.

Conditions

Patient Safety

Organizational Change

Study ID

NCT02574104

Start date

Sep, 2014

Status verified date

Nov, 2016

Completion date

Mar, 2018

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • NICUs transitioning during the study period will be recruited.
  • Active NICU staff at each institution will be encouraged to participate without regard to age, gender, race, pregnancy or health status.
  • The participants will be a representative sample of the overall staff, which includes primarily women in most NICUs.

Exclusion Criteria:

  • Institutions unable to commit resources for simulation preparation, latent safety threat correction, or study reporting requirements

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Institution 1

McGill University Health Center NICU staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Complete

Institution 2

Rochester University Medical Center NICU staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Complete

Institution 3

Parkland Memorial Hospital NICU Staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Complete

Institution 4

Eastern Maine Medical Center NICU Staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Active

Institution 5

Brigham and Women's Hospital NICU Staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Active

Institution 6

Centre hospitalier universitaire Sainte-Justine NICU Staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Active

Institution 7

Golisano Children's Hospital of Southwest Florida NICU Staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Preparing

Institution 8

Florida Hospital for Children NICU Staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Preparing

Institution 9

Memorial Hospital of South Bend NICU Staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Pending

Institution 10

recruiting

Simulate a functional NICU prior to moving patients to preserve safety at transition

Institution 11

recruiting

Simulate a functional NICU prior to moving patients to preserve safety at transition

Institution 12

recruiting

Simulate a functional NICU prior to moving patients to preserve safety at transition

Institution 13

recruiting

Simulate a functional NICU prior to moving patients to preserve safety at transition

Institution 14

recruiting

Simulate a functional NICU prior to moving patients to preserve safety at transition

Institution 15

recruiting

Simulate a functional NICU prior to moving patients to preserve safety at transition

Interventions

Simulate a functional NICU prior to moving patients

Test translation of care paradigms in the new environment a priori. Invest significant time and resources into scenario design, staffing, preparing and orchestration the simulations. 80-160 staff participate in simulations, discover and resolve latent safety threats

Primary outcome measure

  • Cumulative Latent Safety Threats (LST) discovered [ Time Frame: Two months leading up to transition ]

Central Contacts and Locations

Central contacts

Megan Hennessey-Green, CRA

4012741100mhennesseygreene@carene.org

Andrea Pacheco-Medeiros

4012741100APacheco@CareNE.org

Locations

Women & Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Principal Investigator:

Jesse Bender, MD

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Nov 6, 2016

Last verified

Nov, 2016

Keywords

  • Intensive Care Units, Neonatal
  • Patient simulation
  • Interdisciplinary Communication
  • Human factors
  • Hazard Analysis and Critical Control Points

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2016-11-06.