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UnknownNCT02574104

Generalizing TESTPILOT to New Single Family Room NICUs

Generalizing TESTPILOT-NICU: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing in Neonatal Intensive Care Units

Status
Unknown
Phase
Study type
Observational
Enrollment
1,200 (estimated)
Sponsor
Women and Infants Hospital of Rhode Island · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Detailed description

Prior to opening the nation's largest single family room NICU in 2009, Women \& Infants Hospital developed TESTPILOT: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing. The investigators simulated a functional NICU. 164 latent safety threats (LST) were identified without exposing a single neonate to risk. Practical changes were made to a) verbal and written communication protocols, b) admissions workflows, c) rapid team responses, d) family centered care e) scripting, f) facilities, g) supplies and equipment, and h) staffing and training issues. "Generalizing TESTPILOT" studies how learnable and applicable this simulation-based methodology is at other institutions. Six institutions have successfully implemented TESTPILOT-NICU as of 2015. The investigators hypothesize implementations will succeed across a spectrum of care delivery structures, simulation experience and magnitudes of culture change, resulting in a broad blueprint for integrating simulation into transitioning healthcare services. Our goals include: 1. Share lessons learned and support local simulation teams in their preparations; 2. Quantitatively demonstrate improvement in system readiness and staff preparedness at each institution 3. Assess saturation of latent safety threats over successive TESTPILOT implementations, resulting in a blueprint for similar transitions. During Phase I the investigators standardized, refined and validated survey instruments with NICU staff and process experts. Phase II includes implementation of TESTPILOT at 15 institutions over three years. The Principal Investigator recruits each institution and guides them through the methodology, typically lasting six to eight months. Each institution's Co-Investigator and core simulation team recruits local staff for simulation, LST discovery and resolution, and survey completion.

Conditions

Interventions

TypeNameDescription
OTHERSimulate a functional NICU prior to moving patientsTest 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

Timeline

Start date
2014-09-01
Primary completion
2017-10-01
Completion
2018-03-01
First posted
2015-10-12
Last updated
2016-11-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02574104. Inclusion in this directory is not an endorsement.