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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02574104
Acronym
TESTPILOT
Enrollment
1200
Registered
2015-10-12
Start date
2014-09-30
Completion date
2018-03-31
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organizational Change, Patient Safety

Keywords

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

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.

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.

Interventions

OTHERSimulate 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

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Women and Infants Hospital of Rhode Island
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative Latent Safety Threats (LST) discoveredTwo months leading up to transitionLSTs are discovered during simulations, documented during debriefings, fed back to workflow committees for corrective action, and solutions may be retested in subsequent simulations

Secondary

MeasureTime frameDescription
Average change in system readinessBaseline (12-8 weeks prior to move), post-TESTPILOT (6-4 weeks prior), post-workshop (10 days prior) and post-transition (4-8 weeks post)Clinical staff will document the readiness improvement trajectory of 24 key NICU processes with 6-point Likert responses to surveys in these time frames
Average change in staff preparednessBaseline (12-8 weeks prior to move), post-TESTPILOT (6-4 weeks prior), post-workshop (10 days prior) and post-transition (4-8 weeks post)Clinical staff will document the improvement trajectory of their preparedness to perform these same 24 key NICU processes with 6-point Likert responses to surveys in the time frames
Qualitative review of successes and challenges90 minute focus group discussion three months after transitionStructured team discussion on successes and ongoing challenges

Countries

United States

Contacts

Primary ContactMegan Hennessey-Green, CRA
mhennesseygreene@carene.org4012741100
Backup ContactAndrea Pacheco-Medeiros
APacheco@CareNE.org4012741100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026