Clinical trial NCT02574104: Generalizing TESTPILOT to New Single Family Room NICUs
Official title: Generalizing TESTPILOT-NICU: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing in Neonatal Intensive Care Units
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Safety
Organizational Change
Keywords: Intensive Care Units, Neonatal
Patient simulation
Interdisciplinary Communication
Human factors
Hazard Analysis and Critical Control Points
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-10-12
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Institutions building a new single family room or hybrid Neonatal Intensive Care Unit (NICU)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Latent Safety Threats (LST) discovered
timeFrame: Two months leading up to transition
Secondary outcomes:
measure: Average change in system readiness
timeFrame: Baseline (12-8 weeks prior to move), post-TESTPILOT (6-4 weeks prior), post-workshop (10 days prior) and post-transition (4-8 weeks post)
measure: Average change in staff preparedness
timeFrame: Baseline (12-8 weeks prior to move), post-TESTPILOT (6-4 weeks prior), post-workshop (10 days prior) and post-transition (4-8 weeks post)
measure: Qualitative review of successes and challenges
timeFrame: 90 minute focus group discussion three months after transition
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Jesse Bender, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bender J, Shields R, Kennally K. Transportable enhanced simulation technologies for pre-implementation limited operations testing: neonatal intensive care unit. Simul Healthc. 2011 Aug;6(4):204-12. doi: 10.1097/SIH.0b013e3182183c0b.
citation: Kobayashi L, Shapiro MJ, Sucov A, Woolard R, Boss RM 3rd, Dunbar J, Sciamacco R, Karpik K, Jay G. Portable advanced medical simulation for new emergency department testing and orientation. Acad Emerg Med. 2006 Jun;13(6):691-5. doi: 10.1197/j.aem.2006.01.023. Epub 2006 Apr 24.
citation: Kaji AH, Bair A, Okuda Y, Kobayashi L, Khare R, Vozenilek J. Defining systems expertise: effective simulation at the organizational level--implications for patient safety, disaster surge capacity, and facilitating the systems interface. Acad Emerg Med. 2008 Nov;15(11):1098-103. doi: 10.1111/j.1553-2712.2008.00209.x. Epub 2008 Aug 20.
citation: Villamaria FJ, Pliego JF, Wehbe-Janek H, Coker N, Rajab MH, Sibbitt S, Ogden PE, Musick K, Browning JL, Hays-Grudo J. Using simulation to orient code blue teams to a new hospital facility. Simul Healthc. 2008 Winter;3(4):209-16. doi: 10.1097/SIH.0b013e31818187f3.
citation: Bender GJ. In situ simulation for systems testing in newly constructed perinatal facilities. Semin Perinatol. 2011 Apr;35(2):80-3. doi: 10.1053/j.semperi.2011.01.007.