Generalizing TESTPILOT to New Single Family Room NICUs

Study Overview
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Brief Summary
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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
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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: Share lessons learned and support local simulation teams in their preparations; Quantitatively demonstrate improvement in system readiness and staff preparedness at each institution 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.

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

Conditions
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Patient Safety, Organizational Change

Intervention / Treatment
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* Other: Simulate a functional NICU prior to moving patients


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Institution 1<br>McGill University Health Center NICU staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 2<br>Rochester University Medical Center NICU staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 3<br>Parkland Memorial Hospital NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 4<br>Eastern Maine Medical Center NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 5<br>Brigham and Women's Hospital NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 6<br>Centre hospitalier universitaire Sainte-Justine NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 7<br>Golisano Children's Hospital of Southwest Florida NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Preparing | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 8<br>Florida Hospital for Children NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Preparing | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 9<br>Memorial Hospital of South Bend NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Pending | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 10<br>recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 11<br>recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 12<br>recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 13<br>recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 14<br>recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|
| Institution 15<br>recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition | Other: Simulate a functional NICU prior to moving patients<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Latent Safety Threats (LST) discovered | LSTs are discovered during simulations, documented during debriefings, fed back to workflow committees for corrective action, and solutions may be retested in subsequent simulations | Two months leading up to transition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change in system readiness | Clinical staff will document the readiness improvement trajectory of 24 key NICU processes with 6-point Likert responses to surveys in these time frames | 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) | 
| Average change in staff preparedness | 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 | 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) | 
| Qualitative review of successes and challenges | Structured team discussion on successes and ongoing challenges | 90 minute focus group discussion three months after transition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Units, Neonatal, Patient simulation, Interdisciplinary Communication, Human factors, Hazard Analysis and Critical Control Points