Generalizing TESTPILOT to New Single Family Room NICUs (TESTPILOT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Patient Safety; Organizational Change
• Intervention / Treatment: Other: Simulate a functional NICU prior to moving patients

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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Women & Infants Hospital
      • Contact: Jesse Bender, MD; Phone Number: 47445 401-274-1122; Email: gbender@wihri.org
      • Contact: Lisa Seawell; Phone Number: 47403 4012741122; Email: lseawell@wihri.org
      • Principal Investigator: Jesse Bender, MD
      • Sub-Investigator: James Padbury, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Institutions building a new single family room or hybrid Neonatal Intensive Care Unit (NICU)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

15

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Institution 1; 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; 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
Institution 2; 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; 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
Institution 3; 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; 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
Institution 4; 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; 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
Institution 5; 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; 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
Institution 6; 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; 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
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	Other: 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
Institution 8; 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; 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
Institution 9; 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; 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
Institution 10; recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition	Other: 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
Institution 11; recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition	Other: 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
Institution 12; recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition	Other: 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
Institution 13; recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition	Other: 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
Institution 14; recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition	Other: 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
Institution 15; recruiting Simulate a functional NICU prior to moving patients to preserve safety at transition	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Jesse Bender, MD, Women & Infants Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Bender

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 12, 2015

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Human factors; Intensive Care Units, Neonatal; Patient simulation; Interdisciplinary Communication; Hazard Analysis and Critical Control Points
• Other Study ID Numbers: 792397-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Summary level data will be made available to other researchers