Generalizing TESTPILOT to New Single Family Room NICUs

NCT ID: NCT02574104

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-03-31

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:

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

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Patient Safety Organizational Change

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Institution 1

McGill University Health Center NICU staff

Simulate a functional NICU prior to moving patients to preserve safety at transition

STATUS: Complete

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Simulate a functional NICU prior to moving patients

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Jesse Bender

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesse Bender, MD

Role: PRINCIPAL_INVESTIGATOR

Women & Infants Hospital

Locations

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Women & Infants Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Hennessey-Green, CRA

Role: CONTACT

Phone: 4012741100

Email: [email protected]

Andrea Pacheco-Medeiros

Role: CONTACT

Phone: 4012741100

Email: [email protected]

Facility Contacts

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Jesse Bender, MD

Role: primary

Lisa Seawell

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21546863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16636356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18717649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19088665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21440815 (View on PubMed)

Other Identifiers

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792397-1

Identifier Type: -

Identifier Source: org_study_id