Generalizing TESTPILOT to New Single Family Room NICUs

Women and Infants Hospital of Rhode Island

Status: Unknown

Conditions: Patient Safety; Organizational Change

Treatments: Other: Simulate a functional NICU prior to moving patients

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02574104

792397-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,200 participants in 15 patient groups

Institution 1

Description:

McGill University Health Center NICU staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 2

Description:

Rochester University Medical Center NICU staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 3

Description:

Parkland Memorial Hospital NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 4

Description:

Eastern Maine Medical Center NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 5

Description:

Brigham and Women's Hospital NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 6

Description:

Centre hospitalier universitaire Sainte-Justine NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 7

Description:

Golisano Children's Hospital of Southwest Florida NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Preparing

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 8

Description:

Florida Hospital for Children NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Preparing

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 9

Description:

Memorial Hospital of South Bend NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Pending

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 10

Description:

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

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 11

Description:

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

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 12

Description:

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

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 13

Description:

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

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 14

Description:

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

Treatment:

Other: Simulate a functional NICU prior to moving patients

Institution 15

Description:

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

Treatment:

Other: Simulate a functional NICU prior to moving patients