Generalizing TESTPILOT to New Single Family Room NICUs

Sponsor
Women and Infants Hospital of Rhode Island (Other)
Overall Status
Unknown status
CT.gov ID
NCT02574104
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
1,200
1
42
28.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Generalizing TESTPILOT-NICU: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing in Neonatal Intensive Care Units
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cumulative Latent Safety Threats (LST) discovered [Two months leading up to transition]

    LSTs are discovered during simulations, documented during debriefings, fed back to workflow committees for corrective action, and solutions may be retested in subsequent simulations

Secondary Outcome Measures

  1. Average change in system readiness [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)]

    Clinical staff will document the readiness improvement trajectory of 24 key NICU processes with 6-point Likert responses to surveys in these time frames

  2. Average change in staff preparedness [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)]

    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

  3. Qualitative review of successes and challenges [90 minute focus group discussion three months after transition]

    Structured team discussion on successes and ongoing challenges

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women & Infants Hospital Providence Rhode Island United States 02905

Sponsors and Collaborators

  • Women and Infants Hospital of Rhode Island
  • Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Jesse Bender, MD, Women & Infants Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Jesse Bender, Neonatologist, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT02574104
Other Study ID Numbers:
  • 792397-1
First Posted:
Oct 12, 2015
Last Update Posted:
Nov 6, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Jesse Bender, Neonatologist, Women and Infants Hospital of Rhode Island

Study Results

No Results Posted as of Nov 6, 2016