Generalizing TESTPILOT to New Single Family Room NICUs

NCT02574104 | Unknown DMC

• 1 other identifier: 792397-1
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Safety; Organizational Change

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• Qualitative review of successes and challenges

  90 minute focus group discussion three months after transition

Study Arms (15)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Interventions

Simulate a functional NICU prior to moving patients 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 1; Institution 10; Institution 11; Institution 12; Institution 13; Institution 14; Institution 15; Institution 2; Institution 3; Institution 4; Institution 5; Institution 6; Institution 7; Institution 8; Institution 9

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Institutions unable to commit resources for simulation preparation, latent safety threat correction, or study reporting requirements

Sponsors & Collaborators

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

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 21546863 BACKGROUND

• 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.

  PMID: 16636356 BACKGROUND

• 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.

  PMID: 18717649 BACKGROUND

• 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.

  PMID: 19088665 BACKGROUND

• 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.

  PMID: 21440815 BACKGROUND

Study Officials

• Jesse Bender, MD

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Hennessey-Green, CRA

CONTACT

4012741100; mhennesseygreene@carene.org

Andrea Pacheco-Medeiros

CONTACT

4012741100; APacheco@CareNE.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 12, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: November 7, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)