Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 9:43 AM
Study NCT ID:
NCT02574104
Status:
UNKNOWN
Last Update Posted:
2016-11-07
First Post:
2015-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Generalizing TESTPILOT to New Single Family Room NICUs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-04', 'studyFirstSubmitDate': '2015-10-07', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Latent Safety Threats (LST) discovered', 'timeFrame': 'Two months leading up to transition', 'description': 'LSTs are discovered during simulations, documented during debriefings, fed back to workflow committees for corrective action, and solutions may be retested in subsequent simulations'}], 'secondaryOutcomes': [{'measure': 'Average change in system readiness', 'timeFrame': '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)', 'description': 'Clinical staff will document the readiness improvement trajectory of 24 key NICU processes with 6-point Likert responses to surveys in these time frames'}, {'measure': 'Average change in staff preparedness', 'timeFrame': '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)', 'description': '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'}, {'measure': 'Qualitative review of successes and challenges', 'timeFrame': '90 minute focus group discussion three months after transition', 'description': 'Structured team discussion on successes and ongoing challenges'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intensive Care Units, Neonatal', 'Patient simulation', 'Interdisciplinary Communication', 'Human factors', 'Hazard Analysis and Critical Control Points'], 'conditions': ['Patient Safety', 'Organizational Change']}, 'referencesModule': {'references': [{'pmid': '21546863', 'type': 'BACKGROUND', 'citation': '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': '16636356', 'type': 'BACKGROUND', 'citation': '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': '18717649', 'type': 'BACKGROUND', 'citation': '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': '19088665', 'type': 'BACKGROUND', 'citation': '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': '21440815', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\n"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:\n\n1. Share lessons learned and support local simulation teams in their preparations;\n2. Quantitatively demonstrate improvement in system readiness and staff preparedness at each institution\n3. Assess saturation of latent safety threats over successive TESTPILOT implementations, resulting in a blueprint for similar transitions.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Institutions building a new single family room or hybrid Neonatal Intensive Care Unit (NICU)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NICUs transitioning during the study period will be recruited.\n* Active NICU staff at each institution will be encouraged to participate without regard to age, gender, race, pregnancy or health status.\n* The participants will be a representative sample of the overall staff, which includes primarily women in most NICUs.\n\nExclusion Criteria:\n\n* Institutions unable to commit resources for simulation preparation, latent safety threat correction, or study reporting requirements'}, 'identificationModule': {'nctId': 'NCT02574104', 'acronym': 'TESTPILOT', 'briefTitle': 'Generalizing TESTPILOT to New Single Family Room NICUs', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Generalizing TESTPILOT-NICU: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing in Neonatal Intensive Care Units', 'orgStudyIdInfo': {'id': '792397-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Institution 1', 'description': 'McGill University Health Center NICU staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Complete', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 2', 'description': 'Rochester University Medical Center NICU staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Complete', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 3', 'description': 'Parkland Memorial Hospital NICU Staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Complete', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 4', 'description': 'Eastern Maine Medical Center NICU Staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Active', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 5', 'description': "Brigham and Women's Hospital NICU Staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Active", 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 6', 'description': 'Centre hospitalier universitaire Sainte-Justine NICU Staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Active', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 7', 'description': "Golisano Children's Hospital of Southwest Florida NICU Staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Preparing", 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 8', 'description': 'Florida Hospital for Children NICU Staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Preparing', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 9', 'description': 'Memorial Hospital of South Bend NICU Staff\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition\n\nSTATUS: Pending', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 10', 'description': 'recruiting\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 11', 'description': 'recruiting\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 12', 'description': 'recruiting\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 13', 'description': 'recruiting\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 14', 'description': 'recruiting\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}, {'label': 'Institution 15', 'description': 'recruiting\n\nSimulate a functional NICU prior to moving patients to preserve safety at transition', 'interventionNames': ['Other: Simulate a functional NICU prior to moving patients']}], 'interventions': [{'name': 'Simulate a functional NICU prior to moving patients', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jesse Bender, MD', 'role': 'CONTACT', 'email': 'gbender@wihri.org', 'phone': '401-274-1122', 'phoneExt': '47445'}, {'name': 'Lisa Seawell', 'role': 'CONTACT', 'email': 'lseawell@wihri.org', 'phone': '4012741122', 'phoneExt': '47403'}, {'name': 'Jesse Bender, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'James Padbury, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Women & Infants Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Megan Hennessey-Green, CRA', 'role': 'CONTACT', 'email': 'mhennesseygreene@carene.org', 'phone': '4012741100'}, {'name': 'Andrea Pacheco-Medeiros', 'role': 'CONTACT', 'email': 'APacheco@CareNE.org', 'phone': '4012741100'}], 'overallOfficials': [{'name': 'Jesse Bender, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Women & Infants Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Summary level data will be made available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': 'Jesse Bender', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}