Patient SafetyTESTPILOTNCT02574104
Generalizing TESTPILOT to New Single Family Room NICUs
An observational study of Patient Safety and Organizational Change, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Organizational Change
- What is being tested?
- Simulate a functional NICU prior to moving patients
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Institutions building a new single family room or hybrid Neonatal Intensive Care Unit (NICU)
Who may be able to join
- 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.
Who cannot join
- Institutions unable to commit resources for simulation preparation, latent safety threat correction, or study reporting requirements
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Women & Infants Hospital
Providence, Rhode Island, 02905
Jesse Bender, MD, 401-274-1122 ext. 47445, gbender@wihri.org
Lisa Seawell, 4012741122 ext. 47403, lseawell@wihri.org
About this study
Official title: Generalizing TESTPILOT-NICU: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing in Neonatal Intensive Care Units
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.
Read the 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:
- Share lessons learned and support local simulation teams in their preparations;
- Quantitatively demonstrate improvement in system readiness and staff preparedness at each institution
- 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
- Patient Safety, Organizational Change
- Being tested
- Simulate a functional NICU prior to moving patients
- Keywords
- Intensive Care Units, Neonatal, Patient simulation, Interdisciplinary Communication, Human factors, Hazard Analysis and Critical Control Points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulate a functional NICU prior to moving patientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Institution 1 | McGill University Health Center NICU staff
Simulate a functional NICU prior to moving patients to preserve safety at transition
STATUS: Complete Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Simulate a functional NICU prior to moving patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two months leading up to transition
Secondary outcomes (3)
Average change in system readiness
Clinical staff will document the readiness improvement trajectory of 24 key NICU processes with 6-point Likert responses to surveys in these time frames
Measured: 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
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
Measured: 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
Structured team discussion on successes and ongoing challenges
Measured: 90 minute focus group discussion three months after transition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jesse Bender, Women and Infants Hospital of Rhode Island
- Investigators
- Jesse Bender, MD, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574104
- Sponsor's protocol ID
- 792397-1
- Acronym
- TESTPILOT
- Status last verified
- Nov 2016
- First submitted
- 7 Oct 2015
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Summary level data will be made available to other researchers
Publications
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.
PubMed 21546863Kobayashi 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.
PubMed 16636356Kaji 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.
PubMed 18717649Villamaria 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.
PubMed 19088665Bender 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.
PubMed 21440815
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalizing TESTPILOT-NICU: Transportable Enhanced Simulation Technologies for Pre-Implementation Limited Operations Testing in Neonatal Intensive Care Units
- ClinicalTrials.gov ID
- NCT02574104
- Acronym / sponsor ID
- TESTPILOT / 792397-1
- Conditions
- Patient Safety, Organizational Change
- Keywords
- Intensive Care Units, Neonatal, Patient simulation, Interdisciplinary Communication, Human factors, Hazard Analysis and Critical Control Points
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- Share lessons learned and support local simulation teams in their preparations;
- Quantitatively demonstrate improvement in system readiness and staff preparedness at each institution
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Institution 1 | – | Other: Simulate a functional NICU prior to moving patientsMcGill University Health Center NICU staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete |
| Institution 2 | – | Other: Simulate a functional NICU prior to moving patientsRochester University Medical Center NICU staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete |
| Institution 3 | – | Other: Simulate a functional NICU prior to moving patientsParkland Memorial Hospital NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Complete |
| Institution 4 | – | Other: Simulate a functional NICU prior to moving patientsEastern Maine Medical Center NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active |
| Institution 5 | – | Other: Simulate a functional NICU prior to moving patientsBrigham and Women's Hospital NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active |
| Institution 6 | – | Other: Simulate a functional NICU prior to moving patientsCentre hospitalier universitaire Sainte-Justine NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Active |
| Institution 7 | – | Other: Simulate a functional NICU prior to moving patientsGolisano Children's Hospital of Southwest Florida NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Preparing |
| Institution 8 | – | Other: Simulate a functional NICU prior to moving patientsFlorida Hospital for Children NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Preparing |
| Institution 9 | – | Other: Simulate a functional NICU prior to moving patientsMemorial Hospital of South Bend NICU Staff Simulate a functional NICU prior to moving patients to preserve safety at transition STATUS: Pending |
| Institution 10 | – | Other: Simulate a functional NICU prior to moving patientsrecruiting Simulate a functional NICU prior to moving patients to preserve safety at transition |
| Institution 11 | – | Other: Simulate a functional NICU prior to moving patientsrecruiting Simulate a functional NICU prior to moving patients to preserve safety at transition |
| Institution 12 | – | Other: Simulate a functional NICU prior to moving patientsrecruiting Simulate a functional NICU prior to moving patients to preserve safety at transition |
| Institution 13 | – | Other: Simulate a functional NICU prior to moving patientsrecruiting Simulate a functional NICU prior to moving patients to preserve safety at transition |
| Institution 14 | – | Other: Simulate a functional NICU prior to moving patientsrecruiting Simulate a functional NICU prior to moving patients to preserve safety at transition |
| Institution 15 | – | Other: Simulate a functional NICU prior to moving patientsrecruiting Simulate a functional NICU prior to moving patients to preserve safety at transition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Institutions building a new single family room or hybrid Neonatal Intensive Care Unit (NICU)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Institutions unable to commit resources for simulation preparation, latent safety threat correction, or study reporting requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulate a functional NICU prior to moving patientsTest 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 | Other | 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 |
Primary outcome
Cumulative Latent Safety Threats (LST) discovered
Time frame: 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
3 secondary outcomes
Average change in system readiness
Time frame: 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
Time frame: 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
Time frame: 90 minute focus group discussion three months after transition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Background: PubMed 21546863Bender 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.
- Background: PubMed 16636356Kobayashi 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.
- Background: PubMed 18717649Kaji 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.
- Background: PubMed 19088665Villamaria 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.
- Background: PubMed 21440815Bender 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.
- Individual participant dataSharing planned: No. Summary level data will be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Bender, MD principal investigator
Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety and Organizational Change, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Hennessey-Green, CRA (4012741100, mhennesseygreene@carene.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Latent Safety Threats (LST) discovered (time frame: Two months leading up to transition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574104, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.