In Situ Simulation and Clinical Outcomes in Infants Born Preterm.

OBJECTIVE: To evaluate impact of a multihospital collaborative quality improvement project implementing in situ simulation training for neonatal resuscitation on clinical outcomes for infants born preterm. STUDY DESIGN: Twelve neonatal intensive care units were divided into 4 cohorts; each completed a 15-month long program in a stepped wedge manner. Data from California Perinatal Quality Care Collaborative were used to evaluate clinical outcomes. Infants with very low birth weight between 22 through 31 weeks gestation were included. Primary outcome was survival without chronic lung disease (CLD); secondary outcomes included intubation in the delivery room, delivery room continuous positive airway pressure, hypothermia (<36°C) upon neonatal intensive care unit admission, severe intraventricular hemorrhage, and mortality before hospital discharge. A mixed effects multivariable regression model was used to assess the intervention effect. RESULTS: Between March 2017 and December 2020, a total of 2626 eligible very low birth weight births occurred at 12 collaborative participating sites. Rate of survival without CLD at participating sites was 74.1% in March to August 2017 and 76.0% in July to December 2020 (risk ratio 1.03; [0.94-1.12]); no significant improvement occurred during the study period for both participating and nonparticipating sites. The effect of in situ simulation on all secondary outcomes was stable. CONCLUSIONS: Implementation of a multihospital collaborative providing in situ training for neonatal resuscitation did not result in significant improvement in survival without CLD. Ongoing in situ simulations may have an impact on unit practice and unmeasured outcomes.

A Novel Method for Administering Epinephrine during Neonatal Resuscitation.

OBJECTIVE: This study aimed to determine if prefilled epinephrine syringes will reduce time to epinephrine administration compared with conventional epinephrine during standardized simulated neonatal resuscitation. STUDY DESIGN: Timely and accurate epinephrine administration during neonatal resuscitation is lifesaving in bradycardic infants. Current epinephrine preparation is inefficient and error-prone. For other emergency use drugs, prefilled medication syringes have decreased error and administration time. Twenty-one neonatal intensive care unit nurses were enrolled. Each subject engaged in four simulated neonatal resuscitation scenarios involving term or preterm manikins using conventional epinephrine or novel prefilled epinephrine syringes specified for patient weight and administration route. All scenarios were video-recorded. Two investigators analyzed video recordings for time to epinephrine preparation and administration. Differences between conventional and novel techniques were evaluated using the Wilcoxon Signed Rank Tests. RESULTS: Twenty-one subjects completed 42 scenarios with conventional epinephrine and 42 scenarios with novel prefilled syringes. Epinephrine preparation was faster using novel prefilled epinephrine syringes (median = 17.0 s, interquartile range [IQR] = 13.3-22.8) compared with conventional epinephrine (median = 48.0 s, IQR = 40.5-54.9, n = 42, z = 5.64, p < 0.001). Epinephrine administration was also faster using novel prefilled epinephrine syringes (median = 26.9 s, IQR = 22.1-33.2) compared with conventional epinephrine (median = 57.6 s, IQR = 48.8-66.8, n = 42, z = 5.63, p < 0.001). In a poststudy survey, all subjects supported the clinical adoption of prefilled epinephrine syringes. CONCLUSION: During simulated neonatal resuscitation, epinephrine preparation and administration are faster using novel prefilled epinephrine syringes, which may hasten return of spontaneous circulation and be lifesaving for bradycardic neonates in clinical practice. KEY POINTS: · Currently, epinephrine administration in neonatal resuscitation is inefficient and error prone.. · Prefilled epinephrine syringes hasten medication administration in simulated neonatal resuscitation.. · Clinical use of prefilled epinephrine syringes may be lifesaving for bradycardic neonates..

Neonatal Healthcare Professionals' Experiences When Implementing a Simulation and Debriefing Program in Neonatal Intensive Care Settings: A Qualitative Analysis.

BACKGROUND: Simulation-based training (SBT) and debriefing have increased in healthcare as a method to conduct interprofessional team training in a realistic environment. PURPOSE: This qualitative study aimed to describe the experiences of neonatal healthcare professionals when implementing a patient safety simulation and debriefing program in a neonatal intensive care unit (NICU). METHODS: Fourteen NICUs in California and Oregon participated in a 15-month quality improvement collaborative with the California Perinatal Quality Care Collaborative. Participating sites completed 3 months of preimplementation work, followed by 12 months of active implementation of the simulation and debriefing program. Focus group interviews were conducted with each site 2 times during the collaborative. Content analysis found emerging implementation themes. RESULTS: There were 234 participants in the 2 focus group interviews. Six implementation themes emerged: (1) receptive context; (2) leadership support; (3) culture change; (4) simulation scenarios; (5) debriefing methodology; and (6) sustainability. Primary barriers and facilitators with implementation of SBT centered around having a receptive context at the unit level (eg, availability of resources and time) and multidisciplinary leadership support. IMPLICATIONS FOR PRACTICE AND RESEARCH: NICUs have varying environmental (context) factors and consideration of unit-level context factors and support from leadership are integral aspects of enhancing the successful implementation of a simulation and debriefing program for neonatal resuscitation. Additional research regarding implementation methods for overcoming barriers for both leaders and participants, as well as determining the optimal frequency of SBT for clinicians, is needed. A knowledge gap remains regarding improvements in patient outcomes with SBT.

Using Simulation to Support Evidence-Based Design of Safer Health Care Environments.

The design of health care environments and the technologies used within them have tremendous influence on the performance of the professionals who care for patients in those spaces. In turn, the performance of those professionals greatly impacts the safety of the care that is delivered to patients. Active and latent safety errors can be greatly reduced by rigorous testing of the patient care environment. · Prior to the approval of final design specifications and actual construction.. · After construction is complete before the first patients move in.. · On an ongoing basis once patient care is in progress.. While there are numerous types of testing that can be conducted, this manuscript will focus on the use of simulated clinical scenarios in realistic/real physical environments to detect and remediate weaknesses in the design of those environments with a focus on their use in perinatal centers. KEY POINTS: · Environmental design influences human performance.. · Realistic clinical simulation can improve the design.. · Simulation should be done on a continuous basis..

Validation of an Instrument for Real-Time Assessment of Neonatal Intubation Skills: A Randomized Controlled Simulation Study.

OBJECTIVE: This study aimed to evaluate the construct validity and reliability of real-time assessment of a previously developed neonatal intubation scoring instrument (NISI). STUDY DESIGN: We performed a randomized controlled simulation study at a simulation-based research and training facility. Twenty-four clinicians experienced in neonatal intubation ("experts") and 11 medical students ("novices") performed two identical elective intubations on a neonatal patient simulator. Subjects were randomly assigned to either the intervention group, receiving predefined feedback between the two intubations, or the control group, receiving no feedback. Using the previously developed NISI, all intubations were assessed, both in real time and remotely on video. Construct validity was evaluated by (1) comparing the intubation performances, expressed as percentage scores, with and without feedback, and (2) correlating the intubation performances with the subjects' level of experience. The intrarater reliability, expressed as intraclass correlation coefficient (ICC), of real-time assessment compared with video-based assessment was determined. RESULTS: The intervention group contained 18 subjects, the control group 17. Background characteristics and baseline intubation scores were comparable in both groups. The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7-22.8%] vs. 1.4% [0.0-5.7%], respectively; p = 0.013). The 95% CI for this 10.2% difference was 2.2 to 21.4%. The subjects' experience level correlated significantly with their percentage scores (Spearman's R = 0.70; p <0.01). ICC's were 0.95 (95% CI: 0.89-0.97) and 0.94 (95% CI: 0.89-0.97) for the first and second intubation, respectively. CONCLUSION: Our NISI has construct validity and is reliable for real-time assessment. KEY POINTS: · Our neonatal intubation scoring instrument has construct validity.. · Our instrument can be reliably employed to assess neonatal intubation skills directly in real time.. · It is suitable for formative assessment, i.e., providing direct feedback during procedural training..

Pilot study of the DART tool - an objective healthcare simulation debriefing assessment instrument.

BACKGROUND: Various rating tools aim to assess simulation debriefing quality, but their use may be limited by complexity and subjectivity. The Debriefing Assessment in Real Time (DART) tool represents an alternative debriefing aid that uses quantitative measures to estimate quality and requires minimal training to use. The DART is uses a cumulative tally of instructor questions (IQ), instructor statements (IS) and trainee responses (TR). Ratios for IQ:IS and TR:[IQ + IS] may estimate the level of debriefer inclusivity and participant engagement. METHODS: Experienced faculty from four geographically disparate university-affiliated simulation centers rated video-based debriefings and a transcript using the DART. The primary endpoint was an assessment of the estimated reliability of the tool. The small sample size confined analysis to descriptive statistics and coefficient of variations (CV%) as an estimate of reliability. RESULTS: Ratings for Video A (n = 7), Video B (n = 6), and Transcript A (n = 6) demonstrated mean CV% for IQ (27.8%), IS (39.5%), TR (34.8%), IQ:IS (40.8%), and TR:[IQ + IS] (28.0%). Higher CV% observed in IS and TR may be attributable to rater characterizations of longer contributions as either lumped or split. Lower variances in IQ and TR:[IQ + IS] suggest overall consistency regardless of scores being lumped or split. CONCLUSION: The DART tool appears to be reliable for the recording of data which may be useful for informing feedback to debriefers. Future studies should assess reliability in a wider pool of debriefings and examine potential uses in faculty development.

Simulation in Neonatal-Perinatal Medicine Fellowship Programs.

OBJECTIVE: This study aimed to investigate the use of simulation in neonatal-perinatal medicine (NPM) fellowship programs. STUDY DESIGN: This was a cross-sectional survey of program directors (PDs) and simulation educators in Accreditation Council for Graduate Medical Education (ACGME) accredited NPM fellowship programs. RESULTS: Responses were received from 59 PDs and 52 simulation educators, representing 60% of accredited programs. Of responding programs, 97% used simulation, which most commonly included neonatal resuscitation (94%) and procedural skills (94%) training. The time and scope of simulation use varied significantly. The majority of fellows (51%) received ≤20 hours of simulation during training. The majority of PDs (63%) wanted fellows to receive >20 hours of simulation. Barriers to simulation included lack of faculty time, experience, funding, and curriculum. CONCLUSION: While the majority of fellowship programs use simulation, the time and scope of fellow exposure to simulation experiences are limited. The creation of a standardized simulation curriculum may address identified barriers to simulation.

Understanding the Heterogeneity of Labor and Delivery Units: Using Design Thinking Methodology to Assess Environmental Factors that Contribute to Safety in Childbirth.

OBJECTIVE: There is limited research exploring the relationship between design and patient safety outcomes, especially in maternal and neonatal care. We employed design thinking methodology to understand how the design of labor and delivery units impacts safety and identified spaces and systems where improvements are needed. STUDY DESIGN: Site visits were conducted at 10 labor and delivery units in California. A multidisciplinary team collected data through observations, measurements, and clinician interviews. In parallel, research was conducted regarding current standards and codes for building new hospitals. RESULTS: Designs of labor and delivery units are heterogeneous, lacking in consistency regarding environmental factors that may impact safety and outcomes. Building codes do not take into consideration workflow, human factors, and patient and clinician experience. Attitude of hospital staff may contribute to improving safety through design. Three areas in need of improvement and actionable through design emerged: (1) blood availability for hemorrhage management, (2) appropriate space for neonatal resuscitation, and (3) restocking and organization methods of equipment and supplies. CONCLUSION: Design thinking could be implemented at various stages of health care facility building projects and during retrofits of existing units. Through this approach, we may be able to improve hospital systems and environmental factors.

Perspectives on periviability counselling and decision-making differed between neonatologists in the United States and the Netherlands.

AIM: American guidelines suggest that neonatal resuscitation be considered at 23 weeks of gestation, one week earlier than in the Netherlands, but how counselling practices differ at the threshold of viability is unknown. This pilot study compared prenatal periviability counselling in the two countries. METHODS: In 2013, a cross-sectional survey was sent to 121 Dutch neonatologists as part of a nationwide evaluation of prenatal counselling. In this pilot study, the same survey was sent to a convenience sample of 31 American neonatologists in 2014. The results were used to compare the organisation, content and decision-making processes in prenatal counselling at 24 weeks of gestation between the two countries. RESULTS: The survey was completed by 17 (55%) American and 77 (64%) Dutch neonatologists. American neonatologists preferred to meet with parents more frequently, for longer periods of time, and to discuss more intensive care topics, including long-term complications, than Dutch neonatologists. Neonatologists from both countries preferred shared decision-making when deciding whether to initiate intensive care. CONCLUSION: Neonatologists in the United States and the Netherlands differed in their approach to prenatal counselling at 24 weeks of gestation. Cross-cultural differences may play a role.

Simulation-Based Patient-Specific Multidisciplinary Team Training in Preparation for the Resuscitation and Stabilization of Conjoined Twins.

The resuscitation of conjoined twins is a rare and complex clinical challenge. We detail how patient-specific, in situ simulation can be used to prepare a large, multidisciplinary team of health care professionals (HCPs) to deliver safe, efficient, and effective care to such patients. In this case, in situ simulation allowed an 18-person team to address the clinical and ergonomic challenges anticipated for this neonatal resuscitation. The HCPs trained together as an intact team in the actual delivery room environment to probe for human and system weaknesses prior to this unique delivery, and optimized communication, teamwork, and other behavioral skills as they prepared for the simultaneous resuscitation of two patients who were physically joined to one another.

Implementing Delivery Room Checklists and Communication Standards in a Multi-Neonatal ICU Quality Improvement Collaborative.

BACKGROUND: The 2015 American Academy of Pediatrics Neonatal Resuscitation Program (NRP) and International Liaison Committee on Resuscitation (ILCOR) resuscitation guidelines state, "It is still suggested that briefing and debriefing techniques be used whenever possible for neonatal resuscitation." Effective communication and reliable delivery of evidence-based best practices are critical aspects of the 2015 NRP guidelines. To promote optimal communication and best practice-focused checklists use during active neonatal resuscitation, the Readiness Bundle (RB) was integrated within the larger change package deployed in the California Perinatal Quality Care Collaborative's (CPQCC) 12-month Delivery Room Management Quality Improvement Collaborative. METHODS: The RB consisted of (1) a checklist for high-risk neonatal resuscitations and (2) briefings and debriefings to improve teamwork and communication in the delivery room (DR). Implementation of the RB was encouraged, compliance with the RB was tracked monthly up through 6 months after the completion of the collaborative, and satisfaction with the RB was evaluated. RESULTS: Twenty-four neonatal intensive care units (NICUs) participated in the CPQCCDR collaborative. Before the initiation of the collaborative, the elements of the RB were complied with in 0 of 740 reported deliveries (0%). During the 12-month collaborative, compliance with the RB improved to a median of 71%, which was surpassed in the 6-month period after the collaborative ended (80%). One-hundred percent of responding NICUs would recommend the RB to other NICUs working on improving DR management. CONCLUSIONS: The RB was rapidly adopted, with compliance sustained for 6 months after completion of the collaborative. Inclusion of the RB in the next generation of the NRP guidelines is encouraged.

Impact of Standardized Communication Techniques on Errors during Simulated Neonatal Resuscitation.

AIM: Current patterns of communication in high-risk clinical situations, such as resuscitation, are imprecise and prone to error. We hypothesized that the use of standardized communication techniques would decrease the errors committed by resuscitation teams during neonatal resuscitation. METHODS: In a prospective, single-blinded, matched pairs design with block randomization, 13 subjects performed as a lead resuscitator in two simulated complex neonatal resuscitations. Two nurses assisted each subject during the simulated resuscitation scenarios. In one scenario, the nurses used nonstandard communication; in the other, they used standardized communication techniques. The performance of the subjects was scored to determine errors committed (defined relative to the Neonatal Resuscitation Program algorithm), time to initiation of positive pressure ventilation (PPV), and time to initiation of chest compressions (CC). RESULTS: In scenarios in which subjects were exposed to standardized communication techniques, there was a trend toward decreased error rate, time to initiation of PPV, and time to initiation of CC. While not statistically significant, there was a 1.7-second improvement in time to initiation of PPV and a 7.9-second improvement in time to initiation of CC. CONCLUSIONS: Should these improvements in human performance be replicated in the care of real newborn infants, they could improve patient outcomes and enhance patient safety.

Modification of the Neonatal Resuscitation Program Algorithm for Resuscitation of Conjoined Twins.

There are no national or international guidelines for the resuscitation of conjoined twins. We have described how the U.S. Neonatal Resuscitation Program algorithm can be modified for delivery room resuscitation of omphaloischiopagus conjoined twins. In planning for the delivery and resuscitation of these patients, we considered the challenges of providing cardiopulmonary support to preterm conjoined twins in face-to-face orientation and with shared circulation via a fused liver and single umbilical cord. We also demonstrate how in situ simulation can be used to prepare a large, multidisciplinary team of health care professionals to deliver safe, efficient, and effective care to such patients.

Leveraging Health Care Simulation Technology for Human Factors Research: Closing the Gap Between Lab and Bedside.

OBJECTIVE: We describe health care simulation, designed primarily for training, and provide examples of how human factors experts can collaborate with health care professionals and simulationists-experts in the design and implementation of simulation-to use contemporary simulation to improve health care delivery. BACKGROUND: The need-and the opportunity-to apply human factors expertise in efforts to achieve improved health outcomes has never been greater. Health care is a complex adaptive system, and simulation is an effective and flexible tool that can be used by human factors experts to better understand and improve individual, team, and system performance within health care. METHOD: Expert opinion is presented, based on a panel delivered during the 2014 Human Factors and Ergonomics Society Health Care Symposium. RESULTS: Diverse simulators, physically or virtually representing humans or human organs, and simulation applications in education, research, and systems analysis that may be of use to human factors experts are presented. Examples of simulation designed to improve individual, team, and system performance are provided, as are applications in computational modeling, research, and lifelong learning. CONCLUSION: The adoption or adaptation of current and future training and assessment simulation technologies and facilities provides opportunities for human factors research and engineering, with benefits for health care safety, quality, resilience, and efficiency. APPLICATION: Human factors experts, health care providers, and simulationists can use contemporary simulation equipment and techniques to study and improve health care delivery.

The Society for Obstetric Anesthesia and Perinatology consensus statement on the management of cardiac arrest in pregnancy.

This consensus statement was commissioned in 2012 by the Board of Directors of the Society for Obstetric Anesthesia and Perinatology to improve maternal resuscitation by providing health care providers critical information (including point-of-care checklists) and operational strategies relevant to maternal cardiac arrest. The recommendations in this statement were designed to address the challenges of an actual event by emphasizing health care provider education, behavioral/communication strategies, latent systems errors, and periodic testing of performance. This statement also expands on, interprets, and discusses controversial aspects of material covered in the American Heart Association 2010 guidelines.

Variability of characteristics and outcomes following cardiopulmonary resuscitation events in diverse ICU settings in a single, tertiary care children's hospital*.

OBJECTIVE: The primary objective of this study was to compare and contrast the characteristics and survival outcomes of cardiopulmonary resuscitation for "monitored" events in pediatric patients treated with chest compressions more than or equal to 1 minute in varied ICU settings. DESIGN: Retrospective observational study. SETTING: Three different specialized ICUs in a single, tertiary care, academic children's hospital. PATIENTS: We collected demographic information, preexisting conditions, preevent characteristics, event characteristics, and outcome data. The primary outcome measure was survival to hospital discharge. Secondary outcome measures included return of spontaneous circulation, 24-hour survival, and survival with good neurologic outcome. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Four hundred eleven patients treated with chest compressions for more than or equal to 1 minute were included in the analysis: 170 patients were located in the cardiovascular ICU, 157 patients in the neonatal ICU, and 84 patients in the PICU. Arrest durations were longer in the cardiovascular ICU than other ICUs. Use of extracorporeal cardiopulmonary resuscitation was more prevalent in the cardiovascular ICU (cardiovascular ICU, 17%; neonatal ICU, 3%; PICU, 4%). Return of spontaneous circulation, 24-hour survival, survival to hospital discharge, and good neurologic outcome were highest among neonatal ICU patients (survival to discharge, 53%) followed by cardiovascular ICU patients (survival to discharge, 46%) and PICU patients (survival to discharge, 36%). In a multivariable model controlling for patient and event characteristics, using cardiovascular ICU as reference, adjusted odds of survival in PICU were 0.33 (95% CI, 0.14-0.76; p = 0.009) and odds of survival in neonatal ICU were 0.80 (95% CI, 0.31-2.11; p = 0.65). CONCLUSIONS: Comparative analysis of pediatric patients undergoing cardiopulmonary resuscitation in three different ICU settings demonstrated a significant variation in baseline, preevent, and event characteristics. Although outcomes vary significantly among the three different ICUs, it was difficult to ascertain if this difference was due to variation in the disease process or variation in the location of the patient.

Characterizing continuous positive airway pressure (CPAP) Belly Syndrome in preterm infants in the neonatal intensive care unit (NICU).

OBJECTIVE: Reproducibly define CPAP Belly Syndrome (CBS) in preterm infants and describe associated demographics, mechanical factors, and outcomes. STUDY DESIGN: A retrospective case-control study was conducted in infants <32 weeks gestation in the Stanford Children's NICU from January 1, 2020 to December 31, 2021. CBS was radiographically defined by a pediatric radiologist. Data analysis included descriptive statistics and comparator tests. RESULTS: Analysis included 41 infants with CBS and 69 infants without. CBS was associated with younger gestational age (median 27.7 vs 30 weeks, p < 0.001) and lower birthweight (median 1.00 vs 1.31 kg, p < 0.001). Infants with CBS were more likely to receive bilevel respiratory support and higher positive end expiratory pressure. Infants with CBS took longer to advance enteral feeds (median 10 vs 7 days, p = 0.003) and were exposed to more abdominal radiographs. CONCLUSIONS: Future CBS therapies should target small infants, prevent air entry from above, and aim to reduce time to full enteral feeds and radiographic exposure.

Anterolateral congenital diaphragmatic hernia with omphalocele: a case report and literature review.

The combination of congenital diaphragmatic hernia (CDH) and omphalocele is quite rare but can be seen in several syndromes. We report on a female newborn with this combination that had not been diagnosed prenatally. The patient suffered respiratory failure that persisted despite intensive care support, suggesting severe secondary pulmonary hypoplasia. Autopsy revealed the combination of an anterolateral CDH and omphalocele in the absence of other anomalies. We believe this to be the first such case to be reported in the literature.

The Evolution of Neonatal Patient Safety.

Human factors science teaches us that patient safety is achieved not by disciplining individual health care professionals for mistakes, but rather by designing systems that acknowledge human limitations and optimize the work environment for them. Incorporating human factors principles into simulation, debriefing, and quality improvement initiatives will strengthen the quality and resilience of the process improvements and systems changes that are developed. The future of patient safety in neonatology will require continued efforts to engineer and re-engineer systems that support the humans who are at the interface of delivering safe patient care.

The Debriefing Assessment in Real Time (DART) tool for simulation-based medical education.

BACKGROUND: Debriefing is crucial for enhancing learning following healthcare simulation. Various validated tools have been shown to have contextual value for assessing debriefers. The Debriefing Assessment in Real Time (DART) tool may offer an alternative or additional assessment of conversational dynamics during debriefings. METHODS: This is a multi-method international study investigating reliability and validity. Enrolled raters (n = 12) were active simulation educators. Following tool training, the raters were asked to score a mixed sample of debriefings. Descriptive statistics are recorded, with coefficient of variation (CV%) and Cronbach's α used to estimate reliability. Raters returned a detailed reflective survey following their contribution. Kane's framework was used to construct validity arguments. RESULTS: The 8 debriefings (µ = 15.4 min (SD 2.7)) included 45 interdisciplinary learners at various levels of training. Reliability (mean CV%) for key components was as follows: instructor questions µ = 14.7%, instructor statements µ = 34.1%, and trainee responses µ = 29.0%. Cronbach α ranged from 0.852 to 0.978 across the debriefings. Post-experience responses suggested that DARTs can highlight suboptimal practices including unqualified lecturing by debriefers. CONCLUSION: The DART demonstrated acceptable reliability and may have a limited role in assessment of healthcare simulation debriefing. Inherent complexity and emergent properties of debriefing practice should be accounted for when using this tool.