Influences of a Remote Monitoring Program of Home Nasogastric Tube Feeds on Transition from NICU to Home.

OBJECTIVE: The transition from the neonatal intensive care unit (NICU) to the home is complex and multifaceted for families and infants, particularly those with ongoing medical needs. Our hospital utilizes a remote monitoring program called Growing @ Home (G@H) to support discharge from the NICU with continued nasogastric tube (NGT) feeds. We aim to describe the experience of the transition from NICU to home for families enrolled in G@H. STUDY DESIGN: Using a semistructured interviewing technique, parents of infants discharged on G@H were interviewed at NICU discharge, at 1 month, and at 6 months after NICU discharge. Interviews were recorded and transcribed into data analysis software. Conventional content analysis was used to analyze qualitative data. Codes were assigned to describe key elements of the interviews and used to identify major themes. RESULTS: Parents (n = 17) identified three major themes when discussing the effect of G@H on the transition to home. The program provided a means of escape from the NICU, allowing families to stop living split lives between their homes and the NICU. It acted as a middle ground between the restrictive yet supportive NICU environment, and the normal yet isolated home environment. G@H served as a safety net for families, providing a continued connection to the NICU for their still-fragile infants. CONCLUSION: G@H utilizes telehealth to positively support the complex transition from NICU to home for families and infants discharged with NGT feeds. KEY POINTS: · G@H program supported parents in their transition from NICU to home.. · G@H program provided a means of escape from the NICU.. · G@H program was a middle ground between the NICU and home.. · G@H program created a safety net after discharge.. · Follow-up with a consistent provider was essential to a positive parent experience..

Ventilatory Assistance Before Umbilical Cord Clamping in Extremely Preterm Infants: A Randomized Clinical Trial.

Importance: Providing assisted ventilation during delayed umbilical cord clamping may improve outcomes for extremely preterm infants. Objective: To determine whether assisted ventilation in extremely preterm infants (23 0/7 to 28 6/7 weeks' gestational age [GA]) followed by cord clamping reduces intraventricular hemorrhage (IVH) or early death. Design, Setting, and Participants: This phase 3, 1:1, parallel-stratified randomized clinical trial conducted at 12 perinatal centers across the US and Canada from September 2, 2016, through February 21, 2023, assessed IVH and early death outcomes of extremely preterm infants randomized to receive 120 seconds of assisted ventilation followed by cord clamping vs delayed cord clamping for 30 to 60 seconds with ventilatory assistance afterward. Two analysis cohorts, not breathing well and breathing well, were specified a priori based on assessment of breathing 30 seconds after birth. Intervention: After birth, all infants received stimulation and suctioning if needed. From 30 to 120 seconds, infants randomized to the intervention received continuous positive airway pressure if breathing well or positive-pressure ventilation if not, with cord clamping at 120 seconds. Control infants received 30 to 60 seconds of delayed cord clamping followed by standard resuscitation. Main Outcomes and Measures: The primary outcome was any grade IVH on head ultrasonography or death before day 7. Interpretation by site radiologists was confirmed by independent radiologists, all masked to study group. To estimate the association between study group and outcome, data were analyzed using the stratified Cochran-Mantel-Haenszel test for relative risk (RR), with associations summarized by point estimates and 95% CIs. Results: Of 1110 women who consented to participate, 548 were randomized and delivered infants at GA less than 29 weeks. A total of 570 eligible infants were enrolled (median [IQR] GA, 26.6 [24.9-27.7] weeks; 297 male [52.1%]). Intraventricular hemorrhage or death occurred in 34.9% (97 of 278) of infants in the intervention group and 32.5% (95 of 292) in the control group (adjusted RR, 1.02; 95% CI, 0.81-1.27). In the prespecified not-breathing-well cohort (47.5% [271 of 570]; median [IQR] GA, 26.0 [24.7-27.4] weeks; 152 male [56.1%]), IVH or death occurred in 38.7% (58 of 150) of infants in the intervention group and 43.0% (52 of 121) in the control group (RR, 0.91; 95% CI, 0.68-1.21). There was no evidence of differences in death, severe brain injury, or major morbidities between the intervention and control groups in either breathing cohort. Conclusions and Relevance: This study did not show that providing assisted ventilation before cord clamping in extremely preterm infants reduces IVH or early death. Additional study around the feasibility, safety, and efficacy of assisted ventilation before cord clamping may provide additional insight. Trial Registration: ClinicalTrials.gov Identifier: NCT02742454.

Remote monitoring for neonates requiring continued nasogastric tube feeding: implementation, patient characteristics, and early outcomes.

OBJECTIVE: Our neonatal intensive care unit utilizes remote patient monitoring to facilitate hospital discharge with nasogastric tube (NGT) feeds. Program implementation, patient characteristics, and initial outcomes are described. STUDY DESIGN: Data was collected prospectively in this implementation study. Descriptive statistics define weight gain, number of NGT feed days, number of days on monitoring, and physician time spent. Patient characteristics, readmissions, and implementation details are described. RESULTS: One-hundred and four babies consented to and completed data collection. Average weight gain on monitoring was 31.4 g/day (SD 10.2). Eighty-nine babies (85.6%) achieved full oral feeds while on the program, requiring a median 5 NGT feed days (IQR 2-13) and a median 15 days on monitoring (IQR 11-27). Average physician time spent was 9.1 min per day (SD 3.7). Six babies (5.8%) had unscheduled readmissions while on the program. CONCLUSION: Remote monitoring programs can facilitate discharge for babies with continued NGT needs.

Video-Assisted Informed Consent in a Clinical Trial of Resuscitation of Extremely Preterm Infants: Lessons Learned.

OBJECTIVE: Obtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks' gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a postconsent survey, we sought to describe the impact of the video on patient recruitment, satisfaction with the consent process, and knowledge about the study. STUDY DESIGN: This is a descriptive survey-based substudy. RESULTS: Of the sites participating in the VentFirst trial that obtained institutional review board (IRB) approval to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey substudy. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the postconsent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on five knowledge questions about the study was 63 to 98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video. CONCLUSION: Watching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small substudy. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study. KEY POINTS: · Informed consent in acute clinical contexts is difficult.. · Videos offer an alternative communication tool.. · Continued research is necessary to optimize the consent process..

Entrustment Decision Making in the Core Entrustable Professional Activities: Results of a Multi-Institutional Study.

PURPOSE: In 2014, the Association of American Medical Colleges defined 13 Core Entrustable Professional Activities (EPAs) that all graduating students should be ready to do with indirect supervision upon entering residency and commissioned a 10-school, 5-year pilot to test implementing the Core EPAs framework. In 2019, pilot schools convened trained entrustment groups (TEGs) to review assessment data and render theoretical summative entrustment decisions for class of 2019 graduates. Results were examined to determine the extent to which entrustment decisions could be made and the nature of these decisions. METHOD: For each EPA considered (4-13 per student), TEGs recorded an entrustment determination (ready, progressing but not yet ready, evidence against student progressing, could not make a decision); confidence in that determination (none, low, moderate, high); and the number of workplace-based assessments (WBAs) considered (0->15) per determination. These individual student-level data were de-identified and merged into a multischool database; chi-square analysis tested the significance of associations between variables. RESULTS: The 2,415 EPA-specific determinations (for 349 students by 4 participating schools) resulted in a decision of ready (n = 997/2,415; 41.3%), progressing but not yet ready (n = 558/2,415; 23.1%), or evidence against student progression (n = 175/2,415; 7.2%). No decision could be made for the remaining 28.4% (685/2,415), generally for lack of data. Entrustment determinations' distribution varied across EPAs (chi-square P < .001) and, for 10/13 EPAs, WBA availability was associated with making (vs not making) entrustment decisions (each chi-square P < .05). CONCLUSIONS: TEGs were able to make many decisions about readiness for indirect supervision; yet less than half of determinations resulted in a decision of readiness to perform this EPA with indirect supervision. More work is needed at the 10 schools to enable authentic summative entrustment in the Core EPAs framework.

Developing an Entrustment Process: Insights from the AAMC CoreEPA Pilot.

One of the main goals of the CoreEPA pilot has been to determine the feasibility of developing a process to make summative entrustment decisions regarding entrustable professional activities (EPAs). Five years into the pilot, we report results of a research study we conducted to explore approaches to the entrustment process undertaken by our ten participating schools. We sought to identify the choices that participating schools made regarding the entrustment process and why these decisions were made. We are sharing these results, highlighting ongoing challenges that were identified with the intent of helping other medical schools that are moving toward EPA-based assessment. We conducted semi-structured interviews with representatives of all 10 medical schools in the CoreEPA pilot to understand their choices in designing the entrustment process. Additional information was obtained through follow-up communication to ensure completeness and accuracy of the findings. Several common themes are described. Our results indicate that, while approaches to the entrustment process vary considerably, all schools demonstrated consistent adherence to the guiding principles of the pilot. Several common barriers to the entrustment process emerged, and there was a consensus that more experience is needed with the process before consequential entrustment decisions can be made. The CoreEPA pilot schools continue to address challenges identified in implementing entrustment processes and making entrustment decisions for our students graduating in the Class of 2020.

Finding a Path to Entrustment in Undergraduate Medical Education: A Progress Report From the AAMC Core Entrustable Professional Activities for Entering Residency Entrustment Concept Group.

PROBLEM: To better prepare graduating medical students to transition to the professional responsibilities of residency, 10 medical schools are participating in an Association of American Medical Colleges pilot to evaluate the feasibility of explicitly teaching and assessing 13 Core Entrustable Professional Activities for Entering Residency. The authors focused on operationalizing the concept of entrustment as part of this process. APPROACH: Starting in 2014, the Entrustment Concept Group, with representatives from each of the pilot schools, guided the development of the structures and processes necessary for formal entrustment decisions associated with students' increased responsibilities at the start of residency. OUTCOMES: Guiding principles developed by the group recommend that formal, summative entrustment decisions in undergraduate medical education be made by a trained group, be based on longitudinal performance assessments from multiple assessors, and incorporate day-to-day entrustment judgments by workplace supervisors. Key to entrustment decisions is evidence that students know their limits (discernment), can be relied on to follow through (conscientiousness), and are forthcoming despite potential personal costs (truthfulness), in addition to having the requisite knowledge and skills. The group constructed a developmental framework for discernment, conscientiousness, and truthfulness to pilot a model for transparent entrustment decision making. NEXT STEPS: The pilot schools are studying a number of questions regarding the pathways to and decisions about entrustment. This work seeks to inform meaningful culture change in undergraduate medical education through a shared understanding of the assessment of trust and a shared trust in that assessment.

Shared Decision Making in Neonatal Quality Improvement.

Since the Institute of Medicine published Crossing the Quality Chasm in 2001, healthcare systems have become more focused on improving the quality of healthcare delivery. At Oregon Health & Science University and Doernbecher Children's Hospital, we recognize the need to take an interprofessional, team-based approach to improving the care we provide to our current and future patients. We describe here an ongoing quality improvement project in the Doernbecher Neonatal Intensive Care Unit (NICU), with specific attention to the factors we believe have contributed to the implementation and early success of the project. These factors include the history of quality improvement work in our NICU and in the field of neonatology, the "dyad leadership" structure under which we operate in our NICU, and our developing understanding of the concept of "team intelligence." These elements have led to the formation of a team that can practice shared decision making and work as one to realize a shared goal.

Plastic bags for prevention of hypothermia in preterm and low birth weight infants.

BACKGROUND AND OBJECTIVES: Hypothermia contributes to neonatal mortality and morbidity, especially in preterm and low birth weight infants in developing countries. Plastic bags covering the trunk and extremities of very low birth weight infants reduces hypothermia. This technique has not been studied in larger infants or in many resource-limited settings. The objective was to determine if placing preterm and low birth weight infants inside a plastic bag at birth maintains normothermia. METHODS: Infants at 26 to 36 weeks' gestational age and/or with a birth weight of 1000 to 2500 g born at the University Teaching Hospital in Lusaka, Zambia, were randomized by using a 1:1 allocation and parallel design to standard thermoregulation (blanket or radiant warmer) care or to standard thermoregulation care plus placement inside a plastic bag at birth. The primary outcome measure was axillary temperature in the World Health Organization-defined normal range (36.5-37.5°C) at 1 hour after birth. RESULTS: A total of 104 infants were randomized. At 1 hour after birth, infants randomized to plastic bag (n = 49) were more likely to have a temperature in the normal range as compared with infants in the standard thermoregulation care group (n = 55; 59.2% vs 32.7%; relative risk 1.81; 95% confidence interval 1.16-2.81; P = .007). The temperature at 1 hour after birth in the infants randomized to plastic bag was 36.5 ± 0.5°C compared with 36.1 ± 0.6°C in standard care infants (P < .001). Hyperthermia (>38.0°C) did not occur in any infant. CONCLUSIONS: Placement of preterm/low birth weight infants inside a plastic bag at birth compared with standard thermoregulation care reduced hypothermia without resulting in hyperthermia, and is a low-cost, low-technology tool for resource-limited settings.

Using simulation to enhance the acquisition and retention of clinical skills in neonatology.

Neonatal care occurs in extremely complex and dynamic environments and requires providers to operate under intense time pressure in coordination with multiple disciplines. Teaching the clinical skills requisite to effective practice requires the meticulous application of curricular design principles. Simulation can be used as an effective instructional strategy in achieving learner acquisition and retention of the cognitive, technical, and behavioral skills essential to optimal delivery of care in neonatology.