Development and Evaluation of a Rural Longitudinal Neonatal Resuscitation Program Telesimulation Program (MOOSE: Maine Ongoing Outreach Simulation Education).

OBJECTIVE: Neonatal resuscitation is a high-acuity, low-occurrence event and many rural pediatricians report feeling underprepared for these events. We piloted a longitudinal telesimulation (TS) program with a rural hospital's interprofessional delivery room teams aimed at improving adherence to Neonatal Resuscitation Program (NRP) guidelines and teamwork. STUDY DESIGN: A TS study was conducted monthly in one rural hospital over a 10-month period from November 2020 to August 2021. TS sessions were remotely viewed and debriefed by experts, a neonatologist and a simulation educator. Sessions were video recorded and assessed using a scoring tool with validity evidence for NRP adherence. Teamwork was assessed using both TeamSTEPPS 2.0 Team Performance Observation Tool and Mayo High-Performance Teamwork Scale. RESULTS: We conducted 10 TS sessions in one rural hospital. There were 24 total participants, who rotated through monthly sessions, ensuring interdisciplinary team composition was reflective of realistic staffing. NRP adherence rate for full code scenarios improved from a baseline of 39 to 95%. Compared with baseline data for efficiency, multiple NRP skills improved (e.g., cardiac lead placement occurred 12× faster, 0:31 seconds vs. 6:21 minutes). Teamwork scores showed improvement in all domains. CONCLUSION: Our results demonstrate that a TS program aimed at improving NRP and team performance is possible to implement in a rural setting. Our pilot study showed a trend toward improved NRP adherence, increased skill efficiency, and higher-quality teamwork and communication in one rural hospital. Additional research is needed to analyze program efficacy on a larger scale and to understand the impact of training on patient outcomes. KEY POINTS: · Optimal newborn outcomes depend on skillful implementation of NRP.. · Telesimulation can deliver medical education that circumvents challenges in rural areas.. · A longitudinal NRP TS program is possible to implement in a rural setting.. · A rural NRP telesimulation program may improve interprofessional resuscitation performance.. · A rural NRP telesimulation program may improve interprofessional resuscitation teamwork..

Clinician Stakeholder Experience With Telemedicine Consults to Assess Neonatal Encephalopathy in a Rural State.

BACKGROUND: Serial neonatal encephalopathy (NE) examinations are difficult to perform in rural community hospitals as on-site experts are not readily available. We implemented a synchronous, acute care model of teleconsultation-the Maine Neonatal Encephalopathy Teleconsultation program (Maine NET)-to provide remote, joint assessment of NE by pediatric neurology and neonatology at nine community hospitals and one tertiary care center. We performed a qualitative study to interview clinicians about their experience of this program. METHODS: From April 2018 to October 2022, we employed a semistructured interview format with 16 clinicians representing all participating hospitals. We utilized deductive analysis to assign a set of predefined codes to the transcribed interviews. RESULTS: Thematic analysis supported the anticipated benefits of Maine NET, demonstrating that clinicians felt resource utilization, collaborative decision making, communication, and continuity of care were improved. Clinicians overwhelmingly supported the program: "This program has truly saved babies' lives and future function. I have not met any parents through this journey, who aren't incredibly grateful for the care that is provided" and emphasized the benefit of collaboration between all care team members. Teleconsultation was felt to be "more than adequate to [assess] NE." Connectivity issues were cited as a limitation. CONCLUSIONS: Maine NET has positively impacted care delivery for newborns with clinical concerns for NE. Additionally, the program has improved resource allocation, collaborative decision making, communication, and equity of care. Addressing technological challenges will be vital to the success and sustainability of the planned Maine NET expansion.

Combined immunotherapy with controlled interleukin-12 gene therapy and immune checkpoint blockade in recurrent glioblastoma: An open-label, multi-institutional phase I trial.

BACKGROUND: Veledimex (VDX)-regulatable interleukin-12 (IL-12) gene therapy in recurrent glioblastoma (rGBM) was reported to show tumor infiltration of CD8+ T cells, encouraging survival, but also up-regulation of immune checkpoint signaling, providing the rationale for a combination trial with immune checkpoint inhibition. METHODS: An open-label, multi-institutional, dose-escalation phase I trial in rGBM subjects (NCT03636477) accrued 21 subjects in 3 dose-escalating cohorts: (1) neoadjuvant then ongoing nivolumab (1mg/kg) and VDX (10 mg) (n = 3); (2) neoadjuvant then ongoing nivolumab (3 mg/kg) and VDX (10 mg) (n = 3); and (3) neoadjuvant then ongoing nivolumab (3 mg/kg) and VDX (20 mg) (n = 15). Nivolumab was administered 7 (±3) days before resection of the rGBM followed by peritumoral injection of IL-12 gene therapy. VDX was administered 3 hours before and then for 14 days after surgery. Nivolumab was administered every two weeks after surgery. RESULTS: Toxicities of the combination were comparable to IL-12 gene monotherapy and were predictable, dose-related, and reversible upon withholding doses of VDX and/or nivolumab. VDX plasma pharmacokinetics demonstrate a dose-response relationship with effective brain tumor tissue VDX penetration and production of IL-12. IL-12 levels in serum peaked in all subjects at about Day 3 after surgery. Tumor IFNγ increased in post-treatment biopsies. Median overall survival (mOS) for VDX 10 mg with nivolumab was 16.9 months and for all subjects was 9.8 months. CONCLUSION: The safety of this combination immunotherapy was established and has led to an ongoing phase II clinical trial of immune checkpoint blockade with controlled IL-12 gene therapy (NCT04006119).