scholarly journals 29 Using Simulation in a Clinical Care Setting to Evaluate a Novel Medical Device with Families and Bedside Staff – Phase 1: Perceptions of the NeoVest under a Family Integrated Care (FICare) Model

2020 ◽  
Vol 25 (Supplement_2) ◽  
pp. e11-e11
Author(s):  
Avery Longmore ◽  
Kathleen Hollamby ◽  
Jeanne Zielonka ◽  
Douglas M Campbell

Abstract Background Newborn infants are at increased risk of requiring respiratory support with a mechanical ventilator. Nasal continuous positive airway pressure (nCPAP) is the most commonly used non-invasive respiratory support. Current nCPAP support is not synchronized to an infant’s breathing efforts, and can contribute to patient discomfort, skin breakdown, and interference with mother-infant bonding. An alternative to nCPAP is negative pressure ventilation. Our NeoVest was developed as a wearable vest that utilizes Neurally Adjusted Ventilator Assist (NAVA) technology to synchronize with the infant’s own respiratory drive and control. NeoVest and NAVA have demonstrated efficacy/feasibility in preliminary experiments emulating neonatal respiratory distress in animal models. Before implementation of this new technology in NICUs, it is important to assess the perspectives of NICU multi-disciplinary staff and parents to optimize design and understand its impact. Objectives The objective was to assess both clinicians’ and NICU parents’ perceptions of the NeoVest as compared with traditional nCPAP devices. Design/Methods Nurses, respiratory therapists and NICU parents at St. Michael’s Hospital in Toronto, Canada were invited to participate in the study. Research Ethics Board approval was obtained for this study. Parents were approached if their baby has previously been on CPAP. After consent, participants attended simulations that demonstrated the utility of the NeoVest. After the simulation, participants completed a survey that assessed their satisfaction and stress level regarding use of the NeoVest in a clinical setting. Numeric Likert scale responses and free text comments were collected from participants and analyzed. Free text comments were assessed using the principles of thematic analysis. Results Thirty clinicians (16 nurses, and 14 RTs), and 4 parents answered the survey. Almost all respondents were excited by the new technology and believed the use of simulation in the NICU was beneficial. Respondents reported that the NeoVest would not add stress to their roles in the NICU, and the majority of clinicians also believed that the NeoVest will improve care of the infant patient. Parents and clinicians both suggested that nCPAP can cause stress, and that the NeoVest would be preferred. One of the major themes regarding how the NeoVest may improve care from the perspective of both parents and clinicians was improved parent-child bonding through improved eye contact. Clinicians also believed it would reduce irritation, maintain skin integrity and have less complications as compared to nCPAP. The major themes with respect to clinician concerns about the NeoVest included: examining the neonate, umbilical line access, and the learning curve for new technology. The major themes with respect to parental concerns included: interference with skin to skin and holding their child. Conclusion Survey responses were overall favourable for introduction of new NICU technology, in this case a novel breathing device: the NeoVest. Although small, this cohort provided invaluable insight regarding the NeoVest’s impact on future patient populations. This highlights the importance of patient feedback in innovation. Next steps include a pilot study assessing the feasibility and efficacy of the NeoVest in the clinical setting, with re-administration of the questionnaires to compare reality and simulation.

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 11-12
Author(s):  
Blake T. Langlais ◽  
Carolyn Mead-Harvey ◽  
Heidi E. Kosiorek ◽  
Gina L. Mazza ◽  
Ruben Mesa ◽  
...  

Background The COVID-19 pandemic continues to challenge effective treatment delivery to hematologically-compromised patients, including those with myeloproliferative neoplasms (MPNs). MPNs are characterized by clonal proliferation of hematopoietic cell lines in bone marrow. As such, increasing reports of COVID-19 related thrombotic events highlight how MPN patients are at an increased risk in navigating potential complications during this pandemic. Mitigation strategies to lesson MPN patient exposure to COVID-19 are vital. Though, such efforts come at an inherent cost to effective healthcare delivery. Restriction of regular in-clinic treatments and reported shortages of MPN pharmacotherapies present these patients with diminishing continued care. To understand how MPN patient care has been impacted by COVID-19, an internet-based questionnaire was deployed surveying a variety of disease and pandemic related items (reported elsewhere; Palmer J et al, ASH 2020 submitted). A single free-text response item instructed respondents to: "Please tell us anything else (bad or good) about how the COVID-19 outbreak has impacted your MPN care." This qualitative analysis evaluated first-hand comments directly from patients in order to form a richer understanding of how those with MPNs have been managing disease-related care amidst this pandemic. Methods This COVID-19 survey was hosted via Mayo Clinic's secured REDCap system for online surveys and posted on MPN organizational partner websites. Surveys were completely anonymous. The free-text responses describing impacts to MPN care were each independently reviewed by 2 individuals for overall sentiment (positive, negative, both, or neutral [no impact]) and categorized for themes. The 2 reviewers were assessed for agreement. Conflicting reviews were evaluated then adjudicated by an algorithm for cases meeting selected conditions or by lead author review for all remaining cases. Descriptive statistics are reported. Results Of the 1217 consenting adult patients participating in the overall COVID-19 study, 824 provided free-text responses. Of these, respondent MPN diagnoses included, essential thrombocythemia (n=324, 39%), polycythemia vera (n=251, 30%), myelofibrosis (n=153, 19%), and other/undisclosed (96, 12%); 69% (n=567) were female; median age was 63 (range 21-93); 38% (n=313) were from the US, 38% (n=313) UK, and 24% (n=198) other/unknown. There was 89% (n=734) sentiment agreement between reviewers. Free-text responses about the impact of COVID-19 on MPN care were 49% (n=400) negative, 21% (n=177) positive, 8% (n=65) both positive and negative, and 22% (n=182) neutral/no impact. Table 1 shows a selection of MPN patient free-text responses reflecting common negative and positive sentiment themes. Negative impact (n=400): The most common negative impact involved delays or cancellations of visits or perceived inaccessibility to regular providers (n=261, 65%). Primarily this sentiment was driven by lack of clinic availability and restrictions at treatment centers or by providers. However, some respondents reported delaying or canceling visits themselves due to fear of COVID-19 exposure. Perceived health consequences from this delay were also expressed. There were 129 (32%) respondents with concern regarding changes or access to medications, including explicit drug supply shortages. Some patients resorted to self-adjusting medications and reusing single-use supplies. General anxiety, stress, and isolation were also reported (n=98, 25%). Positive impact (n=177): Availability of telemedicine comprised the majority of positive impacts of the pandemic (n=95, 54%), with many noting the reduced travel time to visits. Routine local testing coupled with follow-up telemedicine was favorable. Despite general positivity towards telemedicine, some reported preferences for in-person visits; commenting that telemedicine was impersonal, difficult to schedule or receive virtual communication, and expressed concern for lack of spleen examinations during virtual visits. Conclusion Positive and negative aspects were reported including MPN-specific issues. Healthcare systems should use such data to emerge from the COVID-19 pandemic and retain the positive impacts such as telemedicine, while developing education materials and other resources to address the reported negative impacts where possible. Disclosures Mesa: CTI BioPharma: Research Funding; Promedior: Research Funding; Novartis: Consultancy; Sierra Oncology: Consultancy; Samus Therapeutics: Research Funding; Genentech: Research Funding; AbbVie: Research Funding; Incyte: Research Funding; LaJolla Pharmaceutical Company: Consultancy; Bristol Myers Squibb: Research Funding.


2020 ◽  
Vol 52 (1) ◽  
pp. 17-23
Author(s):  
Jennifer Edwards-Johnson ◽  
Julie P. Phillips ◽  
Andrea Wendling

Background and Objectives: Medical students often lack curricular offerings specific to the care of underserved populations. We surveyed first- and second-year students to inform the development of a 4-week course on the skills necessary to care and advocate for underserved populations within a primary care context. This study assessed students’ interest in the potential course, interest in primary care (PC) and underserved care (UC), and factors that would make the course more or less interesting to students. Methods: The authors designed and offered a survey examining UC, PC, and course interest to all first- and second-year students at one institution. Open-ended free-text survey responses were qualitatively analyzed using content analysis. Results: Response rate was 72% (271/374). Most responding students (90%; 198/220) were very to somewhat interested in UC; 60% (132/220) were very to somewhat interested in PC; and 79% (173/220) were very to somewhat interested in the described course. Very interested students were more likely to endorse interest in learning about community advocacy, having a faculty mentor, clinical care experience, and loan repayment than those with low course interest (P<.001). Analysis of open-ended responses revealed an emphasis on advocacy and career feasibility, resulting in the inclusion of these topics in the final course curriculum. Conclusions: This manuscript outlines potential areas of engagement for students demonstrating low or high interest in a Caring for Underserved Patients course. Our study may inform educators seeking to develop similar curricular interventions, particularly those who aim to recruit students to PC or UC careers.


2020 ◽  
Vol 51 (3) ◽  
pp. 120-124
Author(s):  
Dominik Dytfeld

AbstractIn spite of the introduction of several new drugs in the last 10 years, multiple myeloma (MM) remains incurable. Thus, an adoptive cellular therapy using chimeric antigen receptor T (CART), a strategy to increase the frequency of tumor-directed and functionally active T cells targeting antigens present on the cancer cell, might change the treatment in MM as it did in lymphoma and ALL. There are several targets for CART therapy in MM on different levels of development, which are discussed in the manuscript. B-cell maturation antigen (BCMA) being tested in the studies of phase 1–2 is the most promising, but so far CART has not been approved in the cure of MM and remains an experimental approach. The hematological society is facing a new technology which with its potential ability to cure MM, in spite of its complexity, cost, and toxicity, will definitely and soon change the landscape of myeloma in Europe and world-wide.


Author(s):  
Suzanne C. E. H. Sallevelt ◽  
Alexander P. A. Stegmann ◽  
Bart de Koning ◽  
Crool Velter ◽  
Anja Steyls ◽  
...  

Abstract Purpose Consanguineous couples are at increased risk of being heterozygous for the same autosomal recessive (AR) disorder(s), with a 25% risk of affected offspring as a consequence. Until recently, comprehensive preconception carrier testing (PCT) for AR disorders was unavailable in routine diagnostics. Here we developed and implemented such a test in routine clinical care. Methods We performed exome sequencing (ES) for 100 consanguineous couples. For each couple, rare variants that could give rise to biallelic variants in offspring were selected. These variants were subsequently filtered against a gene panel consisting of ~2,000 genes associated with known AR disorders (OMIM-based). Remaining variants were classified according to American College of Medical Genetics and Genomics/Association for Molecular Pathology (ACMG/AMP) guidelines, after which only likely pathogenic and pathogenic (class IV/V) variants, present in both partners, were reported. Results In 28 of 100 tested consanguineous couples (28%), likely pathogenic and pathogenic variants not previously known in the couple or their family were reported conferring 25% risk of affected offspring. Conclusion ES-based PCT provides a powerful diagnostic tool to identify AR disease carrier status in consanguineous couples. Outcomes provided significant reproductive choices for a higher proportion of these couples than previous tests.


2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Malika D. Shah ◽  
Ola Didrik Saugstad

Abstract After more than 1 year of the SARS-CoV-2 pandemic, a great deal of knowledge on how this virus affects pregnant women, the fetus and the newborn has accumulated. The gap between different guidelines how to handle newborn infants during this pandemic has been minimized, and the American Academy of Pediatrics (AAP)’s recommendations are now more in accordance with those of the World Health Organization (WHO). In this article we summarize present knowledge regarding transmission from mother to the fetus/newborn. Although both vertical and horizontal transmission are rare, SARS-CoV-2 positivity is associated with an increased risk of premature delivery and higher neonatal mortality and morbidity. Mode of delivery and cord clamping routines should not be affected by the mother’s SARS-CoV-2 status. Skin to skin contact, rooming in and breastfeeding are recommended with necessary hygiene precautions. Antibodies of infected or vaccinated women seem to cross both the placenta and into breast milk and likely provide protection for the newborn.


Author(s):  
Ranjit Unnikrishnan ◽  
Anoop Misra

AbstractThe advent and rapid spread of the coronavirus disease-2019 (COVID19) pandemic across the world has focused attention on the relationship of commonly occurring comorbidities such as diabetes on the course and outcomes of this infection. While diabetes does not seem to be associated with an increased risk of COVID19 infection per se, it has been clearly demonstrated that the presence of hyperglycemia of any degree predisposes to worse outcomes, such as more severe respiratory involvement, ICU admissions, need for mechanical ventilation and mortality. Further, COVID19 infection has been associated with the development of new-onset hyperglycemia and diabetes, and worsening of glycemic control in pre-existing diabetes, due to direct pancreatic damage by the virus, body’s stress response to infection (including cytokine storm) and use of diabetogenic drugs such as corticosteroids in the treatment of severe COVID19. In addition, public health measures taken to flatten the pandemic curve (such as lockdowns) can also adversely impact persons with diabetes by limiting their access to clinical care, healthy diet, and opportunities to exercise. Most antidiabetic medications can continue to be used in patients with mild COVID19 but switching over to insulin is preferred in severe disease.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ranjit Unnikrishnan ◽  
Anoop Misra

AbstractThe advent and rapid spread of the coronavirus disease-2019 (COVID19) pandemic across the world has focused attention on the relationship of commonly occurring comorbidities such as diabetes on the course and outcomes of this infection. While diabetes does not seem to be associated with an increased risk of COVID19 infection per se, it has been clearly demonstrated that the presence of hyperglycemia of any degree predisposes to worse outcomes, such as more severe respiratory involvement, ICU admissions, need for mechanical ventilation and mortality. Further, COVID19 infection has been associated with the development of new-onset hyperglycemia and diabetes, and worsening of glycemic control in pre-existing diabetes, due to direct pancreatic damage by the virus, body’s stress response to infection (including cytokine storm) and use of diabetogenic drugs such as corticosteroids in the treatment of severe COVID19. In addition, public health measures taken to flatten the pandemic curve (such as lockdowns) can also adversely impact persons with diabetes by limiting their access to clinical care, healthy diet, and opportunities to exercise. Most antidiabetic medications can continue to be used in patients with mild COVID19 but switching over to insulin is preferred in severe disease.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S435-S436
Author(s):  
Sarath G Nath ◽  
Francesca Lee ◽  
Anjali Bararia ◽  
Ank E Nijhawan

Abstract Background C.difficile Toxin Polymerase Chain Reaction (C.diff PCR) and C.difficile Toxin Enzyme Immunoassays (toxin EIA) are commonly used tests to diagnose Clostridoides difficile infection (CDI). C.diff PCR cannot differentiate between colonization and infection, leading to a higher false-positive diagnosis of CDI. Toxin EIA has low sensitivity leading to a missed diagnosis of CDI. In patients with C.diff PCR positive(+) and Toxin EIA negative(-), clinical judgment is often needed regarding the decision to treat or not to treat. C.diff cytotoxic assay (CCA), is a more sensitive method to detect the toxin but is time-consuming and not readily available. Methods Between 6/2019 and 12/2019, 83 patients who were admitted to the hospital, met our inclusion criteria (C.diff PCR+/EIA-). Clinicians who cared for these patients were contacted and surveyed with a predesigned questionnaire evaluating the rationale of treatment. Also, a simultaneous medical records review was done to ensure consistency. Along with this C.diff PCR+/EIA- stool samples were sent to ARUP laboratories for CCA. The CCA results were not available for clinicians and did not impact clinical care. Average cost for a CCA assay was $29 Results Demographics of the clinicians were variable (Table 1). Several parameters were considered when making decisions regarding treatment and GI/ID were frequently involved (figure 1). Among the 83 patients, 41(49%) were CCA (+) and 42(51%) were CCA (-). 48 of 83 (58%) patients received treatment for CDI. 25 of 48 (52%) patients who were treated were CCA positive while 23 of 48 (48%) patients were CCA negative. Among the untreated patients, 16/35 (46%) were CCA+ while 19/35(54%) were CCA-. There was no statistically significant correlation between clinical judgment and CCA assay results (p: 0.56 on the Chi test). Demographics of the clinicians Clinician survey responses CDI Treatment and by CCA positivity Conclusion Clinicians regardless of their background and training face challenges with the treatment of C.diff PCR+/EIA- patients. Patient outcomes based on the incorporation of CCA assay into an algorithm for C.diff PCR+/EIA- patients, need to be evaluated. But it has a potential role in stopping unnecessary CDI treatment as well as avoidance of missed treatment opportunities while possibly also being cost-effective. Disclosures Ank E. Nijhawan, MD, MPH, Gilead (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)


2020 ◽  
Vol 41 (S1) ◽  
pp. s278-s279
Author(s):  
Maiko Kondo ◽  
Matthew Simon ◽  
Esther Babady ◽  
Angela Loo ◽  
David Calfee

Background: In recent years, several rapid molecular diagnostic tests (RMDTs) for infectious diseases diagnostics, such as bloodstream infections (BSIs), have become available for clinical use. The extent to which RMDTs have been adopted and how the results of these tests have been incorporated into clinical care are currently unknown. Methods: We surveyed members of the Society for Healthcare Epidemiology of America Research Network to characterize utilization of RMDT in hospitals and antimicrobial stewardship program (ASP) involvement in result communication and interpretation. The survey was administered using Qualtrics software, and data were analyzed using Stata and Excel software. Results: Overall, 57 responses were received (response rate, 59%), and 72% were from academic hospitals; 50 hospitals (88%) used at least 1 RMDT for BSI (Fig. 1). The factors most commonly reported to have been important in the decision to adopt RMDT were improvements in antimicrobial usage (82%), clinical outcomes (74%), and laboratory efficiency (52%). Among 7 hospitals that did not use RMDT for BSI, the most common reason was cost of new technology. In 50 hospitals with RMDT for BSI, 54% provided written guidelines for optimization or de-escalation of antimicrobials based upon RMDT results. In 40 hospitals (80%), microbiology laboratories directly notified a healthcare worker of the RMDT results: 70% provided results to a physician, nurse practitioner, or physician assistant; 48% to the ASP team; and 33% to a nurse. Furthermore, 11 hospitals (22%) had neither guidelines nor ASP intervention. In addition, 24 hospitals (48%) reported performing postimplementation evaluation of RMDT impact. Reported findings included reduction in time to antibiotic de-escalation (75%), reduction in length of stay (25%), improved laboratory efficiency (20%), and reduction in mortality and overall costs (12%). Among the 47 hospitals with both RMDT and ASP, 79% reported that the ASP team routinely reviewed blood culture RMDT results, and 53.2% used clinical decision support software to do so. Finally, 53 hospitals (93%) used 1 or more RMDT for non–bloodstream infections (Fig. 1). Fewer than half of hospitals provided written guidelines to assist clinicians in interpreting these RMDT results. Conclusions: RMDTs have been widely adopted by participating hospitals and are associated with positive self-reported clinical, logistic, and financial outcomes. However, nearly 1 in 4 hospitals did not have guidelines or ASP interventions to assist clinicians with optimization of antimicrobial prescribing based on RMDT results for BSI. Also, most hospitals did not have guidelines for RMDT results for non-BSI. These findings suggest that opportunities exist to further enhance the potential benefits of RMDT.Funding: NoneDisclosures: None


2021 ◽  
Vol 8 (1) ◽  
pp. e000967
Author(s):  
Kay Por Yip ◽  
Simon Gompertz ◽  
Catherine Snelson ◽  
Jeremy Willson ◽  
Shyam Madathil ◽  
...  

IntroductionMany respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers.MethodsA respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP.ResultsOn integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence.DiscussionIntegrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.


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