Publications by Colleges and Departments (MSU - Bozeman)
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Item A global pilot comparative, cross-sectional study of clinical research nurses/research midwives: Definition, knowledge base, and communication skills related to the conduct of decentralized clinical trials(Cambridge University Press, 2024-01) Johnson, Elizabeth A.; Hill, Gordon; Smith, Hazel Ann; Marsh, Lisa; Beer, KellyBackground: A gap in the literature exists pertaining to a global research nurse/research midwife resources and communication skill set necessary to engage with participants of diverse populations and geographic regions in the community or home-based conduct of decentralized clinical trials. Aims: An embedded mixed methods study was conducted to examine research nurse/research midwife knowledge base, experiences, and communication skill sets pertaining to decentralized trials across global regions engaged in remote research: the USA, Republic of Ireland, United Kingdom, and Australia. Methods: An online survey was deployed across international research nurse/research midwife stakeholder groups, collecting demographics, decentralized trial experience, barriers and facilitators to optimal trial conduct, and the self-perceived communication competence (SPCC) and interpersonal communication competence (IPCC) instruments. Results: 86 research nurses and research midwives completed the survey across all countries: The SPCC and IPCC results indicated increased clinical research experience significantly correlated with increased SPCC score (p < 0.05). Qualitative content analysis revealed five themes: (1) Implications for Role, (2) Safety and Wellbeing, (3) Training and Education, (4) Implications for Participants, and (5) Barriers and Facilitators. Conclusions: Common trends and observations across the global sample can inform decentralized trial resource allocation and policy pertaining to the research nurse/research midwife workforce. This study demonstrates shared cultural norms of research nursing and midwifery across varied regional clinical trial ecosystems.Item Developing a Preclinical Nurse-Nurse Communication Framework for Clinical Trial Patient-Related Safety Information(Ovid Technologies, 2022-11) Johnson, Elizabeth A.; Rainbow, Jessica G.; Reed, Pamela G.; Gephart, Sheila M.; Carrington, Jane M.Clinical trial trials have become increasingly complex in their design and implementation. Investigational safety profiles are not easily accessed by clinical nurses and providers when trial participants present for clinical care, such as in emergency or urgent care. Wearable devices are now commonly used as bridging technologies to obtain participant data and house investigational product safety information. Clinical nurse identification and communication of safety information are critical to dissuade adverse events, patient injury, and trial withdrawal, which may occur when clinical care is misaligned to a research protocol. Based on a feasibility study and follow-up wearable device prototype study, this preclinical nurse-nurse communication framework guides clinical nurse verbal and nonverbal communication of safety-related trial information to direct patient care activities in the clinical setting. Communication and information theories are incorporated with Carrington's Nurse-to-Nurse Communication Framework to encompass key components of a clinical nurse's management of a trial participant safety event when a clinical trial wearable device is encountered during initial assessment. Use of the preclinical nurse-nurse communication framework may support clinical nurse awareness of trial-related wearable devices. The framework may further emphasize the importance of engaging with research nurses, patients, and caregivers to acquire trial safety details impacting clinical care decision-making.Item Clinical Nurses' Identification of a Wearable Universal Serial Bus Used for Pediatric Oncology Clinical Trial Participant Safety Management(Wolters Kluwer Health, 2023-01) Johnson, Elizabeth A.; Rainbow, Jessica G.; Carrington, Jane M.The expanded access to clinical trials has provided more patients the opportunity to participate in novel therapeutics research. There is an increased likelihood of a patient, as a pediatric oncology clinical trial participant, to present for clinical care outside the research site, such as at an emergency room or urgent care center. A novel wearable universal serial bus device is a proposed technology to bridge potential communication gaps, pertaining to critical information such as side effects and permitted therapies, between research teams and clinical teams where investigational agents may be contraindicated to standard treatments. Fifty-five emergency and urgent care nurses across the United States were presented, via online survey without priming to the context of clinical trials or the device, a picture of a pediatric patient wearing the novel wearable device prompted to identify significant, environmental cues important for patient care. Of the 40 nurses observing the patient photo, three identified the wearable device within Situational Awareness Global Assessment Tool formatted narrative response fields. Analysis of the narrative nurse-participant responses of significant clinical findings upon initial assessment of the pediatric patient photo is described, as well as the implications for subsequent prototyping of the novel universal serial bus prototype.Item Trouble for trials - The worrying state of the research nurse workforce(Elsevier BV, 2022-09) Johnson, Elizabeth A.Clinical research nurses (CRNs) are a specialty of Registered Nurses that are highly trained to support the breadth of clinical trial operations and manage participant care in community settings new to research. CRNs are uniquely equipped with a scope of practice that permits product administration, participant assessments, and data management. As clinical trials and their management expand beyond traditional, site-based operations models to decentralized or remote models, the need becomes great to ensure adequate staffing of experienced research professionals, such as CRNs. However, the 2020 National Nursing Workforce Survey reported consecutive contractions in the number of CRNs practicing in the U.S in both 2017 and 2020 surveys when compared to previous reports in 2013 and 2015. The Society of Clinical Research Associates 2020 Salary Survey further described much of the current CRN workforce as nearing or at retirement age, raising concern for additional reductions. This workforce contraction tangents one of the highest volumes of clinical trial starts in modern history, prompting concern for adequate staffing of CRNs to facilitate continued examination of novel therapies and devices. Complex investigative products and evolving safety profiles coupled with an increased focus on community participant enrollment requires CRN involvement in heightened safety monitoring and interdisciplinary communication among clinical providers and research collaborators. This paper examines the contributory factors of the CRN workforce contraction and response efforts at professional and organizational system levels.Item Revisiting the nursing metaparadigm: Acknowledging technology as foundational to progressing nursing knowledge(Wiley, 2022-06) Johnson, Elizabeth A.; Carrington, Jane M.The nursing metaparadigm, as described by Fawcett in 1984, includes human, health, nursing, and the environment, all of which support theory development by giving direction to our focus as a scientific body. Nursing scientists make their mark in biotechnological applications, mobile health, informatics, and human factors research. We give voice to the patient through design feedback and incorporating technological advancements in our evolving nursing knowledge; however, we have not formally acknowledged technology in our metaparadigm. To continue patient-centered care in this age where machines are enmeshed in daily human life, we propose technology must be a domain of the metaparadigm to continue advancing nursing science and knowledge. In this paper, we propose a separate domain of technology within the metaparadigm to challenge nurses to consider approaches within their research and practice of how technology will impact patient care and their personal development within the profession. A technology-specific domain within the metaparadigm also is a signal to other bodies of science of our willingness and ability to run at pace with novel, exciting new discoveries while adding our perspective. Nurses may become active agents in novel developments rather than passive adopters, continuing our legacy of patient advocacy through new knowledge generation. Emerging and continuing nurse leadership has set the stage for the next era of nurse-led innovation and technology development, which provides an opportunity to embed technology as a core aspect of the nursing metaparadigm.Item Revisiting the nursing metaparadigm: Acknowledging technology as foundational to progressing nursing knowledge(Wiley, 2022-06) Johnson, Elizabeth A.; Carrington, Jane M.The nursing metaparadigm, as described by Fawcett in 1984, includes human, health, nursing, and the environment, all of which support theory development by giving direction to our focus as a scientific body. Nursing scientists make their mark in biotechnological applications, mobile health, informatics, and human factors research. We give voice to the patient through design feedback and incorporating technological advancements in our evolving nursing knowledge; however, we have not formally acknowledged technology in our metaparadigm. To continue patient-centered care in this age where machines are enmeshed in daily human life, we propose technology must be a domain of the metaparadigm to continue advancing nursing science and knowledge. In this paper, we propose a separate domain of technology within the metaparadigm to challenge nurses to consider approaches within their research and practice of how technology will impact patient care and their personal development within the profession. A technology-specific domain within the metaparadigm also is a signal to other bodies of science of our willingness and ability to run at pace with novel, exciting new discoveries while adding our perspective. Nurses may become active agents in novel developments rather than passive adopters, continuing our legacy of patient advocacy through new knowledge generation. Emerging and continuing nurse leadership has set the stage for the next era of nurse-led innovation and technology development, which provides an opportunity to embed technology as a core aspect of the nursing metaparadigm.