Digital Repository Masters Projects Spring 2023 An Onboarding Program for the Oncology Nurse Research Department Shelly Tolley Weber State University Follow this and additional works at: https://dc.weber.edu/collection/ATDSON Tolley, S. 2023. An onboarding program for the oncology nurse research department. Weber State University Masters Projects. https://dc.weber.edu/collection/ATDSON This Project is brought to you for free and open access by the Weber State University Archives Digital Repository. For more information, please contact scua@weber.edu. WSU REPOSITORY MSN/DNP An Onboarding Program for the Oncology Nurse Research Department Project Title by Shelly Tolley, BSN, RN, MSN Student Student’s Name A project submitted in partial fulfillment of the requirements for the degree of MASTERS OF NURSING Annie Taylor Dee School of Nursing Dumke College of Health Professions WEBER STATE UNIVERSITY Ogden, UT Date Michelle Tolley, BSN, RN, CPHON, MSN Student 4/1/23 Student Name, Credentials Date (electronic signature) Tressa Quayle, PhD, RN 4/21/23 MSN Project Faculty Date (electronic signature) 05/25/2023 Melissa NeVille Norton (electronic signature) DNP, APRN, CPNP-PC, CNE Graduate Programs Director Note: The program director must submit this form and paper. Date 1 An Onboarding Program for the Oncology Nurse Research Department Shelly Tolley, BSN, RN, MSN Student Weber State University NRSG 6801 & 6802 April 2, 2023 2 Abstract Oncology research nursing is a specialized and expanding field. As a newer field, it needs more structural support for its growth. There needs to be more formal onboarding to establish common ground, successful training methods, and adequate staff retention for oncology research nurse department nurses. Currently, there is no formal onboarding process for new hires. Foundational training and intentional onboarding would allow new nurses to blossom in their research roles by providing confidence, support, and team cohesion. Critical elements for the onboarding process were identified after a formal literature review. These elements were incorporated into developing a research nurse onboarding program. Cocooning the new hire through each step prepares the nurse for the everyday challenges of this specialized profession, such as introducing terminology, research foundations, and workflow variations. This project aims to create a successful onboarding program for new-hire nurses within the oncology research nurse department that includes a staged mechanism to progress through the onboarding process and scheduled check-in meetings with the manager to provide connection and encourage employee investment. By providing this foundational program, each new research nurse will be able to succeed in their new role by including transitional considerations, establishing team integration and leadership oversight, establishing team mentorship and supervision, and integrating quality assurance checks after imperative education. Formal and informal evaluations will occur and routinely improve the program over time. Keywords: onboarding, nursing orientation, nursing research, research nurse, clinical research nurse, tiered-onboarding, staged-onboarding, onboarding in stages 3 An Onboarding Program for the Oncology Nurse Research Department A recipe must precede a satisfying meal, much like great nurses need practical orientation to prepare them for their jobs and roles. There is an increasing need for the position of research nurses within healthcare. As treatments for multiple diseases become specialized, research enables these treatments to improve prognoses. As research needs increase within healthcare, there becomes an increased need for research nurses. With that consideration, it has become essential to many areas worldwide to create a positive and inviting atmosphere to welcome new research nurses. First, it is vital to understand the differences and purposes of onboarding and orientation. Orientation refers to the technical and official aspects of beginning a new position. This may include paperwork, checklists, and specific facility training. Orientation is essential to the new hire and establishes baseline processes and knowledge. Onboarding refers to the collective longterm process of investing in new hires’ role training, development, and progression. Onboarding also refers to laying a successful long-term foundation for both employee and employer, allowing for professional growth and opportunity (Society for Human Resource Management, n.d.). In taking both elements and infusing them into the new hire process, new hires receive the best assistance and direction in their new role. Creating a successful onboarding program is ideal for new oncology research nurse hires, as the current process lacks direction and clear purpose. The term onboarding in this project will refer to the orientation and onboarding process for the oncology research nurse department. Statement of Problem Onboarding programs are ideal for nurse retention, satisfaction, and competence in varying roles, especially in the research nurse role (Backman Lönn et al., 2022; Kunhunny & 4 Salmon, 2017; Kurnat-Thoma et al., 2017; Mercieca-Bebber et al., 2018). For example, in Kurnat-Thoma et al. (2017), hospital staff previously lacked training in hospital affairs, employment, and roles. This problem reflects the current state of the oncology research nurse department hires. The delineation of roles is blurred, training is limited, and future employment opportunities are not adequately conveyed. Just as this study identified specific gaps in the hiring process and addressed them, this project aims to introduce an effective onboarding program through evaluation change to the current process. It is difficult to entice new hires to join the team due to the mystery of what research nurses do and the benefits of the position. Moreover, there needs to be increased staff satisfaction and competency. Both issues could be addressed with formal onboarding or training, especially for new hires in the oncology research nurse role. This MSN project also aims to evaluate and subsequently create an oncology research nurse onboarding program designed to meet the current and future needs of the oncology research department by addressing these more significant concerns of job satisfaction and competency. Implementing this multi-phased onboarding program also aims to meet the needs of new hires by ensuring competency and adequate skillsets for their roles as research nurses. Implementing this new onboarding program is essential for all stakeholders and the success of the oncology research department. Ways Project Contributes to Intended Recipients This department's current oncology research nurse manager began over fifteen years ago as only one of two part-time research nurses, with one more team member- a clinical research coordinator (CRC) employed by the university. Since then, this same department has grown to employ four part-time and two full-time oncology research nurses, with eight full-time CRCs. With continued growth, the nurse manager has yet to implement a standard onboarding process 5 for all new nurse hires, especially since previous experiences onboarding new hires demanded considerably of an already burdened small staff. To address these burdens and concerns, a new hire onboarding program will be implemented to produce adequate staff for increased research needs and address competency and skills at a defined implementation rate for each program phase, with the support of training and direct mentorship. For example, the first phase will take place over 3-6 months, the second phase over 9-12 months, and the last phase will be indefinite depending on each consortium's needs, while each stage uses a mentor to guide the new hire through the process. In the future, due to the anticipated changes, this department will benefit from well-trained new hires, direction for current employees, and exploration of employment opportunities for the future. A Rationale for the Importance of this Project Specializing in the field of research nursing is a challenging role. This role transitions from traditional nursing practice to meticulous data management skills and atypical critical thinking processes. This specialty requires distinct procedures in establishing clinical processes, guiding study management, ensuring human subject protection, providing care coordination within research participation, and contributing to clinical science as an active team member (Kunhunny & Salmon, 2017). With such specialization, qualities of uniformity and consistency in training are essential. Hence, the need for a standardized onboarding program. Entering the specialty of nursing research is akin to entering a new world with incomprehensible language. Time and repetitive exposure to terms, processes, and skills are needed to understand and assimilate into this new world. Despite already being clinical nurses, clinical research nurses struggle to orient themselves to their recent research roles and environments (Backman Lönn et al., 2022; Hernon et al., 2019). As these struggles are identified 6 and addressed, solutions can then take place. For example, Backman Lönn et al. (2022) describe these complex transitional difficulties as periods of confusion and difficulty in professional role identity. Moreover, after identifying these challenges, they are addressed by engaging the staff in new work, encouraging group communication and participation, and empowering nurses to resolve conflict. These solutions to everyday adversities are part of what it takes to onboard a new oncology research nurse. As identified previously, learning how to navigate the research world is challenging. Therefore, adequate education and training are necessary to ensure competency. An onboarding program will provide a way to measure and improve competency with each new hire. By providing resources to succeed and teaching the skills necessary to perform roles and expectations, each new hire may obtain confidence and self-efficacy, also described as the belief that one can achieve a given task, stemming from confidence influenced by personal or environmental factors (Owens, 2020). A good onboarding program will bridge the gap between competency and confidence, allowing nurses to attain role discernment and direction. This standardization also allows for employee uniformity and consistent performance in the workplace. One of the most significant challenges in starting a new job is finding comfort and engagement where one works. This involves feeling accepted in the workgroup and having a purpose there. To address this concern, mentorship is one of the most effective strategies to invest and show belonging within an organization (Backman Lönn et al., 2022; Kurnat-Thoma et al., 2017; McClain et al., 2022). Through leadership involvement and mentorship, investment in new hires is shown and provides guidance and direction. New hires can feel supported and fit in with other team members' support, especially leadership (Anselmo-Witzel, 2017). Including 7 leadership and mentors will ensure positive experiences for new hires and is necessary to help them feel a part of the team and welcome. With purposeful onboarding, employees are adequately prepared through competency improvement, encouraging leadership and mentor involvement, and establishing team cohesiveness through teamwork in onboarding and employee advancement opportunities. A formal, intentional onboarding program ensures success for new hires and the organization. By addressing concerns such as employee engagement, role demarcation, and leadership involvement, new hires feel welcome and committed to their new roles. Encouraging positive new hire experiences is paramount for a successful oncology research nurse department. Literature Review and Framework The framework and the reviewed literature used to develop this project will be introduced in the following few pages. Steering from examples of similar effective programs and discussions of the best evidence-based practice ensures the development of a quality onboarding program. Also included, the literature collective within this next section provides multiple themes directing the best program development while relying on the best evidence. Framework Stetler’s Model of Evidence-Based Practice Change will determine the framework for developing this onboarding program. The Stetler Model framework includes the following five phases in application to the onboarding program: 1. Preparation: Investigate potential program issues and catalysts, focus on high-priority issues with current processes, and define desirable measurable outcomes of a new onboarding and orientation program (Melnyk & Fineout-Overholt, 2019; Stetler, 2001). 8 2. Validation: Critique and rate sourced evidence in the level of quality, differentiate the statistical and clinical significance, critique and synopsize essential components, operational details, and other qualifying factors per sources of evidence (Stetler, 2001). 3. Evaluation/decision making: Synthesize cumulative research findings, and decide whether/what to include (for or against evidential information), such as steps and portions of successful onboarding programs (Stetler, 2001). 4. Translation/application: Format dissemination and the change strategies of the sourced material based on identified relevant research; look for applicability into the new program related to current practices and available resources (Melnyk & Fineout-Overholt, 2019; Stetler, 2001). 5. Evaluation: Consider the cost-benefit of various evaluation efforts, evaluate postimplementation in processes that are informal and formal, and address the application of findings to the project (Melnyk & Fineout-Overholt, 2019; Stetler, 2001). As a practitioner-focused model of change, the indication for using this model is to focus on critical thinking skills and the use of individual findings in comparison to other similar models, such as the Iowa Model, the Model for Change to Evidence-Based Practice, and the ARCC model (Melnyk & Fineout-Overholt, 2019; Rosswurm & Larrabee, 1999; Stetler, 2001). The Stetler model has been revamped multiple times since its inception in 1976. Furthermore, at that time, the model was referred to as “the Stetler Model of Research Utilization,” emphasizing research directing care and promoting its use in practice (Stetler, 2001). The Stetler framework will lead the search and evaluation of best practices from the literature, followed by implementation into the new onboarding program, as discussed. 9 Strengths and Limitations Strengths of Steler’s Model of Evidence-Based Practice change include its five directive phases: preparation, validation, comparative evaluation and decision-making, translation and application, and evaluation (Stetler, 2001). Preparation will focus on internal and external sources, allowing for a compilation of effective researched material to assess as it is implemented (Melnyk & Fineout-Overholt, 2019). Subsequently, validation and evaluation/decision-making will take place, allowing for critiquing of material to determine its efficacy. This will be especially important in the onboarding program as only a few articles in the literature directly involve onboarding oncology research nurses. Critiquing and evaluating, as strengths, will be crucial to determine the fit of each reviewed article so its information can be transitioned into practice. Sadly, a limitation in using this model is that no official current onboarding practice could be used in a comparative evaluation. All data will only come from literature evaluation and will not be compared to an existing program to determine efficacy and improvement, as Stetler suggests (2001). With that in mind, the last two phases of transition/application and evaluation can be implemented. Knowing this limitation, evaluation can still be implemented as to what is be best for the department. Despite this limitation, the Stetler Model is still the best representative model for this project, based on the synthesis and evaluation processes used. Analysis of Literature The literature was analyzed to examine the evidence regarding an onboarding program for newly hired research nurses in the oncology unit to improve nurse knowledge compared to the need for a current orientation process. This analysis reviews published articles to identify solid and reliable methods for creating a successful oncology research nurse onboarding 10 program. The literature review found three distinct themes, including reviewing the history and experiences of new nurses to develop a program foundation, considering the current best practices through similar effective programs, and preparing for future research nurse orientation considerations in anticipated departmental growth through evaluation and improvements. Search Strategies To undergo the literature analysis, Boolean phrases were used, under the over-arching subject of “Nursing,” within the databases of Weber State University Stewart Library’s OneSearch, CINAHL, CINAHL Complete, Medline, Education full text, ERIC, and Health Sources. Relevant research articles and non-research articles were both found. The Boolean phrases included, but were not limited to, a combination of the wording and terms of onboarding, orientation, training, transitioning, oncology nursing, phases, and retention while specifying a search for articles between 2016-2022. Once relevant articles were identified, they were reviewed and selected based on their abstracts, content, titles, and level of evidence. The papers were reviewed thoroughly for applicability, reliability, and validity to create an oncology research nurse onboarding program. Reviewing Nursing Experiences to Create a Program Foundation Appreciating professional roles and identity is essential for creating an onboarding program foundation and any training program. By understanding the background and experiences of each new hire regarding their skills, competencies, perceptions, and knowledge, the combined qualifications regarding individual comfort levels can identify experiences within nursing, oncology, and research (Hines et al., 2022; Kubota et al., 2016; Mackle & Nelson, 2017; Tinkler et al., 2017). Identifying significant educational and personal nursing experiences 11 provide perspective and understanding, allowing the foundation of the onboarding program to be catered to their needs. Nurses in the orientation program will need to understand research development and data management. By identifying comfort levels, knowledge, and competency of research principles like the example of nurse confidence assessment provided by Kubota et al. (2016) (n = 50 in the intervention group; n = 46 in the control group; 80% power), it is found that confidence assessment is essential to know where to start onboarding and training. Hines et al. (2022) (N = 40) found that despite contemporary nurses having more experience with research, many still need help with the language and nuances of the research role. Moreover, Kunhunny and Salmon's (2017) (N = 11) experiences shared that standard nursing rarely presented adequate training and practices for research and research-based practical expertise. Therefore, the onboarding program should include obtaining nurses' comfort levels with research terminology and data program comprehension. Evaluating nursing perspectives and experiences is critical and the consistent theme of the literature. By looking at additional studies, other views also emerged. In addition to understanding research terminology and comfort levels, nurses focused on distinctive experiences, such as those that led to staff retention, increased personal knowledge, and encouraged skill preservation goals, making training effective for the onboarding nurse (McClain et al., 2022). During this study, the focus on staff retention and improved skills increased job satisfaction and retention across the same company. These experiences included job satisfaction related to teamwork, feeling valued, having positive relationships at work, and receiving personal recognition from leadership (Anselmo-Witxel et al., 2017; McClain et al., 2022). By understanding these varied perspectives, developing successful onboarding programs were more 12 accessible. This process includes assessing individual knowledge, comfort levels, and previous onboarding experiences. Training Techniques for New-Hire Groups There are many essential pieces to include within effective onboarding programs, and the literature focuses on several. A few of these elements are prominent in the onboarding of research nurses. For example, staff retention strategies, blended learning formats, and addressing generational workforce gaps were all essential. However, most important was the theme of identifying the role of a research nurse. By identifying the role of a research nurse, clarity of the scope of practice and role expectations become clear (Backman Lönn et al., 2022; Hernon et al., 2019; Kunhunny & Salmon, 2017; Larkin et al., 2019; Mackle & Nelson, 2017; Mori et al., 2007; Tinkler et al., 2018). Role transition is difficult for most, and adding unclear role delineation causes confusion, barriers, and a lack of enthusiasm toward the new role. Despite their long bedside nurse history, several nurses reported difficulty transitioning to research nursing. Role specification provides confidence in fulfilling roles and expectations. Therefore, role delineation and specification should occur at the beginning of any research nurse onboarding program to establish roles for new hires. As addressed before, certain elements are necessary to make an onboarding program successful. The literature establishes some elemental themes such as strategies, including training on good clinical practice, research foundations, study-specific training, ethical considerations, clear competence pathways, and opportunities for progression and leadership development (Backman Lönn et al., 2022; Mercieca-Bebber et al., 2018; Mori et al., 2007). Some of the literature combined learning individual skills by enhancing teamwork. Such programs included facilitating positive work relationships, providing a sense of group cohesion, 13 creating healthy nursing practice environments, and modeling adaptability and assimilation into the organization’s culture at the time of hire (Kunhunny & Salmon, 2017; Kurnat-Thoma et al., 2016; McClain et al., 2022). In Kurnat-Thoma et al. (2017), a 187-bed facility evaluated newhire losses between 2009-2012 before implementing an effective 10-step onboarding program. Once created, this program was standardized across multiple units and disciplines, focusing on practices such as a step process of learning new skills and subsequent timely requirement of management-to-staff communications, as well as establishing 30-, 60- and 90-day new-hire interviews. These techniques reduced new-hire turnover losses from 39.1% to 18.4% (p = 0.04). Selecting the best program elements, such as competencies, skills, and improved leadership communication, has been most influential in generating positive onboarding experiences. Another essential element to consider is the differences in training practices based on generational gaps. McClain et al. (2022) found that addressing generational gaps is necessary. This study demonstrated best practices regarding retention strategies and detrimental barriers through the perspective of generational gaps. Joanna Briggs Institute (JBI) methodology was used, and 38 articles were found. Influential concepts were identified as leadership, work environment, professional growth, and self-actualization. At the same time, some barriers were found, such as a hierarchal work environment, rigid expectations, and an unstable work atmosphere. Still, addressing these barriers showed that operating costs could be reduced, improving patient care and new hire satisfaction (McClain et al., 2022). Kurnat-Thoma et al. (2017) also found appropriate retention strategies and possible barriers identified through exit interviews to support these concepts. Gaps were found and addressed by creating an affirmative culture of addressing concerns, such as developing professional skills and teaching normative 14 group behaviors in the workplace. Addressing identified gaps, such as generational differences and behaviors, helps to overcome the barriers that new research nurses face. Current evidence advocates using specific resources for the best onboarding program formats and consequently provides structures conducive to learning. Taj et al. (2022) found that blended learning effectively improves knowledge, skills, and self-efficacy and represents essential elements to include in these onboarding programs. Blended learning combines virtual and face-to-face opportunities (Taj et al., 2022). Taj et al. (2022) intervened in a limited number of four East African countries by applying an oncology nurse-based blended learning format of 10 individual lessons through eLearning followed by additional face-to-face skills instruction. Pre- and post-assessment evaluations were instituted in this quasi-experimental study. Among the 21 participants, 12 immediately saw improvement in knowledge and skills (p < 0.05), showing the effectiveness of this educational intervention. However, unlike the short-term evaluations, when looking at long-term retention, p was greater than 0.05, indicating a significant lack of knowledge maintained over extended periods. This is, therefore, suggestive of constant refreshers and long-term education models. After all, education, knowledge, and skills stay fresh in the mind when used and revisited frequently. Despite the long-term limitation, data showed that the best educational formats included a blended learning method to meet the varying needs of the employees. Additional effective program techniques include identifying barriers and role challenges, as mentioned in Kurnat-Thoma et al. (2017). Kurnat-Thoma et al. (2017) provided another practical addition to quality onboarding programs. As a quality improvement initiative, the onboarding intervention was created to address identified barriers and increase staff retention at their local institution. It also identified the reliability and effectiveness of this program for more 15 than just one department or discipline. In addition to implementing standards of practice, it included a structure for follow-up after orientation, including managerial oversight, work connections, and staff investment (Kurnat-Thoma, 2016; see also Ravaghi et al., 2020). Implementing an effective program for multiple disciplines demonstrated the effectiveness of various role transitions and follow-up processes. This can apply to an oncology research nurse transition role process as well. Integrating Methods of Program Development Sustainability Growth is inevitable; therefore, an onboarding program must be built to incorporate expected growth and development, as Kurnat-Thoma et al. (2016) suggest. For example, leadership and organizational buy-in are necessary for future successful implementations (Taj et al., 2022). Elements of leadership buy-in, appropriate employee training, and sustained strategies for teaching research information are all necessary considerations for the future of onboarding programs (Backman Lönn et al., 2022; Hines et al., 2022; Kunhunny & Salmon, 2017; KurnatThoma et al., 2016; McClain et al., 2022; Taj et al., 2022). Hines et al. (2022) focus on introducing research into nursing life through a scaffolding method of research education, despite its limitations of representing a specific population- the Australian workforce. This limitation does not negate the study's validity as it provides practical nursing perspectives. In another study, Kurnat-Thoma et al. (2017) illustrated the strengths and limitations of an institution-specific program. Still, they considered sustainability through its implementation in multiple disciplines and over varying timed cohorts. McClain et al. (2022) and Tinkler et al. (2017) understood addressing specific gaps, such as generational gaps in the workforce and knowledge, and addressing bias and misunderstanding between research and non-research staff. These themes were intended to identify retention strategies for the sustainability of nursing 16 professions and, therefore, are applicable moving forward. Lastly, Taj et al. (2022) identified barriers to supportable orientation education programs. Barriers were identified through a lack of knowledge retention over an extended period of more than twelve months. Each of these studies has identified specific themes of strategies, concerns, and barriers influencing sustainability among orientation programs, the final piece identified through this literature review. Summary of Literature Review Findings and Application to the Project This literature review suggests three applicable themes when preparing to create an onboarding program within the oncology research nurse team. First, creating a program requires understanding the population it will apply to; for example, registered nurses, most likely from generation Y, Z, or millennials, will likely present with discomfort and a lack of experience with research; another example is helping research nurses define their roles and responsibilities (Backman Lönn et al., 2022; Kubota et al., 2016; Kunhunny & Salmon, 2017; McClain et al., 2022). Second, the program must cater to the practices and needs of the population who will receive it, such as creating the best standards for a multi-faceted learning process, including accessibility, generational learning styles, and orientation setup (Backman Lönn et al., 2022; Hernon et al., 2019; Mercieca-Bebber et al., 2018; Mori et al., 2007; Patterson et al., 2022; Taj et al., 2022). Third, the research shows the importance of preparing a program for future departmental development by addressing barriers between research, staff, and missing educational elements (Taj et al., 2022; Tinkler et al., 2017). As this literature review demonstrates, all of these factors will contribute to the success of the onboarding program for the oncology research nurse team. 17 Project Methodology Onboarding a new oncology research data nurse requires a strategic and organized plan. The following sections discuss elements necessary for a successful onboarding program implementation, including the deliverables needed to carry it out. Interdisciplinary teamwork and timeline elements will also be addressed, as well as evaluation techniques for the program and a transition plan for new nurse hires. Description and Development of Project Deliverables Three deliverables and a program plan are provided to implement this program appropriately. Kurnat-Thoma et al. (2017) provide excellent examples of program implementation and onboarding program deliverables. This article provided the foundation for developing two deliverables, the onboarding checklist and the pre-onboarding assessment (see Appendix A and B), as well as a guide for the program plan. The program plan will include multiple phased stages to ensure the success of the onboarding process and guided points for the manager to use for each deliverable utilized. A blended-learning approach is used, as demonstrated by Taj et al. (2022), for the last deliverable, which is a short “introduction to research” video (see Appendix C). All of the deliverables will be catered to the needs of the oncology research nurse and will meet the corporation’s standards. Onboarding Retrospective Assessment To improve current onboarding processes, feedback from current employees can add perspective and ideas for those existing processes. The oncology research nurse onboarding process was pieced together over the years out of necessity and inconsistency. It is essential to establish a strong foundation for the new onboarding program; by doing so, it is necessary to understand its heritage. Each currently employed research nurse will complete a retrospective 18 evaluation of their orientation process (Appendix A). This evaluation will be completed immediately to ensure the rapid development of the onboarding program, as hiring a new oncology research nurse is imminent. Fundamental questions about onboarding improvements, experiences, and successes are included. Onboarding Checklist Per the corporation’s standards, this onboarding process will include an onboarding checklist for new hires (Appendix B). It thoroughly lists necessary introductions to process, workflow, and teamwork. The checklist also covers essential responsibilities each onboarding nurse must accomplish, such as completing appropriate certifications, establishing a workspace, and providing an overview of daily, weekly, and monthly tasks. The checklist aims to lead the onboarding nurse into the research nurse role. Introduction to Research Video Research nursing is a unique position in nursing. It is a very analytical role that departs from routine patient care. Most nurses find this transition intimidating and challenging. Therefore, an introductory video will be provided to ease that transition process (Appendix C). The video covers similarities between the roles of the patient-care nurse and the research nurse. It also provides details of the nurse's role that often need clarification, such as standard terms, roles, and departmental functions. Providing this introduction video will help the nurse understand essential research elements and processes that will provide the onboarding nurse clarity and direction. Plan and Implementation Process This onboarding program is designed as a 3-stage process of implementation. The nurse will be assessed at each stage before continuing to the next stage. Per the example of Kurnat- 19 Thoma et al. (2017), each stage focuses on a different essential element of the onboarding process. Stage one is designed to provide a basic orientation to space and office, followed by the direction of necessary training. Stage one lasts about three to six months and overlaps with some of the elements of stage two. In stage two, the onboarding nurse is introduced to the data work of the largest consortium in the pediatric nurse purview. The new nurse will take on additional responsibilities as their competency expands. Stage two is approximately twelve months in length. The last stage, stage three, has no completion date but is used as a stepping stone as the new hire is introduced to other consortiums and their data requirements. Appendix D is a stepby-step plan of these three stages and summarizes the essential tasks of each stage. By following this plan, the onboarding nurse will begin their research nurse role with a solid foundation, poised to progress and learn the multiple facets of their position. Interdisciplinary Teamwork The current oncology research team comprises various team members of different roles from two separate corporations. The two corporations have an agreement to use one institutional review board (IRB) to determine whether all research is appropriate and safe. To create an environment of safety, there are research coordinators in the department to manage eligibility and protocol adherence. These employees come from one corporation. The other corporation provides the oncology research nurses for data entry and follow-up. By having these two corporations work together daily, they exemplify interdisciplinary teamwork as nurses, doctors, regulatory coordinators, and clinical research coordinators work side-by-side. No matter the corporation, all employees will be introduced to the new onboarding nurse and interact with them to accomplish necessary regulatory training, certifications, and data entry requirements. This will be the new nurse’s support system and their cheerleaders for success. They will mold 20 and shape the nurse’s progress in the research world as a team, encouraging them and answering their questions. Timeline of Implementation The oncology research nurse onboarding program will be implemented with the following new hire in the research nurse group. As a part of initial training, the new hire will start in stage one and progress to stage two. Formal evaluations regarding the project will occur at specific time points as indicated, which are reflected in the onboarding schedule plan (Appendix D). After implementation, the oncology research nurse manager intends to review the program at formal and informal time points with this educator to assess opportunities for improvement. The oncology research nurse manager plans to review each step with this educator before proceeding to the next stage. These assessments identify changes in the program and address the new hire’s needs. Informally, opportunities for change will be reviewed with this educator biweekly, then less frequently, as the new hire progresses through their program. This will allow for real-time resolutions to issues. These resolutions will be addressed as a constant cycle of improvement while the new hire goes through the program and before other new hires. Plan for Evaluation of the New Hires By completing a preliminary pre-onboarding assessment of the current nurses, areas of improvement will be identified. Then, each stage will be evaluated according to the elements of that stage. In the first stage, the manager will complete check-ins at 30, 60, and 90 days after the new nurse begins their onboarding process. These check-ins will evaluate competency, teamwork cohesion, and checklist accomplishment. The manager determines the progression into each stage. 21 After stage one, the nurse will be evaluated like the other nurses are currently assessed in the department through a standard checks and balances process known as quality assurance checks. This process involves a peer evaluator reviewing a random data entry reporting period completed by the nurse and analyzing for data accuracy and inclusion. This is an established process for all nurses to ensure accuracy and protocol adherence in the research participants. Assessing the new hires’ competencies reflects the success of the onboarding program. This is an excellent system to ensure nurses' competency as they complete data entry reporting periods, demonstrating the new nurse’s competency and the teamwork and collaboration of the group. It is important to establish cooperation and group collaboration in this atmosphere, as many research nurses can feel isolated and secluded from entities of patient care, as demonstrated by Backman Lönn et al. (2022). These evaluations will occur in addition to the formal and informal evaluation processes implemented into the project's timeline. Plan for Evaluation of the Project Overall, this project is lengthy, and each stage must be evaluated for success. The onboarding nurse will be given a condensed version of the Onboarding Retrospective Assessment at each stage to assess stage efficacy and use. If changes need to be made, they will be implemented appropriately. After fifteen months of onboarding, the final Onboarding Retrospective Assessment will be given to address the whole project. From the assessments, the manager will decide on essential project elements to keep and others to remove. Ethical Considerations As each new nurse is hired, each will be expected to go through this onboarding program. It has been deemed appropriate and necessary by the nurse manager to ensure competency and effective preparation for teamwork and process. The onboarding nurse may choose to refuse 22 program participation or elements thereof. The manager will encourage participation and address the need for compliance with it. Parts of the program will likely need to be changed to meet each new hire's needs, but most of the onboarding program is geared toward improvement. Discussion The following discussion addresses this onboarding program's efficacy, efficiency, and limitations. Effectively onboarding new oncology research nurses fills a gap within the oncology research nurse department. Previously, exponential growth and historically limited resources have prevented an adequate onboarding program from ever being created. This project fulfills the long-awaited need, as discussed in the following pages. Evidence-based Solutions for Dissemination This onboarding project will be disseminated through poster presentations at multiple conferences, including one for the Annie Taylor Dee School of Nursing peers and faculty at Weber State University. Other poster presentations will take place at industry and national conferences. As this project is designed for long-term implementation, the project dissemination will occur slowly to allow sufficient time for data collection. This process may take up to five years to complete. Significance to Advance Nursing Practice Research nursing is an expanding field. The demand for competent research nurses, wellprepared for the workforce, is necessary for this field to continue on its upward trajectory. This project sets a standard for the oncology research nurse onboarding process, ensuring that competent, knowledgeable, and efficient nurses are in the field to provide the best data and research for the future of healthcare. As research grows, the demand for research nurses will continue to grow, followed by a high demand for adequate onboarding. 23 Implications This project's most significant limitation is the limited number of onboarding nurses that occurs at a time. The department hires only one research nurse at a time, usually about a year between each hire. Due to this limited onboarding number, evaluations and assessments of the program are subjective and occur infrequently. A genuinely efficacious evaluation of the project would be over a more extended period, such as five years, to allow for a reflection of multiple onboarding nurses. Despite this limitation, the project is designed to meet each oncology research nurse’s needs individually. This program’s limitation presents its greatest strength as it allows for an individualized approach to onboarding. Frequent formal and informal assessments of program functionality and individual new hire needs allow for the best method to enhance this program, as it is designed to be improved regularly. Also, a foundational strength of this project is that it addresses the common issues facing research nurses as their field of expertise expands. Common problems such as foreign terminology, isolation, and lack of direction are addressed through systematic phases of education and advancement. Without addressing this, the risk of a floundering new oncology research nurse could be tremendous. This program speaks to these concerns. Recommendations This project addresses some immediate concerns in onboarding new oncology research nurses. However, the lack of continued education is a significant gap reflected in the research (Taj et al., 2022). Onboarding education provides direct, up-front, and efficient levels of competency so that nurses can perform their job accurately and efficiently. Additionally, as Taj et al. (2022) demonstrated, consistent education provides the potential for long-term knowledge retention. Implementing long-term education must be studied further to ensure adequate 24 knowledge retention within the research nursing group over more extended periods. Providing the research nursing group with consistent and equivalent education theoretically allows for more accurate data collection and reporting uniformity. Conclusions In summary, this oncology research nurse onboarding project stems from a need within the oncology research nurse department to develop an effective onboarding mechanism for new hires while addressing the challenging and expanding role of the research nurse. As the literature was reviewed, key elements were found meaningful and indispensable to this project. Research nursing is challenging both in function and terminology (Backman Lönn et al., 2022; Hernon et al., 2019; Kunhunny & Salmon, 2017; Larkin et al., 2019). New research nurses will need a successful transition through adequate training and exposure to research terms, programs, and processes. Due to increasing generational nursing gaps, a mentor must guide the transition process, tailoring learning to meet individual needs (Kurnat-Thomas et al., 2017). A mentor and leadership provide guidance, experience, and perspective to each new hire. Another critical program element includes creating an onboarding program with a staged process (KurnatThomas et al., 2017). A staged onboarding program gives automatic time points to assess competency, comfort levels, and team cohesion while providing opportunities to instill confidence in new hires. By instilling these critical elements into the oncology research nurse onboarding program, it is intended for success. 25 References Anselmo-Witzel, S., Orshan, S., Heitner, K., & Bachand, J. (2017). Are generation Y nurses satisfied on the job? Understanding their lived experiences. The Journal of Nursing Administration, 47(4), 232-237. https://doi.org/10.1097/NNA.0000000000000470 Backman Lönn, B., Hörnsten, Å ., Styrke, J., & Hajdarevic, S. (2022, January 7). Transitioning to the clinical research nurse role- A qualitative descriptive study. Journal of Advanced Nursing, 00, 1-13. https://doi.org/10.1111/jan.15397 Hernon, O., Dalton, R., & Dowling, M. (2019, November 24). Clinical research nurses' expectations and realities of their role: A qualitative evidence synthesis. Journal of Clinical Nursing, 29, 667–683. https://doi.org/10.1111/jocn.15128 Hines, S., Ramsbotham, J., & Coyer, F. (2022). Registered nurses' experiences of reading and using research for work and education: A qualitative research study. BioMed Central, Inc. Nursing, 21(114). https://doi.org/10.1186/s12912-022-00877-3 Kubota, Y., Okuyama, T., Uchida, M., Umezawa, S., Nakaguchi, T., Sugano, K., Ito, Y., Katsuki, F., Nakano, Y., Nishiyama, T., Katayama, Y., & Akechi, T. (2016). Effectiveness of a psycho-oncology training program for oncology nurses: A randomized control trial. Psycho-Oncology, 25, 712-718. https://doi.org/10.1002/pon.4000 Kunhunny, S., & Salmon, D. (2017, August 22). The evolving professional identity of the clinical research nurse: A qualitative exploration. Journal of Clinical Nursing. https://doi.org/10.1111/jocn.14055 Kurnat-Thoma, E., Ganger, M., Peterson, K., & Channell, L. (2017). Reducing annual hospital and registered staff turnover-A 10-element onboarding program intervention. SAGE Open Nursing, 3, 1-13. https://doi.org/10.1177/2377960817697712 26 Larkin, M. E., Beardslee, B., Cagliero, E., Griffith, C., Milaszewski, K., Mugford, M. T., Myerson, J. M., Ni, W., Perry, D. J., Winkler, S., & Witte, E. R. (2019). Ethical challenges experienced by clinical research nurses: A qualitative study. Nursing Ethics, 26(1), 172–184. https://doi.org/10.1177/096973301769344 Mackle, D., & Nelson, K. (2017, October 30). Research nurses in New Zealand intensive care units: A qualitative descriptive study. Australian Critical Care, 32, 148–154. https://doi.org/10.1016/j.aucc.2018.03.005 McClain, A., Palokas, M., Christian, R., & Arnold, A. (2022). Retention strategies and barriers for millennial nurses: A scoping review. JBI Evidence Synthesis, 20(1), 121– 157. https://doi.org/10.11124/JBIES-20-00577 Melnyk, B. M., & Fineout-Overholt, E. (2019). Evidence-based practice in nursing & healthcare: A guide to best practice (4th ed). Wolters Kluwer. Mercieca-Bebber, R., Calvert, M., Kyte, D., Stockler, M., & King, M. T. (2018). The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators regarding their roles and experiences, challenges, and training. Contemporary Clinical Trials Communications, 9, 23–32. https://doi.org/10.1016/j.conctc.2017.11.009 Mori, C. Mullen, N., & Hill, E. (2007). Describing the role of the clinical research nurse. Research Practitioner, 8(6), 220-228. Owens, A. A. (2020). Filling in some gaps: A pre-nursing bioscience and study skills intervention. Collegian, 27, 141-146. 27 Patterson, B., Brewington, J., Krouse, A., & Hall, M. (2022). Building academic leadership capacity through coaching. Nursing Education Perspectives, 43(4), 222–227. https://doi.org/10.1097/01.NEP.0000000000000981 Rosswurm, M. A., & Larrabee, J. H. (1999). A model for change to evidence-based practice. Journal of Nursing Scholarship, 31(4), 317-322. https://doi.org/10.1111/j.15475069.1999.tb00510.x Society for Human Resource Management. (n.d.). Understanding employee onboarding. https://www.shrm.org/resourcesandtools/tools-and-samples/toolkits/pages/understandingemployeeonboarding.aspx#:~:text=Onboarding%20is%20often%20confused%20with,last%20up% 20to%2012%20months Smythe A., Carter, V., Dube, A., & Cannaby, A.-M. (2022, September). How a better understanding of nursing research roles may help to embed research into clinical structures. British Journal of Nursing 31(17). Mark Allen Publishing. Stetler, C. (2001). Updating the Stetler model of research utilization to facilitate evidence-based practice. Nursing Outlook, 49(6), 272–279. https://doi.org/10.1067/mno.2001.120517 Taj, M., Ukani, H., Lalani, B., Madhani, N., Sulaiman Khan, Z., Zaidi, F., Sayani, S., & Muzammil, M. (2022). Blended oncology nursing training: A quality initiative in East Africa. Seminars in Oncology Nursing, 38(4). https://doi.org/10.1016/j.soncn.2022.151299 Tinkler, L., Smith, V., Yiannakou, Y., & Robinson, L. (2017, July 6). Professional identity and the clinical research nurse: A qualitative study exploring issues having an impact on 28 participant recruitment in research. Journal of Advanced Nursing, 74(2), 318–328. https://doi.org/10.1111/jan.13409 29 Appendix A Personal Review of Orientation and Onboarding to Research Data Nursing Recall your personal experiences when you were oriented to data nursing. Assessment available at: https://forms.office.com/r/n6NNNd4jVf 1. Please indicate how your orientation and training experience in research nursing apply to the following statements. Please indicate your answer between the answers 1 and 5, 1 being "not at all," 3 being "somewhat," and five being “very.” i. It was comprehensive 1 2 3 4 5 ii. It was effective 1 2 3 4 5 2. Beginning from your start date, when did you feel “independent” due to your onboarding experience? Independent refers to a feeling of independently accomplishing tasks and data management. a. <1 month b. 1-2 months c. 3-6 months d. 7-9 months e. 10-12 months 3. Please put in order from start to finish when you begin each orientation process. Start with your beginning orientation processes at the top and the last methods at the bottom. a. Learn how to answer phones, send emails, look at the COG group calendar, etc. b. Daily tasks (i.e., chart prep, attend Safety Rounds, or check study patients) c. Weekly tasks (i.e., study drug update or attend weekly meetings) d. Monthly tasks (i.e., SADD list) e. Establish COG membership f. Completed CITI training (i.e., Human Research and GCP training) g. Set up a personal workstation (i.e., given a laptop, set up a phone number, or assigned a specific desk) h. Learn the roles of the team (both U of U and Intermountain team members) i. Establish computer access (i.e., V-Drive, Teams, Adobe Creative Cloud) j. Establish access to Oncore and Microsoft Access 4. Please put in order from start to finish when you learned each research nursing skill. Start with your beginning orientation skills, with the last learned skills at the end. a. Participate in a consortium/protocol visit (i.e., SIV, Monitoring, Audit) b. Learn a COG follow-up reporting period c. Change patient information in Oncore or Access (i.e., follow-up, death, off protocol, LTFU) d. Create an AE log, a ConMed log, a Pharmacy script, or a Medication diary e. Fax a medical record request f. Learn a COG Maintenance reporting period g. Learn a COG starting (Induction, Consolidation, IM, or DI) reporting period 30 h. Learn another Consortium reporting period (other than COG) 5. What would you have changed about the onboarding process outlined in the previous question? 6. Please share any insight, comments, or experiences you believe would be helpful. References: Cuaron, J., Gillespie, E., Gomez, D., Khan, A., Mychalczak, B, & Cahlon, O. (2019, Nov 21). From orientation to onboarding: A survey-based departmental improvement program for new radiation oncology faculty physicians. Journal of Clinical Oncology, Oncology Practice, 16(4), e395-e405. https://doi. org/10.1200/JOP.19. 00641 31 Appendix B Research Nurse Orientation Checklist Approval Date: Research Data Nurse Onboarding Checklist Employee Name: Employee ID# : Skill / Skill Set: LMS Item # Position: Department/Facility: Pass Off initiated (mm/dd/yyyy): Instructions: 1. 2. 3. 4. Print the pass-off. Review the supporting documents and other assigned materials. Take the pass-off to the skill instructor for evaluation and sign-off. Upon completing the sign-off of all skills, turn in the pass-off to your Educator or designated unit/department personnel for documentation and record completion. Supporting Documents: ฀ ฀ Cuaron, J., Gillespie, E., Gomez, D., Khan, A., Mychalczak, B, & Cahlon, O. (2019, Nov 21). From orientation to onboarding: A surveybased departmental improvement program for new radiation oncology faculty physicians. Journal of Clinical Oncology, Oncology Practice, 16(4), e395-e405. https://doi. org/10.1200/JOP.19. 00641 Lönn, B. B., Hörnsten, A., Styrke, J., & Hajdarevic, S. (2022, January 7). Transitioning to the clinical research nurse role- A qualitative descriptive study. Journal of Advanced Nursing 00, 1-13. DOI: 10.1111/jan.15397 Skill Pass-Off: Competency Verification Method Key: D = Demonstrated/observed; V = Verbalized; R = Review of documentation; O = Other/see comment Resources/ Comments Behavioral Objectives (Complete all applicable skills or write “n/a” and explain in Comments) Competency Verification (see key above*) Date verified (mm/dd/yyyy) Method* Initials Verbalize scope of Research Data Nursing 1. Data abstraction 2. Data Entry 3. AE identification 4. SAE identification 5. SAE and AE Reporting 6. Ensure protocol adherence 7. Interdisciplinary team communication 8. Maintain trainings and certifications Upfront tasks 1. 2. 3. COG Membership GCP training (renew every 3 years) CITI training (renew every 3 years as associate with University of Utah) Verbalize the following roles of the team: 1. 2. 3. 4. Updated 2/11/23 CRCs CRAs PIs CTO Page 1 of 5 32 Approval Date: Research Data Nurse Onboarding Checklist Employee Name: Employee ID# : Skill / Skill Set: LMS Item # Position: Department/Facility: Pass Off initiated (mm/dd/yyyy): Competency Verification Method Key: D = Demonstrated/observed; V = Verbalized; R = Review of documentation; O = Other/see comment Resources/ Comments Behavioral Objectives (Complete all applicable skills or write “n/a” and explain in Comments) 6. Competency Verification (see key above*) Date verified (mm/dd/yyyy) Method* Initials DOA Verbalize the role of the following outside groups and programs 1. COG vs COG Industry (JAZZ, Incyte, Novartis, Merck) 2. Other consortiums: PNOC, SUNSHINE, BCC, TACL, PEPCTN, POETIC, NEXT, SWOG 3. EDCs: REDCap, RAVE, Inform, DataLabs, Oncore, CTEPAERS 4. CTCAE: versions 4 &5 5. SPEERS Coordinate Access to Common items: 1. 2. 3. 4. 5. Updated 1/28/23 Computer set-up Phone and extension: a. Voicemail Review Helpful Programs a. Excel (ie AE & Conmed logs, personal password sheet) b. Word (ie logs & prescriptions, med diaries, faxes) c. Icentra through data entry eyes (upcoming appts, order proprosals, results review- group & table tabs, pathology, documents/notes, imaging, therapeutic class pharmacy, eMAR, patient lists: Study Drug Patients, Induction/Consolidation AALL1731/1732) d. Microsoft Teams (Teams: Research Data Nurses, COG CRA, Peds L/L team) Computer access a. V drive- access to: COG Studies, COG Archive, and COG CRA b. COG Calendar c. Programs are requested as needed d. Locate Microsoft Teams/other resources e. Kronos/ time card exceptions/RTO f. Microsoft Access Database g. Huntsman Oncore h. Acrobat Pro DC (Acrobat cloud) Copy machine/Fax machine Page 2 of 5 33 Approval Date: Research Data Nurse Onboarding Checklist Employee Name: Employee ID# : Skill / Skill Set: LMS Item # Position: Department/Facility: Pass Off initiated (mm/dd/yyyy): Competency Verification Method Key: D = Demonstrated/observed; V = Verbalized; R = Review of documentation; O = Other/see comment Resources/ Comments Behavioral Objectives (Complete all applicable skills or write “n/a” and explain in Comments) 5. 6. Competency Verification (see key above*) Date verified (mm/dd/yyyy) Method* Initials U of U IRB DOA Verbalize the role of the following outside groups and programs 1. COG vs COG Industry (JAZZ, Incyte, Novartis, Merck) 2. Other consortiums: PNOC, SUNSHINE, BCC, TACL, PEPCTN, POETIC, NEXT, SWOG 3. EDCs: REDCap, RAVE, Inform, DataLabs, Oncore, CTEPAERS 4. CTCAE: versions 4 &5 5. SPEERS Coordinate Access to Common items: 1. 2. 3. 4. Updated 2/11/23 Computer set-up Phone and extension: a. Voicemail Review Helpful Programs a. Excel (ie AE & Conmed logs, personal password sheet) b. Word (ie logs & prescriptions, med diaries, faxes) c. Icentra through data entry eyes (upcoming appts, order proprosals, results review- group & table tabs, pathology, documents/notes, imaging, therapeutic class pharmacy, eMAR, patient lists: Study Drug Patients, Induction/Consolidation AALL1731/1732) d. Microsoft Teams (Teams: Research Data Nurses, COG CRA, Peds L/L team) Computer access a. V drive- access to: COG Studies, COG Archive, and COG CRA b. COG Calendar c. Programs are requested as needed d. Locate Microsoft Teams/other resources e. Kronos/ time card exceptions/RTO f. Microsoft Access Database g. Huntsman Oncore Page 2 of 5 34 Approval Date: Research Data Nurse Onboarding Checklist Employee Name: Employee ID# : Skill / Skill Set: LMS Item # Position: Department/Facility: Pass Off initiated (mm/dd/yyyy): Competency Verification Method Key: D = Demonstrated/observed; V = Verbalized; R = Review of documentation; O = Other/see comment Resources/ Comments Behavioral Objectives (Complete all applicable skills or write “n/a” and explain in Comments) 5. 6. Competency Verification (see key above*) Date verified (mm/dd/yyyy) Method* Initials h. Acrobat Pro DC (Acrobat cloud) Copy machine/Fax machine Email: PC-COG (Add to email receipt list; understand who is included in email; understand when to include all of COG or just the data research nurse team) Demonstrate COG CRA Navigation: 1. 2. 3. 4. 5. 6. 7. 8. Reminders Fax med record requests NTF (Note to File) AE Logs Investigational drug prescriptions Concomittant drug log RECIST (measuring tumors) Patient folder (if they have one) Demonstrate Regular Tasks: 1. 2. 3. 4. 5. 6. 7. 8. Updated 2/11/23 Pulling roadmaps Identify Doc box location & Research team box location Check patient lists (study drug, induction/consolidation, queries) Checking Charts: a. Review Standard Operating Procedures (SOP) b. Requirements for study versus non-study patients i. Protocol ammendments ii. Audit errors and corrections iii. Audit roadmap completion iv. AOM c. Add to Calendars & invite specific individuals Locate Satelite Pharmacy & Investigational Pharmacy Study drug update bi-weekly for Investigational Pharmacists Leukemia/Lymphoma Meeting (weekly on Wednesdays at 1600-1700 in PCH auditorium/virtual) Weekly Wednesday (data nurse’s meetings, weekly on Wednesdays at 1100-1200, in a local conference room) Page 3 of 5 35 Approval Date: Research Data Nurse Onboarding Checklist Employee Name: Employee ID# : Skill / Skill Set: LMS Item # Position: Department/Facility: Pass Off initiated (mm/dd/yyyy): Competency Verification Method Key: D = Demonstrated/observed; V = Verbalized; R = Review of documentation; O = Other/see comment Resources/ Comments Behavioral Objectives (Complete all applicable skills or write “n/a” and explain in Comments) Competency Verification (see key above*) Date verified (mm/dd/yyyy) Method* Initials 9. Research meeting (COG team, weekly on Thursdays at 1300, in conference room) 10. Solid/Liquid team meetings Demonstrate or Verbalize Communication: 1. 2. 3. 4. 5. Closing the interdisciplinary communication loop Chain of command Telephone calls, voicemails Emails Coverage for out of office Coordinate access to Studies/Consortiums: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. COG PNOC BCC (NMTRC) Novartis Incyte SUNSHINE Pfizer POETIC GAIN NEXT SWOG TACL Completed Trainings: 1. 2. Updated 2/11/23 Current COG Protocols: b. See open studies list in V DriveàCOG StudiesàConsents DO NOT DELETE folder (top of list) c. AALL1731, AALL1732, AAML1831, AAML18P1 d. ADVL1831, ACNS1531 Current PNOC Protocols a. PNOC007, PNOC008, PNOC016, PNOC019 Page 4 of 5 36 Approval Date: Research Data Nurse Onboarding Checklist Employee Name: Employee ID# : Skill / Skill Set: Position: LMS Item # Department/Facility: Pass Off initiated (mm/dd/yyyy): Final Pass-Off: The following signatures confirm that this employee has been trained and observed in the above skill set and has demonstrated competency. Evaluator Name (print): __________ Position: Department/Facility: Evaluator Signature: Initials: Employee Signature: Date (mm/dd/yyyy): Date (mm/dd/yyyy): Additional Evaluators if Applicable: Initials Updated 2/11/23 Name Role Initials Name Role Page 5 of 5 37 Appendix C Nursing Orientation Video to Primary Children’s Oncology Research Department Formal presentation video available at: https://1533221.mediaspace.kaltura.com/media/Research+Nurse+Orientation/1_4gp5nsge Formal PowerPoint slides are available on the following pages. 38 2/11/23 Terms to Know within Oncology Research Nursing Orientation to Primary Children’s Pediatric Oncology Research Department Consortium: a group or organization that directs research and treatment options for specific oncologic diseases EDC: Electronic Data Capture system (where data is collected and stored) Protocol: A document directing standard of care and study requirements for a specific oncologic disease Shelly Tolley, RN, BSN, CPHON, MSNEd student Terri Baker, RN, BSN, Data Nurse Manager 1 Roadmap: A therapy delivery map designating therapy, observations, and timepoints within the protocol. 2 By the Numbers: @ Primary Children’s Hospital Oncology Research Department Positions to Understand on the Pediatric Oncology Research Team Research nurse: Research nurses complete data abstraction and entry; they are employed by Intermountain CRCs: Clinical Research Coordinators, ensure eligibility and enrollment of participants; they are employed by the U of U M anagers: Direct process and flow of the separate teams, participate in team’s workflow; they are employed by either Regulatory Coordinators: Handle the regulations and processes when opening and keeping protocols; they are employed by the U of U 46 77 134 3x Patients on total COG therapeutic studies in 2019 Patients on total COG therapeutic studies in 2020 Patients on total COG therapeutic studies in 2021 Tripled PCH enrollment on therapeutic studies in 3 years Children’s Oncology G roup. (n. d.) 3 4 Comparing COG 2021 Enrollments UT Sout hw es t er n/ Sim m ons Canc er C ent er - Dal al s ( Dal al s Chi dl r en' s ) Seat t el Chi dl r en 's H os pi ta l Sai nt J ude Chi dl r en' s R es ear chH os pit al ( St. uJ d e's ) We need you and are excited to have you! Chi dl er n's Hos pi ta l of Phi al d elph ai ( CHO P) Chi dl er n's Hos pi ta l L os An gele s (C HL A) # 2 total enrolling Chi dl er n's Hos pi ta l of Col or ado Chi dl er n's Heal th c are of A t al nt a- Ege sl t on # 1 total Bayl or C oll ege of M edi c ni e enrolling Ann & Ro ber t H. L u ir e Chil dr en' s Ho s pit al of C hic ago PCH #3 Pr m i ar y Chi dl r en' s H os pit al ( UT) total enrolling 0 Tot a l Enr ol m l en ts 50 No n- th e ar p eut ci enr oll m ent s 100 150 200 Ther ape ut ic e nr oll m ent s w it h in du s rt y fun din g 250 300 350 Ther ape ut ic e nr oll m ent s Created by: Rebecca Stoffel, 4 April 2022 Tolley, S. (2022, N ovem ber 11). 5 6 1 39 2/11/23 M embers and Roles of the Research Team continued… M embers & Roles of the Research Team Top Row, Left to Right: Jen Taggart (CRC, solid tumors) Rebecca Stoffel (Clinical Research Manager) Andrew Newton (Lead CRC, liquid tumors) Luke Maese (Director of Research) Diana Bareyan (CRC, solid tumor) Terri Baker (Intermountain Research Nurse Manager) Second Row, Left to Right: Shelly Tolley (Research data RN, liquid tumors) Keeley Best (CRC, liquid tumors) Genesis Arko (Regulatory coordinator, liquid tumors) Michelle Grant (Research data RN, solid tumors) Nicole Manning (Research data RN, liquid tumors) Natalie Higginson (Research data RN, solid tumors) 7 Not Pictured: Jessica Jensen (Research data RN, solid tumors) Melanie Gauci (Regulatory coordinator, solid tumors) Mindy Torman (Regulatory coordinator, early phase trials) 8 D a ily : • • • • • Research Data Nurse Onboarding Stages Stage 1 Research Nurse Tasks Stage 3 Stage 2 Attend H em Onc Clinic Safety Rounds Chart Checks Pull roadm aps CO G Calendar updates Check Study Patient List for SAEs W e e k ly : L / Ly • Check Induction/Consolidation Patient List on AALL1731/1732 for hom e chem o com pliance docum entation (Ara-C, Steroids, 6M P, 6TG ) Orientation, Access & Trainings Introduction to systems, processes, and procedures Reporting Periods (R.P.) Start with AALL1731 Follow-up R.P., followed by other R.P. within COG Other Consortium s Ongoing R.P.s within other consortiums Competency Evaluation Checklist completion Competency Evaluation Quality Assurance (Q.A.) Checks Com petency Evaluation Q.A. Checks Le ngth: 1-3 m onths • • • CTSU, SW O G , AALL1521 data queries Attend L/Ly service line m eeting Attend nurse group m eetings B iw e e k ly • Q u a rte rly • SADD list deadline is last day of every quarter Length: 6-12 m onths 9 Update Upcom ing Study Drug Pharm acy list M o n th ly • SADD list 10 Research Process in our Service Line Regular Research Nursing Task Systems • CITI - through U of U access • GCP - through U of U access • COG Member • • • EPIC • uNID • U of U Oncore Analyzes and interprets data Creates new studies to improve standard of care • • 01 Opens studies at PCH Ensures eligibility & Enrolls patients on the study Sets up study specimens/ questionnaires for the clinical care team • Research Team (RNs) • • Ubox • SIP/Exostar 11 Research Team (CRCs, Regulatory Coordinators) Study Consortium • Investigates and reports all applicable clinical data to the consortium Ensures accurate clinical data 04 02 Clinical Care Team • 03 • Follow s guidance of protocol and cares for patient per best clinical practice Documents all clinical cares 12 2 40 2/11/23 Consortiumsassociated with PCH Oncology SWOG SUNSHINE Project TACL PNOC Pfizer What programs do we use? NM RTC COG NEXT HEAD START IV GAIN How do we know what is each consortium? What protocols associate with what consortium? SARC PEP-CTN It gets confusing. Let’s sort it out…. POETIC 13 14 EDC’s Consortiums Protocols S O L ID S LIQ U ID S AALL1731 ADVL1823 AALL1732 ADVL1521 AAM L1831 ACN S1422 AALL1621 ACN S1723 AALL1821 ACN S1831 COG (Children’s Oncology Group) M edidata AALL1631 AALL1521 AAM L18P1 AN H L1931 APEC14B1 Associated with: National Cancer Institute (AKA RAVE) AN BL00B1 COG Industry TACL DataLabs (Therapeutic Advances in Childhood Leukemia & Lymphoma) Protocols TACL Novartis AALL1931/ JZP458-201 AALL1721/ CC TL019G 2201J ADVL1621/ M K3475-051 M ERCK ADV L1921/ A5481092 AD VL2121/2020-012-G LOB2 TA C L TACL 2012-002 TACL 2020-003 Associated with: CHLA UCSF Oncore (EDC) Advarra (EDC) Forte (EDC) Sharepoint (Data Repository) AALL1521/ IN CB18424-269 Suvoda Inform Phaseforward Consortiums AREN 1721 AREN 1921 AHEP1531 ARST1431 ACN S1833 ARST1921 AN C1931 APEC14B1 M CI ACN S2021 APEC1621AG CT1531 A,B,D, F, I, K, M , AG CT1532 &N INCYTE JAZZ Pharm aceuticals Programs AN BL19P1 AN BL1232 AREN 03B2 PNO C PNOC (Pacific Pediatric Neuro-Oncology Consortium) Associated with: UCSF PN OC007 PN OC008 PN OC022 PN OC016 PN OC025 Hutchison M ed Pharm a Limited 15 16 Programs Consortiums Protocols Oncore (EDC) (Pediatric Oncology Experimental Therapeutics Investigators’ Consortium) & ROCHE (Drug Co.) MOFFITT/ SUNSHINE (aka “The Sunshine Project”) P O E T IC G 040872 RedCap Atrium Health SHAREPOINT (Data repository) (a k a N M R TC ) Inform Exostar Firecrest/ICON M O F F IT T M CC20339 Associated with: National Pediatric Cancer Foundation 17 Consortiums Protocols BCC P O E T IC Almac Medidata/RAVE Programs (Beat Childhood Cancer) Associated with: Nationwide Children’s Hospital Pfizer P O E T IC G 040872 P f ize r A5481092 18 3 41 2/11/23 Programs Consortiums Protocols NEXT (National Experimental Therapeutics) H e a d S ta rt IV Associated with: Nationwide Children’s Hospital Questions? PEP-CTN (Pediatric Early Phase Clinical Trials Network) Associated with: National Cancer Institute P E P -C T N PEPN 2111 19 Ask away…. 20 References • American Cancer Society. (2022, January 12). Key Statistics for Childhood Cancers. Types of Cancer that Develop in Children • Children’s Oncology Group. (n. d.) In stitutiona l Report Ca rd: 1/1/2019-12/31/2021. • Lönn, B. B., Hörnsten, A., Styrke, J., & Hajdarevic, S. (2022, January 7). Transitioning to the clinical research nurse role- A qualitative descriptive study. Jou rn al o f A d vanced N ursin g 00, 1-13. DOI: 10.1111/jan.15397 • Tinkler, L., Smith, V., Yiannakou, Y., & Robinson, L. (2017, July 6). Professional identity and the clinical research nurse: A qualitative study exploring issues having an impact on participant recruitment in research. Jou rnal of A dva nced N ursin g 74 , 318-328. DOI: 10.1111/jan.13409 • Tolley, S. (2022, November 11). M arket A n alysis of CO G en ro llm ents 2021. • Stoffel, R. (2022, November 11). 2022 PCH Enrollm ents. 21 4 42 Appendix D Onboarding Schedule Plan