One of the key components to achieving Magnet® designation is integrating evidence-based practice and research with the goal of developing knowledge and best practice. The Magnet Model requires organizations to demonstrate new nursing knowledge, innovations, and improvements.1 During the journey to Magnet designation or redesignation, 2 completed nursing studies and 1 nursing study in progress are required. The American Nurses Credentialing Center (ANCC) stipulated that multisite research satisfies this requirement. Each site participating in a multisite research study must have its own principal investigator (PI) who obtains institutional review board (IRB) approval. The increased focus on research and evidence-based practice activities may present challenges for hospitals that have not developed a plan for meeting these designation expectations.2
The 1st multisite Magnet study was initiated in 2012 in response to organizational requests to the ANCC to participate in rigorous, high-quality, multisite research.3 The success of this multisite study motivated the ANCC to support additional multisite studies to facilitate the ability of Magnet organizations to meet research standards.3 In addition to supporting Magnet designation, multisite research studies have numerous benefits for organizations, including the opportunity for nurse engagement and participation in research-related activities, shared learning experiences with collaborating sites, and mentorship with experienced nurse researchers. Sharing of expertise and experience between institutions provides rich data for multiple levels of analysis.4 Many hospitals lack the infrastructure and personnel to organize, lead, and execute a nursing research program despite having master's or doctorally prepared nurses.5 Through multisite collaboration, hospitals with less experienced nursing research programs learn from external experts, promoting the opportunity for novice nursing research programs to learn effective strategies for sustaining nursing research efforts, share expertise, and integrate best practices for engaging nurses in the conduct of research.
The 1st pediatric multisite study funded by the ANCC, titled Parent Education Discharge Support Strategies (PEDSS) for Children Newly Diagnosed with Cancer, presented an opportunity for 16 hospitals to engage in a multisite collaboration anchored by strong leadership and administrative engagement of a lead site. The concept arose from the Children's Oncology Group (COG) Nursing Disciplines' recognition that significant variability of patient/family education across COG institutions existed, and there was a clear opportunity for innovation and improvement using a multisite model.6 The COG is a National Cancer Institute supported clinical trials collaborative devoted exclusively to childhood and adolescent cancer research. The mission of the COG Nursing Discipline is to set a standard of excellence for the care of children and adolescents with cancer treated on COG clinical trials and to transform the practice of nursing in pediatric oncology by developing and conducting research within COG. The PEDSS study accrued rapidly and created an opportunity for direct care nurses to participate in meaningful research directly related to the care they provide in their role. Multisite collaboration provided significant benefits to the clinical nurse through the opportunity to learn about and participate in research-related activities. The PEDSS study experience demonstrated that direct care nurses can engage in meaningful research with leadership support, research mentors, study infrastructure, and consistent internal and multisite communication.
Overview of PEDSS Study
Parents of children receiving a diagnosis of cancer are overwhelmed with the information that they receive during the child's initial hospitalization.7 They are often apprehensive about caring for the child at home and want concise, focused information.8 The PEDSS study is a cluster randomized control trial to assess the effectiveness and feasibility of 2 interventions created to educate parents before the child's initial hospital discharge. Each site is randomized to 1 of 2 interventional arms and provides the assigned intervention until study completion. The 1st intervention is a symptom management strategy that includes providing a written card describing the most commonly experienced treatment-related physical symptoms, each symptom, strategies to reduce symptom distress, and when and how to contact the cancer team. The 2nd intervention is a support strategy accompanied by a written card with material adapted from the American Cancer Society regarding dealing and coping with cancer. In both interventional groups, nurses review and discuss content before discharge and through subsequent clinic visits, hospitalizations, and at study assessments. Preexisting educational practices at each site remain unchanged, and the intervention is supplementary. Study assessments occur before discharge and at 4 and 8 weeks postdischarge. Patient pain, nausea, appetite changes, fatigue, and sleep disturbances are self- or parent-reported through web-based tools. Unscheduled clinic visits, emergency department visits, unplanned hospitalizations, and septic events during the study time-frame are documented. Parents provide information regarding the feasibility of the intervention. Study nurses engage in subject identification, enrollment, provision of the intervention, data collection, ongoing reinforcement of the intervention, and study assessments.
PEDSS is the 1st American ANCC pediatric multisite trial. There are 16 participating hospitals that range from small, community-based to major medical centers. Each site was surveyed for direct care nurse engagement and involvement in the PEDSS study. Figure 1 highlights nursing job titles involved in the PEDSS study (N = 14). Table 1 outlines nurses by their role within the PEDSS study at their hospital.
Essential Steps to Study Implementation
Organizational leaders and direct care nurses are 2 critical stakeholders to engage before participation in multisite nursing research. Nurses have reported positive attitudes toward nursing research and the importance of research in guiding clinical practice.9 However, the perception of an unsupportive research environment, including lack of nursing administration support for time to participate in nursing research, exists.9 Nurses with limited research experience report significantly greater overall satisfaction when provided the opportunity to engage in nursing research, whereas those with specialty certification or previous research experience perceive institutional barriers, such as lack of time.2 Furthermore, literature has described the need for leaders to provide a formal research infrastructure to promote continuing professional development activities.10,11 Yet, minimum standards to support the infrastructure required to conduct or participate in nursing research within healthcare organizations are not clearly defined. Subsequently, variation occurs among leadership support, resource allocation, and level of creativity used to promote successful study implementation across hospitals. Multisite PIs must be cognizant of such variation and provide an implementation toolkit that is standardized and flexible to allow sites to adapt while maintaining the integrity of the research study.
The PI and research personnel of the PEDSS lead site strategically framed and communicated an overview of the research study as well as the opportunity and requirements for additional sites to participate to the COG Nursing Discipline. The COG Nursing Discipline consists of engaged nurses representing all participating COG hospitals. Study presentation before the call for participation allowed time for nurses to identify and engage organizational leaders, clinical nurses, and research personnel from their individual hospital.
Engaging Key Stakeholders
The 1st essential step to successful multisite implementation is to engage leaders and stakeholders within the organization. Key leaders or stakeholders may include, but are not limited to, the chief nursing officer (CNO), Magnet coordinator, nurse leadership (director and manager), clinical nurse specialists, and physicians. Early engagement allows an opportunity for the study team to outline the benefits of study participation and discuss potential challenges. Leaders or stakeholders may be able to share ideas to ensure benefits are actualized and challenges are mitigated. Presenting an opportunity for multisite study participation that includes an approach to resource utilization with beneficial outcomes is fundamental to gain buy-in and support in a time of financial stewardship. When an opportunity for nurse professional development arises, managers may approve resources needed if appropriate and mutually beneficial.11 Furthermore, stakeholders need to clearly understand what is required for study participation and how the study team plans to meet those requirements. The PEDSS study's call for applications explicitly outlined the benefits and expectations for sites, providing potential study leaders access to the information needed to initiate a dialogue with site stakeholders. Information sessions were held by teleconference for interested sites to ask questions and gain information about the study. This gave site administrators and leaders a chance to evaluate participation.
Direct Care Nurses
Once supported by leadership, it is pivotal to recruit direct care nurses as study personnel. The new knowledge component of the Magnet Model can be the most daunting for direct care nurses especially if they have never participated in a research project.5 Other barriers to nurse engagement in research are lack of access to a nurse scientist or research mentor and lack of time and fiscal resources.12 When developing a research protocol for the clinical environment it is important to integrate study procedures into preexisting daily activities of the nurse that does not threaten or compromise job satisfaction and access to a designated research mentor within or outside the hospital. When this is feasible, recruiting direct care nurses is a win-win, allowing simultaneous engagement in a professional development opportunity while fulfilling their role as a nurse. Direct care nurses work intimately with the patients and families; having this baseline comfort level with the subjects is a benefit for approaching subjects for study participation. For the direct care nurses involved in the PEDSS study, there was an initial investment of time away from the bedside for required training; however, most of the intervention and data collection were incorporated into their workflow.
Clinical ladder or achievement programs allow direct care nurses to receive further recognition for participation in professional development and activities with associated outcomes. The use of a research tract within the clinical ladder may promote nurses to participate as study personnel. Direct care nurses play an instrumental role as study personnel in identifying potential subjects, consenting, providing the intervention, and collecting data. By engaging direct care nurses, they learn about the research process and implementation science and potentially advance their own passion and interest in nursing research. The PEDSS study site PIs introduced the study to interested direct care nurses and conducted required trainings within their hospitals. When asked about being part of this research, one of the direct care nurses responded, “As a staff nurse being an active part of this study has made me feel more engaged in the research process. This opened my eyes to another part of the nursing discipline after 20 years of being a nurse.” Another clinical nurse participating in the PEDSS study stated, “I feel that the time spent during the initial [study] conversation allows parents to open up to the nurses and voice concerns that they may be having. While they aren't always related to the study it improves rapport between the family and nurse and continues even after the first intervention.”
Implementation of a Toolkit
As PIs embark on recruiting organizations to participate in a multisite study, the following areas should be addressed in a comprehensive implementation toolkit: regulatory information, including protocol and intervention training, communication pathways within and outside the study team(s), data collection requirements, and reporting issues. The toolkit should be geared toward each role represented as study personnel, including direct care nurses. Before PEDSS study implementation, a toolkit was established for standardization among all study sites.
Site Investigator and Study Personnel Training
Before PEDSS study initiation, each site investigator reviewed a video created by the PIs to ensure that all research personnel were reliably obtaining consent and delivering the intervention. The video included an example of consenting a patient/caregiver for the PEDSS study and delivering the intervention. Each site investigator was responsible for validating consent and intervention delivery with all site study personnel before participation in study procedures. One best practice technique is to utilize preexisting meetings as educational opportunities or platforms to complete necessary study education and required annual competencies. The PEDSS study's education and competencies occurred at annual site investigator meetings, allowing for validation of consent and intervention delivery between site PIs. The site investigators then repeated the training with all site study personnel. This technique allows for real-time feedback and assurance that the study intervention is delivered reliably. Another best practice is to develop a standardized education checklist for all sites and study personnel when validating consent and intervention delivery. This technique allows the multisite PI to ensure that all sites are documenting training and education accurately.
Communication With Study Personnel and Stakeholders at Individual Sites
Communication is frequently noted as a difficulty associated with multisite research.13 The PEDSS coordinating site hosted monthly multisite telephone conferences using a Cisco Webex platform to provide a consistent approach to sharing study information with inclusion of an agenda, site enrollment status and metrics, regulatory updates, discussion of issues from the coordinating site and opportunity for site investigators to raise issues, and timeline for future activities, including dissemination. The approach provided sites with information to cascade to their study teams and organizational leaders. This information is helpful for site PIs to communicate outcomes associated with direct care nurses' involvement in research. In addition to monthly calls, the coordinating site promoted annual in-person meetings within the COG Nursing Discipline infrastructure. Strategic scheduling of the PEDSS study meeting during the COG meeting allowed sites to double-up on professional activities while only providing financial support for travel to a single meeting.
Data Collection Across the Continuum of Care
Many healthcare organizations do not have budgets allocated to support direct care nurse time for nursing research studies during nonproductive working hours. To overcome this challenge, the PEDSS study encouraged participating sites to engage individuals in exempt roles to serve in 2 capacities: 1) support study oversight and 2) provide support to direct care nonexempt nurses who were unable to complete study-related activities, including data collection across multiple time points in the protocol-driven time frame.
The PEDSS approach prioritized direct care nurses' completion of study-related activities while maintaining a sustainable safety net to support successful site participation. The study information was communicated internally by PEDSS study sites to support study requirements across the continuum of care, including eligible subjects, need for consenting of interested subjects, data collection, and completion dates. Study site investigators reported minimal impact on staffing and limited need for nurses to pass off activities to exempt personnel.
Simpson et al14 described an approach to manage challenges experienced in complex clinical trials. Three broad challenges categories are those arising from the research site, those arising to the protocol itself, and those arising from the research team.14 Providing clarity on the origin of the challenge is critical to ensure an appropriate response within a study site or across multiple sites. The PEDSS study monthly telephone conference led by the PI and attended by site investigators is one way to ensure adequate communication and allow ample opportunity for sites to discuss challenges and problem solve. These opportunities are especially useful when implementing a study in a clinical setting, where many contextual factors can inadvertently influence study implementation.
Essential Leadership Roles for Administrators
Administrator Role in Research
Chief nursing officers and nursing leaders within Magnet-designated hospitals support evidence-based practice and research, but participation may be ranked a low priority because of minimal budgeted resources.15 To overcome this major barrier, it is important that Magnet CNOs and other administrators enable others to act through supporting nursing research endeavors. It is essential to have leadership support to be successful with any nurse-driven research project.16 Nursing administration's support of research promotes direct care nurse engagement and is essential to Magnet sustainability. The PEDSS study provided an opportunity for administrators to overcome the major institutional barriers linked to research through the benefits of participation in a multisite study including external support by experienced nurse PIs, data management, and publication and presentation mentorship.
Professional Growth and Development
Engagement in a multisite study can assist hospitals in several ways. Many nurses have limited experience and resources to initiate and oversee a research study. A multisite study relies on the PI's experience to develop the protocol, biostatistics, study design, and resources for the site to participate. Multisite studies allow for novice nurse researchers to learn and practice research skills alongside more seasoned and experienced nurse researches.
Clinical research requires dissemination of the research findings through publication and presentation. The multisite PI coordinates and assumes the responsibility for the dissemination of the study experience and research findings. Each organization has the ability to contribute and receive recognition for their contribution.
Participation in research gives direct care nurses the opportunity to be innovators. “Nurses are natural innovators. When there is a nurse, there is an idea about how to make patient care safer, more convenient, or more comfortable.”12(p55-56) Once involved in research, direct care nurses are empowered to continue developing new ideas and grow as professionals. Leadership support and research mentorship for the PEDSS study led to the ability to train direct care nurses in the outpatient and inpatient settings as study personnel to obtain consent, deliver the intervention, and collect data. Direct care nurses had the benefit of working within a large group with a facilitator to help them through the process. The PEDSS study provided opportunity throughout the study continuum for direct care nurses to professional develop dissemination of new nursing knowledge skills through poster presentations and publications. Before the study closing for accrual, nurses have developed 2 manuscripts and completed 1 poster presentation, with plans of several more.
Nursing practice will be enhanced when more nurses participate in research and generate new knowledge or assess clinical applicability of interventions to improve the nursing care of children. Successful advancement of new knowledge for a Magnet hospital takes commitment from the nurse executive to the direct care nurse.17 Although this component of Magnet designation and/or redesignation can be daunting, it also yields tremendous reward for hospitals and nurse professional development. For the PEDSS research team, the opportunity to learn and develop through a multisite research study fostered strong relationships between experienced and novice nurse researchers. All barriers for multisite studies with PEDSS strategic approaches to overcome are highlighted in Table 2. The PEDSS study engaged direct care nurses and provided a mentored experience while facilitating the integration of nursing evidence-based practice and research required for Magnet designation.
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