Abstract Book 2013 - IACRN · MSN, PNP Clinical Research Nursing and Pediatric Psychiatry: Poster...

Abstract Book 2013

IACRN 2013 Abstract Book |

Author Index

Abstract Number Primary Author Title

Presentation Type

1 Andrea Hale, RN, BSN, MPH

Nursing: The Nurse Investigator: How Nurse Project Managers Assist with Nursing Research

Poster

2 Andrea Hale, RN, BSN, MPH

You want to do what to my patient?: When your research patient is NOT on a research floor!

Podium

4 Jennifer Rees, RN Practice Facilitators Enhancing Positive Research Outcomes

Poster

5 Mary Larkin, MS, RN, CDE

Bionic Pancreas Clinical Trials: Capturing the Patient Experience

Poster

6 Kathryn Hall, MS, ANP-BC

Development of Nursing-Sensitive Indicators for the Clinical Research Setting

Poster

7 Linda Godfrey-Bailey, MSN, ACNS, BC

Collaborative development of best practices to enhance quality care in the research setting

Podium

8 Margo Moore, BSN, RN, CCRP

Nurses as Research Participants: Ethical Considerations

Podium

9 Kathlyn Schumacher, CRNP, MSN, ANP-BC

Creating Policy: Retrograde IVs for the Research Subject

Poster

11 Erin Fassett, RN, MSN, MBA

The Cycle of Change - The Research Participants Role Poster

12 Roxann Moritz, RN Focused Assessment Guides Poster 14 Anne Fekete, RN Assuming New Roles in Research--A Journey of

Enlightenment and Lessons Learned Poster

15 Audrey Nathanson, RN, BSN

The Role of Harvard Catalyst Clinical Research Nurses (HCCRN) in Addressing the Unique Care Needs of Healthy Control Volunteers Participating in Extended Stay, Sleep and Circadian Rhythm Research Protocols

Poster

16 Carolynn Thomas Jones, BS, BSN, MSPH, RN

Evolving CRN Roles in a Dynamic Research Enterprise: A Framework for Advocacy and Vigilance to Preserve Quality and Ethics

Podium

17 Carolynn Thomas Jones, BS, BSN, MSPH, RN

Research Nurse Manager Perceptions of Study Performance of Non-Nurse, Non-Licensed Clinical Research Coordinators

Podium

18 Laura Goergen, RN BSN The Future of Research Data Capture: Electronic Handheld Documentation to Support Nursing Practice

Poster

19 Catherine Griffith, R.N., ACNP-BC, PhD(c)

Evolution of Best Practice Group Poster

20 Abigail Thomas, BS, RN Clinical Research Nurses Team Up With Principle Investigators to Enhance the Research Process: A Relationship-Based Model of Clinical Research Care

Poster

21 Carrie Romig, BSN, RN Analyzing required vs. actual number of venipuncture attempts for research studies conducted at a clinical research center.

Poster

22 Jennifer Hall, RN, MSN The Development of an Open Registry Protocol Podium 23 Lisa Berry, RGN, Dip

NSc (Adult) Implementing Emergency Scenario Training and Assessment in a Clinical Research Facility.

Both

25 Courtney Balliro, RN Taking it to the Streets: Best practices in a simulated home-environment study

Podium

26 Raquel Bunge, BSN, RN, CCRC

Establishing a Protocol Review and Evaluation Process (PREP) for New Studies to Promote Efficient Study Start Up

Poster


28 Deborah Kolakowski, RN, DNP

Research Activities that Contribute to Nursing Workload and Staffing in a Clinical Research Setting

Podium

29 Noriko Fujiwara, RN, MHSc, OCNS, CCRP

Establishment of the Acknowledged Specialist Position for Clinical Research Nurses Certificate at the Research Hospital of The Institute of Medical Science, The University of Tokyo, Japan

Poster

31 Diane Lawrence, RN, MSN, PNP

Clinical Research Nursing and Pediatric Psychiatry: Poster

33 Eileen Beckman, RN, BSN, CCRC

The Research Nurse Advancement Program - What We Have Learned

Podium

34 Jayne Hardicre, RN, BSc, MSc, PGDip

Developing a taxonomic approach to competency development for researchers

Podium

35 Yehudit Chenzion, BSN MPA

My brother's keeper past present and future in ethics and clinical trials

Podium

37 Pauline Todd, RN, BSN, MBA

Restructuring an Academic Trial Center – Our Experience at The Methodist DeBakey Heart & Vascular Center

Podium

38 Lisa Hyatt, BSc (Hons), MSc

The Role of the Clinical Research Nurse: an evaluation of the core elements of the clinical research role in a district general hospital in the UK

Podium

39 Brian Beardslee, RN, MSN

Navigating Research Participants Through The Clinical Trial Enrollment Process: Development of a Toolbox With Practice Tools For Clinical Research Nurses

Poster

42 Penelope Jester, MPH, BSN, RN

Clinical Trials.gov: what it means to you Podium

43 Eveline Lapidus-Krol, RN, BScN, MSc

The Clinical Research Nurse Coordinator role and its recognition at The Hospital for Sick Children, Toronto

Podium

45 Elizabeth Eisenhauer, RN, MLS

Information behavior of clinical research participants Podium

46 Jolene Lewis, RN, BSN Development of a SOP to Allow Nurses in the Clinical Research Unit to Manage a Hyperinsulinemic-Euglycemic Clamp

Poster

47 Catherine Griffith, RN, MSN, ACNP-BC

Advancing the International Association of Clinical Research Nurses (IACRN) as a professional association through local chapter development

Podium

48 Maggie Malsch, RN, BSN, CPHON

Investigating the Complexity of Caring for Clinical Research Trial Patients in Pediatric Oncology

Poster

49 Jean Addis, RN, MSB, NEA-BC

Challenges Implementing an Electronic Health Record System

Poster

50 Mary Gillitzer, RN Standardizing the Research Protocol Implementation Process on the University of Wisconsin Clinical Research Unit (UW-CRU)

Poster

51 Tamara Kempken Mehring, MS, RN

University of Wisconsin Clinical Research Unit (UW-CRU) Data Collection Time Point Analysis

Poster

52 Mary Jane Williams, DNP, MPH, RN

Identifying Professional Needs and Benefits Expected by Clinical Research Nurses: What should IACRN Membership Offer?

Poster

53 Andrea Linder, RN,MS,CCRC

Genetics and Genomics: Evolution of the Role of the Clinical Research Nurse

Podium

54 Hiroko Nakahama Challenges to Education for Cancer Clinical Trials Nursing in Japan

Poster

55 Karen A. Francoeur, RN Orientation of Infusion Nurses to the Role of Research Nurse

Poster


Abstract 1 -‐ Poster Nursing” the Nurse Investigator: How Nurse Project Managers Assist with Nursing Research Andrea Hale, RN, BSN, MPH, Bethany Trainor, RN, BSN; Grace Yoon, RN, MSN; Christine McNally Dufort, RN, MBA; Lucinda Williams, RN, MSN. PNP, NE-‐BC Boston Children’s Hospital Boston Children’s Hospital (BCH) has a rich history and is world renowned for innovation, research and discovery. Nurse Investigators, of which a growing number are direct care giving nurses, develop studies to improve nursing care to children and play an integral role in the institution and its commitment to research. An innovative model of research nurse project management was developed by nurses in the CTSU (Clinical Translational Study Unit) at BCH, whereby Nurse Investigators and Nurse Project Managers (NPMs) have joined forces to operationalize cutting edge research by nurses. Background/Significance: Clinical research involves the coordination of time sensitive and detailed tasks. The NPM has the rare skill set of in-‐depth research expertise and clinical knowledge and judgment. With these competencies, NPMs are uniquely qualified to plan, implement and manage clinical studies. NPMs are prepared to anticipate potential clinical and research issues and plan for them through interactions, teaching and engaging other clinicians and staff members working in the clinical environment where the trial is conducted. Furthermore, these nurses are able to fulfill responsibilities that require licensure such as assessment, history taking, medication administration and care coordination. Conclusions: The NPM partners with Nurse Principal Investigator for the duration of the study. The NPM guides the nurse investigator through the step-‐by-‐step sequence of activities required to successfully launch and complete the study. The portfolio of studies managed by NPMs includes studies conducted by Nurse Investigators. NPMs have unique insight into the field of nursing research and can provide valuable assistance to other nurses who are conducting clinical studies

Abstract 2 -‐ Podium You want to do what to my patient?: When your research patient is NOT on a research floor! Andrea Hale, RN, BSN, MPH, Lucinda Williams Boston Childrens Hospital In the current research climate, it is becoming more common and important to recruit study subjects and conduct clinical research projects in a non-‐research specific setting such as a standard clinical care unit. The recent transition of the General Clinical Research Units to the Clinical and Translational Study Units (CTSUs) underlies some of this change. With the inception of the CTSUs there was a new emphasis by the NIH on supporting clinical research outside of the discrete CTSUs (former GCRCs) The NIH viewed this change as central to achieving their goal of more quickly translating findings from the lab to the bedside. Some clinical research is amendable to being conducted in a research specific unit such as a CTSU. These locations provide a controlled environment, with very experienced research nurses and other research trained staff, to provide optimal care to both the research subjects while ensuring study protocol compliance. However, the optimal study environment for many study subjects is where the requisite subspecialty medical and nursing practice are housed; be that an inpatient or outpatient environment of care. . . Non-‐research specific units present a unique set of challenges with regard to study planning, implementation and study conduct. Often in these standard-‐of-‐care environments there is a lack of direct caregiving personnel with research experience or knowledge about such topics as recruiting subjects in


busy clinical environments, blinding, the ongoing nature of informed consent, administration of investigational agents, etc. This presentation/poster will discuss how to conduct a clinical research study when your patient is a non-‐research specific setting. The following points will be reviewed: 1. What to consider about during study start up 2. Screening and recruitment procedures 3. Obtaining informed consent on a busy inpatient floor 4. Conducting a research visit 5. Ensuring the appropriate follow up 6. Involving and educating direct care giving staff 7. Examples of successful inpatient studies, including recruiting patients in an ICU and inpatient pulmonary floor.

Abstract 4 -‐ Poster Practice Facilitators Enhancing Positive Research Outcomes Jennifer Rees, RN, Jacquie Halladay, MD University of North Carolina, Co-‐Director North Carolina Network Consortium Katrina Donahue, MD University of North Carolina Co-‐Director North Carolina Network Consortium Madeline Mitchell, MURP University of North Carolina, Associate Director North Carolina Network Consortium Lindsay Kuhn, MHS, PA-‐C, Director of Clinical Trials and Quality Carolinas HealthCare System University of North Carolina Abstract: Background: There is a growing trend across the United States for research to be conducted in clinical settings outside of academic medical centers, in community based practices where over 95% of patients receive their care. There is a need to conduct research in these settings to better understand how most patients receive care, to measure and report patient care outcomes, and to disseminate and evaluate evidence-‐based practices. Practice Facilitators are research and resource liaisons that connect and support practices, community organizations and researchers in participatory research efforts. Purpose: To understand the value of Practice Facilitation to bridge these groups and to enhance evidence translation. Methods: By describing 2 projects involving practice facilitation conducted by the North Carolina Network Consortium, we showcase the role of the Practice Facilitator in studies of varying complexity. Case Studies: In study A, the Practice Facilitator helped align the values and needs of the academic team and the clinical practice by centering the work on the practice’s goal to achieve Patient Centered Medical Home (PCMH) recognition and bringing emerging evidenced based practice to clinical care delivery. In study B, the Practice Facilitator trained clinical providers as health coaches to guide patients in shared decision making when choosing their asthma treatment plan. Outcomes: The Practice Facilitators were able to bring clinical knowledge and expertise to the practices and enhanced the knowledge and skills of practice staff members. Conclusion: Practice Facilitators are able to enhance many aspects of translational research related to clinical care in community settings. The development of ongoing relationships with primary care providers and their staff provides a mechanism for further dissemination of evidence based practices.

Abstract 5 -‐ Poster Bionic Pancreas Clinical Trials: Capturing the Patient Experience Mary Larkin, MS, RN, CDE, Mallory A. Hillard, BS, Laurel Macey, BA, Kendra Magyar, NP Kerry B. Grennan, NP Manasi Sinha, M.D, MPH, Steven J. Russell M.D., Ph.D. Massachusetts General Hospital


Purpose:The purpose was to explore aspects of clinical trial participation from the perspective of subjects with type 1 diabetes enrolled in a bionic pancreas study. Background/ Significance: Despite the growing number of clinical trials investigating new insulin delivery systems, little information exists regarding the personal experience of those who have enrolled in such trials. 72 participants were studied in a study exploring the use of a bionic pancreas at MGH. Methodology: An investigator-‐designed survey was distributed to adults (n=37) and children (n=35) to assess their personal experiences. Data was entered into a Research Electronic Data CAPture (REDCap) database and analysis included summarizing the descriptive statistics and finding common themes. Results: A total of 51 subjects (78% of adults/63% of children) responded. Males and females responded at equivalent rates. Diabetes duration was 20 + 15 (2-‐54) years. Participants reported that their usual diabetes regimen interfered with daily life 46 + 29% of the time (prior to study entry. The most common concerns and challenges during study participation included discomfort, large meals specified by the protocol, blood glucose fluctuations, early termination, confinement and interrupted sleep. Rewarding aspects included promoting progress and interactions with study staff, freedom from diabetes self-‐management with good glucose control, and increased knowledge of diabetes and new technologies. Optimism regarding this technology was 1.7 + 1.0 on a scale of 0-‐3 prior to participation and 2.7 + 0.7 after. Discussion: Capturing the patient experience provides insight into the motivations, burdens and benefits of participating in the bionic pancreas study. Implications for Nursing Practice and/or Future Research: Targeted nursing interventions to reduce concerns and challenges identified can be addressed through education, comfort measures and ongoing support and encouragement particularly in cases of early termination. Results from this survey have been used to develop a comparative, prospective survey for future bionic pancreas studies measuring the participant’s perspective pre and post study enrollment.

Abstract 6 -‐ Poster Development of Nursing-‐Sensitive Indicators for the Clinical Research Setting Kathryn Hall, MS, ANP-‐BC Massachusetts General Hospital Nursing-‐sensitive indicators represent the structure, process and outcome of nursing care. Development of new indicators occur when no Nursing-‐sensitive indicators (NSI) exist in a given practice area that embody nursing’s contribution to patient care. The development of new NSI begins with literature review and benchmarking. Once potential indicators are identified they are evaluated to ensure that they are nursing-‐sensitive, clinically relevant to that practice area, and are not burdensome to the unit for data collection. The next step is pilot testing. Some current NSI include: Nursing Turnover, Patient Falls, and Pressure Ulcer rate. At this time no NSI have been identified for the work of Clinical Research Nurses. Massachusetts General Hospital (MGH) is a Magnet Hospital which is part of the Harvard Catalyst Clinical Translational Science Center. Three years ago we began the process of evaluation and establishment of NSI for our Clinical Research Center (CRC). This work was done in collaboration with the Patient Care Services Office of Quality and Safety. We monitor quality metrics related to patient falls and nursing turnover, however no other NSI information is maintained for the MGH Clinical Research Center. Our assessment resulted in the pilot of two research specific NSI: “Verification of informed consent by CRC nurses” and “Correct tray set up per protocol”. The Joint Commission (TJC) target for each of these metrics was set at 100%. Data has been collected and maintained for each quarter on the CRC since July of 2010. The results of the research specific NSI will be shared, as well as the work flow for data collection and process improvements. Moving forward we plan to submit our NSI to the American Nurses Association for consideration as national measures. The use of NSI in the Clinical Research setting is a method by which we as nurse directors can demonstrate the quality and safety of the care that our


nursing staff provide participants, further advancing and defining the practice of Clinical Research Nurses.

Abstract 7 -‐ Podium Collaborative development of best practices to enhance quality care in the research setting Linda Godfrey-‐Bailey, MSN, ACNS, BC, Kathryn Hall, MS, ANP-‐BC Sheila Driscoll, MS, RN Catherine Ricciardi, DNP, RN Harvard Catalyst Clinical Research Center at Beth Israel Deaconess Medical Center In 2008 with the inception of the Harvard Catalyst CTSA, five sites and five nursing directors joined together under one organizational structure. Five years later, as the second grant cycle begins, we reflect on past accomplishments, current challenges and next steps. The challenges we faced were institutional and regulatory barriers and preconceptions about sharing information. Accomplishments included development of processes, and systems to share information as well as the unexpected opportunity to leverage the strengths of each site, to the benefit of all. Catalyst developed software such as Resource Review and Subject Study Scheduling giving leadership common tools. The Nursing Best Practice committee brought together nurses from all sites to develop additional tools such as an orientation manual for research nursing, best practices and guidelines, which have benefitted nurses at all of our sites. An interdisciplinary retreat we hosted in 2012 for research centers across Massachusetts discovered many similarities in our day-‐to-‐day operations and concerns, validating our shared approach to problem solving. Leadership completed a needs assessment to identify focal areas of work for 2013 and beyond. It was determined that creating a User Agreement and Standard Operating Procedures (SOPs) would to provide clarity and a frame work that would benefit the Harvard Catalyst Investigators and Clinical Research Centers (CRCs). We will share specifics of our User Agreement and SOP development as well as the services and infrastructure available to our investigators to streamline and simplify their work. By use of these tools we anticipate a reduction in redundancy and increased transparency. This will in turn increase uniformity and improve efficiencies across the CRCs.

Abstract 8 -‐ Podium Nurses as Research Participants: Ethical Considerations Margo Moore, BSN, RN, CCRP, Stephanie Sealschott,BSN,RNC-‐NIC Cincinnati Children's Hospital and Medical Center Research in Patient Services 3333 Burnet Avenue, Cincinnati, Ohio 45229 513-‐803-‐1534 [email protected] Cincinnati Childrens Hospital Medical Center Purpose: To explore ethical considerations associated with nurses as research participants in a study involving sensitive data conducted at the nurses’ place of employment. Background: Extensive research is needed to determine if healthcare system changes have a positive effect on health outcomes. Nurses as frontline caregivers are responsible for providing direct patient care and constitute professional stakeholders whose engagement in research is needed. Recruitment of nurses can be difficult if the research is conducted at their place of employment and is related to their care delivery practices. Protections for nurses as vulnerable human subjects are needed to ensure confidentiality and minimize risk of harm such as loss of employment. Research Aim: To describe strategies used to protect nurses as in a research study in which they reported on missed nursing care for individual patients while obtaining


high quality data to meet the objectives of the study. Theoretical Framework: The Belmont Report provided the conceptual model as the researchers employed beneficence, justice and respect for persons to safeguard the participants from harm. Methods: Strategies used in a study of missed nursing care in a neonatal intensive care unit to protect nurses as human subjects will be described. Results: Strategies used to ensure beneficence included robust privacy practices, the use of a federal Certificate of Confidentiality, and agreements with hospital administrators to remain naïve to the data until study completion and data de-‐identification. Respect for persons was achieved through the informed consent and by multiple opportunities to meet with the study investigator before and after making a decision to enroll in the study. Justice was ensured through multiple opportunities to enroll in the study for all eligible nurses. Attending to these important ethical considerations, we were able to enroll 116 nurses in the study representing 70% of the accessible population. Conclusion/Relevance to Practice: Best practices for the protection of research subjects requires knowledge of the vulnerabilities of potential subjects as well as knowledge of current regulatory guidelines. Careful planning and implementation of strategies that encourage participation while maintaining human subjects protections are needed to ensure high quality research data and outcomes.

Abstract 9 -‐ Poster Creating Policy: Retrograde IVs for the Research Subject Kathlyn Schumacher, CRNP, MSN, ANP-‐BC, Elizabeth A. Leonard, MSN, MBE, RN-‐BC, CCRP Hospital of the University of Pennsylvania Hospital of the University of Pennsylvania The insertion of retrograde IVs into the dorsal hand of a heated hand, for the procurement of “arterialized” venous blood sampling, is a preferred method for the collection of targeted research data. A retrograde IV is a line that is placed in the opposite direction of the standard IV, offering a more distal site for blood collection. Two research nurses took the lead and created hospital policy reflecting this nursing practice of retrograde IV insertion in the Clinical & Translational Research Center (CTRC). Hospital nursing policy defining retrograde IV insertion is now in place at our Magnet® institution.

Abstract 11 -‐ Poster The Cycle of Change -‐ The Research Participats Role Erin Fassett, RN, MSN, MBA Baylor All Saints Medical Center The cycle of change model describes the evolving role experienced by clinical research participants. Perception The majority of Americans agree that clinical research is critical to discovering life saving treatments and advancing medicine. However, the individual American has limited experience and awareness of the elements that surround clinical research. The clinical research coordinator acts as a guide to facilitate the participant’s journey through the cycle of change. Participation Research participants take on an immense responsibility by consenting to participate in a study. By deciding to join a clinical trial participants claim a more active role in their medical condition. This active role offers research participants a level of control that might otherwise be out of reach. The clinical research coordinator is in a unique position to reinforce the participant’s comprehension of the research study and why compliance is essential. Follow Up The research participant’s experience should extend beyond the


end of treatment or end of observation visit. The research participant has a shared interest in the outcome of the trial. The research participant’s role post trial may include education on trial results and follow up to ensure a sense of importance. The clinical research coordinator must understand this desire and bridge the gap so participants have a deeper connection to their role in research. Shared Experiences A fully empowered research participant is able to share their research experience among family, friends, co-‐workers, and peers. Research participants explore relationships developed with study staff and the distinction of that relationship on the overall treatment experience. Through this exchange participants can compare and contrast previous and present expectations with final outcomes. Awareness During awareness the research participant has an involved familiarity of the research process. There is more than just a glimpse into the process but an active conscience in regards to existing research. The CRC’s involvement supports the research participant’s knowledge base moving them beyond participant into public educationalist.

Abstract 12 -‐ Poster Focused Assessment Guides Roxann Moritz, RN; Laurie Vazquez, FNP; Nicole Hansen, RN, MSN CTSC Clinical Research Center (CCRC) University of California, Davis Medical Center Clinical research nurses working in NIH funded, academic research centers are often expected to care for research subjects of all ages and with every disability. With this requirement for broad clinical knowledge and skill, we recognized the need for a tool to assist research nurses prepare for the clinical demands of rare disease patients enrolled in research trials. A focused assessment library containing guides specific to a disease process or patient population was created and stored electronically in a shared folder. Each guide includes a brief review of associated pathophysiology, age appropriate assessment guidelines, and nursing considerations pertinent to maintaining the safety of the subject during the course of the research trial. The guides are created, reviewed and approved collaboratively. The purpose was to establish a concise, reliable and resourceful tool for clinical research nurses caring for a specific patient population; to encourage our clinical research nurses to share their own nursing experience and specialized clinical knowledge of various health conditions with one another; to standardize the clinical knowledge of our research nurse staff; to reduce the stress of implementing a new protocol that includes caring for patients with rare or unfamiliar diseases; an to enhance the research experience for each subject and investigator by providing optimal, standardized patient care while maintaining protocol fidelity. Concise and standardized guides proved to be clinically useful at the bedside.

Abstract 14 -‐ Poster Assuming New Roles in Research-‐-‐A Journey of Enlightenment and Lessons Learned Anne Fekete, RN; Laurie Vazquez, FNP; Nicole Hansen, RN, MSN; Joe Ann Sheppard, RN, BSN CTSC Clinical Research Center (CCRC) University of California, Davis Medical Center Economic restrictions and loss of personnel often require clinical research nurses (CRNs) to wear multiple hats and assume new duties. CRNs must be ready to take on additional assignments, including


coordinator roles. Coordinator responsibilities are much different than those of a unit-‐based CRN and the challenges faced when taking on such a role can be daunting. Successful outcomes of coordinator duties rely upon a well-‐organized and methodical approach that ensures patient safety, protocol adherence, and upholding regulatory compliance. The three step approach we have developed is a continuous cycle of Assessment, Knowledge, and Prioritization. This method is supported by a checklist used continuously to track needs, progress, important information and communication.

Abstract 15 -‐ Poster The Role of Harvard Catalyst Clinical Research Nurses (HCCRN) in Addressing the Unique Care Needs of Healthy Control Volunteers Participanting in Extended Stay, Sleep and Circadian Rhythm Research Protocols Audrey Nathanson, RN, BSN, Tracy L. Cragin, BSN, RN, HCCRC @ BWH Mona Lauture BSN, RN, HCCRC @ BIDMC Harvard Catalyst Clinical Research Center at Beth Israel Deaconess Medical Center Purpose/Aim: The purpose of this project was to identify across the Harvard Catalyst Clinical Research Centers the unique nursing care needs of healthy control volunteers enrolling in research studies. Once the nursing care needs were identified, our aim was to develop standardized nursing care plans that will address the concerns of these participants. Background: The Harvard Catalyst Translational Science Award (HCTSA) system implements a model of nursing practice where staff nurses come together to discuss high frequency nursing problems in their research participant population. The Clinical Research Centers (CRC) from Beth Israel Deaconess Medical Center (BIDMC) and Brigham and Women’s Hospital (BWH) met to discuss study populations we have in common. We identified our extended stay sleep and circadian population to be uniquely challenging from a nursing care perspective. In the process of identifying the research participant’s unique needs, we conducted an extensive literature review, but found no studies or nursing literature that addressed the nursing care needs of this research population. As a result of this gap, it is imperative that the needs be identified and the role of nursing be articulated in this population. Method: The nurses from the BIDMC and BWH met to discuss common nursing problems and interventions that would improve the care of these healthy volunteers. In the process, we worked together to develop a nursing care plan that highlights the common issues of concern for healthy control extended stay sleep and circadian research volunteers. Results: We discovered a high potential for unmet needs that had not previously been identified or documented in this research population. This highlighted a need for nursing education and improved documentation. Conclusion: We created a standardized nursing care plan that can be used in these 2 HCTSA facilities. If successful, this care plan will improve nursing assessments and documentation and help to assure best clinical practices and quality for this unique study population.

Abstract 16 -‐ Podium Evolving CRN Roles in a Dynamic Research Enterprise: A Framework for Advocacy and Vigilance to Preserve Quality and Ethics Carolynn Thomas Jones, BS, BSN, MSPH, RN University of Alabama at Birmingham


Clinical research nurses (CRNs) are at a pivotal juncture in their professionalization. Publications on the varied roles of CRNs have increased in the last two decades. The definition of, and domain of practice for CRNs has been defined and accepted by members of the International Association of Clinical Research (IACRN) and scopes and standards of practice for CRNs are evolving through IACRN. An overarching objective of the CRN role is to narrow three potential quality and ethics gap points (pre-‐trial, during the trial and site to site benchmarking) to best assure quality data, GCP adherence and study participant protections. Advocacy and vigilance are key nursing themes contributing to such CRN role performance. Moreover, a backdrop of evolving new trends in the clinical trial enterprise pose additional role challenges for CRNs working as professional members of interdisciplinary teams. Role tensions can compromise issues in quality and ethics. Despite a general acceptance of the domain of practice activities of CRNs, results from a recent survey suggest that there may remain conflict among CRNs themselves about the performance of many of the defined activities. By informing education and training needs, and the generation of additional research on the CRN roles, nurses can improve role efficacy and assure the growth and acceptance of the profession. Recent meetings among professional research associations are beginning to embrace harmonization of clinical research competencies and the alignment of roles and job classifications to better address education and certification based on levels. CRN involvement in those discussions will give voice to CRN professionals. Finally, establishing a nursing concept framework for clinical research nurses provides a necessary nursing platform for describing and supporting CRN roles in the current environment. This presentation will review results of a survey of CRN perceptions of role performance and highlight new trends in the clinical research enterprise that will inform the scope of CRN contributions. A proposed nursing framework for CRN role levels will be presented. (321 words)

Abstract 17 -‐ Podium Research Nurse Manager Perceptions of Study Performance of Non-‐Nurse, Non-‐Licensed Clinical Research Coordinators Carolynn Thomas Jones, BS, BSN, MSPH, RN University of Alabama at Birmingham Despite increasing literature on the role of nurses in clinical research coordination and management, many references fail to differentiate between nurse and non-‐nurse roles that may be working in the same realm. A review of role descriptions and delegation of activities have revealed violations in scopes in practice. Coordinator perceptions of the frequency of non-‐nurse study coordinator activities that are unsupervised, particularly those activities that are clinical in nature, exceed the rate that nurse coordinators deem appropriate. There exists a need for further research on issues in the delegation of clinical research activities, especially those that could pose potential violations of scope in practice, jeopardize safety of study participants and impair the quality of study data and results. A focus group study using the nominal group process (NGP) with experienced clinical research managers (RNMs) was conducted to assess perceived issues in non-‐nurse, non-‐licensed clinical research coordinators. The research question explored how experienced RNMs at the University of Alabama at Birmingham (UAB), using their combined experiences as NCRCs, perceive are key job performance issues of NNCRC activities, through a two-‐stage focus group discussion using NGP. The primary objectives of this study were to use the nominal group process to (1) identify a final ranked list of issues that could lead to gaps in quality, safety and scope of practice for NNCRCs serving in clinical research roles, and (2) develop suggested policies to mitigate gaps in quality, safety and scope of practice. Secondary objectives will be to describe the process and utility documenting of the NGP in a RNM focus group setting including: (a) demographic description of RNM study participants, (b) evolution of lists of issues generated during the NGP, (c)


discussion points of issues, (d) vignettes illustrating key issues and (e) a ranking of key issues. Descriptive and qualitative data will be presented.

Abstract 18 -‐ Poster The Future of Research Data Capture: Electronic Handheld Documentation to Support Nursing Practice Laura Goergen, RN BSN, Courtney Flynn BS, RN; Mary Larkin MS, RN, CDE Massachusetts General Hospital Diabetes Research Center Massachusetts General Hospital Diabetes Research Center The objective of this project was to change the electronic documentation process used by research nurses to improve continuity of care, team communication, and protocol adherence. In a six day study focusing on safety and efficacy of an experimental bionic pancreas, nurses monitored subjects around the clock and one-‐on-‐one in a simulated home environment and within a three mile area in downtown Boston. An iPhone to contact on-‐call providers and an iPad mini to document data and nursing interventions were utilized. Nurses were initially excited about the use of the iPad to record data, as electronic documenting affords access to information that is essential to guide nursing care. Access to nursing notes is critical in research studies where nurses are ensuring subject safety and adherence to protocol, particularly in this study’s unique and autonomous practice setting outside the hospital walls. However, the electronic logs initially in use were limited to the current day’s data only and were unwieldy to manage. The cohesive teamwork and innovative thinking of the five study nurses invoked a thorough evaluation of possible alternative models for documentation to better support their daily responsibilities. They reviewed other tools, designed study-‐specific logs, and trialed a new system over a period of three weeks. The newly selected tool enabled them to review all necessary data when needed and was easier to use as it reduced scrolling and the number of clicks needed to enter data from five to two. The nurses transitioned to documenting solely on the iPhone, which enabled more mobile, hand-‐held documenting in the field and reduced study costs by eliminating the need for the iPad. The tool brought numerous other benefits, such as automating the previous task of transcribing each datum entered from logs to spreadsheets, thereby increasing efficiency, eliminating transcription errors, and promoting accuracy. Data also became more robust as the logs prompted additional entries around nursing interventions. The new documentation tool overall improved the research nurses’ professional practice environment by ensuring access to information that promoted continuity of care as well as guided research practice and supported flexibility in the field.

Abstract 19 -‐ Poster Evolution of Best Practice Group Catherine Griffith, R.N., ACNP-‐BC, PhD(c), Sharon Maginnis, R.N., BSN Massachusetts General Hospital Massachusetts General Hospital Background: The CTSA Best Practice Committee was started 5 years ago in an effort to standardize nursing practices across five Harvard Catalyst Boston Hospitals. Representative staff nurses with clinical expertise and experience began meeting in October of 2008 to identify and share clinical research nursing guidelines and experiences. Aim: The purpose of this poster is to describe the evolution of the Best Practice Group. Method: One to two staff nurses from five Harvard Catalyst hospitals met monthly,


rotating hospital meeting sites, providing the opportunity to look at different working environments. The agenda initially was developed around research skills and techniques and matured to a best nursing practice for all to use. Results: In the beginning of the committee’s existence, the focus of the meetings was establishing consistency and standardization of technical research procedures. Overtime, it became apparent that most procedures were dictated by institutional policy. The group began to reframe the description of nurse’s work as best practice guidelines and principles. Documents were developed such as the RN role in the consent process, protocol development, implementation of an orientation manual, and identifying technology as a method of communicating and housing documents. Discussion: In reflection, the original intent of the committee was ambitious. The committee did not take into account the dynamics of committee members from different hospitals. As the committee worked together, we developed trust, honesty, and a commitment to work together and become the best nursing practice representing five Harvard Catalyst Boston Hospitals.

Abstract 20 -‐ Poster Clinical Research Nurses Team Up With Principle Investigators to Enhance the Research Process: A Relationship-‐Based Model of Clinical Research Care Abigail Thomas, BS, RN, Karen Hoary-‐Rockefeller University, Lisa Tsatsas-‐ Rockefeller University The Rockefeller University The clinical research setting is an environment that brings the healthcare team and the research design together to ultimately benefit science and mankind. The process is exciting, and the Clinical Research Nurses at Rockefeller University Hospital are not only helping to facilitate this bond, but are working to expand and improve it. Clinical Research Nurses provide specialized support to Clinical Investigators. They are experts in providing ongoing informed consent assessments. Their priority is to ensure that protection of human subjects is being adhered to throughout the implementation of the protocol. Due to the increasing complexity of protocol development, a relationship based model of clinical research care was developed. In the spring of 2013, the nurses at Rockefeller’s Outpatient Research Center, along with the guidance and oversight of their Director of Nursing and Clinical Operations Manager developed this new model to elevate the nurses’ role in protocol development, execution, and management. This model will ultimately enhance the subject's experience of participating in a research study. This would be a patient centered model of care that would guide the role of the modern Clinical Research Nurse. The ingredients to the formula were created; care teams. Each nurse would be assigned to specific protocols based on prior nursing experience and interest for a specific study. Care teams would be formulated consisting of the Principal Investigator, Research Coordinator, Nurse Practitioner, the Clinical Research Nurse, and Nursing Assistant. Nurses would serve as the Principal Investigator’s resource person for any information regarding protocol startup, execution, management, and feedback. Each nurse would be tasked with overseeing their assigned studies from inception to execution and beyond to ensure safe and efficient implementation. This model would allow nurses to be an integral part of the research process. The nurses would attend protocol development meetings and follow assigned protocols closely for any study amendments, deviations, and study design revisions with the continued maintenance of human subject protection. This would be the perfect solution to join the nursing care model with the research team to create an enhanced experience for the subject and greater protocol efficiency and accuracy.


Abstract 21 -‐ Poster Analyzing required vs. actual number of venipuncture attempts for research studies conducted at a clinical research center. Carrie Romig, BSN, RN, Holly Bookless, BSN, RN, BC, NM CRC David Phillips, MGS, Administrative Manager, CRC Carson Reider, PhD, RSA, CRC FYI: Carrie's membership is in process and she plans to register once July budget is approved through the medical center. (She and I (Holly Bookless)will be attending.) Center for Clinical and Translational Science at The Ohio State University Wexner Medical Center This ongoing quality improvement project investigates the actual number of venipuncture attempts vs. the minimum number of venipuctures required. This project allows the opportunity to identify factors that may be able to reduce the number of venipunctures performed to obtain the required numbers of blood samples for a variety of clinical research protocols. The nursing team at The Center for Clinical and Translational Science’s Clinical Research Center at The Ohio State University Wexner Medical Center documented venipuctures that were performed as well as noted if assistive devices (i.e., heating pad, Accuvein) were used and characteristics of the participants’ veins of the various studies. To validate the collected data we compared the number of required sticks (intravenous or butterfly) for the protocol with the number of actual sticks performed. The total number of required sticks over the first month of assessment came to 113 compared to the total number of actual sticks, which were 128. This led to 15 extra venipuncture attempts throughout the month; 13% more than the minimum number of sticks required. The assistive devices were used to aid with the second attempt or extra stick. The Accuvein was used to assist with 3 venipuncture attempts and the heating pad was used for 27 venipuncture attempts. The use of these devices should be considered during first venipuncture attempts to reduce the extra number of sticks. Acknowledgment: Research reported in this publication was supported by the National Center For Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR000090. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Abstract 22 -‐ Podium The Development of an Open Registry Protocol Jennifer Hall, RN, MSN Cincinnati Children's Hospital Medical Center Background: The Colorectal Center at Cincinnati Children’s Hospital performs numerous retrospective chart reviews in order to analyze outcomes and improve future treatment. With charts dating back 20 years, and encompassing over 3,000 patients, it is highly unlikely to have updated contact information in order to obtain consent. Therefore, each time a new study protocol is written, a waiver of consent is requested stating the aforementioned issue. Although these protocols have been approved by the IRB, the Colorectal Center has strived to improve their research standards and take a proactive approach to chart review research by developing an Open Registry. Methods: An Open Registry protocol was developed and approved by the IRB (#2011-‐2385). The Open Registry allows all patients seeking treatment at the Colorectal Center the opportunity to consent to three items: 1) consent to use their clinical data for research purposes, 2) consent to use tissues removed during surgery for research purposes, and 3) consent to contact them in the future for research purposes. Patients seen prior to the approval of the


Open Registry would have a waiver of consent so their data could still be utilized. The consent form is reviewed with new patients presenting to clinic by a member of the research team. At this time patients can decide whether or not they would like to enroll. The target enrollment is 75% of all colorectal patients. Results: A review of the Screening/Enrollment Log over the past 3 months (February 2013 – April 2013) showed that 173 (81%) of the 213 eligible colorectal patients enrolled in the Open Registry. Discussion: The implementation of the Open Registry protocol has been a long process requiring collaboration from many individuals. It has been successfully running since November 2011 and it has improved the quality of research practices in the Colorectal Center by allowing patients to learn about the research being conducted in the Center and have the opportunity to make an informed decision about whether or not they want their clinical data to be utilized.

Abstract 23 – Podium & Poster Implementing Emergency Scenario Training and Assessment in a Clinical Research Facility. Lisa Berry, RGN, Dip NSc (Adult), Co Author: Caroline Grabau, NIHR Wellcome Trust Southampton Clinical Research Facility, UK Acknowledgement: Jennier Allison, NIHR Wellcome Trust Southampton Clinical Research Facility, UK NIHR Wellcome Trust Southampton Clinical Research Facility, UK The Medicines and Healthcare Products Regulatory Agency (MHRA) expect that Clinical Research Facilities conducting Phase 1 studies in the United Kingdom, ensure that staff are trained to manage medical emergencies and for periodic testing of emergency scenarios to occur (MHRA, 2012). The NIHR Wellcome Trust Southampton Clinical Research Facility (NIHRWTCRF) has been utilising a nurse led structured emergency scenario training and assessment programme since January 2008. This has been developed to enhance resuscitation training, increase participant safety and enable staff to confidently initiate CPR, administer emergency drugs and use the defibrillator in a safe and controlled environment. To enhance fidelity and quality, clinical simulators are used in all resuscitation training within the NIHRWTCRF. SimMan® and Simbaby® are instructor controlled, full body manikins that allow the simulation of basic and advanced life support skills and assessment. A wide range of conditions and complications can be simulated and verbal response is relayed via hidden speakers. Drugs can be delivered intravenously, subcutaneous & intramuscularly and SimMan enables practitioners to intubate and defibrillate. Scenarios are filmed and stored using SimMan® software which provides detailed feedback regarding timing and effectiveness of interventions. The simulation equipment also enables analysis of the written observation logs against the filmed evidence and the software report. Since implementing these standards the following has been observed: • 100% compliance and pass rate for Basic and Intermediate Life Support training (RCUK, 2010). • Emergency scenario testing occurs 10-‐12 times per year. • Scenarios are attended by paediatric and adult nurses. • All scenarios reflect clinical emergencies that may occur in the NIHRWTCRF. • Attendance, training logs and scenario reports are completed and distributed to all clinical staff. • Staff report more confidence in their ability to detect and manage medical emergencies. • Enhanced links with critical care, resuscitation and clinical skills departments have contributed to effective collaborative working. This programme is constantly under review to effectively meet the needs of the NIHRWTCRF and to gain formal Phase I Accreditation by MHRA. Future plans include the development of a feedback tool to evaluate staff confidence in managing clinical emergencies. (References: Medicines and Healthcare Products Regulatory Agency (2012). Good Clincial Practice Guide. London. Resuscitation Council UK (2010) Resuscitation Guidelines 2010.London.)


Abstract 25 -‐ Podium Taking it to the Streets: Best practices in a simulated home-‐environment study Courtney Balliro, RN, Kerry Grennan, RN, ANP-‐BC, CDE Laura Grace Goergen, BSN, RN Mary E. Larkin, MS, RN, CDE Massachusetts General Hospital The expanded role of technology has changed the landscape of clinical research. In a study of a bionic pancreas, it framed a new practice setting outside the hospital walls for the research nurse team. Study participants wore a bionic pancreas for six days while staying at a hotel in close proximity to the research center. Nurses monitored participant safety and function of the experimental device as they shadowed participants one on one around the clock within a three mile radius of downtown Boston. Challenges faced by the team included having access to necessary supplies at all times, convenient documentation methods, and ensuring sufficient privacy for participants. Nurses carried supplies in a backpack (equipment for blood glucose testing and treatment, sharps safety, IVs, pump catheters and other related materials). The planned documentation process on a portable device proved cumbersome prompting the nursing team to develop forms in an iPhone application for easy access while navigating the city. One of the most challenging yet important issues confronted by the nurses was maintaining participant privacy. Participants consented to continuous chaperoning as part of the protocol, but the nurse was charged with monitoring them closely without being intrusive. This created a delicate balance between supervision and independence requiring sensitivity to the individual participant’s routine, privacy needs and level of comfort with this ongoing and constant monitoring. The nursing team responded to the challenges of this practice setting by developing patient education materials, organizing team communication meetings, and initiating a new method of documentation. Their flexibility, creativity and preparedness along with sensitivity to each participant’s daily routines demonstrated a high level of team responsiveness in this autonomous practice setting. The research nurses successfully transferred their expertise from within the research center to the streets of a major metropolis. Sharing best practices and lessons learned from this experience may provide a model for nursing care in other studies.

Abstract 26 -‐ Poster Establishing a Protocol Review and Evaluation Process (PREP) for New Studies to Promote Efficient Study Start Up Raquel Bunge, BSN, RN, CCRC, Pauline Todd, RN, MBA Patricia Mendoza, RN, CCRA LaShawna Green, RN, CCRC Jane Joseph, CCRC All affiliated with the Methodist DeBakey Heart and Vascular Center. The Methodist DeBakey Heart and Vascular Center Our research center has adapted a new process for study start-‐up based on process improvement, quality improvement, and lean six sigma principles (continuous quality improvement, i.e. Plan-‐Do-‐Check-‐Act). The establishment of the PREP -‐ Protocol review and evaluation process was put in place in 2013. “PREP” involves presentation of the study logistics to a clinical trial oversight committee made up of experienced interdisciplinary research staff (nurses, clinical trial managers, clinical trial director, financial analysts, and quality assurance). Research Coordinators are expected to present the following to the PREP team: Regulatory Submission & Essential Documents; Data Collection & Management plan; Subject Management; In-‐service materials or any type of information that provides an example of the coordinator’s efforts for study start and will orient other healthcare providers and ancillary support to


provide safe care to research subjects; Site Initiation/ Study Kick-‐Off. The study review/management team will be looking for the coordinators to essentially walk us through a mock research subject from site entry to exit for each study visit and present all facets of the visit including how each will be managed from the coordinators perspective. To prepare, the study coordinator has established communication plans with applicable members of the trial: financial, regulatory, clinical, and research. Following the presentation the PREP team will complete an initial assessment of presentation; address weaknesses and/or issues with the coordinator/team in a collegial & collaborative manner; develop a corrective action plan to address any issues identified to support the trial’s objectives and team focus on safety and protocol compliance. Our goal is to have the coordinator present their strategy for study coordination and have the ability to work together to help launch a new study. The study review/management team will serve as a resource for the study coordinator with regards to study management and help to facilitate study success at The Methodist DeBakey Heart and Vascular Center. This activity results in continuous quality improvement and education for all members of the PREP team.

Abstract 28 -‐ Podium Research Activities that Contribute to Nursing Workload and Staffing in a Clinical Research Setting Deborah Kolakowski, RN, DNP National Institutes of Health Clinical Center Background In 2007, Nursing and Patient Care Services at the National Institutes of Health Clinical Center embarked on an initiative to define the specialty practice of Clinical Research Nursing (CRN 2010). This initiative resulted in the selection and implementation of a patient classification system to measure productivity and provide benchmarking data in a clinical research setting.. Clinical research nurses questioned whether the nursing workload captured the added demands of the patient’s interaction with the research process as well as the clinical care provided. Objective The purpose of the study was to determine the feasibility of using a patient classification instrument to quantify nursing workload measures in a clinical research setting and to identify classification, procedure and user defined indicators that described the research requirement of care. Methods A non-‐experimental, descriptive study conducted at the National Institute of Health Clinical Center was used to validate the feasibility of using a patient classification instrument on a medical oncology and a medical surgical specialty unit. Descriptive statistics were utilized to describe workload measures of acuity, complexity; hours per patient day (HPPD), inter-‐rater reliability and indicator selection to distinguish research care needs. Results Acuity was a strong indicator of the types of research studies conducted on each unit. The research acuity on the medical oncology unit (M=1.41) was higher than the medical surgical specialties unit (M=0.86). The mean recommended HPPD to support the research requirements of care in medical oncology were 9.3 hours of care representing 78% of all hours required. The medical surgical specialty unit mean HPPD were 5.9 hours for the research care requirements representing 83% of all hours required. Research protocol and procedural requirements on the medical surgical specialty unit required an additional 6.5 hours of care daily. Inter-‐rater reliability scores were greater than 92% for acuity type agreement and 95% for indicator agreement. Conclusion This study demonstrates the feasibility of utilizing a patient classification instrument to quantify nursing workload measures to distinguish clinical care from the research requirements of care.


Abstract 29 -‐ Poster Establishment of the Acknowledged Specialist Position for Clinical Research Nurses Certificate at the Research Hospital of The Institute of Medical Science, The University of Tokyo, Japan Noriko Fujiwara, RN, MHSc, OCNS, CCRP, Mika Kogayu RN, PNIPC Tomoko Sato, RN Toshiko Chino RN Hiroko Sato, RN, CNA, MSc Yukie Takemura, RN, CNA, PhD Department of nursing in Research Hospital, The Institute of Medical Science, The University of Tokyo, Japan Division of Clinical Trial Safety Management and Division of Nursing, Research Hospital, the Institute of Medical Science, The University of Tokyo Background Promoting a team approach is the key for successful clinical trials. At our research institution, great attention has been given to clinical research nurses (CRNs). However, most clinical nurses have few opportunities to learn about clinical trials and are unfamiliar with the CRN role in Japan. The Japanese Nursing Association has developed a certification system to authorize nurses with advanced skills and special nursing knowledge. However, there is no program currently in place for CRN certification. The hospital of the Institute of the Medical Science, the University of Tokyo (IMSUT) aims at translating cutting-‐edge research results into clinical practice and promoting the progress of medical science. The Department of Nursing at our research hospital provides high-‐quality nursing care in conducting appropriate clinical trials. We provide many education courses, including those in the clinical research field. Validation of CRN as an Acknowledged Specialist Position is fundamental to high-‐quality research. Purpose The Department of Nursing at IMSUT Hospital has created the Acknowledged Specialist position for CRN certificate. Methods Nurse managers, directors and specialist nurses in each field at the Department of Nursing at our institution agreed upon a program for educating and certifying CRNs. Results Candidates for the Acknowledged CRN specialist position with CRN certification have to pass a test administered by the certification commission in the Department of Nursing. They should receive recommendation from their nurse managers. Completion of CRN education training and performance of CRN activities within and outside our hospital is required. The CRN educational training program participants can attend educational lectures for CRNs at our hospital or seminars administered by Clinical Research Coordinators outside our hospital. They can gain on-‐the-‐job training under clinical research professionals. The evaluation and dissemination of this program is an ongoing objective. Conclusions CRNs are clinical staff nurses who focus on care of research participants, provide high-‐quality nursing care, and contribute to high-‐quality research. The Department of Nursing at our institution created the Acknowledged Specialist Position for CRN certification. Candidates for this position are required to attend lecture courses, gain on-‐the-‐job training, and pass a certification test to become acknowledged CRNs.

Abstract 31 -‐ Poster Clinical Research Nursing and Pediatric Psychiatry: Diane Lawrence, RN, MSN, PNP, Bruce Steakley, RN, BSN Nurse Manager, 1SW & OP4 Acting Nurse Manager, 7SE Pediatric & Adult Inpatient Behavioral Health Ambulatory Care Behavioral Health Clinic Bldg. 10, Rm. 1-‐3637 10 Center Drive Bethesda, MD 20892 [email protected] 301-‐451-‐1517 Lieutenant Commander Reggi Parker, RN, BSN United States Public Health Service 1SW Pediatric Behavioral Health 10 Center Drive Bethesda MD 20892 [email protected] 301-‐451-‐1515 National Institutes of Health


Abstract: Improving the practice of pediatric psychiatric nursing on a clinical research unit involves interactions that prioritize patient needs as well as ensuring reliable and consistent data collection. Severe Attention Deficit Hyperactive Disorder, intense irritability, and anxiety are the hallmark symptoms of pediatric patients enrolled in a protocol studying Severe Mood Dysregulation on this inpatient unit. During the complicated medication washouts and double blind placebo controlled phases of research the patient is supported by the Clinical Research Nurse in dual research and clinical roles. These psychiatric Clinical Research Nurses are highly skilled at recognizing the patient’s needs and capacity and respond with effective behavioral accommodations. This results in less intense expressions of irritability within this controlled environment. Inpatients and day treatment patients enrolled in this protocol are rated weekly by nurses who collect data several times a day using the Direct Observation Form and the Overt Aggression Scale. A series of 4 training modules involving in-‐services and discussion on the topics of irritability, outbursts, sadness, anxiety, fear, worry, elevated mood and hyperarousal symptoms as well as identifying the supports and accommodations related to these symptoms were attended over the course of a year resulting in improvement of nurse assessment and interrater reliability. Through the process of improving the overall nurse interrater reliability, clinical practice was elevated by focusing attention on observations of behavior and identifying effective interventions. The outcome has been the near elimination of seclusion, restraint, and physical holds by staff as well as a decreased need of patients to respond with aggression.

Abstract 33 -‐ Podium The Research Nurse Advancement Program -‐ What We Have Learned Eileen Beckman, RN, BSN, CCRC, Julie Denlinger, RN, BSN Cincinnati Children's Hospital Medical Center Sarah McCarthney, RN, BSN, CCRC, CPN Cincinnati Children's Hospital Medical Center Dana L. Raab, RN, BSN, MS Cincinnati Children's Hospital Medical Center Cincinncati Children's Hospital Medical Center The Research Nurse Forum (RNF) at Cincinnati Children’s Hospital Medical Center is comprised of all of the 90 research nurses working at the institution across 25 different divisions/departments. Recognizing that recruiting and retaining expert research nurses is essential to quality and ethics in clinical research, in mid-‐2010, the RNF developed specific research nurse performance and advancement standards including position descriptions (current performance and advancement standards were based on clinical nurse descriptions). With the support of human resources, patient services, and the research foundation, a subcommittee of research nurses was created to develop performance and advancement standards applicable to research nurses. As a result of a year and a half of work by the subcommittee, research nurse performance standards, position descriptions, and advancement documents now accurately reflect the roles and responsibilities of the research nurses. The new Research Nurse Advancement Program with an ad-‐hoc advancement committee was successfully launched July 1, 2011. Research nurse electronic advancement materials are readily available on-‐line with a step-‐by-‐step guide to clarify and ease the submission process. To date, the research nurse advancement committee, led by the clinic research nurse leader has reviewed 18 advancement packets with 11 approvals and 7 deferrals. As the program matures with a noted 61% success rate for advancement, the committee is currently reviewing the advancement process with the hope of identifying improvements to both streamline the process and increase success rate to help promote career development, satisfaction, and retention of expert research nurses. Initial review indicates revisions such as creating a preliminary check list and a recommended timeline for the advancement process, mentoring guidelines and requirements, and developing concrete criteria for job specific standards for each level will help with these goals. The committee is also reviewing reasons why applicant’s packets were deferred. Necessary revisions will be made to the


process over the next 3-‐6 months. The lessons learned and ensuing development of performance and advancement materials has allowed us to differentiate the role of the research nurse from novice to expert across the institution and could similarly be shared outside our institution.

Abstract 34 -‐ Podium Developing a taxonomic approach to competency development for researchers Jayne Hardicre, RN, BSc, MSc, PGDip Salford Royal NHS Foundation Trust Research as a career option for nurses and allied health professionals is gaining popularity as valid career option with longevity. In the UK it is anticipated that the clinical research nurse workforce will be about 10,000 (Pidd, 2011) and is set to increase year upon year. The development and retention of highly skilled research nurses is crucial to the success of research teams and institutions and requires investment in both time and resources. Highly skilled researchers are priceless to any team and organisation as they play a key role in the delivery and management of high quality research (UKCRC, 2007) and as such they should be nurtured from the very start of their career. In addition to this a structured approach to career progression is also of high importance. This paper describes the development of competency based development programme for the research community of a large hospital Trust in the United Kingdom. A learning needs analysis was undertaken across the research community of 135 research nurses and assistants. This provided the framework and intelligence to underpin a structured educational programme spanning the whole research process from idea generation to results dissemination. Individual development is guided by the use of a ‘research competency development toolkit’. This uses a 5 point taxonomic approach to competency level progression. The needs analysis also identified the need for additional support among the research community. This paper will also discuss the development of a ‘buddy model’ to provide an extra layer of informal support to researchers and will explore the implementation of this peer support model following extensive consultation and engagement throughout the community. This paper will be of interest to researchers, managers and educationalists. Pidd, H (2011) Maximising the Nursing Contribution to the UK Clinical Research Agenda. Version 2. (Internet). Available from: http://bit.ly/100PxBI. Date accessed 1st June 2013 UK Clinical Research Collaboration (2007) Developing the best research professionals Qualified graduate nurses: recommendations for preparingand supporting clinical academic nurses of the future. (Internet). Available from: http://www.ukcrc.org/publications/reports/ Date accessed 9th June 2013

Abstract 35 -‐ Podium My brother's keeper past present and future in ethics and clinical trials Yehudit Chenzion, BSN MPA RAMBAM MEDICAL CENTER The main ethical concern associated with clinical research is the possibility of participant exploitation. To plan future ethical goals and shape the unique role of research nurses, it is essential to know the past, understand the development of bioethics and then evaluate where we stand today. Human beings have been conducting clinical trials since before the dawn of civilization, starting from the Old Testament through ancient Greek, Roman, and Arab medical works, up to the 12th-‐ 13th Centuries A.D. when the


first ethical codes regarding human experimentation were written. In the pre-‐World War II era, most researchers performed clinical experiments using either themselves or their patients as test subjects. D.J. Rothman describes World War II as the "transforming event" in the conduct of clinical trials. Out of this horror came formalized ethical rules -‐ the Nuremberg Code.Over the years International community's have responded to scandals, by developing guidelines to prevent their recurrence [Helsinki (1964), Institutional Review Board (IRB), National Commission for Protection of Human Subjects (1973), the Belmont Report (1979)]. Despite this, abuse of human participants in clinical trials continued in many countries. Professional codes, laws, regulations, and ethics committees can provide guidance but the final determinant of how research is performed, rests with the research team's value system and moral code. Nowadays, clinical research has become diverse, involving academic institutions, pharmaceutical companies, and research organizations.This introduces the potential for different kinds of benefits and thus different moral concerns which may be less evident but are equally important. These are part of the challenges that nurse study coordinators face. The nature of nursing which focuses on caring, preventing harm and protecting dignity together with the advocate role of nurses which calls for defending the rights of patients, places us at the heart of ethical dilemmas of clinical trials. Research nurses have the commitment and capabilities to play an active role in shaping the future of medicine. Cain's words symbolized people's unwillingness to accept responsibility for the welfare of their brothers. History has proven that keepers are essential. Research nurses can and should be our brothers' keepers

Abstract 37 -‐ Podium Restructuring an Academic Trial Center – Our Experience at The Methodist DeBakey Heart & Vascular Center Pauline Todd, RN, BSN, MBA, Raquel R. Bunge, RN, BSN, CCRC (Submitting author) -‐ IACRN Member -‐ The Methodist DeBakey Heart and Vascular Center, Houston, TX The Methodist DeBakey Heart and Vascular Center Named after heart surgery pioneer Dr. Michael DeBakey, the Methodist DeBakey Heart & Vascular Center (MDHVC) is committed to providing patients with the highest quality care today and fostering a brighter tomorrow through research and innovation. Toward these goals, under new nursing research leadership, a new clinical trial management process has been implemented at MDHVC. Restructuring targeted three key areas of study management: pre-‐study start-‐up, study conduct and study close-‐out. Programs were divided into three functional areas, with a clinical trials manager and medical leader for each overseeing the studies and resources while managing competing program-‐related priorities. For each area, key components were identified as critical to the success of the clinical program. The first component of the process focused on study start-‐up and included feasibility assessment, budget preparation and negotiation ensuring compliance with applicable regulations, and a PREPP process to ensure coordinator readiness in terms of protocol comprehension and logistics. An established research executive review committee was resurrected to help review study feasibility and resource management. The intent was to ensure successful implementation of studies given current resources and management of competing priorities. The second component targeted study conduct, with focus on coordinator recruitment and performance, data management/GCP and financial management to keep revenue and expense matched relative to timing and study progress. A quality manager helped provide oversight on an ad hoc basis with periodic review of regulatory and subject binders. Also, we established a clinical trials management team consisting of Clinical Trials Managers and the MDHVC Research Director, setting performance goals for our research nurses and coordinators, regulatory specialists, and financial analysts. These measurable indicators could then be used to assess study goals and quality indicators. Department goals were aligned to institutional pillars to ensure that our work successfully facilitated the overall goals of the institution


and the mission of MDHVC. Lastly, we implemented a study close-‐out process that focused on study close-‐out procedures from the sponsor and institutional perspectives. The study team met to review lessons learned concerning trial conduct. Finance focused on final invoicing and close-‐out procedures to ensure financial and study status reconciliation.

Abstract 38 -‐ Podium The Role of the Clinical Research Nurse: an evaluation of the core elements of the clinical research role in a district general hospital in the UK Lisa Hyatt, BSc (Hons), MSc, Emma Munro, Trust Lead Research Nurse, Portsmouth Hospitals NHS Trust Portsmouth Hospitals NHS Trust Background: The role of the Clinical Research Nurse (CRN) in the United Kingdom (UK) has evolved over the last decade. There has been a shift away from being simply a data collector (Green, 2011), to a role that is varied, challenging and encompassing a wide range of skills (Watmough et al, 2010). However, existing evidence to support the daily role of the CRN is largely descriptive and anecdotal. Therefore, an empirical evaluation of the activities of CRNs across clinical specialties was performed to identify the core elements of the daily role. Methods: For this evaluation, a novel data collection tool was collaboratively designed to capture all core elements of the daily role of CRNs. Two periods of data collection took place over a week in November 2010 and in March 2013. Results: Locally, CRNs are actively involved in all stages of the clinical trial process. CRNs spent the largest proportion of time performing clinical trial activities that involved direct contact with a patient at both the 2010 and 2013 data collection points (44.09% and 52.82% respectively). These activities included identifying patient cohorts, screening, consent, trial assessments, data collection, follow-‐ups and patient education. CRNs also spent a good proportion of time performing lab and office based tasks directly related to clinical trials (29.27% and 22.70% respectively) and general administrative tasks (20.47% and 20.33% respectively). Discussion: This empirical evaluation has provided vital data to begin to benchmark the CRN role. The results support the anecdotal and descriptive evidence for the CRN role being varied and encompassing a wide range of skills. The results have also provided confirmation that the CRN role is mainly patient-‐facing. CRNs are managing a large caseload of patients and their potential impact on the patient journey is evident. However, further evaluation is required to establish the burden of follow-‐up, and the average size of caseload per CRN. References: •Green, L. (2011) Explaining the role of the nurse in clinical trials. Nursing Standard 25 (22): pp35-‐39. •Watmough, S., Flynn, M., Wright, A., Fry, K. (2010) Research Nurse or Nurse Researcher? British Journal of Cardiac Nursing 5 (8): pp396-‐399.

Abstract 39 -‐ Poster Navigating Research Participants Through The Clinical Trial Enrollment Process; Development Of A Toolbox With Nursing Practice Tools For Clinical Research Nurses. Brian Beardslee, RN, MSN The Dana Farber Cancer Institute Background/Significance: Clinical research nurses (CRNs) working in an outpatient, academic ambulatory cancer centers screen and enroll patients into complex clinical studies. These CRNS provide care to research participants along with specific activities: supporting protocol implementation, data collection, and human subject protection. This role is delineated through the clinical research nursing


practice domain encompassed in 5 dimensions including care, coordination, and continuity, study management, clinical practice, human subject protection, and contributing to science. Protocols contain specific guidelines that include eligibility requirements, detailed treatment regimens, patient evaluations, and data collection schedules. An organizational tool box to organize and direct the collection of research participant study requirements may be useful to CRNs. Practice Solution: Development of a nursing toolbox comprising a series of nursing practice tools contain the 5 dimensions described within the practice of clinical research nursing. These tools assist the CRN to navigate research participants through the clinical trial screening and enrollment process using a systematic organized approach that facilitates protocol compliance and patient safety. Nursing Implications: Nursing practice tools organize the CRNs and research participant’s timeline from screening to the study start date and are adaptable across clinical settings. These tools support study accuracy, safety, timeliness, and decrease stress for research participants and the research study team. Nursing practice tools can reduce study violations thereby maintaining protocol compliance supporting foundational principles for the protection of human research subjects and good clinical practice. Conclusion: Use of these nursing practice tools provides the CRN with a systematic approach adaptable across research settings that will maximize accuracy, timeliness, and safety of participant’s enrolling in clinical research trials.

Abstract 42 -‐ Podium Clinical Trials.gov: what it means to you Penelope Jester, MPH, BSN, RN University of Alabama in Birmingham This presentation will focus on the regulatory requirements of ClinicalTrials.gov registration and results reporting, and will describe how these regulations may impact the research nurse and research nurse coordinator. The presentation will review the federal regulations and requirements of ClnicalTrials.gov. Basic review of the database system and how to use the database system will be provided. Best practices will describe how the RN and RNC might contribute to ClinicalTrials.gov results reporting and registration. The presentation will highlight common problems in registration and reporting, and how these might be avoided. Additionally, suggestions will provided on how to minimize problems related to use of Clinicaltrials.gov reporting. If a research nurse or research nurse coordinator is involved in the development of a protocol, guidance will be offered on ways to assure that ClinicalTrials.gov registration and results reporting can be easily managed.

Abstract 43 -‐ Podium The Clinical Research Nurse Coordinator role and its recognition at The Hospital for Sick Children, Toronto Eveline Lapidus-‐Krol, RN, BScN, MSc Hospital for Sick Children, Canada, Toronto Background: Clinical specialized expertise of Registered Nurses has broadened and increased significantly in the past few decades including nursing careers in clinical research with growing emphasis on utilizing evidence best practice to improve patient care. Although there are published guidelines about the CRNC role responsibilities, little is known about the reality of the role. Objective: To describe the CRNC role and its responsibilities as applied to pediatrics; compare to CRNS role by classifying main


functions the CRNC is engaged in and assessing day-‐to-‐day challenges. Outcomes: The CRNC integrates knowledge and skills in clinical research coordination, project management and information technology with in-‐depth nursing knowledge and clinical expertise related to the study population planning, managing, and evaluating the overall research program, in collaboration with the Principal Investigator. The CRNC is engaged in several aspects of clinical research coordination: Clinical Practice, Study Management, Care Coordination and Continuity, Human Subjects Protection acting as a liaison across multidisciplinary professions and taking roles of leadership, education and knowledge translation. Daily activities focus on care of research participants by advocating for patients and families ensuring that their care meets their individual needs and the study requirements; study coordination, and maintenance of data management and integrity, with central focus on managing subject recruitment and enrollment, consistency of study implementation and compliance with regulatory requirements and reporting. Five major challenges to success in the CRNC role were identified: (1) Obtaining truly informed consent in the acutely ill and complex pediatric population; (2) integrating research into daily clinical routines; (3) encouraging busy staff to enter patients into trials; (4) ethics process approval; (5) maintenance of research funding. Conclusion: The CRNC plays a pivotal role in the successful performance of clinical research providing care and protection to research participants assuring ongoing maintenance of informed consent, supporting protocol implementation and accuracy of research data collection. The role has multiple aspects, and the CRNC must anticipate a number of specific challenges that must be faced in order to be successful. However, further nursing articulation, recognition and evaluation of the CRNC role in the conduct and context of clinical research is needed.

Abstract 45 -‐ Podium Information behavior of clinical research participants Elizabeth Eisenhauer, RN, MLS Doctoral Student, School of Nursing, University of Michigan Lack of clinical research participants slows the process of getting important medical research treatments to the public. Understanding the information behavior of clinical research participants would help enable researchers to develop more effective study designs. In turn this understanding would also help researchers provide participants with the level of information they need in order to participate in studies, potentially increasing future levels of enrollment. Semi-‐structured interviews were conducted with research participants currently enrolled in a clinical study. Transcripts of the interviews were analyzed for recurring themes. Research questions included: How do participants find a study or determine which study to join? What information do they need, or seek, to decide to enroll? What was the extent of their information seeking before they made their decision to participate? How confident were they about their decision? Data were analyzed primarily through the lens of Dervin’s Sense-‐Making theory. The interviews revealed themes of Interest, Compensation, Altruism, and Convenience which relate to broader categories of Content, Process, and Motivation and speak to the sense-‐making journey of the research volunteers. Viewing clinical research participation as a holistic process via Dervin’s Sense Making theory could help inform research professionals about how to better serve this important population. The findings of this study have numerous implications for physicians, nurses, research assistants, primary investigators, health science librarians and others involved with clinical research study design, recruitment, and support. Additionally the findings strengthen recent arguments that nurses are uniquely qualified to become clinical research coordinators and that research recruitment and participation is a complex phenomenon.


Abstract 46 -‐ Poster Development of a SOP to Allow Nurses in the Clinical Research Unit to Manage a Hyperinsulinemic-‐Euglycemic Clamp Jolene Lewis, RN, BSN, Ovalle, Fernando, MD, University of Alabama at Birmingham, Birmingham, Alabama, Chacana, Teresa, MSN, RN, University of Alabama at Birmingham, Birmingham, Alabama University of Alabama at Birmingham Clinical research nurses (CRNs) are often delegated the implementation of assessments and invasive interventions that are part of clinical research protocols. As clinical trials evolve in complexity, training on a variety of specialized procedures is often required by CRNs. At the onset of a new study on insulin sensitivity, the use of a hyperinsulinemic-‐euglycemic clamp was required. Hyperinsulinemic-‐euglycemic clamp is a method that allows for the measurement of glucose utilization based on insulin activity under conditions that define stable insulinemia and stable euglycemia. This test is the gold-‐standard for assessment of insulin sensitivity and involves measuring blood glucose at close intervals during the test to adjust the glucose infusion to maintain a glucose of 90 mg/dl while the insulin infusion is maintained at a constant rate . The nursing staff of the Clinical Research Unit (CRU), at UAB, assists investigators with managing hyperinsulinemic-‐euglycemic clamps. The standard practice has been for a physician to be present giving directions to adjust the rate of the glucose infusion at each hyperinsulinemic-‐euglycemic clamp test. Because of the quantity of these procedures performed at the CRU, we elected to investigate the development of a new standard that could potentially permit nurses to independently run a hyperinsulinemic-‐euglycemic clamp. The training for conducting a hyperinsulinemic-‐euglycemic clamp is done under the tutelage of an experienced physician investigator who routinely conducts this procedure in the CRU. The same investigator reviewed and approved the SOP to train and validate the nursing staff performing the procedure. The implementation of this training program and the creation of the respective SOP, involved research into current processes at other institutions, review of nurse practice guidelines, as well as hospital guidelines to ensure compliance. Developing the SOP broadened our understanding of nursing research practice, strengthened our nursing skills, and assures that the procedure will be performed correctly for patient safety We are planning for follow up research on the outcomes affecting the participants, the physician and the nursing staff at the CRU after implementing this change in practice.

Abstract 47 -‐ Podium Advancing the International Association of Clinical Research Nurses (IACRN) as a professional association through local chapter development Catherine Griffith, RN, MSN, ACNP-‐BC, Lauren Donahue, RN, BSN, Brigham and Women’s Hospital Kerry Milaszewski, BS, RN, CDE, Joslin Diabetes Center Linda Pitler, RN, MS, CCRC, Massachusetts General Hospital Amy Sbrolla, RN, BSN, ACRN, Massachusetts General Hospital Mary E Larkin, MS, RN, Massachusetts General Hospital Massachusetts General Hospital Background: Memberships in professional associations, referred to as communities of practice, enhance nurses’ professional development, responsibility and opportunity. Chapter development offers mechanisms for maximizing reach of parent organizations with additional opportunities for collaboration, networking, and sharing best practice. Operating as a Pilot for over a year, Boston Chapter


IACRN (International Association of Clinical Research Nurses) became the first regional IACRN community of practice, officially recognized as a Chapter in March 2013. Spanning several years, IACRN-‐National founding members created an infrastructure, instituted intensive marketing, incorporated as a professional association in 2008 and hosted the inaugural international conference in 2009. Clinical Research Nurses across the globe have since identified with IACRN as their specialty organization, heightening their awareness of an international peer group, and expressing interest in certification of Clinical Research Nursing as a specialty practice. Objective: The aim is to chart the journey from individual CRNs having shared vision to achieving recognition as a regional “Boston Chapter” of IACRN, with current representation from six large medical institutions. Steps taken, tools used, lessons learned and logistical considerations are detailed with the intent to provide examples for others to follow when establishing IACRN Chapters. Implementation: Evolutionary phases of development included: drafting mission and goals, establishing feasibility and level of interest among Boston area CRNs; conducting needs assessments to determine general and specific topics of interest; marketing, recruiting speakers, establishing a slate of officers with a succession plan; logistical considerations related to meeting frequency, location and collaboration with IACRN-‐National to create and demonstrate a model for chapter development. Outcome: Boston-‐IACRN has entered year three, including one year prior to Pilot designation. Average meeting attendance numbers thirty CRNs representing six institutions. Boston Chapter members have attended each IACRN annual meeting, consistently submitting abstracts and delivering presentations. Implications: Building a successful chapter requires diligence and commitment among the founding members. Ongoing sustainability requires engaging the membership, fostering leadership development, and providing activities valued by attendees. The Boston Chapter provides a local forum to support IACRN’s mission, promote growth of the Association, and embraces the vision of enhancing clinical research quality and safety through specialized nursing practice.

Abstract 48 -‐ Poster Investigating the Complexity of Caring for Clinical Research Trial Patients in Pediatric Oncology Maggie Malsch, RN, BSN, CPHON, Cailin Toomey, RN, BSN, CPHON, Dana Farber Cancer Institute, Boston, MA USA, [email protected], 617-‐632-‐3960 Margaret Hill, MS, RN, Dana Farber Cancer Institute, Boston, Ma, USA, [email protected] Boston Children's Hospital/Dana Farber Cancer Institute There is an enormous amount of work that goes into screening, enrolling and caring for patients on clinical trials. There is little published data on acuity of caring for research patients. The workload of research nurses can be impacted by the complexity of each individual trial and patient/family. A literature search and evidence based inquiry of current practices in pediatric based institutions was performed. Literature search revealed minimal information regarding the current practice for determining workload of caring for clinical trial patients. Clinical trial workload and patient intensity tools have been published (Smuck et al, 2011 & Cusack, 2004), however, these tools don’t take into account all of the day-‐to-‐day tasks of research nurses. Inquiry into other institutions revealed lack of consistency in current practices for determining caseload; this supports the need to develop a workload tool. We intend to break down the nursing workload involved in pediatric oncology clinical trials (phases 1 through 3) at our institution to identify nursing requirements from start to finish and use that information to create an acuity tool. Having a tool, will enable research nurses to articulate the complexity of the workload involved in caring for clinical trial patients. It will improve the research nurses ability to be protocol compliant, allow staff to more accurately identify volume/acuity of workload, and provide concrete support for current staffing. Cusack, G, Jones-‐Wells, A, Chisholm, L.


(2004). Patient Intensity in an Ambulatory Oncology Research Center: A Step forward for the Field of Ambulatory Care. Nursing Economics 22(2)Pages 58-‐63 Smuck, B, Bettllo,P, Berghout, K, Hanna, T, Kowaleski, B, Phippard, L, Au, D, Friel, K (2011). Ontario Protocol Assessment Level: Clinical Trial Complexity Rating Tool for Workload Planning in Oncology Clinical Trials. Journal of Oncology Practice 7(2) Pages 80-‐84

Abstract 49 -‐ Poster Challenges Implementing an Electronic Health Record System Jean Addis, RN, MSB, NEA-‐BC, DeAnna Sheeley, RN, MSN UCSF Medical Center 505 Parnassus Ave SF, CA 94143 UCSF Benioff's Chidren's Hospital Health Information Technology for Economist and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act, was enacted in February 2009 to promote adoption of meaningful use of Health Information Technology. As of 2015, providers who are not utilizing electronic health records (EHR) will have monetary penalties. As EHR systems are implemented in health care organizations challenges may arise, without careful planning during the build phases, for the researcher, research teams, and clinical research centers located within a Medical Center. It is important to review the implementation process and anticipate problems early. Challenges that a clinical Research Center located in an Academic Medical Center encountered with implementation included: defining how the research unit should operate (inpatient, outpatient, Hospital Outpatient Department [HOD]); determining employee training requirements and developing training content; terminology of staff; defining roles and access requirements; computerized physician order entry (CPOE) and pending orders for research protocols; complex billing needs; establishing standards for documentation on research protocols; and establishing limited access to confidential research data. Recommendations for a successful implementation process include: building and planning sessions with EHR team at least one year prior to actual go live implementation date; identifying a principal investigator, research nurse, study coordinator and business analysts champions prior to initiating an EHR; conducting a research workflow assessment; building/adapting the EHR to accommodate protocol driven MD orders; planning to manage financial aspects of complex funding mechanisms; and adequate research training from all research perspectives. Successful implementation requires the EHR consultant training team and dedicated research end users to develop research workflows focused on testing all technology components prior to go live date. This critical planning and development prior to implementation will avoid challenges resulting in wasted resources, alienated principal investigators, stoppage of key work flow, incorrect billing resulting in liability issues as well as loss of confidence by participants, quality data, and patient safety issues.

Abstract 50 -‐ Poster Standardizing the Research Protocol Implementation Process on the University of Wisconsin Clinical Research Unit (UW-‐CRU) Mary Gillitzer, RN, Tamara Kempken Mehring, MS, RN University of Wisconsin Hospital and Clinics Kristi Everson University of Wisconsin Hospital and Clinics University of Wisconsin Hospital and Clinics


BACKGROUND Implementation of research protocols on the University of Wisconsin Clinical Research Unit (UW-‐CRU) is complicated due to multiple factors: • Principal investigators (PIs) and study teams are often unfamiliar with requirements of the UW-‐CRU and other institutions (e.g. Institutional Review Boards, UW Hospital and Clinics, School of Medicine and Public Health, Institute for Clinical and Translational Research). • Complexity of the research protocol implementation process. • Lack of clear direction and guidelines for the use of these required resources. Guiding study teams and responding to constant and repeated questions beyond the knowledge base of the UW-‐CRU staff creates increased workloads and inefficiencies in research protocol implementation. PIs and study teams have verbalized frustration with the process and their lack of guidance. PURPOSE The purposes of this creative solutions project are to: • Increase efficiencies in the research protocol implementation process by defining the roles and responsibilities of the UW-‐CRU, study teams, and other institutions in the protocol implementation process. • Identify resources for study teams. • Increase UW-‐CRU user satisfaction with the implementation process. IMPLICATIONS FOR FUTURE WORK The workgroup will develop and conduct an electronic survey pre-‐ and post-‐intervention of PIs and study teams to: • Measure level of satisfaction with the current process. • Identify barriers to efficient protocol implementation. • Evaluate education needs. The workgroup will develop tools and procedures based on information gathered in the survey as well as historic experience of the workgroup to achieve the goals identified. This project will result in a comprehensive UW-‐CRU user guide that will clarify guidelines and increase ease of navigation of resources when implementing a protocol on the UW-‐CRU. Due to the project’s current timeline, results are not available at this time, but are anticipated by the October publication date.

Abstract 51 -‐ Poster University of Wisconsin Clinical Research Unit (UW-‐CRU) Data Collection Time Point Analysis Tamara Kempken Mehring, MS, RN, Mary Jane Williams, DNP, MPH, RN Mary Gillitzer, RN University of Wisconsin Hospital and Clinics BACKGROUND The University of Wisconsin’s Clinical Research Unit (UW-‐CRU) is dedicated to conducting clinical trials by supporting principal investigators across multiple disciplines. This includes maintaining strict adherence to research protocol requirements and quality data collection. Fidelity to the research protocol is central to the success of any clinical trial. Precise data collection is essential in clinical research. Data collection impacts the research findings, making accurate data collection of paramount importance. After conducting a review of the academic literature, little was found discussing benchmarks for timed data collection points in clinical research. PURPOSE The purpose of this time point collection analysis was to establish benchmarks for timed data collection points on the UW-‐CRU. The knowledge that is gained from this project will be used to set standards for research nurses on the UW-‐CRU. The knowledge gained may be extended to other clinical research units globally in order to compare accuracy of timed data collection points, based on best practices. METHODS This project was carried out using a retrospective review of data. Beginning in October 2012 the project team compiled information about study participants who were participating in a research protocol on the UW-‐CRU that required a timed data collection point. The team reviewed daily census schedules and identified subjects participating in research protocols that required timed data collections, including blood draws, urine collections, vital signs, ECGs, and medication administration times. Research subject identifiers were removed. Time points were entered into a spreadsheet and ideal versus actual times were compared. Variances were calculated and reasons for variances were documented. RESULTS/FINDINGS Data is in the process of being analyzed and will be completed by the presentation date. A standardized tool will be used for analysis. IMPLICATIONS FOR FUTURE WORK Next steps include presenting this information to the UW-‐CRU staff, leadership and investigators. Data will be used to establish standards and measure outcomes of


timed specimen collections and medication administration. Other clinical research units will be invited to participate in de-‐identified data collection to expand the data pool, thereby establishing a national or international standard for measurement of research time point outcomes and identify best practices.

Abstract 52 -‐ Poster Identifying Professional Needs and Benefits Expected by Clinical Research Nurses: What should IACRN Membership Offer? Mary Jane Williams, DNP, MPH, RN University of Wisconsin Hospital and Clinics Identifying Professional Needs and Benefit Expectation of Clinical Research Nurses: What Should IACRN Membership Offer? BACKGROUND Professional associations provide tangible benefits to today’s working population. Associations must continually evaluate the needs of members in order to satisfy the specialized group. Successful associations seek to learn from their valued members. Associations are strengthened by identifying professional benefits and designing services that deliver those desired benefits. PURPOSE The purpose of these surveys was to identify professional benefits IACRN members and non-‐members attending the 2010 and 2012 Annual IACRN conferences reported they wished to gain from membership in IACRN. METHODS Attendees of the 2010 and 2012 IACRN conferences were surveyed using a six-‐part questionnaire to determine professional benefits they wish to gain from membership. Questionnaires were placed at the registration desk and announced at the meeting. Part I of the survey asked the respondent to identify as a member or non-‐member. Part II asked the respondent to rate the following benefits, using a Likert scale of five ordered response levels from strongly agree to strongly disagree: (1) networking, (2) educational opportunities, (3) professional community, (4) leadership opportunity, (5) volunteerism, and (6) career advantages. Part III asked respondents to use an ordinal scale to rank the same benefits in order of importance to them, with one being the most important. Parts IV and V asked respondents to list missing benefits, rate the level of importance of the benefit they listed, and offer additional comments related to benefits. Part VI collected demographic information on each respondent in the categories of clinical research experience, primary role, practice setting, highest degree achieved, highest nursing degree, primary work location, funding source, population served, and facility type. RESULTS/FINDINGS Data is in the process of being analyzed and will be completed by the presentation date. A standardized tool will be used for analysis. IMPLICATIONS FOR FUTURE WORK Next steps include presenting this information to the IACRN board, members, and 2013 conference attendees. Findings will be used by IACRN leadership to guide core decisions on professional benefits offered by the association, including educational offerings, agendas for annual conferences, and growing the association in a way that meets the needs of the membership. References: Brooks, A. (2008). Where the Winners Meet: Why Happier More Successful People Gravitate Toward Associations. Report published by The William E. Smith Institute for Research established and funded by SmithBucklin Corporation, Chicago, IL.

Abstract 53 -‐ Podium Genetics and Genomics: Evolution of the Role of the Clinical Research Nurse Andrea Linder, RN,MS,CCRC, Donna WIlliams, RN,PHN, Stanford University School of Medicine, GI Oncology Research Stanford University School of Medicine


The practice and delivery of nursing care to patients with hematological or oncological diseases is undergoing a paradigm shift. Research nurses are on the vanguard of implementation of novel treatments and as such can lead efforts in education and implementation of genetic and genomic guided treatments to patients. Many tumors contain hallmark mutations within oncogenes or tumor suppressor (TS) genes that may confer a heightened susceptibility to targeted anticancer therapies. Patient prognosis can often be predicted based on these acquired genetic mutations. Treatments often vary according to patient specific acquired mutations with directed targeted therapy drugs for treatment. In various hematologic diseases such as CML targeted therapy for the BCRabl gene is individualized for treatment. Recently medication to target acquired JAK2 mutations with myelofibrosis patients is at the forefront of practice. Rituxan is a monocloncal molecularly targeted biological therapy used for lymphomas now in use with other oncologic disease treatment In solid tumors, well-‐established examples include KIT mutations in gastrointestinal stromal tumors (GISTs) that predict response to imatinib or nilotinib. The presence of other mutations predicts a lack of response to targeted therapy. For example, lung and colorectal cancers that harbor mutations in the KRAS oncogene are unresponsive to treatment with anti-‐EGFR agents. KRAS testing reveals which patients have a KRAS mutation and will thus not benefit from treatment with cetuximab or panitumumab clinical decision-‐making based on tumor genetic information will increasingly be informed by the mutational status of multiple cancer genes. However, generating a comprehensive profile of target-‐able or otherwise “actionable” tumor DNA mutations in the clinical arena remains challenging. As clinical research nurses in hematology and oncology there are a plethora of educational opportunity for patient care with the genetic and genomic guided treatments. Nurses may influence the outcomes for patients and their families by providing guidance and integrating clinical standards for these evolving technologies and treatments. Research nurses have the opportunity and the responsibility to assist in clearing the current barriers for genetic and genomic guided treatments for patient care. These include concise reporting and integration of genetic information into the electronic medical record (EMR), misunderstandings regarding HIPPA guidelines and a lack of standard processes for documenting the genetic information. Additional barriers include lack of reimbursement for genetic testing or competition for serum or tumor samples. Research nurses being at the forefront of new discoveries are uniquely poised to develop the education, policy and implementation of standards to streamline reporting, education and guidance for patients and staff seeking to understand the significance of genetic markers informing treatment options in hematologic/oncological disease.

Abstract 54 -‐ Poster Challenges to Education for Cancer Clinical Trials Nursing in Japan Hiroko Nakahama, Kazuko Nasu, Yasuhiro Fujiwara National Cancer Center Hospital Background: In the US, oncology clinical trials nursing has been fully established, and appropriately trained nurses play an important role in this research. However, in Japan, nurses rarely study oncology clinical trials in their nursing education in university or postgraduate nursing programs, thus giving them fewer opportunities to obtain sufficient knowledge on oncology clinical trials and review their roles. Furthermore, the majority of medical institutions perform clinical trials and provide general practices within the same environment, meaning that nurses would have to manage clinical trials while engaging in busy general practice, making it difficult to provide effective care. Therefore, it is necessary to provide nurses with the requisite knowledge of oncology clinical trials and to broaden their roles in this research field. We report here our development of an opportunity for nurses to obtain such requisite knowledge through postgraduate education programs for use in busy hospitals. Purpose: To report on nursing


education at the National Cancer Center Hospital (NCCH) in Japan. Methods: This section explains a nursing education program for oncology clinical trials in the NCCH. Results: For all nurses in the NCCH, we provided ethics training in the first year, basic knowledge about oncology clinical trials in the second year, and advanced education about clinical trials in the fifth to seventh years. We also offered an optional advanced course to develop nursing experts in clinical trials, such as chemotherapy nursing and radiotherapy nursing. Conclusions: We believe our continuous nursing education program is effective: it provides nurses with extensive knowledge on oncology clinical trials and provides good opportunities for them to discuss and perform nursing care in a balanced manner between general practice and clinical trials. Therefore, we must further establish oncology clinical trials in nursing education to achieve and maintain the best team medical care in the future.

Abstract 55 -‐ Poster Orientation of Infusion Nurses to the Role of Research Nurse Karen A. Francoeur, RN

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