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Professional Issues
Guadalupe R. Palos, RN, LMSW, DrPH—Associate Editor
A Nursing Workforce Program to Advance Knowledge and Skills for Nurses Implementing Cancer Clinical Research Cindy Samborski, MSN, MHA, RN, CCRC, Debbie Neimanis, RN, BSN, CCRC, OCN®, Anne D. Paquette, BSN, RN, CCRC, Lise Hernandez, BSN, MPH, RN, CCRC, CHTC, Kathleen Klaes, RN, and Karen Rudnicki, BSN, RN, CCRP
Clinical nursing research is an emerging subspecialty that enhances nursing expertise. In an effort to provide a basic educational curriculum on cancer research and clinical trials, a major academic cancer center launched a novel program titled Clinical Research Nursing Grand Rounds that allowed nurses to receive continuing education units. The purpose of the current article is to describe the development and content of the education model, challenges encountered, and implications for oncology nursing education, practice, and research. Cindy Samborski, MSN, MHA, RN, CCRC, is a clinical research educator and Debbie Neimanis, RN, BSN, CCRC, OCN®, Anne D. Paquette, BSN, RN, CCRC, Lise Hernandez, BSN, MPH, RN, CCRC, CHTC, Kathleen Klaes, RN, and Karen Rudnicki, BSN, RN, CCRP, are clinical research coordinators, all at Roswell Park Cancer Institute in Buffalo, NY. The authors take full responsibility for the content of the article. The authors did not receive honoraria for this work. No financial relationships relevant to the content of this article have been disclosed by the authors or editorial staff. Samborski can be reached at cynthia.samborski@roswellpark .org, with copy to editor at [email protected]. Key words: clinical nursing research; grand rounds; continuing nursing education Digital Object Identifier: 10.1188/14.CJON.119-121
C
linical nursing research, an emerging subspecialty, is challenging to understand without the appropriate knowledge, skills, and education. The National Institutes of Health ([NIH], 2011) and other healthcare organizations recognize that patient safety, study integrity, and nursing expertise in clinical research are enhanced with appropriate education and training.
Nurses’ Role in Oncology Clinical Trials As the complexity and diversity of cancer treatment and prevention trials continue to steadily increase, the demand for nurses to be well educated in the emerging subspecialty of oncology clinical trials grows. Many professional organizations have launched comprehensive initiatives to define the scope and practice of this nursing specialty (Daugherty, Schmie-
der, Good, Leos, & Weiss, 2010; NIH, 2011; ONS, 1998). The standard template consisted of definitions of the scope and practice, explanations of the core competencies, and discussion of the overall protection of study participants, management of study protocols, integrity of data, and adherence to regulatory guidelines. In the current article, the focus is on definitions and core competencies that include the fundamental knowledge, skills, and expertise required to proficiently (a) identify and care for participants in clinical trials with a past, current, or potential diagnosis of cancer, (b) manage oncology clinical trials in diverse settings, (c) ensure protection of subjects enrolled in clinical trials, and (d) ensure that scientific integrity is maintained through data reliability and strict adherence to regulatory mandates (Daugherty et al., 2010). Those core competencies also are maintained by
Clinical Journal of Oncology Nursing • Volume 18, Number 1 • Professional Issues
clinical research coordinators. Previously, clinical research coordinators were RNs; however, the limited availability of academic or professional education programs, the increasing shortage of nurses in the workforce, and the reluctance of nurses willing to work in research have led to an increase in other allied health professionals filling that role. The growing trend to use professionals who are not nurses in that role has led to a lack of RNs in the study’s implementation in some outpatient settings. The confluence of these trends increases the need for nurses in all clinical settings to better understand the complexity of clinical research development, implementation, and maintenance.
Developing the Module The development, implementation, and evaluation of the current pilot effort were conducted in three steps: establishing the need, developing the content and applying for Oncology Nursing Society (ONS) credit, and evaluating the outcomes.
Establishing the Need A baseline survey was distributed to all nurses at Roswell Park Cancer Institute to determine if nurses expressed a need for educational programs related to clinical research and its application. The nurses’ feedback indicated an interest existed in obtaining additional education on clinical research. Nurses identified specific topics that included implementation of a clinical research study, the role of the nurse and the clinical research coordinator, and documentation procedures for documenting and tracking patient participation in clinical trials. 119
Using those results, the first clinical research program was launched in 2012. The 10-minute program focused on the basics of clinical research and was presented by a clinical research educator. However, several barriers (e.g., logistical issues, limited awareness or knowledge of the program) contributed to low attendance. Based on those observations and the commitment to educating more nurses, the authors concluded that major revisions were needed before offering a second program.
Developing the Revised Program A team of six expert clinical research coordinators evaluated the need for additional education based on experiences with clinical staff, and they identified three primary revisions. First, a traditional approach used in medicine called grand rounds was selected as the mode for presenting the material. Second, the planning group reviewed the Manual for Clinical Trials Nursing (Klimaszewski, Bacon, Deininger, Ford, & Westendorp,
2008) and identified six fundamental topics of clinical research to cover during the grand rounds. Third, the group concluded that offering continuing education units (CEUs) was an excellent strategy to encourage nurse attendance. To allow better flexibility for nurses to access the information, two options for obtaining education were used. The original one-hour program was broken into two 30-minute programs to allow the nurses a shorter time frame to be away from their units. To provide scheduling flexibility, two identical sessions were offered at 11:30 am and noon. The other option, designed for nurses who could not attend the sessions, was a video recording of the program that was available online. Based on those revisions, the resulting program series was titled Clinical Research Nursing Grand Rounds. The series focused on six basic clinical research topics, each of which was featured in a 60-minute program. Table 1 presents the six core components critical to teaching the basics of clinical research. The series was approved by ONS, and each 60-minute program (online and in person) earned one CEU.
Evaluating the Grand Round Series Pre- and postprogram evaluations were distributed to all attendees. The first was 120
TABLE 1. Framework for the Clinical Research Nursing Grand Rounds Module
Description
Challenges in developing a drug: From plant to synthetic
Introduction to the discovery and development of new drug discoveries through clinical research
A day in the life of the research patient
Discussion between patient and clinician about the steps needed to receive a research drug, including the consent process, nursing assessment, and the impact on research
Role of the study coordinator
Orientation and detailed dialogue of the roles and responsibilities of the clinical research coordinator
Clinical research and chronic myeloid leukemia
Review of the discovery and treatment of chronic myeloid leukemia and its epidemiological trends and influence in clinical research
Phases of research for drug development
Description of the phases of research and the process for a study to be approved by the U.S. Food and Drug Administration
Basics of clinical research
Review of the history of clinical research; significance of assessing and documenting adverse events, and their impact on the patient and study
The authors’ goal was to help nurses have a better understanding of clinical research and how the process affects the nursing profession. The educational program faced two primary issues. The first was the reluctance of nurses to leave their floors for an educational session, and the second was the omission of the clinical research team to educate administrative and managerial support about the program. Although the program evaluation indicated that the series was successful, the authors experienced low participation from nurses working on inpatient and outpatient units, which were the target populations.
will feel more supported in their current roles, increase their understanding of their role in research, and enhance their standing within the nursing community (Hill & MacArthur, 2006). A new team was developed with the same goal, but changes were made based on feedback from the evaluations. The grand rounds team collaborated with the nursing education department and developed a communication plan to inform all levels of the institution of the series. As a first step, all nurse managers will be the first to be informed about the program schedule and the offer of CEU. The authors believe engaging nurse managers early in the process will improve attendance. Based on the program evaluation results, the content will be revised to include topics suggested by previous attendees. CEU also will be offered by ONS for each session in the new program titled Clinical Research Nursing Grand Rounds II.
Lessons Learned
Implications for Nurses
To best equip nurses for research, recognizing their needs, providing support, and providing adequate theoretical and practical preparation is important (ONS, 1998). By establishing mechanisms that encourage peer support, dissemination of information, and provision of appropriate educational opportunities, nurses
The current pilot found that nurses expressed a need for continuing education in the area of clinical research, that grand rounds was the preferred method for presenting the educational content, and that managerial leadership support was critical to nurse participation. Examples of core concepts that nurses should be
distributed to the nurses before their participation in the grand rounds series. The second evaluation was distributed after the completion of the six-part grand rounds series.
Challenges Encountered
February 2014 • Volume 18, Number 1 • Clinical Journal of Oncology Nursing
aware of include how to safely and ethically implement clinical research studies, knowledge of the ethical principles involved in informed consent, understanding the concept of scientific misconduct, and familiarity with institutional procedures for reporting concerns about research practices (Cibulka, 2011). Patients with a diagnosis of cancer who are asked to participate in clinical trials are a particularly vulnerable population who depend on having a trusting relationship with their nurse. When working in clinical research, nurses must have a basic understanding of the clinical research process and core principles to build a strong trusting relationship and have effective communication and strong support with patients and their families. The goals of clinical research are to develop new approaches to prevent, detect, and treat disease, and to improve quality of life and care of people who are at risk for developing or who have cancer (Klimaszewski et al., 2008). Educational programs offered in the workplace are essential in supporting nurses to provide safe and highquality care to their patients. Nurses can advance their knowledge and skills in clinical research by participating in learning opportunities to ensure that creativity, innovation, and knowledge are incorporated into oncology nursing practice.
References Cibulka, N.J. (2011). Educating nurses about research ethics and practices with a self-directed practice-based learning program. Journal of Continuing Education in Nursing, 42, 516–521. doi:10.3928/00220124-20110701-02 Daugherty, P., Schmieder, L., Good, M., Leos, D., & Weiss, P. (2010). Oncology clinical trials nurse competencies. Pittsburgh, PA: Oncology Nursing Society. Hill, G., & MacArthur, J. (2006). Professional issues associated with the role of the research nurse. Nursing Standard, 20, 41–47. Klimaszewski, A., Bacon, M., Deininger, H.E., Ford, B.A., & Westendorp, J. (Eds.). (2008). Manual for clinical trials nursing (2nd ed.). Pittsburgh, PA: Oncology Nursing Society. National Institutes of Health. (2011). Building the foundation for clinical research nursing: A clinical research nursing model of care. Retrieved from http://1.usa.gov/1eAeEn5 Oncology Nursing Society. (1998). Cancer research and cancer clinical trials [Position statement]. Oncology Nursing Forum, 25, 973–974.
Do You Have an Interesting Topic to Share?
[email protected]
Copyright of Clinical Journal of Oncology Nursing is the property of Oncology Nursing Society and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Professional Issues
Guadalupe R. Palos, RN, LMSW, DrPH—Associate Editor
A Nursing Workforce Program to Advance Knowledge and Skills for Nurses Implementing Cancer Clinical Research Cindy Samborski, MSN, MHA, RN, CCRC, Debbie Neimanis, RN, BSN, CCRC, OCN®, Anne D. Paquette, BSN, RN, CCRC, Lise Hernandez, BSN, MPH, RN, CCRC, CHTC, Kathleen Klaes, RN, and Karen Rudnicki, BSN, RN, CCRP
Clinical nursing research is an emerging subspecialty that enhances nursing expertise. In an effort to provide a basic educational curriculum on cancer research and clinical trials, a major academic cancer center launched a novel program titled Clinical Research Nursing Grand Rounds that allowed nurses to receive continuing education units. The purpose of the current article is to describe the development and content of the education model, challenges encountered, and implications for oncology nursing education, practice, and research. Cindy Samborski, MSN, MHA, RN, CCRC, is a clinical research educator and Debbie Neimanis, RN, BSN, CCRC, OCN®, Anne D. Paquette, BSN, RN, CCRC, Lise Hernandez, BSN, MPH, RN, CCRC, CHTC, Kathleen Klaes, RN, and Karen Rudnicki, BSN, RN, CCRP, are clinical research coordinators, all at Roswell Park Cancer Institute in Buffalo, NY. The authors take full responsibility for the content of the article. The authors did not receive honoraria for this work. No financial relationships relevant to the content of this article have been disclosed by the authors or editorial staff. Samborski can be reached at cynthia.samborski@roswellpark .org, with copy to editor at [email protected]. Key words: clinical nursing research; grand rounds; continuing nursing education Digital Object Identifier: 10.1188/14.CJON.119-121
C
linical nursing research, an emerging subspecialty, is challenging to understand without the appropriate knowledge, skills, and education. The National Institutes of Health ([NIH], 2011) and other healthcare organizations recognize that patient safety, study integrity, and nursing expertise in clinical research are enhanced with appropriate education and training.
Nurses’ Role in Oncology Clinical Trials As the complexity and diversity of cancer treatment and prevention trials continue to steadily increase, the demand for nurses to be well educated in the emerging subspecialty of oncology clinical trials grows. Many professional organizations have launched comprehensive initiatives to define the scope and practice of this nursing specialty (Daugherty, Schmie-
der, Good, Leos, & Weiss, 2010; NIH, 2011; ONS, 1998). The standard template consisted of definitions of the scope and practice, explanations of the core competencies, and discussion of the overall protection of study participants, management of study protocols, integrity of data, and adherence to regulatory guidelines. In the current article, the focus is on definitions and core competencies that include the fundamental knowledge, skills, and expertise required to proficiently (a) identify and care for participants in clinical trials with a past, current, or potential diagnosis of cancer, (b) manage oncology clinical trials in diverse settings, (c) ensure protection of subjects enrolled in clinical trials, and (d) ensure that scientific integrity is maintained through data reliability and strict adherence to regulatory mandates (Daugherty et al., 2010). Those core competencies also are maintained by
Clinical Journal of Oncology Nursing • Volume 18, Number 1 • Professional Issues
clinical research coordinators. Previously, clinical research coordinators were RNs; however, the limited availability of academic or professional education programs, the increasing shortage of nurses in the workforce, and the reluctance of nurses willing to work in research have led to an increase in other allied health professionals filling that role. The growing trend to use professionals who are not nurses in that role has led to a lack of RNs in the study’s implementation in some outpatient settings. The confluence of these trends increases the need for nurses in all clinical settings to better understand the complexity of clinical research development, implementation, and maintenance.
Developing the Module The development, implementation, and evaluation of the current pilot effort were conducted in three steps: establishing the need, developing the content and applying for Oncology Nursing Society (ONS) credit, and evaluating the outcomes.
Establishing the Need A baseline survey was distributed to all nurses at Roswell Park Cancer Institute to determine if nurses expressed a need for educational programs related to clinical research and its application. The nurses’ feedback indicated an interest existed in obtaining additional education on clinical research. Nurses identified specific topics that included implementation of a clinical research study, the role of the nurse and the clinical research coordinator, and documentation procedures for documenting and tracking patient participation in clinical trials. 119
Using those results, the first clinical research program was launched in 2012. The 10-minute program focused on the basics of clinical research and was presented by a clinical research educator. However, several barriers (e.g., logistical issues, limited awareness or knowledge of the program) contributed to low attendance. Based on those observations and the commitment to educating more nurses, the authors concluded that major revisions were needed before offering a second program.
Developing the Revised Program A team of six expert clinical research coordinators evaluated the need for additional education based on experiences with clinical staff, and they identified three primary revisions. First, a traditional approach used in medicine called grand rounds was selected as the mode for presenting the material. Second, the planning group reviewed the Manual for Clinical Trials Nursing (Klimaszewski, Bacon, Deininger, Ford, & Westendorp,
2008) and identified six fundamental topics of clinical research to cover during the grand rounds. Third, the group concluded that offering continuing education units (CEUs) was an excellent strategy to encourage nurse attendance. To allow better flexibility for nurses to access the information, two options for obtaining education were used. The original one-hour program was broken into two 30-minute programs to allow the nurses a shorter time frame to be away from their units. To provide scheduling flexibility, two identical sessions were offered at 11:30 am and noon. The other option, designed for nurses who could not attend the sessions, was a video recording of the program that was available online. Based on those revisions, the resulting program series was titled Clinical Research Nursing Grand Rounds. The series focused on six basic clinical research topics, each of which was featured in a 60-minute program. Table 1 presents the six core components critical to teaching the basics of clinical research. The series was approved by ONS, and each 60-minute program (online and in person) earned one CEU.
Evaluating the Grand Round Series Pre- and postprogram evaluations were distributed to all attendees. The first was 120
TABLE 1. Framework for the Clinical Research Nursing Grand Rounds Module
Description
Challenges in developing a drug: From plant to synthetic
Introduction to the discovery and development of new drug discoveries through clinical research
A day in the life of the research patient
Discussion between patient and clinician about the steps needed to receive a research drug, including the consent process, nursing assessment, and the impact on research
Role of the study coordinator
Orientation and detailed dialogue of the roles and responsibilities of the clinical research coordinator
Clinical research and chronic myeloid leukemia
Review of the discovery and treatment of chronic myeloid leukemia and its epidemiological trends and influence in clinical research
Phases of research for drug development
Description of the phases of research and the process for a study to be approved by the U.S. Food and Drug Administration
Basics of clinical research
Review of the history of clinical research; significance of assessing and documenting adverse events, and their impact on the patient and study
The authors’ goal was to help nurses have a better understanding of clinical research and how the process affects the nursing profession. The educational program faced two primary issues. The first was the reluctance of nurses to leave their floors for an educational session, and the second was the omission of the clinical research team to educate administrative and managerial support about the program. Although the program evaluation indicated that the series was successful, the authors experienced low participation from nurses working on inpatient and outpatient units, which were the target populations.
will feel more supported in their current roles, increase their understanding of their role in research, and enhance their standing within the nursing community (Hill & MacArthur, 2006). A new team was developed with the same goal, but changes were made based on feedback from the evaluations. The grand rounds team collaborated with the nursing education department and developed a communication plan to inform all levels of the institution of the series. As a first step, all nurse managers will be the first to be informed about the program schedule and the offer of CEU. The authors believe engaging nurse managers early in the process will improve attendance. Based on the program evaluation results, the content will be revised to include topics suggested by previous attendees. CEU also will be offered by ONS for each session in the new program titled Clinical Research Nursing Grand Rounds II.
Lessons Learned
Implications for Nurses
To best equip nurses for research, recognizing their needs, providing support, and providing adequate theoretical and practical preparation is important (ONS, 1998). By establishing mechanisms that encourage peer support, dissemination of information, and provision of appropriate educational opportunities, nurses
The current pilot found that nurses expressed a need for continuing education in the area of clinical research, that grand rounds was the preferred method for presenting the educational content, and that managerial leadership support was critical to nurse participation. Examples of core concepts that nurses should be
distributed to the nurses before their participation in the grand rounds series. The second evaluation was distributed after the completion of the six-part grand rounds series.
Challenges Encountered
February 2014 • Volume 18, Number 1 • Clinical Journal of Oncology Nursing
aware of include how to safely and ethically implement clinical research studies, knowledge of the ethical principles involved in informed consent, understanding the concept of scientific misconduct, and familiarity with institutional procedures for reporting concerns about research practices (Cibulka, 2011). Patients with a diagnosis of cancer who are asked to participate in clinical trials are a particularly vulnerable population who depend on having a trusting relationship with their nurse. When working in clinical research, nurses must have a basic understanding of the clinical research process and core principles to build a strong trusting relationship and have effective communication and strong support with patients and their families. The goals of clinical research are to develop new approaches to prevent, detect, and treat disease, and to improve quality of life and care of people who are at risk for developing or who have cancer (Klimaszewski et al., 2008). Educational programs offered in the workplace are essential in supporting nurses to provide safe and highquality care to their patients. Nurses can advance their knowledge and skills in clinical research by participating in learning opportunities to ensure that creativity, innovation, and knowledge are incorporated into oncology nursing practice.
References Cibulka, N.J. (2011). Educating nurses about research ethics and practices with a self-directed practice-based learning program. Journal of Continuing Education in Nursing, 42, 516–521. doi:10.3928/00220124-20110701-02 Daugherty, P., Schmieder, L., Good, M., Leos, D., & Weiss, P. (2010). Oncology clinical trials nurse competencies. Pittsburgh, PA: Oncology Nursing Society. Hill, G., & MacArthur, J. (2006). Professional issues associated with the role of the research nurse. Nursing Standard, 20, 41–47. Klimaszewski, A., Bacon, M., Deininger, H.E., Ford, B.A., & Westendorp, J. (Eds.). (2008). Manual for clinical trials nursing (2nd ed.). Pittsburgh, PA: Oncology Nursing Society. National Institutes of Health. (2011). Building the foundation for clinical research nursing: A clinical research nursing model of care. Retrieved from http://1.usa.gov/1eAeEn5 Oncology Nursing Society. (1998). Cancer research and cancer clinical trials [Position statement]. Oncology Nursing Forum, 25, 973–974.
Do You Have an Interesting Topic to Share?
[email protected]
Copyright of Clinical Journal of Oncology Nursing is the property of Oncology Nursing Society and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
