harper © 2010 what we know about clinical research coordinators: a look at the literature jane...
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Harper © 2010
What we know about Clinical Research Coordinators:
A look at the literature
Jane Harper, RN, BSN, MDivResearch Nurse Coordinator
UTHSC Department of Preventive Medicine
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What we know about CRCs: A look at the literature
ContextMethodGoals
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Ellis (1970)
Ellis, R. (1970). The nurse as investigator and member of the research team. Annals of the New York Academy of Sciences, 169(2), 435-441.
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Ellis (1970)
“…have not extensively focused sufficiently upon their participation in human research in their activities…” (435)
Special circumstance—nurse may become a participant in human research without consciously choosing to do so…
Carries responsibilities for nursing care of patients who are receiving experimental treatments
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Ellis (1970)
Notes medical researcher’s reliance/dependence on nurses to:Interpret investigational regimen, such as diet,
drugsObservations & measurementsCollect specimens
Warns that if nurses not informed or included, could work against the investigator
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Ellis (1970)
“Participation in research activities under a physician’s direction does not relieve the professional nurse of responsibility for her own acts and judgments. She should be adequately informed about research or experimental procedures affecting her patients so that her intentional or unintentional actions, conveyance of information, or attitude to the patient is not detrimental to research or to a physician investigator’s plan for therapy” (437).
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Ellis (1970)
American Nurses’ Association (ANA) Code of ethics (1950 and 1960) provided ethical guidelines for nurses
ANA developed guidelines on ethical values for nurses who work in research (1968)
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Hubbard & Devita (1976)
Hubbard, S. & Devita, V. (1976). Chemotherapy Research Nurse. American Journal of Nursing, 36(4), 560-565.
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Hubbard & Devita (1976)
“As complex diagnostic and therapeutic tools have been developed, a new role for the nurse has evolved” (561).
“Major role of the chemotherapy research nurse is to give experimental drugs evaluated in formal protocols for the study of specific diseases” (562).
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Hubbard & Devita (1976)
Collect data, organize and integrate data for publication, analyze research data & define variables
3 major responsibilities are implicit: “patient consent, safety, and data analysis”(561).
“Informed consent is a continuing process, a learning experience for the patient, and…the chemotherapy nurse is often the focal person who keeps the patient informed about the progress of the drug trial”(562).
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Edwards (1976)
Edwards, J.H. (1976). Haematology research nurse in the United States. Nursing Times, 72(5), 194-195.
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Barlock, Howser & Hubbard (1979)
Barlock, A.L., Howser, D.M., & Hubbard, S.M. (1979) Nursing management of adriamycin extravasation. The American Journal of Nursing, 79(1), 94-96.
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Barlock, Howser & Hubbard (1979)
Authors identified as chemotherapy research nurses Medicine Branch, National Cancer Institute, Bethesda, Maryland
Compare 2 methods of treating adriamycin (Doxirubicin) extravasation
“Suggest” measures to enable nurses to begin immediate treatment of extravasation
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Trenchard (1980)
Trenchard (1980). The research nurse. Nursing Times, 76(4), 560-565.
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Hubbard (1982)
Hubbard, S.M. (1982) Cancer treatment research: The role of the nurse in clinical trials of cancer therapy…the chemotherapy research nurse. Nursing Clinics of North America, 17(4), 763-783.
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Bishop (1983)
Bishop, V. (1983). Colleague, collaborator or handmaiden? The role of the clinical research nurse. Nursing Mirror, 156(25), 31-33.
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Mullin et al., (1984)
Mullin, S.M., Warwick, S., Akers, M., Beecher, P., Helminger, K., Moses, B. et al. (1984). An acute intervention trial: The research nurse coordinator’s role. Controlled Clinical Trials, 5(2), 141-156.
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van Piel & Theunisse (1986)
van Piel, P.L. & Theunisse, H.A. (1986). Research nurse in rheumatology. A new tree in the forest? Tijdschrift voor Ziekenverpleging, 39(12) 357-360.
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Dubbleman & Simonetti (1988)
Dubbleman, A.C. & Simonetti, G.P. (1988). The research nurse in the Dutch Cancer Institute. TVZ: Het Vakblad voor de Verpleging, 42(9), 281-282.
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O’Halloran, Curl, Hagen & Sveningson (1989)
O’Halloran, L.J., Curl, V.R., Hagen, L., & Sveningson, L. (1989). A research nurse: Enhancing participation in clinical trials. Progress in Clinical & Biological Research, 293, 355-360.
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O’Halloran, Curl, Hagen & Sveningson (1989)
Fargo CCOP observed that research nurses enhanced CCOP’s participation in clinical trials
Maintained stable accrual levels despite loss of Med Oncologist who historically led accrual totals; among leaders of NCCTG
Although anecdotal, communication between nurses, physicians and data managers had been enhanced
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O’Halloran, Curl, Hagen & Sveningson (1989)
Noting intensity of cancer clinical trials, research nurses began more extensive telephone follow up
Minor violations appeared to be decreasing
Fargo CCOP planned to continue support of the Research Nurse role
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Cooper & Lomax (1989)
Cooper, J. & Lomax, J. (1989). The role of the research nurse in clinical trials. British Journal of Clinical Practice, 43(5), 167-168.
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Seguin (1990)
Seguin, D.A. (1990). My role as a research nurse coordinator. Critical Care Nursing Quarterly, 12(4), 39-44.
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Seguin (1990)
Emergency Trauma Center Research Nurse Coordinator
Harborview Medical CenterSeattle, WashingtonDescribes herself as “”the Ms. Fix-It, the legs,
the brainstormer, the diplomat, and chief ice-breaker” of a study initiated in 1988 looking at the effect, if any, of alcohol on traumatic injuries and the subsequent care of these patients and outcomes.
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Seguin (1990)
Wears many hats in “new role”Using computers for first time, competing
for 2 computers in the ER to get lab results Research process and nursing process
are similar. Therefore studies would benefit from a nursing consultant
Being positive & maintaining a friendly, helpful attitude while showing interest in other’s work always pays off
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Isaacman & Reynolds (1996)
Isaacman, D.J. & Reynolds, E.A. (1996). Effect of a research nurse on patient enrollment in a clinical study. Pediatric Emergency Care, 12(5), 340-342.
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Isaacman & Reynolds (1996)
Purpose: To assess the effect of adding a shared research nurse on patient enrollment in an ongoing clinical study
Setting: Urban Pediatric Emergency Department
Results: Enrollment was 14% in the year before the research nurse was added. Increased to 50% in second year after research nurse was added (p<0.001)
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Isaacman & Reynolds (1996)
Conclusion: “With major changes occurring in health care, it is reasonable to assume that academic institutions will be faced with an increased need to develop methods for greater cost-effectiveness in the area of clinical research. We believe that the addition of a research nurse, as described in this report, not only maximizes efficiency but also adds a valuable dimension to the research effort” (342).
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Pelke & Easa (1997)
Pelke, S. & Easa, D. (1997). The role of the clinical research coordinator in multicenter clinical trials. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 26, 279-285.
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Pelke & Easa (1997)
“To help the neophyte CRC understand the complexities of this role and to share practical ideas, based on our institution's successful participation in 13 multicenter clinical trials during past 7 years. We also hope to clarify the CRC role for others who may encounter this role” (279).
“Few resources are available for the inexperienced clinical research coordinator to use in implementing a multicenter clinical trial (279).”
Associates of Clinical Pharmacology offered first certification examination in 1992. About 850 certified as of 1997. Nursing experience helpful, but not essential, depending on the complexities of the trial.
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Pelke & Easa (1997)
Qualities of ideal CRCDetail orientedGood problem-solving skillsAble to create a “climate of inquiry”Motivate staff to cooperate and participate in
current projects and develop their own research potential
Earn respect and cooperation from careful, attentive negotiation and consultation as well as skill demonstration
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Pelke & Easa (1997)
Major stressors of CRCsManaging project budgetHiring and supervising personnelGaining access to subjectsPhysical fatigueEmotional distressAdequate supplies, clerical support and office crucial to
the CRC’s success CRC must develop an interdependent working
relationship with the study’s principal investigator
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Fish (1997)
Fish, L.C. (1997). Special focus: The role of the clinical research nurse. Massachusetts Nurse, 67(5), 8,12.
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Fish (1997)
“Clinical research nurses are registered nurses who are members of a research team headed by a principle investigator who is most often a physician, but may be a scientist (physiologist, pharmacist, psychologist, nurse)” (8).
Role practiced in various ways: Identifying & recruiting research subjectsCollecting and managing dataCoordinating study, directly or indirectly delivering patient
careExperienced research nurse may participate in writing
grant proposals, presenting papers, and publishing in peer-reviewed journals
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Fish (1997)
“According to the five levels of nursing proficiency defined by Patricia Benner, the effective clinical research nurse practices at Level IV (proficient) or Level V (expert)” (12).
“Opportunities for career advancement (and points of negotiation with the principle investigator) are authorship, paper presentations at local and national professional meetings and funding for graduate education or courses in statistics” (12).
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Margitic & Miles (1998)
Margitic, S.E. & Miles, N.L. (1998). Ten Commandments of successful trial management. Preventive Medicine, 27, 84-92.
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Margitic & Miles (1998)
“This report focuses on key management and operational issues with which experienced trial personnel are very likely familiar, but which have not been comprehensively documented in the literature” (84).
Note that poor trial management can lead to recruitment repercussions, premature trial closure, compromised data quality…which can effect investigators’ future ability to gain grant funding
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Margitic & Miles (1998)
1. Thou shalt know and follow the rules2. Thou shalt know and fulfill thy roles3. Thou shalt meet thy commitments4. Thou shalt collaborate5. Thou shalt communicate6. Thou shalt document7. Thou shalt honor thy participants8. Thou shalt keep they participant’s secrets9. Thou shalt revere thy data10. Thou shalt know and accept thy limitations
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Margitic & Miles (1998)
General roles of the trial coordinator Clinician Research professional Administrator Fiscal specialist Recruitment coordinator Liaison Team leader Educator Counselor and confidante Strategic planner Arbitrator Resource person
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Melliza & Woodall (2000)
Melliza, D.M., & Woodall, M. (2000). Radiofrequency ablation of liver tumors: The complementary roles of the clinic and research nurse. Gastroenterology Nursing, 23(5), 210-214.
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Ocker & Pawlick-Plank (2000)
Ocker, B.M., & Pawlick-Plank, D.M. (2000). The research nurse role in a clinic-based oncology research setting. Cancer Nursing, 23(4), 286-292.
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Ocker & Pawlick-Plank (2000)
Describes how the role of clinic research nurse was integrated into Marshfield Clinic, Marshfield, WI
“Critical to have research personnel with an appropriate skill mix to ensure that clinical trials are conducted safely and effectively, while scientific integrity is maintained” (286).
Notes that as early as 1982, Hubbard discussed integration of research into the ambulatory care nurse role
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Ocker & Pawlick-Plank (2000)
Literature review proved to be a challenge because of lack of journal articles
Research nurse rolesEducator—staff and potential subjects via
informed consentPatient advocateProtocol manager—managing protocol and
protocol-related activities
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Kragt, de Boer-Dennert, Bruggeling et al. (2001)
Kragt, K., de Boer-Dennert, M., Huisman, C.A.M., Suur, M.H. (2001). Research nurses in the Netherlands. Applied Clinical Trials, 10(6), 98-101.
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Kragt, de Boer-Dennert, Bruggeling et al. (2001)
Dutch Research Nurse Profile Working GroupGoals
Draft an unambiguous profile for research nurses based on 2 surveys
Clarify the expertise of research nurses Promote the systematic education of research nurses
Questions How did the research nurse evolve? Who is the research nurse? What are his/her responsibilities? What the knowledge, skills, and attitudes required.
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Kragt, de Boer-Dennert, Bruggeling et al. (2001)
“Therapeutic experiments and clinical research at the end of the 19th century led to the systematic development of new drugs and medical interventions. For the most part, research took place at the patient’s bedside and always required the tacit involvement of nurses” (99).
In Europe, the extent of nurses’ involvement in clinical trials poorly documented and often not recognized
In The Netherlands, research nurses are specialized nurses—qualified to provide individual health care—who deal with the correct and safe execution of all phases of clinical trials in various organization
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Kragt, de Boer-Dennert, Bruggeling et al. (2001)
ResponsibilitiesExecution of part or the whole of the trial
according to applicable guidelinesProtection of the physiological, psychological,
social, and emotional integrity of research subjects
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Trocky (2001)
Trocky, N.M. (2001). The journey to becoming a research nurse. Clinical Journal of Oncology Nursing, 5(4), 1-3.
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Trocky (2001)
Case studyOpportunities for nurses
Research nurseData managerProtocol treatment nurse
Oncology nurse administrator’s journey to becoming a research nurse Initial role transitionApplying new knowledge to practiceTaking action to direct professional performance
Self-directed learning
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Raja-Jones (2002)
Raja-Jones, H. (2002). Role boundaries—research nurse or clinical nurse specialist? A literature review. Journal of Clinical Nursing, 11, 415-420.
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Raja-Jones (2002)
Looked at role boundaries between clinical nurse specialists and clinical research nurses working in breast cancer care
Noted an emergence of clinical research nurses within National Health Service and university departments
No relationship identifiedNoted dearth of literature regarding role of
research nurse
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Legge, S. (2003)
Legge, S. (2003). The research nurse in orthopaedics. Journal of Orthopeadic Nursing, 8, 20-24.
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Legge, S. (2003)
Describes her role as a research nurse at two London hospital sites for an international orthopeadic study looking at long-term effects of total-hip and total-knee replacements (10 year study)
Typical day—every day is different Identifies role issues
Space to see patients Can’t order x-rays Doesn’t have office at one site Room for storage of data
Self-directed learning for professional development
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Ehrenberger & Lillington (2004)
Ehrenberg, H., & Lillington, L. (2004). Development of a measure to delineate the clinical trials nursing role. Oncology Nursing Forum, 31(3), 64-68.
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Ehrenberger & Lillington (2004)
Wanted to identify the significant dimensions of the clinical trials nursing role and to construct a reliable and valid survey instrument to reflect these dimensions
Developed Clinical Trials Nursing Questionnaire (CTNQ)
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Bird & Kirshbaum (2006)
Bird, J., & Kirshbaum, M. (2006). Towards a framework of advanced nursing practice for the clinical research nurse in cancer care. Clinical Effectiveness in Nursing, 9, 161-171.
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Bird & Kirshbaum (2005)
Bird, J., & Kirshbaum, M. (2005). Towards a framework of advanced nursing practice for the clinical research nurse in cancer care. Clinical Effectiveness in Nursing, 9, 161-171.
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Bird & Kirshbaum (2005)
Literature reviewAnalysis of published frameworks of
advanced practice in nursingLocates clinical research nursing within
the context of cancer care as advanced practice nursing
Develops proposed holistic model with the caring/helping role in the center
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Bird & Kirshbaum (2005)
Role aspects that encircle caring/helping roleCounselingCritical thinkingManagementTeamwork and coordinationTeaching/EducationCommunicationKnowledgeClinicalAssessmentLeadership
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Bird & Kirshbaum (2005)
Suggests that clinical research nursing has potential to be, but is not necessarily, advanced practice
If so, would have implications for workforce development and education
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Hill & MacArthur (2006)
Hill, G., & MacArthur, J. (2006). Professional issues associated with the role of the research nurse. Nursing Standard, 20(30), 41-47.
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Hill & MacArthur (2006)
Findings of 2 studies 2002-2003 Scotland
Aim: develop profile of research nurses working in the then Lothian University Hospitals NHS Trust (n=108) & to explore related professional issues
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Hill & MacArthur (2006)
Respondents involvement in research process (study 1, n=72)Development of protocols 50%Delivering presentations
36%Contributing to publications 31%Contributing to funding applications 25%Developing studies - nursing practice
15
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Hill & MacArthur (2006)
Identified isolation as a professional issue in literature review (Study 2)
Strategies for coping with isolationDiscussion with clinical colleagues 69%Contact with other research nurses 48%Support from manager 14%Couldn’t find strategy 10%
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Spilsbury, Petherick, Cullum et al., (2008)
Spilsbury, K., Petherick, E., Cullum, N., Nelson, A., & Mason, S. (2008). The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing, 17, 549-557.
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Spilsbury, Petherick, Cullum et al., (2008)
The role of clinical research nurse (CRN) recognized by the Royal College of Nursing
No scientific studies of the CRN found in literature review.
Study aims:ExperienceObservations of care
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Spilsbury, Petherick, Cullum et al., (2008)
Loss of role confidence during transitionIsolation Tension between role as ward nurse and
research nurseLack of co-operationLack of supportWaning motivationDocumentation burden
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Granda, Duane, Munz, & Cannon (2009)
Granda, S.E., Duane, C.G., Munz, D.C., & Cannon, J.C. (2009). A study of factors leading to turnover intentions in clinical research coordinators. The Monitor, 23(5), 55-60
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Granda, Duane, Munz, & Cannon (2009)
Retention of CRCs is an issueMajority of CRCs have fewer than 3
years of experienceGoal: to increase understanding of
the turnover process in CRCs and identify points of intervention that managers
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Granda, Duane, Munz, & Cannon (2009)
Work Context Factors Promotion opportunities Formal training Assistance in workload
Emotion-Related Factors Personal accomplishment Depersonalization Emotional exhaustion
Work Context Factors Autonomy Resources Workload
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Granda, Duane, Munz, & Cannon (2009)
Found a relationship between promotional opportunities, autonomy, personal accomplishment, work experiences, and turnover intentions.
Suggested actions to decrease turnoverDevelop career ladderIncrease autonomy, design the CRC role so
that it includes the freedom to make decisions and work independently
Incentives
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Discussion
What do we know?What are we doing? What else can we do?