Clinical Trial Infusion Nurse Orientation Improves Care for Patients in Investigational Studies

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Clinical Trial Infusion Nurse Orientation Improves Care for Patients in Investigational Studies
Clinical Trial Infusion Nurse Orientation Improves Care for Patients in Investigational Studies

SAN ANTONIO, Tex.—Oncology nurses at Froedtert and the Medical College of Wisconsin in Milwaukee, Wisconsin, established a clinical trial infusion nurse orientation to improve training for nurses so they can better care for patients on investigational trials, according to a presentation at the ONS 41st Annual Congress.1

Oncology clinical trials, particularly those in the early phase, are often detailed, complex, and require close attention to detail and a high level of assessment skills. The infusion nurse needs to be aware of the differences between the protocols of clinical trials and standard of care, otherwise, there may be deviations from the protocol that can impact patient outcomes and facility integrity as a compliant research site.

The oncology nurse is required to possess the knowledge to grade adverse events and understand the importance of completing research-related tasks, such as blood draws, EKGs, and vital signs, in a timely manner. Nurses are expected to communicate all patient symptoms, including those both anticipated and unanticipated, with the clinical research coordinator/nurse, the provider, and the investigational pharmacist to ensure proper ongoing patient treatment and management.

Therefore, nursing staff at Froedtert and the Medical College of Wisconsin developed an orientation for infusion nurses new to working with clinical trial participants. The orientation consisted of Human Subjects Protection and rDNA training, as well as an 8-hour workshop.

Nurses also completed competency checklists that included improving familiarity with research protocols, administration of study treatment with associated research tasks, and understanding of the full clinical trial process by shadowing the clinical research coordinator and investigational pharmacist. This 1-on-1 learning was designed to make the nurse more familiar with other clinicians' duties.

The on-unit orientation pairs the trainee with a preceptor. Trainees complete a Competency Outcome Performance Assessment (COPA) plan, which comprises a checklist with rationale and an evaluation of their performance of direct patient care and planning. Skills taught include blood draws, vital signs, EKGs, centrifuge use, performance status, and the CTCAE assessment tool.

“Training raised awareness for the vigilance required to provide safe, ethical, quality care within the requirements of a clinical trial,” concluded Judy Ranous, BSN, RN, OCN. In addition to this improved awareness, access to research nurses that were approachable and supportive promoted comfort and confidence among learners and encouraged them to ask questions and discuss situations.

“It also makes the infusion center more attractive to researchers,” Ranous said.


1. Ranous J, Riegert M, Rudnitzki T, Senovich H, et al. Clinical trial infusion nurse orientation. Oral presentation at: 2016 Oncology Nursing Society Annual Congress; April 28-May 1, 2016; San Antonio, TX.
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