SAN ANTONIO, Tex.—Oncology nurses at Froedtert & the Medical College of Wisconsin in Milwaukee, Wisconsin, have created a research unit and trained nurses to provide high quality care to patients in oncology clinical trials, according to a presentation at the ONS 41st Annual Congress.1

“We realized that clinical trial protocols are complex and detailed and may require a different level of care,” said Theresa Rudnitzki, MS, RN, AOCNS, an oncology nurse at Froedtert & the Medical College of Wisconsin in Milwaukee, Wisconsin.

Nurses need to complete tasks in a timely manner and monitor patients with careful attention to detail. However, there was dissatisfaction with the patient care process for patients enrolled in a clinical trial in the current model of care as nurses have been unable to meet the demands of each study without an adjusted staffing ratio. Failing to meet the requirements of the clinical study can result in deviations from the study protocol.

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“We thought that training of nurses, creation of a unit, and appropriate staffing ratio would lead to: greater understanding of research protocols, greater appreciation of the complexities and idiosyncrasies of protocols, and a decrease in deviations from the protocol related to infusion nursing care,” Rudnitzki explained.

Therefore, staff at Froedtert & the Medical College of Wisconsin developed an outpatient translational research unit to treat patients enrolled in clinical trials. The creation of this program required a more conducive workflow, staff ratio, and staff education to care for this population.

Further, they developed a workshop formatted to be relevant to the translational research unit nurses, as well as an on-unit orientation, a checklist/self-assessment, and an orientation guide prior to opening the new unit. A research flow sheet was also created to document the frequent blood draws and other research related tasks.

Metric results have shown that the new nursing orientation and care model have reduced the rate of deviations in treatment infusions. Deviation data, which was collected from ONCORE, a clinical trials management system, will continue to be monitored and evaluated.

The findings ultimately suggest that specialized care with improved nurse-to-patient ratios allow nurses to complete all study-related tasks and observations, thus making it safer to care for patients participating in early phase clinical trials.

“Reducing deviations also attracts more study sponsors and increases the implementation of new and more complex clinical trials,” concluded Rudnitzki.


1. Curtis T, Rudnitzki T, Griffie J. Translational research unit: developing staff nurses and a model of care. Oral presentation at: 2016 Oncology Nursing Society Annual Congress; April 28-May 1, 2016; San Antonio, TX.