Clinical Care and Research Nurse Program (CCaRN)
The primary mission of the Clinical Care and Research Nurse (CCaRN) position is to facilitate excellent clinical research in our emergency medical system by providing on sight 24/7 clinical trials screening, enrollment and protocol support for the least expense. This innovative program was conceived and implemented by Dr. Denninghoff two years ago and provides for superior clinical trials screening, enrollment, execution and follow up. Since implementing this program, we have moved into the number one position in trial enrollment in three major trials (ProTECT III, Think Symptoms and INTREPID). A review of our electronic medical records over an 18 month period showed that we had not missed screening any potential patients for these trials during active study enrollment.
The program is so successful because a CCaRN is covering each of the two campus Emergency Departments (ED) for all shifts, every day of the week. When there are no research activities to complete, the CCaRN provides clinical support to the ED. This clinical support does not include being a primary nurse for any particular patient(s), but rather the CCaRN functions as a float nurse assisting the ED staff nurses with patients. While working clinically, the CCaRN is easily able to identify patients that may be research candidates, screen them for the trials that are underway and approach them for consent according to protocol. This innovative shared-staff model permits real-time on sight in person screening of all patients admitted to the ED, as well as identifying those patients meeting pre-defined screening criteria in triage. The cost of this innovative program is offset by clinical care revenue generated when the CCaRN is compensated for documented time spent providing patient care services.
There are CCaRN Managers who supervise the CCaRNs providing both day-to-day oversight and covering some of the CCaRN shifts each week. These administrators are registered nurses (RN) who have excellent clinical skills and additional research training facilitating their function in both roles while working in the ED. The CCaRN managers are responsible for maintaining regulatory compliance, reviewing patient enrollments, contacting research patients for follow-ups, scheduling visits, etc. Other shared duties include providing initial and ongoing training, mentoring, problem-solving, and auditing. The leadership team is available to the CCaRNs at all hours, and the CCaRNs routinely contact leadership for guidance on a variety of issues ranging from triaging research subjects, to double-checking subject eligibility for a clinical trial. The CCaRN is skilled at emergency nursing care, and functions in a float nurse role for the majority of his/her shift. The CCaRN’s primary research duty is to evaluate, enroll and monitor subjects in research trials for the ED and ICU. CCaRNs are trained in obtaining research informed consent via an online program and by working in the ED with a CCaRN manager until passed off on this activity. In addition, research consent training includes a theory portion with a manager. All CCaRNs are trained on each protocol and need to pass a quiz at the end of training to assure competency. The CCaRN is current in all necessary and appropriate certifications including Human Subjects Protection through Collaborative Institutional Training Initiative (CITI) courses on responsible research conduct, health information privacy, and basic biomedical research. All of the CCaRNs received specific training regarding the protection of vulnerable and at-risk populations who participate in clinical trials. They are extensively trained in the process of both informed and Exception From Informed Consent (EFIC), and are familiar with the protocols for all ongoing trials.
The CCaRN communicates daily with nursing leadership, surgical specialist teams and intensivists to identify and screen patients for any of the current research protocols. These interactions may also focus on coordinating trial specific treatment protocols for enrolled subjects. The CCaRN deploys the correct protocol, with the correct patient, at the right time per protocol driven requirements. This includes daily research follow up and tasks while the patient is hospitalized. Subjects are followed while in the hospital being monitored as required per protocol. The bedside nurse is encouraged to use the CCaRN as a resource should any questions arise during the study subject’s stay in the hospital. Research notes can be charted in the electronic medical report and the CCaRN is responsible for consistently refreshing protocol specifics with affected bedside nurses and physicians.
The majority of the CCaRN’s time is spent providing direct patient care on a float basis (not taking a patient assignment). While working clinically, the CCaRN is able to identify patients that may be research candidates. The CCaRNs are a very highly valued resource in the ED because they can be used for just-in-time care capabilities and flex to fill needs as the ED Charge Nurse sees fit. Tasks are accounted for on a shift report, listing time spent on each task including patients screened, enrollments, training, and clinical work.
The CCaRNs are supported in the ED by research assistants who are volunteers with the Research Associate Program (RAP). The RAP volunteers receive basic study training, and Human Subjects Protection and Privacy training through CITI. The function of the RAP volunteer is to identify possible study participants through discussion with hospital staff, by direct observation of the ED, and by visual evaluation of ambulance patients as they arrive. When the RAP volunteer identifies a possible candidate, they alert the CCaRN. The CCaRN continues the screening process and the RAP volunteer assists with appropriate trial-related tasks. The RAP volunteers also conduct quality improvement projects and participate in local investigator trials. Their time requirement is 16 volunteer hours per month. In addition, the DEM has two research specialists supporting daily study activities and follow up of subjects. These individuals work to make sure data is entered in a timely fashion and to flush out any problems early. They also work with study site monitors in regular review of study data collection. They assist with organizing regulatory documents for the individual trials. They have human subjects and HIPAA research training and have significant clinical trials experience.
Research interns are volunteers who work 20 hours each week for at least 9 months. These highly committed individuals assist with our local investigators supporting their projects. They complete chart reviews, data entry, create spreadsheets, and enroll patients. They also have human subjects and HIPAA research training. At times, they are assigned to a clinical trial and assist with data extraction.
Finally, a “backup” system has been implemented for specific clinical trials to ensure that when a patient was randomized into a labor-intensive study, the CCaRN would be able to quickly resume screening. Research Technicians provide support for the CCaRN during the initial phases of the treatment protocols. The Research Technician has completed CITI Human Subjects Protection and Privacy training, as well as training and testing on the consent process and protocol details. The Research Technicians can perform data collection, assist with documentation and expedite timely interventions needed for emergency trials. When a CCaRN randomizes a patient into a complex clinical trial, an on-call Research Technician is called in from home to assist with protocol implementation.. The entire team is supported by the CCaRN program PI (Dr. Denninghoff), one Manager, four Assistant Managers and two full time research coordinators. In summary, the CCaRN is the point person identifying, screening, and enrolling potential research candidates. RAP volunteers assist in locating potential candidates and assist in screening and randomization when relevant, and Research Technicians expand enrollment capacity by assisting with protocol based activities. Primary oversight of the trials is performed by the Program PI and the site PI(s). The combination of this research team provides a strong infrastructure to enroll the greatest number of patients into clinical trials while minimizing costs.
We developed a questionnaire for the States of Arizona and New Mexico that allowed us to complete our community consultation and public disclosure activities for RAMPART and ProTECT III with exceptional efficiency. This approach allowed us to add four additional sites for ProTECT III without incurring prohibitive expenses. The questionnaire results and analysis by an outside research firm provided a detailed report on the attitudes that the population we serve have toward EFIC research. We have developed a strong relationship with our IRBs and have been able to utilize their expertise to reach out to new sites and improve the review, approval and oversight processes at all our spokes.