Nurse orientation program creates continuity in training
Nurse orientation program creates continuity in training
Formal program ties together many loose ends
Before the University of Texas M.D. Anderson Cancer Center in Houston, TX, began its comprehensive, centralized, clinical research (CR) nurse orientation program in January, 2008, there were dozens of CR sites handling training in their own ways.
"We left it to the departments to orient research nurses," says Susan Frisbee-Hume, MS, RN, AOCN, CCRC, program manager of research education and regulatory management.
"Some did a fabulous job of training, and others would hand research to nurses on day one and leave it to nurses to figure out the job," she adds. "It could be frustrating for them."
An estimated 95% of the nurses are new to both research work and oncology, so there's a steep learning curve, Frisbee-Hume notes. "For the research nurses, in addition to research training, the division of nursing provides a three-week orientation and extensive introduction to oncology including on-line modules," she adds.
There were efforts to provide CR nurse orientation years earlier, but this training was limited and provided no follow-up to nurses, who would return to departments where they often wouldn't have preceptors assisting them, says Kristin Bialobok, MSN, CCRA, RN, director of research education and regulatory management.
"Then in 2007, we put together a proposal based on satisfaction surveys, staffing turnover, and other factors to look at what we could do to put a more formal process in place," Bialobok explains.
The program now has three educators who are assigned to specific departments where they assist with developing orientation programs for those CR sites.
"We use a combination approach," Frisbee-Hume says. "We have classes that new research nurses attend and we have educators and preceptors meet regularly with CR nurses to see what progress they're making and to see which gaps we could fill in."
The orientation program was developed with input from a clinical research nurse committee, which helped to write standard operating procedures (SOPs) for orientation, she adds.
The SOPs are comprehensive and, also, specific to the department's needs, Bialobok says. "We asked them to submit their SOPs to a subcommittee so we could make sure all the necessary elements for training research nurses were there."
Most of the SOPs are similar, but they are customized to each department's needs, she adds.
"That was part of the reason we have educators assigned to departments so the educator can learn how that department works and so the department gets to know the educator," Bialobok says.
"The SOPs include the assignment of a preceptor for each new nurse," Frisbee-Hume says. "We implemented a program to make sure preceptors are trained in adult learning principles and are aware of all learning resources available to them."
M.D. Anderson has 34 different clinical departments involved in research, and they range in size from having one research nurse to having a staff of more than 30 nurses, Frisbee-Hume explains.
From September, 2008, to the end of February, 2009, the institution had oriented 41 new research nurses. There were 87 new research nurses who had gone through the program in all, Bialobok says.
So having a preceptor model is the answer to the challenge of providing an orientation program that works well for everyone, she adds.
"We match departments with a preceptor who understands that site's disease process that research nurses will need to learn," Frisbee-Hume says. "Most of the time the preceptor is a research nurse who works in that department and is identified as being an expert in that department who can help the new person understand what needs to be done."
Educators provide the basic orientation information through five half-day classes, Bialobok says.
"Last January we worked with a consultant and revised existing classes, which were very didactic," she explains. "From feedback we found that nurses weren't getting the information they needed on how to apply the information."
The restructured educational sessions provide more exercises and case studies.
Day by day curriculum
The research nurse training classes include a calendar that might look like this:
- Day 1: Research overview, federal regulations, research ethics and the IRB, scientific integrity, FDA inspections, investigational new drugs;
- Day 2: Informed consent overview, informed consent for vulnerable populations, informed consent process and documentation, conflict of interest, intellectual property;
- Day 3: Protocol writing, tissue bank overview, protocol review and approval, overview of adverse events;
- Day 4: Adverse events, serious adverse events, information security;
- Day 5: Lab procedures, investigational pharmacy, audits, and overview.
Also, there are segments on introduction to clinical trials, elements of a protocol, source documentation, principal investigator overrides (waivers), SOP for deviations/violations, and regulatory binders.
The lectures are followed up with some hands-on work.
For example, adverse events have to be reported in a particular way, and nurses learn how to do so from the lecture, Bialobok explains.
"We teach them how to document AEs, and then on a different day we have them come back and meet with a group and complete an AE form," she adds.
"We want them to know how you identify whether something is a serious adverse event and what the common mistakes research nurses make are," she says. "They also talk about real scenarios that nurses have in the clinic."
The educator and manager meet for about an hour with the research nurse every couple of weeks for the first three months to make sure the preceptor and new nurse are progressing as expected, Bialobok says.
The orientation process lasts three to six months, depending on how quickly the new nurse learns the job, Frisbee-Hume says.
"The first month is spent in the classroom, and the second and third months provide them with increasing exposure to clinical trials," she says. "By the fifth month, they're more independent, but the preceptor is available to them for back-up assistance."
The orientation program has been incorporated into the research organization's infrastructure, Bialobok says.
Although the program's outcomes have not yet been tabulated, anecdotal evidence suggests that it has been successful, Frisbee-Hume says.
"We have gotten great feedback from supervisors and preceptors, who feel much more supported in their efforts to get nurses up to speed," she adds.
One goal is to expand the orientation program to research coordinators, Bialobok notes.
"We wanted to get our feet wet with nurses first because we have such a large population of them at M.D. Anderson," Frisbee-Hume adds. "But once we're over the learning curve our next goal is to expand the research orientation program to coordinators."
Coordinators can attend the nurse orientation classes, but they are not provided receptors on a formal basis, although some departments might assign mentors, Bialobok says.
A side benefit of the orientation program is that it provides an additional incentive for prospective new hires by ensuring them they'll have marketable skills when they decide to leave the institution.
"The competition for nurses is fierce," Frisbee-Hume says.
"Research nurses who come from M.D. Anderson and are able to do research and oncology are appealing to other research institutions," Bialobok says. "So the fact that a lot of our nurses have training in both of these areas makes them ultra appealing to the outside."Before the University of Texas M.D. Anderson Cancer Center in Houston, TX, began its comprehensive, centralized, clinical research (CR) nurse orientation program in January, 2008, there were dozens of CR sites handling training in their own ways.
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