Nurses Help Conduct Clinical Studies While Protecting Patient Participants

Posted in GUMC Stories

AUGUST 3, 2015—Given that medical treatment is so complex, nurses often specialize, developing expertise in intensive care, pediatric, surgical or oncology nursing, among other fields. They are certified to know just about everything about their specific field and its care.

But there is a group of nurses on the 7th floor of the MedStar Georgetown University Hospital who each specialize in dozens of disorders — the range of maladies affecting patients who participate in research studies conducted by GUMC or MedStar investigators on their Clinical Research Unit (CRU), part of the federally funded Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS).

At any given time, the five nurses on the CRU are assisting in 80-90 ongoing studies, says Shaunagh Browning RN, FNP-BC , the CRU’s nurse manager. About 90 percent of the studies are testing new drugs, and approximately half of CRU research is federally funded.

And while the nurses help investigators conduct their research, they oftentimes school investigators through the research process with a focus on the participant’s safety during study implementation, Browning says.

“Nursing on this unit is really a specialized practice,” she says. “We are meeting the needs of the study protocols while protecting participants as well. That means we are caring for both the participant and the patient — making sure that we are not doing anything in the research that would harm them in any way.”

An example is the drug study that enrolled pregnant women with diabetes, Browning says. “They spent 12 hours with us and we were drawing blood throughout the day. We had to make sure that any discomfort they had, such as cramping, wasn’t due to the agent being tested,” she says.

“In short, we needed to make sure that their pregnancy remained safe while under our care,” Browning says. “Safety is our mantra.”

A fruit basket with thanks

The disorders in clinical study at the CRU range widely, but the most common include Parkinson and Alzheimer’s disease, psychiatric disorders, organ transplantation, scleroderma, diabetes and thyroid disorders, aging, cancer of all kinds, chronic fatigue syndrome and fibromyalgia, Browning says.

While being skilled in treating multiple disorders, as well as understanding the needs of research, represents a challenge to the nursing team, the care delivered is as expert as that found on any specialty unit, she says.

Researchers agree. “The CRU staff has handled the many competing demands with grace and professionalism,” wrote Maxine Weinstein, PhD , distinguished professor in Georgetown’s graduate school of arts and sciences, in a letter to Howard Federoff, MD, PhD, then-executive vice president for health sciences at GUMC.

While working with patients enrolled in MIDUS, a national study on aging, the CRU helped Weinstein collect biomarkers to document age-related changes in key biological indicators. MIDUS-related visits to the CRU were “intensive” for the participants and the nursing staff — they stretched into the evening and began again in the early morning, Weinstein said. Still, the nursing staff balanced “the personal comfort of the participant with the protocol and record-keeping requirements for MIDUS.”

Weinstein recounted that she and her research team “frequently receive letters about their positive experience at the CRU,” from the participants and one time, a note was accompanied by a fruit basket.

The sender wanted to express his appreciation for the “emergency situation” he experienced, which was handled “so smoothly by the nurse on duty with her calm approach, and the nurse manager who determined the participant’s condition through extensive inquiry…” Weinstein wrote.

Indispensable to GUMC research

GUMC rheumatologist Virginia Steen, MD , currently has nine active studies involving scleroderma patients at the CRU. She says her experiences with the CRU nurses have been “simply wonderful.”

They soothe and smooth relations with both patients and investigators, Steen says. “I have many trials and my coordinators have no medical experience so the CRU nurses are critical to making my studies successful. They understand the absolute need for accuracy and following protocols and I never have to worry about mistakes — nothing is ever sloppy,” she says.

“They are particularly good with helping patients understand and cope with ‘doing research.’ They make the patients feel very special and not like they are just numbers in a study,” Steen says. “I couldn’t function without them!” 

“I think this CRU is really an indispensable part of any clinical research work that has been done at this university. It is so very important,” says GUMC neurologist Charbel Moussa, MBBS, PhD , who is currently conducting investigator-initiated trials of Parkinson’s disease and dementia in the CRU. He adds that he has ten years of experience working in a different hospital, “and I have never seen anything more impressive and diligent than this CRU.

“They are responsive on all levels. With investigators, they are very smart at a scientific level as well as the regulatory level. They are also very diligent with the way they treat their patients, both medically and emotionally,” Moussa says. “The CRU staff — everyone from the front desk receptionist to the nurse manager — is very compassionate and personal.”

Seeking certification

Browning believes so much in the extraordinary abilities of CRU nurses that in 2009 she co-founded the International Association of Clinical Research Nurses. One of the chief goals of the organizations is to gain accreditation for clinical research nursing. The group, which now has more than 400 members, is also writing the scope and standards of practice for this specialty nursing, defining competencies needed for certification.

The art and science of clinical research nursing are now taught within clinical research units, Browning says. “That means thousands of nurses are being taught to be clinical research specialists by other nurses without any benefit of standards or certification,” she says.

Sometimes the CRU nursing staff is recognized in published GUMC studies and one researcher named all CRU nurses as co-authors in his scientific abstract, Browning says. “That made us all feel so good. We know what we do in the world of nursing is unique — and a privilege.”

Renee Twombly
GUMC Communications