Boost recruitment efforts by building up referrals
Be ready with updates and thank you's
For clinical trial enrollment success sites need to have solid, long-term relationships with clinicians who refer patients to studies.
"You need to know doctors on a colloquial level," says Pamela Normandin, RN, MSN, CCRC, clinical nurse specialist in the office of research at Iowa Lutheran Hospital in Des Moines, IA.
"What you do is mentor those relationships," Normandin suggests.
Iowa Lutheran Hospital was the top enroller for a study about a tumor necrosis factor (TNF) antibody drug to treat sepsis, and the sponsor attributed the hospital's success to the personal relationships Normandin and other clinical trial (CT) staff developed with emergency room clinicians, she says.
"We were able to tap into every sepsis patient who came in the door," Normandin says. "We enrolled 126 patients over a couple of years."
Here's how the CT site meets enrollment goals:
1. Build trust with referral sources.
Normandin met with nurses and physicians in the emergency room, attended their unit meetings, and discussed the study's goals of improving medical care for sepsis patients.
As the study began enrolling, Normandin would update emergency department staff about the study's progress and how many patients were enrolled.
"One time at a meeting I showed them a bar graph of enrollment and said, 'I was aiming for 26 patients, and you've already given me 18,'" she recalls.
"I would make cookies and bring them to the nurses and put them in the break room," Normandin says. "I'd thank them for their help and say, 'I saw how busy you are this weekend, and I know I added to your workload, so I appreciate all you've done.'"
Another way CT staff could thank referral sources is by finding something they like and having a drawing with the item as a prize, Normandin suggests.
"One time an investigator put all of the nurses' names in a hat and gave the winning nurse a critical care textbook that was worth $100," she says. "Then he bought a few textbooks for the intensive care unit and critical care units."
When a referral source is particularly helpful it's important to acknowledge this.
"I had one nurse who went above and beyond, and I wrote her a personal thank-you note," Normandin says.
These small actions make a huge difference to overworked health care professionals, she notes.
"Some [CT staff] will go to the unit and add to their workload, but they don't understand from the nurse's perspective how hard and laborious it can be to have to gather more data and to do more things because of a research project."
2. Educate referral sources about the study.
Normandin attended residency meetings to discuss the study with physicians representing various disciplines.
"I'd go to their meetings and tell them about research we're doing and the inclusion/exclusion criteria," she says. "Then I'd go through the protocol and tell them that if they thought they had a patient who could be in our study, then they should make sure it was okay with the attending physician to refer the patient."
When studies have inclusion/exclusion cards, these can be handed out to residents and other physicians to carry in their lab coat pockets, she adds.
Normandin also spoke with emergency department staff before the sepsis study began enrolling to make certain they understood the study.
She made sure they knew that the study provided an investigational treatment to patients, but this was an enhancement over the treatment they already were receiving, Normandin says.
"With sepsis patients, we'd give them the same antibiotics and treatment, but we'd add the study treatment," she explains.
Then she kept an eye out for sepsis patients as they came through the ED doors and would meet with ED staff immediately, she says.
"With sepsis, you have such a short time frame," Normandin notes. "I worked with this intensivist who also was a pulmonary specialist, so when someone was diagnosed with sepsis, the patient was referred to him, and we'd be right there."
Normandin also met with medical helicopter crews.
"We're a pretty rural state, and this is a high referral hospital, so with our trauma center we have a helicopter that's sometimes sent to pick up sepsis patients from smaller hospitals that could not manage their care," Normandin explains. "So I'd talk with the helicopter crew about sepsis inclusion criteria so they could alert the physician and say, 'Were you aware of this trial?'"
Then the referring physician would contact Normandin to request that the patient be screened for the study.
For studies where it wasn't as critical to enroll patients immediately upon ED arrival, the CT staff would wait for an ED physician to call with the referral, she adds.
"But, again, in very short time frames, I'd go down to the emergency room and do the initial screening by speaking with the patient or family," Normandin says.
3. Prepare for all informed consent possibilities.
If CT staff found sepsis patients before they lost consciousness, they could provide their own informed consent, she says.
With others, Normandin would meet with the family to discuss the study.
The CT site followed state laws regarding informed consent and family members, and this issue was discussed at lengths by the hospital's ethics group, Normandin says.
She would explain to the family how the investigational treatment would be in addition to the standard treatment and how the research could help stop the escalation of the disease.