Carle and Gulf South Adopt Different Approaches for Successful TMIST Accrual
From the Third Quarter 2019 TMIST Study Updates Newsletter
Posted October 15, 2019
TMIST’s Carle Cancer Center in Champaign-Urbana, IL, and Gulf South Clinical Trials Network’s site in New Orleans, LA, may rank among the trial’s top accruing sites, but they have adopted very different strategies to become successful.
For Carle, TMIST coordinators Tracy Sharp and Samantha Wright say the secret lies in the response of potential subjects to either letters sent via mail or electronic invitations transmitted to them with the help of their electronic health record (EHR). Women typically receive these invitations up to 10 days in advance of their scheduled screening mammography.
For Gulf South’s effort, Eileen Mederos, RN, program manager of Louisiana State University (LSU) Cancer Clinical Trials, says they maximize accruals using an in-person approach. They invite potential subjects to volunteer in the time between their arrival at the facility and their scheduled mammography.
Careful planning, teamwork and a commitment to success make up the common factors that bring the two programs into the top ranks for accrual. Both efforts appreciate the trial’s intricacies and the need to integrate the protocol into normal screening mammography routines.
Carle ranks first among all accruing TMIST trial sites in the National Cancer Institute (NCI) Community Oncology Research Program (NCORP), with 933 patients as of October 1, 2019. University Medical Center New Orleans, a main affiliate in the Gulf South network, ranks fifth among all accruing NCORP sites, with total TMIST accrual of xxx as of October 1.
These performances demonstrate that positive measures of success are possible regardless of which carefully considered and validated approach you take.
Success at Carle Cancer Center
At Carle, much of the daily responsibility for TMIST falls to the coordinators. At the main campus, the job falls to Sharp, while Wright administers a similar program at the Carle Clinic Fairchild in Danville, IL. Twenty to 30 patients per month enroll in TMIST at Carle’s main campus. Another five patients per month join at Danville.
In a phone interview, Sharp outlined the coordinators’ extensive duties, which include recruitment, protocol oversight, data management and serving as the trial’s liaisons with the mammography department. In addition, they assist with many of the more than 100 other cancer-related trials at Carle.
Wright and Sharp (pictured at left) count among their assets the presence of on-site mammography services at both facilities that make it relatively easy to communicate with patients and staff.
Support of their physicians and staff is also vital. “They help us out with whatever we need,” Sharp said.
In response, the two coordinators do as much as they can to make “everything flow easier and to take the burden off the physicians and mammography staff,” she added.
Assigning scanners for newly enrolled subjects is simple because each of the four systems at Carle can perform either 2D or 3D imaging. Mammography technologist Shelly Steward and technologist specialist Jolene Duckett are well-versed in TMIST and, like other staff members, work closely with trial coordinators.
“This includes the women who escort patients to the room for screening,” Sharp said. “They inform the breast tech which kind of mammogram the patient must receive. It is their responsibility to make sure the images are transmitted to the secure exchange so they can be submitted to the TMIST team.”
Efficiencies from Carle’s EHR are another advantage. The EHR generates and transmits electronic letters to about 120 women each week who have upcoming screening mammography appointments. For women who express interest, the coordinator contacts them by phone to tell them more about TMIST.
The next step depends upon the trial candidate’s specific needs. They can either read and sign the necessary consent forms and be randomized to 2D or 3D mammography in the hour before their scheduled screening, or they can choose to visit the breast imaging center on any day leading up to their mammogram. Sharp says they want to make it as easy and convenient as possible for the patient. While she devotes most of her time to TMIST, five or six coordinators are trained to enroll patients in the trial.
“We do not have to turn any patient down because one coordinator is busy with another patient,” Sharp said. “We always have the flexibility to help one another out. That has a lot to do with our success. It is definitely a team effort.”
Carle’s full-time, EHR system administrator lead, Megan Cornwell, helps make the most of the technology to assist accrual. It generates reports to identify patients that have yet to be contacted, patients that have yet to respond and the status of patients in the trial.
Though Carle staff is not allowed to make cold calls, an upcoming enhancement will allow them to send electronic letters to thousands of patients in the facility’s service area with a push of a button, according to Wright.
Success at University Medical Center New Orleans
Careful planning led the TMIST staff in New Orleans in a different direction from Carle. In April 2018, the network assigned the Mary Bird Perkins sub-affiliate site, Woman’s Hospital in Baton Rouge, responsibility for bringing TMIST to Louisiana. After eight months of patient accrual and testing, the lessons learned there were applied when TMIST opened at the University Medical Center in New Orleans. A third TMIST site opened later at the LSU Health Science Center in Shreveport.
Now, the New Orleans site enrolls an average of 48 new patients per month. Eileen Mederos credits radiologists Mignonne B. Morrell, MD, and Brooke L. Morrell, MD (no relation), for being the driving forces behind TMIST’s success at University Medical Center.
“Without them, we would have gone nowhere. You’ve got to have the physicians behind you,” Mederos said in an interview.
They took a team approach to bring everyone involved in mammography to the table, including clinic managers, radiologists, mammography technologists, and waiting room and scheduling clerks. Together, they dissected their clinical processes to identify ways to conduct the clinical trial without disrupting workflow.
The University Medical Center New Orleans TMIST Team is pictured here. From Left: Gwendylon Craig-Frit, Remi Coleman, Brooke L. Morrell, MD, Mignonne B. Morrell, MD, Taylor Mathis, Wendy Feehan and Hannah Cheramie
Eight months of experience at Woman’s Hospital in Baton Rouge showed the TMIST leadership team that letters and phone calls to women scheduled for screening mammography would not draw an adequate response in New Orleans. Direct patient interaction was deemed necessary, which meant that Taylor Mathis at the University Medical Center would have to meet with potential participants on the day they arrived for their scheduled mammography, to recruit them into the trial.
Arrangements were made with the departments’ breast surgeons to write the necessary same-day orders to provide 2D or 3D mammography depending on how the subject was randomized.
Augusto Ochoa, MD, Gulf South’s founder and an NCORP principal investigator worked with the Louisiana Department of Health and Hospitals to assure that Medicaid would cover tomosynthesis.
“Because of our large Medicaid population, our participation in TMIST would not have been feasible if Medicaid had not covered the test,” Mederos said.
At that time, Medicaid still required prior authorization — a barrier to same-day patient enrollment, randomization and imaging. The University Medical Center’s billing department overcame this barrier by applying a week before scheduled mammograms with the local Medicaid carrier for prior authorization to conduct digital mammography or tomosynthesis for potential subjects.
Mederos and her team also learned the importance of tracking TMIST participants from year to year and sending them reminders when it’s time to schedule their next mammogram.
“Your subscribed population can erode because some of your subjects decide to be screened at a different facility, or they forget they’ve enrolled in the TMIST trial,” she said.
While some sites in the Gulf South NCORP were unable to participate in TMIST because they provide 3D breast tomosynthesis exclusively, the others are invigorated by the fact that no other randomized clinical trial has ever attempted to measure the relative clinical efficacy of digital mammography and tomosynthesis.
“As a leading academic facility, there was never a question that we would participate in this trial,” Mederos said.
Editor’s Note to Participating Sites: Through the quarterly e-newsletter, the TMIST team brings you strategies and tactics that you might consider implementing at your own institution. We strongly encourage all TMIST site physicians and staff to consider submitting your own experiences for this regular series of helpful articles. If interested, please send an email to the TMIST staff.