Implementing TMIST at Your Site: The UNM Experience

Launching a large clinical trial can present challenges for the research staff and physicians at any site. With that in mind, Reed G. Selwyn, PhD, DABR, Vice Chair for Research and Imaging Sciences, and his team at the University of New Mexico (UNM), outline below how UNM (NM004) started their TMIST participation.

While different institutions and settings of care may use different approaches, the TMIST study leaders will continue to share with the TMIST community tactics and strategies that are working for your TMIST colleagues. We hope that you will consider implementing these or similar methods at your site to optimize your participation in the trial.

Selecting the team

The first step was to identify the key stakeholders from each institution and department. This was the only way we were able to move TMIST forward. We called on the following institutions and departments to execute this trial:

UNM Comprehensive Cancer Center (principal investigator, research coordinators, regulatory team, clinical trials office)
UNM Department of Radiology (medical physics, radiologist lead, lead imaging research technologist, informatics, research coordinator)
UNM Hospitals (mammography supervisor and technologists, mammography schedulers, radiology executive director, radiology modality directors, radiology scheduling supervisor, radiology registration supervisor)

UNM’s TMIST Team. Back row (L-R): Tabitha Kirkendall, MPH; Jesse Bock, BA; Meaghan Carey-Eiland, DNP, RN, CEN, NE-BC; Sariat Ibrahim; Chandra Gerrard, MPH, BS, RT(R)(CT)(MR)(QM); Ursa Brown-Glaberman, MD; Raina Mendoza, BS, RT(R)(M), ARRT. Front row (L-R) Reed Selwyn, PhD, DABR; Eli Torrez; Aide Atayde-Law, RT(R)(M); Jennifer Saline, MD; Karen Roybal, Clinical Analyst II; Wendy Hine, PhD, MS, MBA. Photo Credit: RuthAnne Bump

Image transfer

The mammography department performing the TMIST imaging is located at an outpatient center, thus it was imperative to develop a process to electronically transfer data without using removable storage devices such as external USB, CD, or DVD

Working with the TRIAD team and vendor (Hologic) support, our site was able to identify the necessary transfer rules on the Hologic units, which allows our site to be able to transfer both the raw and processed data directly to our TRIAD computer

Our site instituted a Virtual Desktop Client (VDC), which allows users from multiple university locations to access TRIAD remotely, without having to go to a physical location. The UNM IT security division had to review the VDC prior to installation.

Identifying participants and workflow

Our site performs many screening mammograms per week, so a method to identify participants several weeks in advance and initiate the screening and recruitment process was necessary

We created an automated schedule report in the Electronic Medical Record (EMR, Cerner), which provides participant data to cancer center research coordinators on a weekly basis for chart reviews. These reports are tailored to include the approved mammography rooms (two of four), the approved days of the week for TMIST subjects, and are sent out far enough in advance (~three weeks), so the cancer center research coordinator will have time to screen and make contact with potential participants.

The UNM Comprehensive Cancer Center developed standard operating procedures for mailing the TMIST packet with the introductory letter and informed consent document, as well as procedures for consenting women by phone. While we are finding same-day consent and randomization to be more successful than the phone method, the flexibility of either in-person or phone consenting is valuable.

Since our site has radiology research coordinators and imaging technologists transferring the data from an off-site location, we developed a TMIST participant email template with required information for randomization and image transfer

The subject of the email includes the acquisition day, which is proving to be extremely helpful for tracking data and ensuring that all data is transferred

Imaging workflow

We had originally developed an internal guide for adding randomization information to the mammography order. This was for the radiology research coordinators to use in the EMR. This process required all randomization information to be available to radiology at least 72 hours prior to the person’s scheduled exam. This became cumbersome and difficult for the cancer center research coordinator to execute in the ~three-week timeline. After several months of slowly ramping up the number of participants, we moved to a more streamlined ‘same-day’ workflow.

Same-day workflow

Same-day workflow allows participants to receive randomization by cancer center research coordinators on the day of their scheduled mammogram. The cancer center research coordinator completes an index card with the randomization information, escorts the participant to the mammography department and works with the mammography schedulers to add the randomization information into the Cerner system. The cancer center research coordinator hand-delivers the index card to the mammography technologist so they have a visual queue that the patient is enrolled in TMIST.

Radiologist dictation workflow

In order to capture the required dictation language for T0 baseline TMIST screening mammograms, and the subsequent study screening mammogram studies, our lead radiologist developed a unique TMIST dictation template within the PenRAD system for radiologists. This template allows the radiologist to include the required language in the final read.

There are additional data elements that need to populate the mammography dictation (time-point, randomization arm, etc.). At our site, the radiology technologist coordinator worked with the mammography supervisor and lead radiologist to identify where in the EMR the TMIST information had to be entered. Once this field was identified, the mammography supervisor educated the technologists about how to collect the EMR information and where to add it into the PenRAD system. This now provides the required randomization language in the dictation and removes the requirement of the radiologist having to: 1) find this information and 2) dictate this information into the report.

TMIST studies are flagged in the PenRAD system, by a color-coding method to ensure the radiologists can easily identify which studies belong to TMIST. This reduces the possibility of a non-TMIST radiologist selecting a TMIST exam.

We are currently implementing two new unique mammography orders in the EMR Radiology Information System (RIS). One will identify the 2D TMIST exams and the other will identify 3D TMIST.

Ongoing QC

Due to the nature of the quality control (QC) requirements, we credentialed only two of the four departmental mammography rooms. This was decided early on in our feasibility meetings with the lead radiologist and mammography supervisor. Our site developed a comprehensive ‘Mammo Tech QC guide’ for the Hologic units. These instructions now include the step-by-step process for when and how to perform the QC and how the mammography technologists can successfully transfer the images to TRIAD.

For the radiology research side, we developed a guide on performing the image grading QC for the weekly image scoring and the process of recording the monthly QC results. The weekly and monthly QC results are now communicated to key personnel of the cancer center, radiology department, hospital system and regulatory department.

Editor’s Note to Participating Sites: Through the new quarterly e-newsletter, the TMIST team will continue to bring to 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 contact the TMIST staff at gro.rcanull@TSIMT.

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