When the COVID-19 pandemic began, the Clinical Research Services Unit, North 8 was a small unit of seven people; now we are a large collaborative network that supports clinical research across the health system. Everyone who has had a hand in making COVID-19 clinical trials a success is recognized.

This includes the CDC, the FDA, our Pharmaceutical sponsors, VCU’s institutional review board, VCU’s Wright Center for Clinical and Transformational Research, our Clinical Research teams, the Clinical Research Pathology, Investigational Pharmacy, the Epidemiology department, the Teletracking team, the Clinical Excellence Team, the Director of Clinical Research, and the Director of Nursing Research and Innovation, Supplemental Staffing and inpatient nursing units including North 9, MRICU, MIICU, STICU, CSICU, NSICU, CICU, North 1/North 2, North 5, North 6, the Security Care Unit and Community Memorial Hospital’s ICU and Medicine Unit.

The North 8 team is composed of four Registered Nurses, one care partner, one Patient Access Representative, and a Nurse Manager. We are supported by the Supplemental Staffing research and oncology float pool, consisting of six Nurses that assist when there are needs in clinical research. Recently, we were able to add a Nurse Clinician to the team. Our unit is a hybrid and acts as an outpatient clinic, infusion center, and overnight observation for patients participating in research studies and clinical trials.

Like the entire world, our small unit was greatly impacted by COVID-19 in many ways and we would like to highlight the positives that have come out of COVID-19 and continue to be part of our infrastructure today.

In March 2020, the COVID-19 pandemic reached Richmond, and VCU Health was called upon to meet the increasing demands for patients. During this time, non-lifesaving research was paused and the patient volume on North 8 decreased significantly with only Massey Clinical Research Trials continuing. Our team looked to leadership for ways that we could support the organization during this crisis. Mid-March, our small team began to grow and spread throughout the hospital to support COVID-19 clinical trials. Dr. Arun Sanyal took a leadership role in the clinical trial of the investigational medication Remdesivir. When this opportunity arose, the North 8 team readily prepared to support this trial and share our expertise in clinical research with the inpatient units. We worked closely with Dr. Mary Harmon, Director of Clinical Research, Dr. Alison Montpetit, Director for Nursing Research and Innovation, the hepatology clinical research coordinators (Shawn Fenner, Rebecca Collen, and RJ Minniti), and Mary Pak, Investigational Pharmacist, to develop educational tools and just-in-time training to support this medication trial. In a matter of two days, this collaboration produced a bedside guide for Nurses that included instructions on administration investigational medications, something that was unique for inpatient Nurses. The first patient was enrolled on March 25th on the North 9 unit. The study team, Dr. Montpetit, and North 8 Nurses provided elbow to elbow support for the North 9 Nurses. In that moment, the North 8 team realized how critical their support was going to be in all of the COVID-19 clinical trials. The North 8 Nurses quickly re-arranged their schedules, to support the patients and teams throughout the organization.

As North 8 began to develop the bedside guide, it quickly became a true collaboration with the other clinical Nurses throughout the organization who were administering investigational medications for the first time. With their feedback, the bedside guide was modified multiple times. Based on daily interactions with our bedside Nurse partners, we realized that Nurses prefer hands-on training. So, over the next couple of weeks, North 8 developed a short video on the administration of investigational medications with our VCU Health marketing and video production partners, Joe Kuttenkuler and Taylor MacKillup, who were incredibly supportive. With editing assistance from Joe and Taylor, the seven-minute video demonstrated the process that is followed when administering any investigational medication.

Although North 8 team members were very flexible, we knew that Nurses would need resources at a moment’s notice. Mary Harmon added a Clinical Research section to the COVID-19 intranet site and worked with Dawn Rosenberg to create a clinical trials intranet site that included the video, nursing bedside guide, study fact sheets, and pharmacy drug sheets. Dawn was an incredible partner, uploading documents quickly increasing access for the organization.

Within weeks of the first Remdesivir enrollment, we were on track to have up to 15 different clinical trials for COVID-19 patients at VCU Health. Sarilumab and Canakinumab trials quickly followed, which required special pre- and post-infusion labs. The North 8 team collaborated with Alison Montpetit, the study teams, and Mary Pak in pharmacy to develop educational tools for the Nurses. North 8 Nurses remained with the bedside Nurses for every dose to ensure they were comfortable, especially given the added responsibility of obtaining multiple labs.

In addition to the investigational medication studies, North 8 also provided support to the convalescent plasma expanded access treatment program. The North 8 team engaged with epidemiology to support this important initiative. We supported the necessary data collection and entry so that patient outcomes could be tracked on a day-by-day basis.

Alison Montpetit worked to develop real-time tracking tools in Teletracking allowing the research teams to track patient’s location, length of stay and provide support for the units caring for the patients. The Teletracking team, Kate Bullifant, Kelley Barry, and Dale Wright, stepped up quickly to meet with the team to determine exactly what we needed and went to work creating it for us. Within a few weeks, the team had a working model for us to begin using. This allowed the clinical research team and North 8 nursing team to access records of all COVID-19 patients in one place. This became our own communication tool for COVID-19 clinical trials, which is still in use today. Not only was the downtown campus facing an overwhelming public health crisis, but our partners at Community Memorial Hospital (CMH) were also facing the same emergent situation.

Dr. Abbate, the principal investigator for the CAN-COVID trial, partnered with the intensivist at CMH, Dr. Sedhai, to offer the Canakinumab investigational medication to CMH patients. The study team, Mary Harmon, Alison Montpetit, VCUHS investigational pharmacy, CMH pharmacy, VCUHS clinical research lab, and the CMH lab collaborated to develop a plan to deliver study drug to CMH and transport required labs. The nursing plan and education were headed by Alison Montpetit and Joni Greer, North 8 Nurse Manager. Even though the downtown campus had resources available for training, they agreed that in-person training would be ideal for CMH. Joni traveled to CMH to provide real-time education and training to the nursing team and lab. Mary Hardin, Chief Nursing Officer, Melissa Black, Nursing Director, Heather Kemp, Nurse Clinician, and Clinical Coordinators, Hilary Tackett, Kathryn Spence, Juanita Turner, and a CMH lab representative all attended the session. CAN-COVID was a more time-intensive clinical trial due to the pre- and post-infusion labs and technical components of the lab draws. The nursing team was excited for the challenge and enrolled their first two patients within two days of the training. The North 8 team also coordinated the preparation and delivery of all lab kits to CMH lab through the nursing team. CMH enrolled 17 patients in this study and is eager to continue clinical research at their site.

Before we knew it, it was mid-May and “Week of the Nurse.” North 8 Nurses recognized the increased workload and dedication of the Nurses on the COVID-19 units. The unit wanted to do something for them to recognize the great work they were doing to support clinical research so we created lollipop bouquets and baskets of goodies for those units. The Nurses loved the goodies and hopefully realized our true appreciation for them. At Christmas, we gave treats again to our COVID-19 partners – we are grateful for their continuing support for our patients and families!

VCU Health has significantly contributed to the science of treatment for COVID-19 and opened critical pathways for our patients to gain access to treatments for this new diagnosis. Over 200 patients have been given access to treatment only available through participation in clinical trials. VCU Health was 11th in the world in enrollment in the Remdesivir studies and the number one enroller in the world for the Canakinumab study. These opportunities for our patients were only possible due to the extraordinary contribution of the North 8 team and larger clinical research collaborative.

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Team Members honored with this DAISY TEAM Award:

Kelley Brady, RN
Melanie Dickerson, RN
Katie Wilson, RN
Dr. Alison Montpetit
Dale Wright, RN
Mary Pak, PharmD
Henly Deutsch, RPh
Dawn Rosenberg
Joe Kuttenkuler
Taylor MacKillup
Kate Bullifant
Kelley Barry
Dr. Arun Sanyal
Shawn Fenner, RN
Rebecca Collen
Melissa Sears, RN
Benjamin Van Tassell, PharmD
George Wohlford, PharmD
Virginia Mihalick, MS
Aldo Bonaventura, MD
Alessandra Vecchie, MD
Marga Johnson, MSHA, MBA
Katrina McCray, BA
Tia Gilchrist, MSHA
Art Carpenter, BS

Community Memorial Hospital Clinical Team
Jessica Gray, MS, RN, BMTCN
Joan Greer, MSN, RN
Shelly Orr, PhD, RN, CNE
Ann Behne, MS, RN
Kim Harrison, CP
Earnestine Johnson, PAR
Kim McKee, BSN, RN
Joyce O'Brien, RN
Catherine Owen, BSN, OCN, CCRP
Dr. Antonio Abbate, Medical Director
VCU Wright Center for Clinical and Transformational Research
Crystal Crewe, DNP, RN, CMSRN
Dr. Mary Harmon
Kareesha Fitzgerald, MPH, MLS(ASCP)cm
Eddie Payne

Clinical Research Pathology
Mary Hardin, CNO
Juanita Turner, RN
Hilary Tackett, RN
Kathryn Spence, RN
Supplemental Staffing
Clinical Excellence Team
Investigational Pharmacy
Teletracking Team

North 9 Progressive Care Medicine
CCH 3 Medical Intermediate and ICU
CCH 4 Medical Respiratory ICU
CCH 9 Surgical Trauma ICU
CCH10 Cardiac Surgery ICU
CCH11 Neuroscience ICU
CCH10 Cardiac ICU
North 1 Acute Care Medicine
North 2 Collaborative Care Medicine
North 5 Comprehensive Medicine Unit
North 6 Medicine Specialty Unit
Security Care Unit
Epidemiology Department