“Our ED was filled with critically ill patients with COVID-19-related respiratory failure, many of them ‘boarding’ in the ED waiting for ICU beds to become available,” explains Julie-Kathryn Graham, PhD, APRN, ACCNS-AG. “Additionally, the high acuity of patients in the ED made it virtually impossible to allocate the resources necessary for administration of monoclonal antibody therapy and subsequent monitoring of patients, which required a minimum of 2 hours of nursing care per patient.”
While this type of therapy can be administered in outpatient infusion centers by registered nurses who specialize in infusion, those centers often provide care for patients who are immunocompromised, Dr. Graham notes. As a result, patients with COVID-19 presented a “considerable risk” to this immunocompromised population.
For a study published in Journal of Infusion Nursing, Dr. Graham and colleagues aimed to determine whether it was possible to administer monoclonal antibody therapy for COVID-19 in a nurse-led, ED-embedded infusion center. The researchers used a Plan-Do-Check-Act model of continuous process improvement to guide implementation. The infusion center was set up outside the 43-bed ED on the main floor of the 449-bed hospital and equipped to manage six patients at a time, with regard for safe transport of a highly infectious patient population as well as sufficient ventilation and social distancing.
ED Infusion Center Safe & Effective
The nurse-led infusion center was run from December 2020 to February 2021, during which time 150 patients were treated with monoclonal antibody infusions. It was a viable option for providing infusion therapy to patients with milder COVID-19 illness at risk for more severe disease, according to the study results. No patients needed hospitalization, nor were there any adverse events. Investigators reported no processing errors— including no inadvertent staff exposures to COVID-19—and an adequate quantity of the therapy was available.
“Our program proved to be very successful in terms of safety and possible prevention of patient deterioration,” says Dr. Graham. “The most important things to stress are person-centeredness and high reliability. The former is the core guiding principle that made this possible. In addition, dedication to and trust in our multidisciplinary team was key. We looked to our own experts in resource allocation, infection control, quality assurance, infusion therapy, nursing care, and project management to ensure no process steps were left unchecked, to protect patients, staff, and physicians.”
There are several points to consider regarding the implementation of such a protocol, the researchers note, including the need to monitor patients for up to 2 hours after treatment. In addition, patients receiving monoclonal antibodies for COVID-19 should refrain from COVID-19 vaccination for 90 days after the infusion, a factor which requires discussion about risks and benefits by healthcare providers during the informed consent process.
Nurse-Led Workflow Applicable in Other Settings
As part of the program, researchers developed evidence-based criteria for monoclonal antibody therapy infusion (Table). “This was developed with guidance from the CDC, the NIH, the Agency for Healthcare Research and Quality, and guidelines of care from the Emergency Nurses Association,” explains Dr. Graham. “Triaging patients into the workflow is entirely nurse-led. If the patient is seeking treatment, the physician is notified of patient eligibility once they have been screened using evidence-based, validated criteria. The physician covers consent and performs medical clearance. Once the patient has consented, the care is protocolized and the rest of the visit is managed by nursing based on standard procedures developed for the infusion center.”
Dr. Graham believes the process they developed for selecting patients for monoclonal antibody therapy infusion could be integrated into other clinics or used as a template for disaster planning and simulation training for future COVID-19 surges.
“Our program supports what is known about the safety of monoclonal antibody therapy in this setting and population,” she says. “Further information is needed regarding the clinical utility of monoclonal antibodies for COVID-19. Additionally, other care gaps may be filled by adopting a highly reliable, person-centered, nurse-led approach to solving clinical problems.”