Background: The ongoing global COVID-19 pandemic has stressed patients, hospital systems, and society and, while treatment modalities are continuously evolving. A phase 3 clinical trial of monoclonal antibody infusion in appropriate patients with Casirivimab and Imbdevimab demonstrated a 70% reduction in hospitalization or all-cause death compared to placebo (ref 1). An emergency use authorization by the FDA in November, 2020 paved the way for CMS to authorize payment models for in-home infusion to expand access to these life-saving treatments . Still, as access to monoclonal antibody therapy is limited by patient mobility, transportation, and brick-and-mortar infusion center capacity, the administration of these treatments has proven difficult to operationalize.
Purpose: To create and deploy a model for hospitalist teams to provide monoclonal antibody therapy for COVID-19 in patients’ homes.
Description: DispatchHealth Advanced Care has built a hospital-substitution model of care that is now providing care in patient’s homes in 8 cities by creating teams of hospitalist physicians, hospitalist APPs, hospital-trained RNs, and emergency medical technicians. These teams provide a broad range of diagnostic and therapeutic services by leveraging existing mobile in-home practice infrastructure which represented a unique and ideal platform for delivering monoclonal antibody therapy in patients’ homes. Our team in Denver developed a pilot program to obtain drug, manage inventory, transport the temperature-controlled drug to patients’ homes, evaluate patients for appropriateness under the FDA’s emergency use authorization, establish IV access and infuse the medication, and monitor the patient for infusion reactions. PDSA cycles yielded a design for a logistics system that included mobile refrigeration, a specific infusion kit including equipment to establish IV access and give the drug using a mobile infusion pump, and safety equipment such as emergency drugs and drug delivery supplies to help help the team safely manage an infusion reaction. Since starting this pilot in October 2021, the team evaluated 29 patients, of which 16 patients qualified and were infused, with 1 experiencing a mild drug reaction. The program will now be deployed in our sister markets.
Conclusions: Monoclonal antibody therapy against COVID-19, which is authorized under the FDA’s EUA can safely and effectively be administered in patients’ homes by teams of hospitalist APPs, hospitalist physicians, and hospital-trained RNs. Establishing such a program depended on using PDSA cycles to rapidly design a clinical evaluation, logistics, drug administration, and documentation system to be able to quickly bring the fight against COVID-19 into patients’ homes.