Patient Perspectives on Anti-spike Monoclonal Antibody Therapy for Mild to Moderate Coronavirus Disease-2019.

Anti-spike monoclonal antibodies emerged as effective early treatment of high-risk individuals with mild-to-moderate COVID-19. Although their clinical and safety outcomes have been reported, patient perspectives of these experimental therapies have not been evaluated. In this survey participated by 644/2412 (26.7% response) individuals evaluated for anti-spike monoclonal antibody therapies, the majority of 523 patients who received the antibody infusion were very satisfied with their overall patient experience, the quality of care provided, and various aspects of medical care. They voiced satisfaction with the communication with providers before and during treatment, including education provided about monoclonal antibody treatment, the potential benefits and adverse effects, detailed instructions on the process of infusion, and safety protocols employed at the infusion facilities. Nearly a quarter (23.6%) of 121 patients who declined therapy indicated they would accept treatment should it be offered again. These patient perspectives may be used to guide healthcare facilities and providers in optimizing the care provided to high-risk outpatients with COVID-19.

Rapid Development and Evolution of Outpatient COVID-19 Nursing Care Teams: Blending Technology and Nursing

Current knowledge of COVID-19 suggests outpatient disease management is appropriate for most infected individuals (Cohen & Blau, 2020). [...]many patients are successfully managed remotely with self-isolation and symptom management support (Geenhalgh et al., 2020). Because of this, nurses working in telehealth are uniquely positioned to assist with the care of these patients. The patient population included individuals who were well enough to remain at home with outpatient telehealth follow-up. Since the program's inception (March 19, 2020), care has been provided to more than 21,000 patients. Early in the program it was identified that patient care needs and individual symptom burden varied. [...]the use of a vended telehealth triage resource - already endorsed by the institution - was promoted as a tool to support symptom assessment and guide directions for home care and care escalation.

Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19.

BACKGROUND: The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies. METHODS: This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis. RESULTS: 59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98). CONCLUSIONS: Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.

A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model.

The administration of spike monoclonal antibody treatment to patients with mild to moderate COVID-19 is very challenging. This article summarizes essential components and processes in establishing an effective spike monoclonal antibody infusion program. Rapid identification of a dedicated physical infrastructure was essential to circumvent the logistical challenges of caring for infectious patients while maintaining compliance with regulations and ensuring the safety of our personnel and other patients. Our partnerships and collaborations among multiple different specialties and disciplines enabled contributions from personnel with specific expertise in medicine, nursing, pharmacy, infection prevention and control, electronic health record (EHR) informatics, compliance, legal, medical ethics, engineering, administration, and other critical areas. Clear communication and a culture in which all roles are welcomed at the planning and operational tables are critical to the rapid development and refinement needed to adapt and thrive in providing this time-sensitive beneficial therapy. Our partnerships with leaders and providers outside our institutions, including those who care for underserved populations, have promoted equity in the access of monoclonal antibodies in our regions. Strong support from institutional leadership facilitated expedited action when needed, from a physical, personnel, and system infrastructure standpoint. Our ongoing real-time assessment and monitoring of our clinical program allowed us to improve and optimize our processes to ensure that the needs of our patients with COVID-19 in the outpatient setting are met.

A mobile unit overcomes the challenges to monoclonal antibody infusion for COVID-19 in skilled care facilities.

BACKGROUND: Residents of nursing homes and long-term care facilities are at increased risk for severe coronavirus disease-19 (COVID-19) but may not be able to access monoclonal antibody therapies offered at outpatient infusion centers due to frailty and logistical issues. We describe a mobile monoclonal antibody infusion program for patients with COVID-19 in skilled nursing facilities and provide descriptive data on its outcomes. DESIGN: Retrospective cohort study. SETTING: Collaboration between Mayo Clinic and skilled nursing facilities in Southeast Minnesota was developed to administer anti-spike monoclonal antibodies under the FDA Emergency Use Authorization. PARTICIPANTS: Seventy five residents of skilled nursing facilities at high risk of COVID-19 complications. EXPOSURE: Emergency use treatment with bamlanivimab and casirivimab-imdevimab. MEASUREMENTS: Hospitalization and medically attended visits. RESULTS: The mobile infusion unit, staffed by Mayo Clinic Infusion Therapy registered nurses and supported by the skilled nursing facility staff, infused anti-spike monoclonal antibodies to 45 of 75 patients (average age, 77.8 years) in December 2020. The infusions occurred at an average of 4.3 days after COVID-19 diagnosis. Fourteen days after infusion, there were no deaths, two emergency department visits, and three hospitalizations, for a combined event rate of 11.1%. There was one reported adverse event. CONCLUSION: The implementation of a mobile infusion unit embedded in a collaborative process resulted in rapid infusion of monoclonal antibodies to high-risk COVID-19 patients in skilled nursing facilities, who would otherwise be unable to access the novel therapies. The therapies were well tolerated and appear beneficial. Further study is warranted to explore the scalability and efficacy of this program.

Managing Patients in the COVID-19 Pandemic: A Virtual Multidisciplinary Approach.

OBJECTIVE: To study the impact of a 60-day pilot of an innovative virtual-care model using general internal medicine physicians and nurses to respond rapidly to more than 1200 coronavirus disease-2019 (COVID-19)-positive nasopharyngeal polymerase chain reaction tests. PATIENTS AND METHODS: The current study was approved by the Mayo Clinic COVID-19 Research Committee and the Mayo Clinic Institutional Review Board. The data for all SARS-CoV-2-positive patients treated by our team were entered into a prospectively maintained internal research electronic data capture database. We searched this database retrospectively for the first 60 days of our program (March 23, 2020 to May 22, 2020). The data included basic deidentified demographics; symptoms at intake into the program; date of symptom onset; risk factors; location; and outcomes including hospitalization, admission to intensive care unit, and death. RESULTS: Patients were contacted, on average, 6.3 hours after their results became available. There was a total of 138 ED visits. Of these, 40% were admitted to the hospital, with 36% of those admitted requiring intensive care unit level of care. Of the 849 patients in this sample, there were only 2 deaths (0.23%) at 60 days. CONCLUSION: Our innovative multidisciplinary COVID team provided excellent clinical care for patients with COVID, with a very low mortality rate compared with the national average. Although data are not available on a national scale for time to contact patient, our team was able to contact patients within the established recommendation for contact within 48 hours of testing, which is optimal.