17. The Impact of Site of Care on Quality and Safety of IVIG: 2024 IgNS Patient 360 Survey Analysis

Background: Immunoglobulin (Ig) therapy is a complex treatment option for various conditions, delivered intravenously (IV) or subcutaneously (SC) in diverse settings, including home, ambulatory infusion centers/suites (AIC/AIS), physician offices, and hospitals. While home-based Ig therapy has traditionally been favored for its convenience and cost-effectiveness, recent payer reimbursement changes have led to a shift towards AIC/AIS-based infusions. This transition raises concerns about the quality of care in AIC/AIS settings, where nurses often lack specialized Ig knowledge and experience compared to their home healthcare counterparts. This study investigates the relationship between the site of care and various aspects of Ig treatment quality, including patient satisfaction, safety, tolerability, and nursing competence.

Purpose: The purpose of this research is to evaluate the relationship between the site of care (home vs. ambulatory infusion center/suite) and the quality of care received by patients undergoing immunoglobulin (Ig) therapy. This evaluation will encompass patient satisfaction, safety, tolerability of the treatment, and perceived nursing competence, ultimately aiming to inform the development of standards of practice, resources, training, education, and credentialing for clinicians administering Ig therapy across all care settings.

Methods: This exploratory, confidential and deidentified survey of patients receiving Ig was distributed to IgNS patient-subscribers via the Jotform HIPAA-compliant survey tool between May and July 2024. An interim analysis of 308 respondents was conducted.

Results: Using data from the IgNS Patient 360 Survey, we explored the relationships between site of care and quality of care. The relationship between site of care quality of care was highly significant, such that quality drops by 1.3 points (on an 11-point scale) when patients receive IV immunoglobulin (IVIG) at an infusion center/suite location versus at home (beta -1.3, t = -5.58, p < .001). The relationship the site of care and the quality of nursing was significant, such that patients treated at infusion centers/suites report lower nursing quality than those who receive care at home (p < .05). The relationship between the site of care and confidence in nurses’ skills and abilities was significant, such that patients express lower confidence in infusion center/suite nurses than those at home (p < .01). Likewise, the relationship between site of care and nurses’ perceived knowledge and skills of infusion pump equipment was significant, such that nurses at infusion centers/suites were perceived as less skilled and knowledgeable than nurses at the home sit of care (, p < .05). Patients at infusion centers/suites were significantly less likely to have their vital signs assessed by a nurse versus those receiving care at home (p < .001). Patients at infusion centers/suites were more likely to experience increases in their infusion rate to decrease infusion time, compared with those receiving care at home (p < .01) Patients at infusion centers/suites were less likely to receive a follow up post-infusion compared with those receiving care at home (p < .001). Overall, patients with neuromuscular and rheumatologic diagnoses reported significantly more side effects than patients with PI (p < .01).

Discussion: For the past several decades, the home has been the main site of care for Ig due its convenience and healthcare cost advantages. In recent years, an increasing number of patients have been transitioning to infusion center/suite-based treatment based on payer reimbursement changes. Nurses in the infusion centers/suites usually work with a variety of infused drugs, and do not specialize in any one therapy, particularly Ig. This gap in education and training is concerning, since Ig infusions require highly-specific types of assessments, monitoring and interventions for the myriad adverse reactions that can occur at any time.

Conclusions: Our findings underscore the critical need for standards of practice, resources, training, education, and credentialing of clinicians working in all practice settings, but particularly the infusion center space.