Natalizumab is an effective treatment for multiple sclerosis that requires 4-weekly infusions that are usually provided in hospital outpatient clinics. In this study, a model of care (MOC), an overarching design for the provision of a health care service, was developed to permit home infusions of natalizumab. The proposed new MOC comprised 9 dimensions, in addition to the central concept of patient-centered care at home. The new MOC is responsive to patient needs and prioritizes the nurse–patient therapeutic relationship. It provides practical examples of patient-centered care to guide clinical practice for this patient population in the home setting.

Objective The delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing‐remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab and usual care (attendance in a hospital out‐patients’ clinic) compared safety, feasibility, patient satisfaction, effectiveness and costs. Methods In this randomised AB/BA crossover trial, 37 adults were randomised to usual care (n = 19) or home infusions (n = 18). After three infusions, patients crossed over to the alternate treatment for another three infusions. Patient safety outcomes and adherence, satisfaction, quality of life, disability and costs were compared. Results No adverse events were recorded from 207 infusions from 35 patients across both home and clinic infusions. There was no difference in adherence (p = 0.71) and infection rates (p = 0.84) between home and clinic settings. Satisfaction with “convenience” of home infusions was significantly greater (p = 0.008) but there were no differences in quality of life measures. Excluding pharmacy, costs were A$74 lower per infusion at home, including A$16 of patients” out‐of‐pocket costs. Interpretation There were no differences in safety and effectiveness between clinic and home infusions of natalizumab. The home infusions were shown to be feasible, more convenient and less expensive than usual care. Larger scale studies are required to verify these preliminary findings, particularly around safety and management of hypersensitivity adverse events in the home setting and for equivalence of clinical outcomes.

IntroductionFor people with multiple sclerosis, monthly infusions at specialist clinics are time consuming, potentially costly and restrictive. Conversely, increased demand for hospital services is driving innovation, including delivery of care in the home. We developed a rigorous model of care for home infusions of natalizumab, which was evaluated in a randomised crossover trial. This pilot study (i) tested feasibility and safety of home infusions, and (ii) compared acceptability and clinical effectiveness with usual clinic-based care in a hospital outpatients clinic.MethodsWe recruited 37 stable adult patients (at least 6 prior natalizumab infusions and assessed as safe by their neurologist) who were randomised to an AB or BA trial arm. After 3 infusions, patients crossed over to the alternate treatment for another 3 infusions. The following outcomes were assessed treatment adherence, patient safety outcomes, quality of life (Multiple Sclerosis Quality of Life Inventory, MSQLI), and patient satisfaction (Treatment Satisfaction Questionnaire for Medication, TSQM).ResultsTwo patients moved out of Adelaide and withdrew. No adverse events resulting from the infusion in either the home or clinic setting were reported. There was no difference between home and clinic in the adherence rate (86/104, 82.7% at home) and (84/103, 81.6% at clinic) (X2=0.0, p=1.0) and number of infections during home care8 compared to clinic10 (X2=0.04, p=0.84). There was no difference in any of the nine sub-scales of the MSQLI (p>0.05). Of the four sub-scales of the TSQM (‘Effectiveness’, ‘Side effects’, ‘Convenience’, ‘Global satisfaction’), patients most recently receiving home care were significantly more satisfied with the Convenience of their treatment (p=0.0008).ConclusionData from the pilot study suggest that delivery of infusions of natalizumab at home is feasible, safe and as effective as the hospital setting. Patients reported that home infusions were more convenient than the clinic.

We developed a new model of care for home infusions of natalizumab for people with multiple sclerosis. The new model of care was then tested in a pilot study comparing home infusions of natalizumab with usual care (attendance in an ambulatory care day units) using an AB/BA randomised crossover trial. In addition to testing feasibility and safety of home infusions for people with natalizumab compared to usual care, we investigated if: (i) home infusions of natalizumab are acceptable to patients and healthcare staff, (ii) home infusions of natalizumab are as effective in treating symptoms, and (iii) home infusions of natalizumab are cost effective? There were 37 stable adult patients (at least 6 prior natalizumab infusions and assessed as safe by their neurologist) randomised to an AB or BA trial arm. After 3 infusions, patients crossed over to the alternate treatment for another 3 infusions.