Abstract
ObjectiveWe conducted a randomized controlled trial evaluating the feasibility of a personalized out-of-pocket cost communication, remote financial navigation and counseling (CostCOM) intervention in decreasing financial hardship among patients with multiple sclerosis (MS). MethodsSixty-two adult patients with diagnosis of MS and a prescription for a disease modifying therapy were randomized into: (1) Usual care (n=30) and (2) CostCOM (n=32). CostCOM included patient-specific out-of-pocket cost communication, remote financial navigation and counseling delivered at enrollment and 3 months. Usual care included routine neurology visits, use of available ancillary staff, and internal or external resources for financial assistance per normal clinic procedures. Feasibility outcomes included participation in and satisfaction with CostCOM. Exploratory financial hardship outcomes included cost-related care nonadherence, material hardship, and financial worry using Comprehensive Score for Financial Toxicity (COST). ResultsMean age was 41.5 (81.0% female; 41.4% White and 51.7% Black race). Of 32 CostCOM patients, 96.8% and 68.7% completed baseline and follow-up intervention. A financial assistance application was completed for 80%. Mean general satisfaction (out of 5) with CostCOM was 3.1±1.0. In multivariable analyses, CostCOM patients had less financial worry (i.e., higher COST scores) at 3 months compared to usual care patients (B coefficient, 3.6; 95% CI (0.1 – 7.1). While CostCOM patients had significant decreases in 3 months non-adherence (72.7%) compared to enrollment (50%), their 3 months nonadherence and material hardship were not significantly different between the two arms. ConclusionCostCOM interventions are feasible, acceptable, and yield potential benefits in decreasing financial hardship. Trial RegistrationThis study is registered at ClinicalTrials.gov (NCT04257071).
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