Clinical trial NCT04257071: Out of Pocket Cost Communication in Multiple Sclerosis Patients
Official title: Pilot Feasibility Study of Out-of-Pocket Cost Communication and Supportive Financial Services for Reducing Financial Toxicity Among Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Financial toxicity
Financial burden
Financial distress
Medical expense
Out of Pocket cost
Cost communication
Cost optimization
Price transparency
Financial navigation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2020-02-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective randomized controlled trial of a cohort of adult multiple sclerosis (MS) patients visiting an outpatient neurology clinic. Sixty participants will be randomly assigned to the intervention arm or a control arm and will be followed for three months.

Detailed description: Patients with multiple sclerosis (MS) spend a substantial amount on healthcare services (total lifetime cost of $4.1 million), and rank second behind congestive heart failure in direct all-cause medical costs for chronic conditions. Among medically bankrupt families, MS is reported to be associated with the highest out-of-pocket expenditure (mean $34,167) followed by diabetes, injuries, stroke, mental illness, and heart disease. With increased costs of MS disease-modifying therapies (DMTs) over the last 20 years, relatively higher out-of-pocket (OOP) costs for advanced imaging tests compared to other common essential health benefits, and increased cost sharing, the financial burden on MS patients continues to escalate. More than half of MS patients lose their ability to generate incomes within a decade after diagnosis due to disability. Accordingly, these patients are at high risk for health-related financial toxicity (a term used interchangeably with financial distress or financial burden, first introduced in the oncology literature to report potential economic impact of modern oncology medications). Financial toxicity is defined as a combination of subjective financial concerns (e.g., anxiety), objective financial consequences of health issues and treatments (e.g., decreased income, medical debt, bankruptcy), and patients' coping behaviors. Financial toxicity, as measured by the Comprehensive Score for Financial Toxicity Patient-Reported Outcome (COST), can harm patients' health-related quality of life (HRQOL). Further, the financial burden from high cost-sharing medical services can be a risk factor for treatment non-adherence. To date, there are no published studies measuring financial toxicity in MS patients, and work in other disease states cannot necessarily be generalized to MS patients. First, the economic burden of MS is different from cancer due to early age of disease onset and its progressive disabling course. Additionally, since MS affects people in the most productive stages of their lives, the disease additionally carries important social burdens.

Providing patients with resources to proactively manage the costs of their care may help to reduce financial toxicity. However, financial navigation, must be provided in a manner that is acceptable, accessible, less cumbersome, thereby not affecting the flow of clinical care. In order to better understand how to equip patients with tools that have the potential to reduce financial toxicity, there is an urgent need to study interventions at the patient, clinic, payer, and policy level.

This is a two-arm, randomized trial with 60 adult MS patients who are receiving disease modifying therapy to test the feasibility of OOP cost communication and optimization through centralized financial navigation and explore its efficacy to reduce financial toxicity and care non-adherence compared to usual care.

Eligibility criteria: Inclusion Criteria:

* known diagnosis of MS as documented in the electronic medical record by a neurologist based on clinical and imaging findings
* a prescription for DMTs as medication
* not enrolled in a clinical trial that covers the cost of DMT
* have capacity to consent

Exclusion Criteria:

* plan to receive treatment elsewhere
* concurrent diagnosis of primary cancers (except for non-melanoma skin cancer)
* unable to read and speak English.

Primary outcomes:
measure: Patient Satisfaction Questionnaire
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Patients Participating in Cost Conversations
timeFrame: Month 3
measure: Minutes of Patient Engagement in Cost Conversations
timeFrame: Month 3
measure: Patient Adherence to Cost Optimization Program
timeFrame: Month 3
measure: Change in Utilization of Financial Supportive Services
timeFrame: Baseline, Month 3
measure: Accuracy of OOP Cost Estimates
timeFrame: Month 3
Other outcomes:
measure: Change in Comprehensive Score for Financial Toxicity (COST) Questionnaire Score
timeFrame: Baseline, Month 3
measure: Change in Cost-related Care Non-adherence
timeFrame: Baseline, Month 3
measure: Change in Financial Hardship
timeFrame: Baseline, Month 3
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
timeFrame: Baseline, Month 3
measure: Change in Coping Behaviors
timeFrame: Baseline, Month 3
measure: Change in Financial Self-Efficacy Scale (FSES) Score
timeFrame: Baseline, Month 3
Locations:
city: Atlanta
country: United States
facility: Neurology Clinic, 12 Executive Park Drive
state: Georgia
Study officials:
affiliation: Emory University
name: Gelareh Sadigh, MD
role: PRINCIPAL_INVESTIGATOR
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