Out of Pocket Cost Communication in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Feasibility Study of Out-of-Pocket Cost Communication and Supportive Financial Services for Reducing Financial Toxicity Among Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Usual Care
* Behavioral: OOP Cost Communication and Optimization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Participants randomized to the usual care study arm will receive the usual care for their MS. | Behavioral: Usual Care<br>* The usual care for MS involves standard patient neurology visits and encounters with pharmacists, financial counselors and social workers if patients need any financial assistance with medication or other expenses.<br>|
| Experimental: OOP Cost Communication and Optimization<br>Participants in this study arm in addition to usual care, will receive a personalized discussion of their OOP cost estimates for treatment obtained through an online price transparency tool, personalized analysis of expenses by financial counselor, and enrollment in any cost optimization opportunities for which they are eligible using a comprehensive financial navigation program. | Behavioral: Usual Care<br>* The usual care for MS involves standard patient neurology visits and encounters with pharmacists, financial counselors and social workers if patients need any financial assistance with medication or other expenses.<br>Behavioral: OOP Cost Communication and Optimization<br>* OOP Cost Communication and Optimization includes personalized discussion of OOP cost estimates for treatment plan obtained through an online price transparency tool, personalized analysis of patients' expenses by financial counselor, and patient enrollment in any cost optimization opportunities for which patient is eligible using a comprehensive financial navigation program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Questionnaire | Patient satisfaction with their experience with the OOP cost discussion and financial counselors is assessed with a 14-item Patient Satisfaction Questionnaire. Participants report how much they agree with each statement on a scale of 1 (strongly disagree) to 5 (strongly agree). Total scores range from 14 to 70 where higher scores indicate greater satisfaction with the financial counselor experiences. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Participating in Cost Conversations | Patient participation in cost conversations is defined as percentage of patients in intervention arm participating in the scheduled conversation to discuss OOP. | Month 3 | 
| Minutes of Patient Engagement in Cost Conversations | Patient engagement in cost conversations is defined as time (in minutes) that participants in the intervention arm spent discussing OOP cost with the financial counselor. | Month 3 | 
| Patient Adherence to Cost Optimization Program | Patient adherence to cost optimization program is defined as the percentage of completed monthly contacts that participants in intervention arm have with study financial counselor. | Month 3 | 
| Change in Utilization of Financial Supportive Services | Use of financial supportive services will be assessed by asking participants if they received any assistance with paying for medication, imaging, or transportation to health provider visits in the past three months. For any financial support received, participants will be asked how they were linked to assistance. This is a qualitative assessment which does not provide a summary score. | Baseline, Month 3 | 
| Accuracy of OOP Cost Estimates | Accuracy of OOP cost estimates provided to patients in the intervention arm will be assessed by comparing the estimates to the amount stated in received medical bills, in a subset of patients who received medical bills. | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Financial toxicity, Financial burden, Financial distress, Medical expense, Out of Pocket cost, Cost communication, Cost optimization, Price transparency, Financial navigation