Out of Pocket Cost Communication in Multiple Sclerosis Patients

February 16, 2022 updated by: Gelareh Sadigh, Emory University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Neurology Clinic, 12 Executive Park Drive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Participants randomized to the usual care study arm will receive the usual care for their MS.
Behavioral: Usual Care
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.
Experimental: OOP Cost Communication and Optimization
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
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.
Behavioral: OOP Cost Communication and Optimization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Questionnaire
Time Frame: Month 3
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
Time Frame: Month 3
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
Time Frame: Month 3
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
Time Frame: Month 3
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
Time Frame: Baseline, Month 3
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
Time Frame: Month 3
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Comprehensive Score for Financial Toxicity (COST) Questionnaire Score
Time Frame: Baseline, Month 3
Financial toxicity is assessed using the COST questionnaire. The COST questionnaire includes 12 items asking how important specific financial scenarios are to participants on a scale of 0 to 4 where 0 = not at all and 4 = very much. Total scores will be calculated using responses from the first 11 items and range from 0 to 44. Certain items are reverse scored so that lower scores indicate greater financial toxicity.
Baseline, Month 3
Change in Cost-related Care Non-adherence
Time Frame: Baseline, Month 3
Participants will be asked if they have forgone or delayed treatment or monitoring visits (e.g., medication, treatment other than prescribed medication, office visits, lab and imaging) related to MS in the last 3 months due to cost. Participants respond with "yes" or "no" and there is not a summary score for this assessment.
Baseline, Month 3
Change in Financial Hardship
Time Frame: Baseline, Month 3
Participants will be asked about any financial hardship they are experiencing due to bills and income related to MS treatment. Participants will report if they had to change living situations, withdraw money from retirement or savings accounts, or if they had changes in income since their diagnosis, or had to obtain loans to pay medical bills. This is a qualitative assessment without a summary score.
Baseline, Month 3
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Time Frame: Baseline, Month 3
Self-reported changes in physical, mental and social health will be assessed with the PROMIS Global Health instrument. This instrument includes 9 items scored from 1 to 5, where 1 is equivalent to poor health and 5 is equivalent to excellent health, plus a tenth item asking respondents to rate their average pain on a scale from 0 (no pain) to 10 (worst pain). Total score for the first 9 items range from 9 to 45 where higher scores indicate greater self-reported health. PROMIS t-scores will be calculated.
Baseline, Month 3
Change in Coping Behaviors
Time Frame: Baseline, Month 3
Participants will be asked about any coping behaviors that were needed, such as decreased basic spending on food/clothing, decreased spending on leisure activities, or missed physician visits, due to bills related to MS treatment. This is a qualitative assessment without a summary score.
Baseline, Month 3
Change in Financial Self-Efficacy Scale (FSES) Score
Time Frame: Baseline, Month 3
The FSES is a 6-item instrument assessing how confidently respondents can manage financial concerns. Responses to items are on a 4 point scale where 1 = exactly true and 4 = not at all true. Total scores range from 6 to 24 where higher scores indicate greater financial self-efficacy.
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Multiple Sclerosis Society

Investigators

  • Principal Investigator: Gelareh Sadigh, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00113357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results reported in the manuscript (including text, tables, figures, and appendices) will be made available for sharing, after deidentification.

IPD Sharing Time Frame

Data will be made available for sharing beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Data will be available to be shared with researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal. Proposals should be directed to gsadigh@emory.edu. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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