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Out of Pocket Cost Communication in Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT04257071
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Gelareh Sadigh, Emory University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Usual Care Behavioral: OOP Cost Communication and Optimization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Feasibility Study of Out-of-Pocket Cost Communication and Supportive Financial Services for Reducing Financial Toxicity Among Multiple Sclerosis Patients
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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 (if they received their bills).


Other Outcome Measures:
  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257071


Contacts
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Contact: Gelareh Sadigh, MD 404-712-4519 gsadigh@emory.edu

Locations
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United States, Georgia
Neurology Clinic, 12 Executive Park Drive Recruiting
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Gelareh Sadigh, MD Emory University
Publications:

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Responsible Party: Gelareh Sadigh, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT04257071    
Other Study ID Numbers: IRB00113357
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be made available for sharing beginning 3 months and ending 5 years following article publication.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gelareh Sadigh, Emory University:
Financial toxicity
Financial burden
Financial distress
Medical expense
Out of Pocket cost
Cost communication
Cost optimization
Price transparency
Financial navigation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases