Out of Pocket Cost Communication in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257071
• Other study ID #: IRB00113357
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Neurology Clinic, 12 Executive Park Drive	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

References & Publications (15)

Adelman G, Rane SG, Villa KF. The cost burden of multiple sclerosis in the United States: a systematic review of the literature. J Med Econ. 2013;16(5):639-47. doi: 10.3111/13696998.2013.778268. Epub 2013 Mar 7. Review. — View Citation

Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer Survivors: A Systematic Review. J Natl Cancer Inst. 2016 Oct 20;109(2). pii: djw205. Print 2017 Feb. Review. — View Citation

Benito-León J. Multiple sclerosis: is prevalence rising and if so why? Neuroepidemiology. 2011;37(3-4):236-7. doi: 10.1159/000334606. Epub 2011 Nov 30. — View Citation

de Souza JA, Yap B, Ratain MJ, Daugherty C. User beware: we need more science and less art when measuring financial toxicity in oncology. J Clin Oncol. 2015 Apr 20;33(12):1414-5. doi: 10.1200/JCO.2014.59.4986. Epub 2015 Mar 2. — View Citation

de Souza JA, Yap BJ, Hlubocky FJ, Wroblewski K, Ratain MJ, Cella D, Daugherty CK. The development of a financial toxicity patient-reported outcome in cancer: The COST measure. Cancer. 2014 Oct 15;120(20):3245-53. doi: 10.1002/cncr.28814. Epub 2014 Jun 20. — View Citation

de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araújo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7. — View Citation

Hartung DM, Bourdette DN, Ahmed SM, Whitham RH. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? Neurology. 2015 May 26;84(21):2185-92. doi: 10.1212/WNL.0000000000001608. Epub 2015 Apr 24. Erratum in: Neurology. 2015 Nov 10;85(19):1728. — View Citation

Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med. 2009 Aug;122(8):741-6. doi: 10.1016/j.amjmed.2009.04.012. Epub 2009 Jun 6. — View Citation

Jensen S, Given B. Fatigue affecting family caregivers of cancer patients. Support Care Cancer. 1993 Nov;1(6):321-5. — View Citation

Lizán L, Comellas M, Paz S, Poveda JL, Meletiche DM, Polanco C. Treatment adherence and other patient-reported outcomes as cost determinants in multiple sclerosis: a review of the literature. Patient Prefer Adherence. 2014 Dec 4;8:1653-64. doi: 10.2147/PPA.S67253. eCollection 2014. Review. — View Citation

Owens GM. Economic burden of multiple sclerosis and the role of managed sare organizations in multiple sclerosis management. Am J Manag Care. 2016 Jun;22(6 Suppl):s151-8. Review. — View Citation

Rosenkrantz AB, Sadigh G, Carlos RC, Silva E 3rd, Duszak R Jr. Out-of-Pocket Costs for Advanced Imaging Across the US Private Insurance Marketplace. J Am Coll Radiol. 2018 Apr;15(4):607-614.e1. doi: 10.1016/j.jacr.2017.12.010. Epub 2018 Feb 22. — View Citation

Rumrill PD Jr, Roessler RT, McMahon BT, Hennessey ML, Neath J. Gender as a differential indicator of the employment discrimination experiences of Americans with multiple sclerosis. Work. 2007;29(4):303-11. — View Citation

Shankaran V, Leahy T, Steelquist J, Watabayashi K, Linden H, Ramsey S, Schwartz N, Kreizenbeck K, Nelson J, Balch A, Singleton E, Gallagher K, Overstreet K. Pilot Feasibility Study of an Oncology Financial Navigation Program. J Oncol Pract. 2018 Feb;14(2):e122-e129. doi: 10.1200/JOP.2017.024927. Epub 2017 Dec 22. — View Citation

Streeter SB, Schwartzberg L, Husain N, Johnsrud M. Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions. J Oncol Pract. 2011 May;7(3 Suppl):46s-51s. doi: 10.1200/JOP.2011.000316. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Comprehensive Score for Financial Toxicity (COST) Questionnaire Score	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
Other	Change in Cost-related Care Non-adherence	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
Other	Change in Financial Hardship	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
Other	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score	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
Other	Change in Coping Behaviors	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
Other	Change in Financial Self-Efficacy Scale (FSES) Score	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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