Out of Pocket Cost Communication in Multiple Sclerosis Patients

NCT04257071 | Completed

• 1 other identifier: IRB00113357
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Financial toxicity; Financial burden; Financial distress; Medical expense; Out of Pocket cost; Cost communication; Cost optimization; Price transparency; Financial navigation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of Patients Participating in Cost Conversations

  Month 3

• Minutes of Patient Engagement in Cost Conversations

  Month 3

• Patient Adherence to Cost Optimization Program

  Month 3

• Change in Utilization of Financial Supportive Services

  Baseline, Month 3

• Accuracy of OOP Cost Estimates

  Month 3

Other Outcomes (6)

• Change in Comprehensive Score for Financial Toxicity (COST) Questionnaire Score

  Baseline, Month 3

• Change in Cost-related Care Non-adherence

  Baseline, Month 3

• Change in Financial Hardship

  Baseline, Month 3

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants randomized to the usual care study arm will receive the usual care for their MS.

Behavioral: Usual Care

OOP Cost Communication and Optimization

EXPERIMENTAL

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; Behavioral: OOP Cost Communication and Optimization

Interventions

Usual Care BEHAVIORAL

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; Usual Care

OOP Cost Communication and Optimization BEHAVIORAL

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.

OOP Cost Communication and Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Neurology Clinic, 12 Executive Park Drive

Atlanta, Georgia, 30329, United States

Location

Related Publications (16)

• 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.

  PMID: 27356024 BACKGROUND

• 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.

  PMID: 23425293 BACKGROUND

• 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.

  PMID: 19501347 BACKGROUND

• 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.

  PMID: 25911108 BACKGROUND

• 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.

  PMID: 18057570 BACKGROUND

• 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. No abstract available.

  PMID: 25732158 BACKGROUND

• 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):djw205. doi: 10.1093/jnci/djw205. Print 2017 Feb.

  PMID: 27754926 BACKGROUND

• 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.

  PMID: 24954526 BACKGROUND

• de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo 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.

  PMID: 27716900 BACKGROUND

• 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.

  PMID: 21886519 BACKGROUND

• Lizan 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.

  PMID: 25525341 BACKGROUND

• Benito-Leon 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. No abstract available.

  PMID: 22133765 BACKGROUND

• Jensen S, Given B. Fatigue affecting family caregivers of cancer patients. Support Care Cancer. 1993 Nov;1(6):321-5. doi: 10.1007/BF00364970.

  PMID: 8156250 BACKGROUND

• 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.

  PMID: 29272200 BACKGROUND

• 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.

  PMID: 29477290 BACKGROUND

• Sadigh G, Coleman D, Lava N, Switchenko J, Vargas D, Duszak R Jr, Carlos RC. Patient-Specific Out-of-Pocket Cost Communication and Remote Financial Navigation in Patients with Multiple Sclerosis: A Randomized Controlled Feasibility Study. Mult Scler Relat Disord. 2022 Jun;62:103797. doi: 10.1016/j.msard.2022.103797. Epub 2022 Apr 10.

  PMID: 35429820 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Financial Stress

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Gelareh Sadigh, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 5, 2020
• Study Start: March 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)