Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

Overview

The overall objective of this study was to develop and evaluate FINassist (Financial and Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology financial and legal navigation program. The program leverages Medical Legal Partnerships to enhance cost of care conversations with pediatric oncology patients and caregivers. FINassist optimizes the team-based care model by integrating clinicians, social workers, financial navigators, and legal advocates who work in tandem to enhance cost of care conversations with patients and caregivers, identify and intervene on patient socio-legal needs, and advocate for system-level changes.

Full Title of Study: “Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Health Services Research
  • Masking: None (Open Label)
• Study Primary Completion Date: September 1, 2022

Interventions

• Other: FINassist
  • The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved
• Other: FINassist
  • The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved

Arms, Groups and Cohorts

• Experimental: Financial Navigation and Insurance Assistance (FINassist) Patient Only
  • Patients only participated in FINassist program
• Experimental: Financial Navigation and Insurance Assistance (FINassist) Patient Caregiver
  • Caregivers of minor patients only participated in FINassist program

Clinical Trial Outcome Measures

Primary Measures

• FINassist Feasibility
  • Time Frame: 12 months
  • Feasibility is defined by number of participants enrolled
• FINassist Adherence
  • Time Frame: through issue resolution up to 12 months
  • Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution
• FINassist Retention
  • Time Frame: through study completion up to 12 months
  • percentage of participants that complete both pre and post-intervention surveys
• FINassist Acceptability
  • Time Frame: Post intervention at 12 months
  • Acceptability is measured using a 5 item post-intervention survey of relevance, helpfulness, convenience, recommendation to others, and value. Ratings on a scale from 0 to 10 where a higher score means greater acceptability
• Change in Financial Toxicity
  • Time Frame: Baseline and post intervention, approximately 12 weeks
  • Measured using the COmprehensive Score for financial Toxicity (COST) tool, a measure that describes the financial distress experienced by cancer patients. Scores range from 0-44 with a higher score representing better financial well-being.
• Change in Participant Quality of Life (physical and mental)
  • Time Frame: Baseline and post intervention, approximately 12 weeks
  • Measured using the 10-item PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Global Health scale. A 7-item summary assessment of a child’s self-reported health with higher scores representing better quality of life.
• Change in Participant Quality of Life (Depression)
  • Time Frame: Baseline and post intervention, approximately 12 weeks
  • Measured using the 6-item Patient-Reported Outcomes Measurement Information System PROMIS® Depression Short Form. Scores range from 6 to 30. Higher scores indicate more of the construct being measured.
• Change in Participant Quality of Life (Anxiety)
  • Time Frame: Baseline and post intervention, approximately 12 weeks
  • Measured using the 4-item Patient-Reported Outcomes Measurement Information System PROMIS® Anxiety short form. Scores range from 4 to 20. Higher scores indicate more of the construct being measured.
• Change in Patient-Provider Trust
  • Time Frame: Baseline and post intervention, approximately 12 weeks
  • Measured using the the Health Care Relationship (HCR) Trust Scale. The HCR-Trust scale is scored from 0 to 4 with a maximum score of 52. Higher scores represent more trust in healthcare providers
• Resolution of Socio-legal Issue
  • Time Frame: 12 months
  • Number of participants that resolved a legal or financial case as a result of FINassist

Secondary Measures

• Number of Participants Receiving Financial Benefit
  • Time Frame: 12 months
  • financial benefit defined as economic hardship avoided or decreased public/government income

Participating in This Clinical Trial

Inclusion Criteria

• Caregivers of patients who have any cancer or hematologic disorder diagnosis at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital – Patients with childhood cancers and/or hematologic disorders at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital – 18 years and older Exclusion Criteria:

• Unable to provide consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Jean Edward
• Collaborator
  • Robert Wood Johnson Foundation
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Jean Edward, Associate Professor – University of Kentucky
• Overall Official(s)
  • Jean Edward, PhD, RN, Principal Investigator, University of Kentucky