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Clinical Trials/NCT05527392
NCT05527392
Active, Not Recruiting
N/A

Assessing the Effect of Virtual Navigation Interventions to Improve Health Insurance Literacy and Decrease Financial Burden: A Childhood Cancer Survivor Study Randomized Trial (HINTII)

Massachusetts General Hospital1 site in 1 country529 target enrollmentMay 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Cancer Survivors
Sponsor
Massachusetts General Hospital
Enrollment
529
Locations
1
Primary Endpoint
Change in Health Insurance Literacy from baseline to 6 months.
Status
Active, Not Recruiting
Last Updated
6 months ago

Overview

Brief Summary

The investigators are conducting a Type I hybrid effectiveness-implementation trial to assess the effectiveness of HINT-S (synchronous) compared to enhanced usual care (EUC) in promoting health insurance literacy, thus reducing worry, unmet health care needs, and financial consequences due to medical costs to improve care and long-term outcomes of childhood cancer survivors. The investigators will also compare HINT-S to HINT-A (asynchronous), a prerecorded, asynchronous version of the 5 HINT-S navigator sessions.

Detailed Description

The present study seeks to evaluate a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort. Childhood cancer survivors face health challenges throughout their lives that require monitoring and ongoing care. This is compounded by the tendency among childhood survivors to have higher rates of underinsurance, unmet healthcare needs, and burdensome costs related to care. These burdensome costs also contribute to underutilization of care among survivors. Dr. Park and her colleagues published findings that suggested LTFU survivors had difficulty in understanding how to use their insurance, and often experienced financial-related distress. Understanding and navigating insurance benefits in the current landscape is crucial for cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to evaluate the effectiveness of an insurance navigation intervention with LTFU participants, delivered in a synchronous and asynchronous modality. The navigation intervention will be delivered by a health insurance navigator via HIPAA-compliant videoconferencing for the synchronous group (HINT-S) and will be delivered via pre-recorded video session for the asynchronous group HINT-A). Participants will be randomized into either the two navigation intervention arms (HINT-S and HINT-A; approximately 234 per intervention arm), or the enhanced usual care arm (approximately 52 for control arm). The sample size per arm was chosen to enable evaluation of feasibility and acceptability goals, as well as to explore meaningful differences in the outcomes. To assess the proposed primary and secondary outcomes, all trial participants will complete a baseline and 6-month and 12-month post-program follow-up survey.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
April 1, 2027
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elyse Park, PhD

Professor

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • are 18 years or older at time of enrollment
  • are able to give informed consent
  • have access to a smartphone, computer, or tablet with internet access
  • have US based health insurance
  • current LTFU cohort participants
  • having access to the CCSS patient portal.

Exclusion Criteria

  • Participants from the pilot trial will not be eligible

Outcomes

Primary Outcomes

Change in Health Insurance Literacy from baseline to 6 months.

Time Frame: 6 months follow up

Change in Health Insurance Literacy, measured with the validated survey (Health Insurance Literacy scale; HIL), will be compared between groups. The HIL is a 16-item measure of participants' self-reported confidence in understanding of terms (e.g., deductible, co-payments, co-insurance) and confidence in knowing how to do health insurance-related activity (e.g. figuring out co-payments, finding an in-network doctor). Items are rated on a 4-point Likert scale with a total scale score ranging from 16-64; higher scores denote lower literacy.

Secondary Outcomes

  • Change in self-reported financial hardship from baseline to 12 months.(12 months follow up)
  • Change in the number of Health Care Visits and Procedures (health care utilization) from baseline to 12 months.(12 months follow up)
  • Change in Health Insurance Literacy from baseline to 12 months.(12 months follow up)
  • Change in annual out-of-pocket costs from baseline to 12 months.(12 months follow up)

Study Sites (1)

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