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临床试验/NCT05527392
NCT05527392进行中(未招募)不适用

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 Hospital2 个研究点 分布在 1 个国家目标入组 529 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
529
试验地点
2
主要终点
Change in Health Insurance Literacy from baseline to 6 months.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Participants from the pilot trial will not be eligible

结局指标

主要结局

Change in Health Insurance Literacy from baseline to 6 months.

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elyse Park, PhD

Professor

Massachusetts General Hospital

研究点 (2)

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