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临床试验/NCT04448678
NCT04448678已完成不适用

Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study

University of Utah6 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
6
主要终点
Feasibility Measurement

研究概览

简要总结

This is a test of an existing health insurance education program (HIEP) in adolescent and young adult (AYA) individuals (aged 18-39) diagnosed with cancer. The study will evaluate whether the HIEP delivered by patient navigators improves participants' health insurance and cost-related literacy compared to usual navigation care, which does not include education on insurance and medical costs. The study team hypothesizes that: The HIEP will improve participants' health insurance and cost-related literacy compared to usual navigation care. Specifically, that participants in the intervention arm will report greater 1) health insurance and cost literacy, including confidence with provider communication about costs, 2) familiarity with ACA policies, and 3) improvement in financial distress related to medical costs. Participants will fill out a survey upon enrollment and a follow up survey 3 months after meeting with a patient navigator where they may or may not receive the HIEP.

详细描述

The goal of this research is to refine and pilot test an existing health insurance education program (HIEP) to improve health insurance and cost-related literacy among adolescent and young adult (AYA) individuals who have recently been diagnosed with cancer. This study will be conducted within the Huntsman-Intermountain Adolescent and Young Adult (HI-AYA) Cancer Care Program, which is a unique collaboration between the Huntsman Cancer Institute and Intermountain Healthcare, the largest oncology providers in Utah. Initially, age-related differences related to health insurance and cost literacy among AYAs diagnosed with cancer ages 18-26 and 27-39 years will be identified, and the HIEP materials will be adapted accordingly. The HIEP delivered by the HI-AYA patient navigators, will be investigated to see if it improves participants' health insurance and cost-related literacy.

Upon enrollment, participants will fill out a survey containing questions about their current health insurance plan, financial status, demographics, health insurance knowledge, and financial toxicity. Participants will then be randomized into separate trial arms after which participants in both groups will meet with a HI-AYA patient navigator. Participants in the interventional arm will receive 4 educational sessions surrounding health insurance use and laws (four sessions total occurring approximately every two weeks). These educational sessions will be conducted, in person, over video conference calls, or over the telephone, and will cover:

  • health insurance terms and concepts
  • insurance coverage (insurance cards, bills, schedule and explanation on benefits)
  • health insurance laws, rights and the appeals process
  • budgeting and resources. These sessions will be scheduled with each participant according to their availability, with the goal of meeting every other week.

Approximately three months after meeting with the patient navigator, participants in both arms of the trial will fill out a second survey, including similar questions to those in the first survey as well as questions surrounding satisfaction with the HIEP and the patient navigator delivery for those who received the HIEP. After the post survey is complete, a small subset of participants in both the intervention and control arm will be randomly selected to complete an interview to better understand satisfaction with patient navigation, the intervention, recommendations for modifications on delivery modality, and recommendations for intervention topics and content modifications to identify components of the HIEP that require refinement prior to potential scaling of the intervention to a larger sample. Another small subset of participants will be randomly selected to complete an interview from the control arm to discuss their satisfaction with their patient navigation and to ask how they found resources concerning health insurance during their treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not know who is receiving additional health insurance navigation or standard navigation. The outcome assessor will also be blinded to which participants received health insurance navigation. Blinding for the outcome assessor will be kept throughout the entirety of the analysis. Groups will be identified for analysis with ambiguous categories such as group 1 and group 2.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Were diagnosed with cancer between the ages of 18 and 39 AND
  • Are within 1 year of a cancer diagnosis AND
  • Are actively receiving chemotherapy, surgery, radiation, and/or hormonal therapy AND
  • Are currently insured AND
  • A patient at Primary Children's Hospital, Intermountain Medical Center or Huntsman Cancer Institute AND
  • Speak English AND
  • Have access to an electronic device compatible with video conferencing (e.g., smartphone, laptop, etc.).

排除标准

  • Are unable to participate due to developmental delay OR
  • Speak a language other than English OR
  • Are currently uninsured OR
  • Do not have access to an electronic device compatible with video conferencing (e.g., smartphone, laptop, etc.).

结局指标

主要结局

Feasibility Measurement

时间窗: Post-Assessment survey (Weeks 13 (+/- 2 weeks))

Comparing total number of individuals enrolled and randomized vs completed study (completion of both surveys for control or both surveys and all of the sessions for intervention.)

Acceptability - Module Satisfaction

时间窗: Post-Assessment interview (Weeks 18 (+/- 2 weeks))

Questions surrounding satisfaction with the HIEP. These will be asked at the post-assessment interview and will consist of participants responses surrounding satisfaction with the HIEP. We will report percentages of participants who did 1 or more session and reported satisfaction with the HIEP.

Navigator Satisfaction

时间窗: Post-Assessment survey (Weeks 13 (+/- 2 weeks))

Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. This score ranges from 0-45 with higher scores indicating higher satisfaction. We will report the mean and standard deviation.

次要结局

  • Changes in Efficacy-Financial Distress(Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks)))
  • Changes in Efficacy- Health Insurance Literacy(Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)))
  • Changes in Efficacy- Affordable Care Act (ACA) Familiarity(Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)))

研究者

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

Anne Kirchhoff

Associate Professor

University of Utah

研究点 (6)

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