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Improving Cancer Patients' Insurance Choices (I Can PIC)

2019年4月29日 更新者:Washington University School of Medicine

Supporting Cancer Survivors' Health Insurance Marketplace Decisions

The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.

研究概览

详细说明

In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors. The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance. In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants. The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network. Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences. The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.

研究类型

介入性

注册 (实际的)

263

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 64年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Ability to read English
  • Diagnosed with cancer in the past 5 years
  • Residing in Missouri or Illinois

Exclusion Criteria:

  • Eligible for Medicaid or Medicare in Missouri or Illinois
  • Enrolled in the following types of health insurance plans: Medicare, Medicaid, TRICARE or other military healthcare, or Indian Health Services

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:I Can PIC
The I Can PIC website will be provided to participants randomized to the experimental/intervention group.
Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.
其他名称:
  • Decision Aid (DA)
无干预:Attention Control
Participants randomized to the attention control group will be provided a link to a website developed by the American Cancer Society Cancer Action Network.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Knowledge Score
大体时间:Completed immediately after using I Can PIC
The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.
Completed immediately after using I Can PIC
Decision Self-efficacy
大体时间:Completed immediately after using I Can PIC.
The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions).
Completed immediately after using I Can PIC.
Certainty about Choice (Decisional Conflict Scale)
大体时间:Completed immediately after using I Can PIC
The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.
Completed immediately after using I Can PIC

次要结果测量

结果测量
措施说明
大体时间
Health Insurance Literacy Measure
大体时间:Completed immediately after using I Can PIC
Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.
Completed immediately after using I Can PIC
Health Insurance Literacy Measure
大体时间:3 month follow-up

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

3 month follow-up
Choice of Health Insurance Plan
大体时间:Completed immediately after using I Can PIC
Participants will be asked what health insurance plan they would choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.
Completed immediately after using I Can PIC
Choice of Health Insurance Plan
大体时间:3 month follow-up

Participants will be asked what health insurance plan they choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

3 month follow-up
Healthcare Utlization
大体时间:3 month follow-up
Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization
3 month follow-up
Knowledge Score
大体时间:3 month follow-up

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

3 month follow-up
Certainty about Choice (Decisional Conflict Scale)
大体时间:3 month follow-up

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

3 month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mary C Politi, PhD、Washington University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年6月27日

初级完成 (实际的)

2019年2月28日

研究完成 (实际的)

2019年2月28日

研究注册日期

首次提交

2018年6月26日

首先提交符合 QC 标准的

2018年7月9日

首次发布 (实际的)

2018年7月19日

研究记录更新

最后更新发布 (实际的)

2019年5月1日

上次提交的符合 QC 标准的更新

2019年4月29日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 201704045

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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