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临床试验/NCT04613739
NCT04613739已完成不适用

Comparing Patient-Centered Outcomes for Adults and Children With Asthma in High-Deductible Health Plans With and Without Preventive Drug Lists: COVID Enhancement

Harvard Pilgrim Health Care2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年12月8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
56
试验地点
2
主要终点
Insurance Coverage

研究概览

简要总结

In addition to its impact on health, the COVID-19 pandemic led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, high-deductibles, and high out-of-pocket costs. Disruptions to employment and insurance coverage during the pandemic threaten to negatively affect asthma care and outcomes.

Our parent project, Asthma in Families Facing Out-of-pocket Requirements with Deductibles (AFFORD), found that patients with asthma may be particularly vulnerable to insurance-related cost barriers and challenges navigating health insurance. Together with the Asthma and Allergy Foundation of America (AAFA), the investigators developed an asthma chat bot to help patients with asthma navigate insurance benefits and optimize health care decisions. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage and how to find lower-cost alternatives for asthma care.

In this supplement to the AFFORD project, the investigators propose a new study to understand and address the insurance and health care cost challenges faced by patients with asthma who lose employer-sponsored coverage due to COVID-19. Our Aims are: 1) to conduct a pilot randomized controlled trial to evaluate the effectiveness and feasibility and acceptability of an insurance navigation intervention, including the chat bot, to help patients with asthma regain coverage after the loss of job-related insurance during the COVID-19 pandemic; and 2) to qualitatively explore the experiences of Aim 1 participants to understand barriers and facilitators to accessing coverage and asthma care more broadly during the COVID-19 pandemic

The study hypothesis is that participants receiving the intervention will be more likely to have coverage after four months and less likely to report non-adherence to asthma medications, delayed/forgone asthma care, and financial burden than those receiving usual care. Findings will provide evidence about the effectiveness of strategies to obtain coverage and maintain access to affordable asthma care and can inform ongoing and future decision making in response to the COVID-19 pandemic and other public health and economic threats.

详细描述

In addition to its impact on health, the COVID-19 pandemic has led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, high-deductibles, and high out-of-pocket costs. Disruptions to employment and insurance coverage during the pandemic threaten to negatively affect asthma care and outcomes.

Our parent project, Asthma in Families Facing Out-of-pocket Requirements with Deductibles (AFFORD), found that patients with asthma may be particularly vulnerable to insurance-related cost barriers and challenges navigating health insurance. Together with the Asthma and Allergy Foundation of America (AAFA), investigators developed an asthma chat bot to help patients with asthma navigate insurance benefits and optimize health care decisions. The chat bot is an artificial intelligence-enabled interactive online tool that can answer insurance-related questions and provide information on coverage and how to find lower-cost alternatives for asthma care.

In this supplement, the investigators propose to capitalize on the work of AFFORD to understand and address the insurance and health care cost challenges faced by patients with asthma who lose employer-sponsored coverage due to COVID-19. Specifically, our Aims are: 1) to conduct a pilot randomized controlled trial to evaluate the effectiveness and implementation outcomes (e.g. feasibility, acceptability) of an existing insurance navigation intervention, including the chat bot, to help patients with asthma regain coverage after the loss of job-related insurance during the COVID-19 pandemic; 2) to qualitatively explore the experiences of Aim 1 participants to understand barriers and facilitators to accessing coverage and asthma care more broadly during the COVID-19 pandemic

Findings will provide evidence about the effectiveness of patient-centered technological strategies to obtain coverage and maintain access to affordable asthma care and can inform ongoing and future decision making in response to the COVID-19 pandemic and other public health and economic threats.

Study Setting

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
None

盲法说明

Outcomes will be assess through an online survey of participants with additional recoding done by an analyst blinded to study group

入排标准

年龄范围
4 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-64 years who have asthma or have a child with asthma aged 4-17 years
  • Lost employer-sponsored health insurance after COVID-19 was declared a pandemic in March 2020

排除标准

  • Previous use of AAFA's insurance chat bot
  • Aim 2 (qualitative study):
  • As above, plus:
  • Inclusion Criteria:
  • Completed four-month follow-up survey for Aim 1

结局指标

主要结局

Insurance Coverage

时间窗: At follow-up (four months)

Coverage status (has any insurance coverage or not)

次要结局

  • Financial Burden(At follow-up (four months))
  • Delayed/Forgone Care Due to Cost(From baseline to follow-up (four months))
  • Medication Adherence(At follow-up (four months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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