Asthma in Families Facing Out-of-pocket Requirements Due to COVID-19
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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

      Study participants will be recruited through the AAFA and Harvard Pilgrim Health Care. As in
      AFFORD, the proposed study will take advantage of AAFA's wide national reach and role as a
      trusted information source to recruit a national sample of patients with asthma or parents of
      children with asthma. We will also recruit through Harvard Pilgrim Health Care, a non-profit
      health plan that offers insurance plans in Massachusetts, Maine, New Hampshire, and
      Connecticut

      Aim 1

      In this aim, the investigators will conduct a pilot randomized controlled trial of patients
      with asthma or parents of children with asthma who lost employer-sponsored coverage during
      the COVID-19 pandemic. Potential study subjects will be recruited through AAFA and Harvard
      Pilgrim. Eligible participants will be randomized into one of two study groups: 1) an
      intervention group that receives access to an asthma chat bot and personalized insurance
      navigation (n=145), or 2) a wait-list control group (n=285). At study entry, participants
      will receive an online baseline survey to assess outcomes related to insurance coverage,
      asthma severity and control, medication use and adherence, asthma care access and
      affordability, and COVID-19 related illness. The intervention group will be offered the chat
      bot and AAFA navigation services. One month later, the investigators will field a follow-up
      survey to measure short-term changes in outcomes; for the intervention group, this survey
      will also measure implementation outcomes including uptake, feasibility, acceptability, and
      usability. Four months later, the investigators will field a second follow-up survey to
      measure longer-term changes in outcomes. Control subjects will be offered the chat bot after
      completion of the follow-up surveys.

      Eligible subjects will include adults aged 18-64 years who have asthma or have a child with
      asthma aged 4-17 years, and lost employer-sponsored health insurance after February 2020.
      Potential subjects will be recruited through AAFA, who will send out a description of the
      study to potential subjects through its online community, email listserv, website, Facebook
      page, and newsletter. Potential subjects will also be recruited through Harvard Pilgrim.
      Members who disenrolled from employer-sponsored plans after February 2020 will be identified,
      and those aged 4-64 with an International Classification of Diseases (ICD)-10 diagnosis code
      for asthma in claims data after January 1, 2019 will be contacted by email and invited to
      participate. The investigators will collect information on race/ethnicity and select a sample
      representative of the racial/ethnic distribution of patients with asthma, with no more than
      60% non-Hispanic White participants selected for the sample.

      The investigators will conduct a pilot randomized controlled trial where they will randomize
      participants who lost coverage to: 1) be offered a combination of automated chat bot and
      personalized outreach provided by AAFA-affiliated navigators (n=145), or 2) be a wait-list
      control (n=285). The investigators will use a wait-list, usual care control group as the
      comparator given that there is no other standard treatment or practice for people with asthma
      who lose insurance coverage to which to compare our navigation intervention. After
      randomization, participants will be given a RedCap link for a baseline survey.

      After completion of the baseline survey, intervention subjects will be sent an email with
      information about AAFA's asthma chat bot and a link to access it and information about AAFA's
      insurance navigation program, how it can help with finding coverage and managing asthma
      costs, and how to access it via group and private messaging within AAFA's asthma community
      platform with the availability of telephonic follow-up from AAFA navigators. Subjects can
      join the private group where they can ask questions and share resources. They will be able to
      send messages to the AAFA navigator to communicate about insurance issues, access to asthma
      care, and assistance with asthma costs. The navigator will offer telephonic follow-up as
      needed.

      One month after receiving the intervention, subjects will be emailed a RedCap link to a
      follow-up survey to measure changes in insurance coverage and other outcomes. The follow-up
      survey will be structured similarly to the baseline survey, with closed-ended questions about
      insurance coverage, asthma care and control, health care access and affordability. For
      intervention subjects, the follow-up survey will also ask closed and open-ended questions
      about implementation outcomes such as uptake, acceptability, feasibility, usability, and
      fidelity.

      Four months later, intervention and control subjects will be emailed a RedCap link to a
      similar follow-up survey to measure changes in insurance coverage, asthma care and control,
      health care access, and affordability. Survey subjects will be asked for permission to be
      contacted again for participation in a telephone interview for Aim 2.

      The primary outcome will be whether the participant with asthma (or their child with asthma)
      has insurance coverage. Secondary outcomes will include whether the person with asthma used
      less asthma medication than prescribed because of cost, and whether they experienced health
      care-related financial burden. Other outcomes will assess asthma care use, asthma control
      using the Asthma Control Test (ACT), health status, mental health/worry, and material
      hardships such as food or housing insecurity.

      The study hypothesis is that participants receiving the intervention will be more likely to
      have coverage at four-month follow up (primary outcome) and will be less likely to report
      non-adherence to asthma medications, delayed/forgone asthma care, and financial burden than
      those receiving usual care (secondary outcomes).

      The investigators will compare unadjusted outcomes between the intervention and control
      groups using chi square and t tests; because of the randomized study design this difference
      measures the causal impact of the intervention. They will conduct post hoc exploratory
      analysis to assess differences in intervention effectiveness by race/ethnicity to assess
      whether the intervention reduces racial/ethnic coverage disparities. Given the small pilot
      nature of this study, these analyses will be hypothesis-generating rather than
      hypothesis-testing. In this pilot study, efficacy testing will be limited but the
      investigators expect to have 100 intervention and 200 control subjects with follow-up data to
      be able to detect absolute differences of 10% or more between study groups in changes in
      uninsurance rates with 80% power with a two-tailed alpha of 0.05. The investigators assume
      30% loss to follow-up from baseline to four-month follow-up. Given the small pilot nature of
      this study, dropout will be carefully tracked in order to inform feasibility assessment and
      planning for a larger trial. The investigators will closely monitor timing of dropout, impact
      of strategies such as telephone outreach, and characteristics of those dropping out compared
      to those retained, and will use multiple imputation methods to conduct a sensitivity analysis
      to test the sensitivity of findings analyzed with and without imputed data. Findings will be
      reported using CONSORT reporting guidelines.

      Aim 2

      In this aim, the investigators will conduct in-depth qualitative interviews to better
      understand barriers and facilitators to accessing coverage and asthma care more broadly
      during the COVID-19 pandemic. Study subjects will be selected from among those who completed
      the follow-up survey and gave permission to be re-contacted for a telephone interview. The
      investigators will approach 100 eligible survey participants by email to invite them to
      participate in an interview. They expect to complete 30 phone interviews, half from the
      intervention group and half from the control group. Interviews will use open-ended questions
      to explore patients' experiences related to obtaining coverage after job loss and associated
      asthma care access and affordability challenges and facilitators. Interviews will be
      conducted by the study investigators and will be audio recorded and the recordings will be
      transcribed.

      Eligible participants will be intervention and control participants who complete the
      four-month follow-up survey, give permission to be re-contacted for an interview, and provide
      an email and/or phone number to use to contact them. The investigators will seek to maximize
      variation in our sample by using survey data to identify potential subjects with a range of
      races/ethnicities, incomes, geographic residences, ages (child vs adult), and asthma
      severity.

      The investigators will collect data from 30 study participants through in-depth qualitative
      interviews. They will approach 100 eligible survey participants by email to invite them to
      participate in an interview. They will then follow up by phone to schedule an interview.
      After scheduling a telephone interview and describing the study, they will obtain verbal
      informed consent. Interviews will last for approximately 45 minutes and will be audio
      recorded with permission and transcribed verbatim. They estimate completing 30 phone
      interviews, half with participants from the intervention group and half from the control
      group.

      The investigators will transcribe recordings of the interviews and analyze these data via
      thematic content analysis. Using a codebook, 2 trained coders will independently code
      transcripts using NVivo, resolving disagreements via discussion. They will describe data
      thematically to probe quantitative findings and describe strengths, weaknesses, and perceived
      intervention impact.
    

Intervention name(s): insurance navigation
Intervention type(s): Behavioral
Intervention description(s): Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: health insurance; COVID-19; out-of-pocket health care costs; adherence; financial burden