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Asthma in Families Facing Out-of-pocket Requirements Due to COVID-19 (AFFORD COVID)

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ClinicalTrials.gov Identifier: NCT04613739
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : March 2, 2021
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Asthma and Allergy Foundation of America
University of North Carolina, Chapel Hill
Harvard School of Public Health
Information provided by (Responsible Party):
Harvard Pilgrim Health Care

Brief Summary:

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. Patients with asthma are at risk for adverse health outcomes during the COVID-19 pandemic, and 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.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: insurance navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Outcomes will be assess through an online survey of participants with additional recoding done by an analyst blinded to study group
Primary Purpose: Health Services Research
Official Title: Comparing Patient-Centered Outcomes for Adults and Children With Asthma in High-Deductible Health Plans With and Without Preventive Drug Lists: COVID Enhancement
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Insurance navigation
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
Behavioral: insurance navigation
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.

No Intervention: Wait-list controls
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)



Primary Outcome Measures :
  1. Insurance coverage [ Time Frame: From baseline to follow-up (four months) ]
    Change in coverage status (has any insurance coverage or not)


Secondary Outcome Measures :
  1. Medication adherence [ Time Frame: From baseline to follow-up (four months) ]
    Change in report of using less asthma medication than prescribed because of cost

  2. Financial burden [ Time Frame: From baseline to follow-up (four months) ]
    Change in report of: 1) problems paying medical bills for asthma care, or 2) having to borrow money because of the amount required to pay for asthma care

  3. Delayed/forgone care due to cost [ Time Frame: From baseline to follow-up (four months) ]
    Change in report of: 1) using less asthma medication than prescribed because of cost,or 2) delaying or avoiding going to the doctor for asthma because of cost



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Aim 1:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613739


Contacts
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Contact: Lauren Cripps, MS 617-867-4316 Lauren_Cripps@harvardpilgrim.org

Locations
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United States, Massachusetts
Harvard Pilgrim Health Care Recruiting
Wellesley, Massachusetts, United States, 02481
Sponsors and Collaborators
Harvard Pilgrim Health Care
Patient-Centered Outcomes Research Institute
Asthma and Allergy Foundation of America
University of North Carolina, Chapel Hill
Harvard School of Public Health
Investigators
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Principal Investigator: Alison Galbraith, MD, MPH Harvard Pilgrim Health Care Institute
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Responsible Party: Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT04613739    
Other Study ID Numbers: IHS-1602-34331
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harvard Pilgrim Health Care:
health insurance
COVID-19
out-of-pocket health care costs
adherence
financial burden
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases