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N/A N=56 Randomized Health Services Research

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

Asthma

Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Insurance Coverage — 11; 17; 1; 8 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
insurance navigation (Behavioral)
Age
Pediatric, Adult · 4+ yrs
Sex
All
Sponsor
Harvard Pilgrim Health Care
Primary completion
Sep 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Insurance Coverage
11; 17; 1; 8
SECONDARY
Medication Adherence
3; 8; 9; 17
SECONDARY
Financial Burden
5; 15; 7; 10
SECONDARY
Delayed/Forgone Care Due to Cost
4; 13; 8; 12

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04613739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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