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

NCT04613739 | Completed Results

• 1 other identifier: IHS-1602-34331
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

health insurance; COVID-19; out-of-pocket health care costs; adherence; financial burden

Outcome Measures

Primary Outcomes (1)

• Insurance Coverage

  Coverage status (has any insurance coverage or not)

  At follow-up (four months)

Secondary Outcomes (3)

• Medication Adherence

  At follow-up (four months)

• Financial Burden

  At follow-up (four months)

• Delayed/Forgone Care Due to Cost

  From baseline to follow-up (four months)

Study Arms (2)

Insurance navigation

EXPERIMENTAL

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

Wait-list controls

NO INTERVENTION

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)

Interventions

insurance navigation BEHAVIORAL

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.

Insurance navigation

Eligibility Criteria

• Age: 4 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Asthma and Allergy Foundation of America: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Harvard Pilgrim Health Care

Wellesley, Massachusetts, 02481, United States

Location

MeSH Terms

Conditions

Asthma; COVID-19; Financial Stress

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Alison Galbraith
• Organization: Harvard Pilgrim Health Care Institute

alison_galbraith@harvardpilgrim.org

617-867-4893

Study Officials

• Alison Galbraith, MD, MPH

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes will be assess through an online survey of participants with additional recoding done by an analyst blinded to study group
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 3, 2020
• Study Start: December 8, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)