Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing

NCT05497999 | Completed

• 1 other identifier: 22-0916
• Study Type: interventional
• Target: 19,113
• Locations: 1 country
• Sites: 3

Brief Summary

In partnership with a large Medicare Advantage (MA) insurer (Humana, Inc.) and as part of a Center for Medicare and Medicaid Innovation demonstration program of Value-Based Insurance Design (VBID), the investigators propose to study a randomized controlled quality improvement trial in which Humana randomized MA beneficiaries with COPD to receive proactive outreach for a VBID benefit that provided large reductions in cost-sharing for their maintenance inhalers and telephone-based COPD medication management services in 2020 and 2021. The investigators will analyze changes in racial disparities for inhaler fills, clinical outcomes, health care spending, and acute care utilization.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Cost sharing; Health insurance; Inhalers; Adherence; Disparities

Outcome Measures

Primary Outcomes (1)

• Maintenance inhaler adherence

  A maintenance inhaler is defined as any inhaler with an inhaled corticosteroid, long-acting beta-agonist, and/or long-acting antimuscarinic antagonist. The proportion of days covered (PDC), a common claims-based measure of adherence, is calculated by dividing number of days covered by a prescription by the total number of days eligible for the medication. In constructing the measure, days covered (numerator) will be number of days on any maintenance inhaler (whether one of a single class, multiple of differing classes, or changes between inhalers), and the days eligible (denominator) will be number of days in the observation period. The primary analysis will treat PDC as a continuous measure.

  1 Year

Secondary Outcomes (3)

• Frequency of acute moderate-to-severe exacerbations

  1 Year

• Number of short-acting inhaler filled

  1 Year

• Total spending

  1 Year

Study Arms (2)

Treatment Group

EXPERIMENTAL

With Black and White Subgroups

Other: Proactive Outreach

Control Group

ACTIVE COMPARATOR

With Black and White Subgroups

Other: No Proactive Outreach

Interventions

Proactive Outreach OTHER

The treatment is proactive outreach that sought to enroll individuals in a VBID program available to all enrollees that provided: 1) large reductions in cost-sharing for maintenance inhalers, and 2) telephone-based COPD medication management services. Proactive outreach for those randomized to the treatment arm included, at a minimum, a phone call and letter in the mail from Humana. Proactive outreach could also have included an email, text message, and/or provider referral.

Treatment Group

No Proactive Outreach OTHER

Control group participants received no proactive outreach but could call to enroll themselves in the VBID program if they learned about it through traditional means, such as the benefits description manual.

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has COPD diagnosis
• Receives health services and prescription drug benefits through a Humana Medicare Advantage plan that includes Part D coverage
• Has at least one prior fill of a COPD maintenance inhaler in the prior 12 months
• Not fully adherent to maintenance inhaler (PDC \< 80%) in year prior to randomization

You may not qualify if:

• Enrolled in Part D Low-Income Subsidy program
• On hospice
• Has end-stage renal disease
• Has mild COPD (i.e., COPD diagnosis but no maintenance inhaler fill, no pulmonary function tests in year prior year, and no acute care use for COPD)
• Enrolled in Humana plan for less than 3 months
• In the coverage gap phase of MA plan at time of assignment
• Receives primary care at select locations of Humana subsidiaries (CenterWell or Conviva)

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• Humana Co.Ltd.: collaborator

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Humana, Inc.

Louisville, Kentucky, 40202, United States

Location

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Agarwal SD, Metzler E, Chernew M, Thomas E, Press VG, Boudreau E, Powers BW, McWilliams JM. Reduced Cost Sharing and Medication Management Services for COPD: A Randomized Clinical Trial. JAMA Intern Med. 2024 Oct 1;184(10):1186-1194. doi: 10.1001/jamainternmed.2024.3499.

  PMID: 39073823 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: January 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)