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

Harvard Medical School (HMS and HSDM)19,113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

19,113

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Locations (3)

University of Chicago

Chicago, Illinois, United States

Humana, Inc.

Louisville, Kentucky, United States

Harvard Medical School

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 Year

Secondary Outcomes

Frequency of acute moderate-to-severe exacerbations

An exacerbation is defined as any acute worsening of symptoms that requires antibiotics or systemic steroids. Moderate exacerbations are those that do not result in hospitalization or death and therefore captures those exacerbations treated on an outpatient basis. Severe exacerbations are exacerbations that result in hospitalization.

Time frame: 1 Year

Number of short-acting inhaler filled

A short-acting inhaler is defined as any inhaler with a short-acting beta agonist and/or short-acting antimuscarinic antagonist.

Time frame: 1 Year

Total spending

Total spending includes both the insurer's payments and beneficiary's out-of-pocket payments over the course of the calendar year. It includes spending across types of service (e.g., drugs) and settings (e.g., acute care).

Time frame: 1 Year