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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Treatment Group

With Black and White Subgroups

Group Type EXPERIMENTAL

Proactive Outreach

Intervention Type 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.

Control Group

With Black and White Subgroups

Group Type ACTIVE_COMPARATOR

No Proactive Outreach

Intervention Type 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.

Interventions

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Proactive Outreach

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.

Intervention Type OTHER

No Proactive Outreach

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.

Intervention Type OTHER

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No