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OpenTrials
Completed

NCT Number: NCT05497999

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

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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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Maintenance inhaler adherence

    Time frame: 1 Year

    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.

Secondary outcomes

  1. Frequency of acute moderate-to-severe exacerbations

    Time frame: 1 Year

    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.

  2. Number of short-acting inhaler filled

    Time frame: 1 Year

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

  3. Total spending

    Time frame: 1 Year

    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).

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Collaborators

  • Humana Co.Ltd.

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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