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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497999
• Other study ID #: 22-0916
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19113
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Harvard Medical School	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Humana, Inc.	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)	Humana Co.Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 Year
Secondary	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.	1 Year
Secondary	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).	1 Year