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

H

Harvard Medical School (HMS and HSDM)

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Other: No Proactive Outreach
Other: Proactive Outreach

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05497999
22-0916

Details and patient eligibility

About

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.

Enrollment

19,113 patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19,113 participants in 2 patient groups

Treatment Group
Experimental group
Description:
With Black and White Subgroups
Treatment:
Other: Proactive Outreach
Control Group
Active Comparator group
Description:
With Black and White Subgroups
Treatment:
Other: No Proactive Outreach

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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