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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Outreach
No Proactive Outreach
Sponsored by
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring Cost sharing, Health insurance, Inhalers, Adherence, Disparities

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Chicago
  • Humana, Inc.
  • Harvard Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

With Black and White Subgroups

With Black and White Subgroups

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
August 8, 2022
Last Updated
March 11, 2023
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
Humana Co.Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05497999
Brief Title
Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
Official Title
Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
Humana Co.Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Cost sharing, Health insurance, Inhalers, Adherence, Disparities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
With Black and White Subgroups
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
With Black and White Subgroups
Intervention Type
Other
Intervention Name(s)
Proactive Outreach
Intervention Description
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
Intervention Name(s)
No Proactive Outreach
Intervention Description
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 Outcome Measure Information:
Title
Maintenance inhaler adherence
Description
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 Outcome Measure Information:
Title
Frequency of acute moderate-to-severe exacerbations
Description
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
Title
Number of short-acting inhaler filled
Description
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
Title
Total spending
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Humana, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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