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| Name | Class |
|---|---|
| Humana Co.Ltd. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | With Black and White Subgroups |
|
| Control Group | Active Comparator | With Black and White Subgroups |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Humana, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39073823 | Derived | Agarwal SD, Metzler E, Chernew M, Thomas E, Press VG, Boudreau E, Powers BW, McWilliams JM. Reduced Cost Sharing and Medication Management Services for COPD: A Randomized Clinical Trial. JAMA Intern Med. 2024 Oct 1;184(10):1186-1194. doi: 10.1001/jamainternmed.2024.3499. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2022 | Aug 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| 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. |
|
| 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 |
| 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 |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Harvard Medical School | Boston | Massachusetts | 02115 | United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |