Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19,113
- 试验地点
- 3
- 主要终点
- Maintenance inhaler adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Treatment Group
With Black and White Subgroups
干预措施: Proactive Outreach (Other)
Control Group
With Black and White Subgroups
干预措施: No Proactive Outreach (Other)
结局指标
主要结局
Maintenance inhaler adherence
时间窗: 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.
次要结局
- Total spending(1 Year)
- Number of short-acting inhaler filled(1 Year)
- Frequency of acute moderate-to-severe exacerbations(1 Year)
研究者
Sumit Agarwal
Instructor
Harvard Medical School (HMS and HSDM)