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临床试验/NCT02560701
NCT02560701已完成不适用

Impact of High Deductible Health Plans on Patients With Bipolar Disorder

Harvard Pilgrim Health Care0 个研究点目标入组 350,823 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
350,823
主要终点
Inpatient Hospitalizations Among Bipolar Patients

研究概览

简要总结

Using eleven years (2004-2014) of claims data from the largest US commercial health insurer, the investigators will assess the impact of switching into high-deductible health plans (HDHPs) on outcomes for patients with bipolar disorder. Patient subgroups will include patients with and without high medication cost-sharing and vulnerable populations (racial/ethnic minorities, poor, rural, major comorbidities). Interviews with patients and caregivers recruited through a major advocacy group will provide further insights into the policy issues with real-life experiences.

详细描述

Bipolar disorder is a severe mental illness affecting about 3% of the U.S. population that causes personal suffering, morbidity, and premature mortality. Continuous access to medications, close monitoring, and other psychiatric care are crucial for avoiding complications of bipolar disorder such as relapse, hospitalization, and suicide. To control rising costs, payers and employers are increasingly adopting high-deductible health plans (HDHPs) with very high out-of-pocket payments. Federally-defined Health Savings Account HDHPs require full cost-sharing for all non-preventive services, including medications and specialist visits; family deductibles for HSA-HDHPs range from $2,500 to $12,700. Enrollment in HDHPs quadrupled nationally between 2006 and 2013 to 38% of all workers. Analysts expect further explosive growth because of continued health care cost pressure on families and employers. Well-informed patients in HDHPs might reduce use of unnecessary services and more expensive treatment options. However, patients might also choose to forego needed care. There is very little evidence on how particularly vulnerable patients such as those with bipolar disorder or other chronic mental illnesses fare when forced to make complex choices about spending for care under HDHPs. Given their rapid escalation, there is an urgent need to understand how vulnerable patients change their patterns of care and medication adherence under HDHPs. We will compare patients with three types of insurance: traditional plans with low or no deductible; HDHPs in which chronic medications are paid fully out-of-pocket until the deductible is met; and HDHPs where medications are subject to the same co-pays as in traditional plans.

OBJECTIVES:

Using ten years of data from the largest U.S. commercial health insurer (~70 million members in all 50 states), we will assess the impact of HDHPs on key outcomes for patients with bipolar disorder experiencing employer-mandated shifts from traditional insurance to HDHPs. Our specific aims are to evaluate: (1) changes in medication adherence, and in intensity and quality of other health care; (2) changes in adverse events; and, (3) changes in patient out-of-pocket costs. We will compare how these outcomes differ for patients in HDHPs with and without medications subject to the deductible. We will assess effects in the overall population of patients with bipolar illness and in specific vulnerable subgroups, including racial/ethnic minorities, poorer patients, rural patients, and patients with other important comorbidities.

METHODS:

We will take advantage of an ongoing natural experiment whereby employers have shifted all their employees at once from traditional insurance to HDHPs. We will use the strongest quasi-experimental, longitudinal methods available to compare the experience of patients switched by their employers into HDHPs with contemporaneous patients whose employers remain in traditional plans. A major advantage of our approach is the inclusion of only employers whose employees had no choice of insurance plans, minimizing member-level selection bias.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 63 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Members age 65 years or older who could be eligible for Medicare benefits, including drug coverage through Medicare Part D.
  • Members whose employer offered a choice of health plan.

结局指标

主要结局

Inpatient Hospitalizations Among Bipolar Patients

时间窗: Year 3

Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients

Emergency Department Visits Among Patients With Bipolar Disorder

时间窗: Year 3

Mean number of annual emergency department visits in the follow-up period among bipolar patients

Medication Adherence for Bipolar Disorder

时间窗: YEAR 2

Mean number of annual bipolar medication fills in the follow-up period among bipolar patients

次要结局

  • Access To Outpatient Services for Bipolar Disorder(YEAR 2)
  • Medication Adherence for Bipolar Disorder - Psychotropic Medications(YEAR 2)

研究者

申办方类型
Other
责任方
Sponsor

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