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NCT03175536 · ClinicalTrials.gov registry record
Asthma in Families Facing Out-of-pocket Requirements With Deductibles
A clinical trial, sponsored by Harvard Pilgrim Health Care.
- Completed
- Registry status
- 12,238
- Enrollment target
NCT03175536: Completed study, sponsored by Harvard Pilgrim Health Care.
NCT03175536 is a clinical trial that has completed, run by Harvard Pilgrim Health Care. The registered enrollment target is 12,238 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03175536 has completed, sponsored by Harvard Pilgrim Health Care.
- COMPLETED
- Registry status
- 12,238 participants
- Enrollment target
Study Summary
Asthma is one of the most common chronic diseases in the U.S. Despite guidelines, adherence to recommended controller medications is low. Cost is an important barrier to adherence. Employers are increasingly adopting high-deductible health plans (HDHPs) which require deductibles of \> $1,000 per individual/$2,000 per family each year. In HDHPs with Health Savings Accounts (HSAs), most medications and non-preventive care must be paid out-of-pocket (OOP) until the deductible is reached. The lower premiums of HSA-HDHPs are appealing, but the high level of OOP costs can lead patients to forgo needed care. HSA-HDHPs can exempt preventive care from the deductible, and employers can add Preventive Drug Lists (PDLs) which exempt certain chronic medications from the deductible (including asthma medications), making them free. PDLs have the potential to improve controller medication use, which could prevent negative health outcomes and reduce cost-related trade-offs for families. The goal of this research is to evaluate the impact of these two developments in the health insurance market -- HSA-HDHPs and PDLs -- on medication use and clinical outcomes for adults and children with asthma. To do this, tteh investigators will first conduct in-depth interviews with patients with asthma and parents of children with asthma who have HDHPs and traditional plans. Interviews will collect patient-reported data on how patients and their families navigate their insurance plan and make health care decisions when faced with OOP costs. Findings from the interviews will inform analyses of data from a large national health plan from 2004-2017. Investigators will select adults and children with asthma whose employer switched them from traditional plans or HSA-HDHPs without PDLs to HSA-HDHPs with or without a PDL. Analyses will examine changes in asthma medication use, emergency department (ED) visits, hospitalizations, and OOP costs before and after changing plans compared to similar patients w
Primary Outcome
Adjusted mean change in adherence for inhaled corticosteroid medications as measured by change in percentage of days covered (PDC), relative to change in PDC for controls
Interventions
- OTHER HDHP with PDL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,238 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2021-04-30 |
What the finished NCT03175536 record still lists
NCT03175536 is an observational study that tracks outcomes without assigning an intervention. Its 12,238 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which HDHP with PDL is the first listed.
NCT03175536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03175536 about?
NCT03175536 is a clinical study titled "Asthma in Families Facing Out-of-pocket Requirements With Deductibles". Asthma is one of the most common chronic diseases in the U.S. Despite guidelines, adherence to recommended controller medications is low. Cost is an important barrier to adherence. Employers are increasingly adopting high-deductible health plans (HDHPs) which require deductibles of \> $1,000 per ind...
What is the current status of trial NCT03175536?
This trial is currently completed. The enrollment target is 12,238 participants. The study started on 2017-03-01. Estimated completion is 2021-04-30.
What interventions are being tested in trial NCT03175536?
The interventions under investigation include: HDHP with PDL (OTHER).
Who is sponsoring clinical trial NCT03175536?
This trial is sponsored by Harvard Pilgrim Health Care, which has 28 total clinical trials registered on ClinicalTrials.gov.
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