CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12,238 enrolled
Drug / intervention
HDHP with PDLother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03175536
NCT03175536N/ACompleted

Comparing Patient-Centered Outcomes for Adults and Children With Asthma in High-Deductible Health Plans With and Without Preventive Drug Lists

Harvard Pilgrim Health Care·observational·Posted Jun 5, 2017·Updated Sep 3, 2024

In Brief

An observational study evaluating HDHP with PDL for Asthma. Completed, enrolled 12,238 participants across 1 site.

Detailed 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 who did not switch to a HSA-HDHP. The study aims to: 1) understand health care decision making and experiences of families with asthma with HDHPs; 2) examine the impact of HSA-HDHPs with and without PDLs on use of asthma medications and asthma-related ED visits and hospitalizations; 3) examine the extent to which the response to HSA-HDHPs and PDLs is affected by the presence of other family members with asthma or other chronic conditions; 4) examine the impact of HSA-HDHPs with and without PDLs on OOP costs for families.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 5, 2017
Enrollment StartMar 1, 2017
Primary CompletionFeb 28, 2021
Study CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.1 years ago

Interventions

HDHP with PDLother

Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of \>$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)