NCT03175536: AFFORD

Asthma in Families Facing Out-of-pocket Requirements With Deductibles

Completed Results posted Last updated 3 September 2024

What this trial tests

trial testing HDHP with PDL in Asthma in 12,238 participants. Completed in 30 April 2021.

Timeline

1 March 2017

Primary endpoint
28 February 2021

30 April 2021

Quick facts

Lead sponsor	Harvard Pilgrim Health Care
Status	Completed
Study type	OBSERVATIONAL
Enrollment	12,238
Start date	1 March 2017
Primary completion	28 February 2021
Estimated completion	30 April 2021
Sites	1 location across United States

Drugs / interventions tested

• HDHP with PDL

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Harvard Pilgrim Health Care — full company profile →

Who can join

Adults 4 to 64, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Percentage of Days Covered for Inhaled Corticosteroids Primary · baseline year to follow up year

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

baseline period

Group	Value	95% CI
HDHP With PDL	51.5	47.0 – 56.1
HDHP Without PDL	44.7	36.4 – 52.9

follow up period

Group	Value	95% CI
HDHP With PDL	37.0	31.6 – 42.5
HDHP Without PDL	29.1	21.3 – 36.9

Change in Percentage of Days Covered for Leukotriene Inhibitors Primary · baseline year to follow up year

Adjusted mean change in adherence for leukotriene inhibitor medications as measured by change in percentage of days covered (PDC), relative to change in PDC for controls

baseline period

Group	Value	95% CI
HDHP With PDL	70.3	67.8 – 72.8
HDHP Without PDL	72.7	68.0 – 77.4

follow up period

Group	Value	95% CI
HDHP With PDL	58.4	54.9 – 62.0
HDHP Without PDL	59.1	52.6 – 65.6

Change From Baseline in Percentage of Days Covered for Inhaled Corticosteroid-long-acting Beta Agonist Medications Primary · baseline year to follow up year

Adjusted mean change in adherence for Inhaled Corticosteroid-Long-Acting Beta Agonist medications as measured by change in percentage of days covered (PDC), relative to change in PDC for controls

baseline period

Group	Value	95% CI
HDHP With PDL	55.9	52.8 – 59.0
HDHP Without PDL	58.6	54.3 – 62.8

follow up period

Group	Value	95% CI
HDHP With PDL	44.3	40.3 – 48.2
HDHP Without PDL	40.1	33.8 – 46.4

Asthma-related Emergency Department (ED) Visits Primary · baseline year to follow up year

Absolute change in asthma-related ED visits per 100 patients relative to controls

baseline period

Group	Value	95% CI
HDHP With PDL	2.29	1.90 – 2.68
HDHP Without PDL	2.48	1.72 – 3.25

follow up period

Group	Value	95% CI
HDHP With PDL	2.10	1.72 – 2.47
HDHP Without PDL	2.10	1.56 – 2.65

Out-of-pocket Costs Primary · baseline year to follow up year

change in out-of-pocket (OOP) costs for asthma medications and other health services

baseline period

Group	Value	95% CI
HDHP With PDL	130	121 – 138
HDHP Without PDL	122	110 – 133

follow up period

Group	Value	95% CI
HDHP With PDL	85	79 – 92
HDHP Without PDL	112	100 – 124

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.