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

NCT03175536 | Completed Results

• 2 other identifiers: PCORI-IHS-1602-34331IHS-1602-34331
• Study Type: observational
• Target: 12,238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

high-deductible health plan; medication adherence; out-of-pocket costs; preventive drug list; value-based insurance design

Outcome Measures

Primary Outcomes (5)

• Change in Percentage of Days Covered for Inhaled Corticosteroids

  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 year to follow up year

• Change in Percentage of Days Covered for Leukotriene Inhibitors

  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 year to follow up year

• Change From Baseline in Percentage of Days Covered for Inhaled Corticosteroid-long-acting Beta Agonist Medications

  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 year to follow up year

• Asthma-related Emergency Department (ED) Visits

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

  baseline year to follow up year

• Out-of-pocket Costs

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

  baseline year to follow up year

Study Arms (3)

HDHP with PDL

Enrollees switched from a health savings account (HSA)-eligible high-deductible health plan (HDHP) without a preventive drug list (PDL) to a HSA-HDHP with a PDL

Other: HDHP with PDL

HDHP without PDL

Enrollees who stayed in a HSA-HDHP without a PDL.

traditional plan

Enrollees who remained in a traditional health plan with a deductible \< $500

Interventions

HDHP with PDL OTHER

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)

HDHP with PDL

Eligibility Criteria

• Age: 4 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children with asthma enrolled in an employer-sponsored plan from a large national insurance carrier between 2004 - 2017.

You may qualify if:

• adult or child with asthma, defined as having one outpatient claim, one emergency department claim, or one inpatient claim with an ICD-9/10 diagnosis code for asthma in the baseline period
• has employer-sponsored insurance from an employer who offers only one plan
• at least 24 months of continuous enrollment with pharmacy benefits between 2004 - 2017

You may not qualify if:

• other co-morbid pulmonary conditions identified in claims data (cystic fibrosis, immunodeficiency, bronchiectasis, congestive heart failure, pulmonary hypertension, or pulmonary embolism)
• enrolled through an employer who offers a choice of health insurance plans

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Harvard School of Public Health (HSPH): collaborator
• Asthma and Allergy Foundation of America: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Harvard Pilgrim Health Care

Wellesley, Massachusetts, 02481, United States

Location

MeSH Terms

Conditions

Asthma; Medication Adherence

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Alison Galbraith
• Organization: Harvard Medical School and Harvard Pilgrim Health Care Institute

alison_galbraith@harvardpilgrim.org

6178674893

Study Officials

• Alison A Galbraith, MD, MPH

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 5, 2017
• Study Start: March 1, 2017
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)