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Asthma in Families Facing Out-of-pocket Requirements With Deductibles (AFFORD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03175536
Recruitment Status : Active, not recruiting
First Posted : June 5, 2017
Last Update Posted : November 13, 2019
Harvard School of Public Health
Asthma and Allergy Foundation of America
Information provided by (Responsible Party):
Harvard Pilgrim Health Care

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.

Condition or disease Intervention/treatment
Asthma Other: HDHP with PDL

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Study Type : Observational
Estimated Enrollment : 111164 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparing Patient-Centered Outcomes for Adults and Children With Asthma in High-Deductible Health Plans With and Without Preventive Drug Lists
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Enrollees switched from a high-deductible health plan (HDHP) to a HDHP with a preventive drug list (PDL)
Other: HDHP with PDL
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 without PDL
Enrollees switched from a traditional plan to a high-deductible health plan (HDHP) without a preventive drug list (PDL). Enrollees who stayed in a HDHP without a PDL will also serve as controls for the study group who switch from HDHPs without PDLs to HDHPs with PDLs.
traditional plan
Enrollees who remained in a traditional health plan with a deductible < $500

Primary Outcome Measures :
  1. Proportion of days covered [ Time Frame: baseline year to follow up year ]
    change in adherence to any asthma controller medications as measured by change in proportion of days covered per month

  2. Medication discontinuation rate [ Time Frame: baseline year to follow up year ]
    change in adherence to any asthma controller medication as measured by change in medication discontinuation rate

  3. Use of asthma rescue medications [ Time Frame: baseline year to follow up year ]
    change in standardized number of inhalers dispensed per month

  4. Asthma-related ED visits and hospitalizations [ Time Frame: baseline year to follow up year ]
    change in asthma-related ED visits or hospitalizations that have a primary ICD-10 diagnosis code for asthma

  5. Out-of-pocket costs [ Time Frame: baseline year to follow up year ]
    change in out-of-pocket costs for asthma medications and other health services, measured by summing deductible, co-pay, and coinsurance amounts into annual measures; also measured as annual family OOP costs as a percent of family income, with cutpoints of >5% and >10% to indicate financially burdensome OOP costs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03175536

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United States, Massachusetts
Harvard Pilgrim Health Care
Wellesley, Massachusetts, United States, 02481
Sponsors and Collaborators
Harvard Pilgrim Health Care
Harvard School of Public Health
Asthma and Allergy Foundation of America
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Principal Investigator: Alison A Galbraith, MD, MPH Harvard Pilgrim Health Care Institute

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Responsible Party: Harvard Pilgrim Health Care Identifier: NCT03175536    
Other Study ID Numbers: PCORI-IHS-1602-34331
IHS-1602-34331 ( Other Grant/Funding Number: PCORI )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harvard Pilgrim Health Care:
high-deductible health plan
medication adherence
out-of-pocket costs
preventive drug list
value-based insurance design
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases