Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population

Study Overview
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Brief Summary
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Reports suggest that the Medicaid population includes a higher percentage of smokers than the general population. A high prevalence of smokers in a population is likely to lead to a higher burden of chronic obstructive pulmonary disease (COPD). Few studies have evaluated the economic burden of COPD in a Medicaid population. The objective of this observational, retrospective cohort study is to estimate the economic burden of COPD in subjects with a COPD diagnosis who are enrolled in Medicaid and are receiving maintenance treatment covered by Medicaid. Specifically, the null hypothesis for the primary outcome measure is that no difference is observed in all-cause costs between subjects with and without COPD. The test hypothesis is that there is a difference in all-cause costs between subjects with and without COPD. Secondary outcomes to be evaluated include all-cause resource use and COPD-related costs for the COPD cohort. The study uses a medical and pharmacy administrative claims database called MarketScan Medicaid Database that contains the medical, surgical, and prescription drug experience of nearly 7 million Medicaid recipients. This analysis will use data from 8 states.

Official Title
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Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Subjects with COPD
* Other: Subjects without COPD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 40 years of age at index date continuously eligible to receive healthcare services through Medicaid in the pre-index and follow-up period enrolled in fee-for-service plans without a diagnosis code of exclusionary comorbid conditions - cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, pulmonary tuberculosis (including fibrosis due to tuberculosis) Exclusion Criteria: age less than 40 at index dates

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medicaid beneficiaries<br>Medicaid beneficiaries with at least one medical or pharmacy claim during each year in the identification period (2004-2006) | Other: Subjects with COPD<br>* Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication<br>Other: Subjects without COPD<br>* Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental costs of COPD | Mean difference in all-cause costs between subjects with and without COPD. Incremental total costs and components of incremental total costs including pharmacy, medical, and long-term care will be reported | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause resource use | The mean number of visits of each type of medical resource use including inpatient hospitalizations, emergency department [ED] visits, physician visits, outpatient visits, home healthcare visits/durable medical equipment, and long-term care visits. | 1 year | 
| COPD-related costs | Mean total, pharmacy, medical and long-term care costs associated with COPD in the cohort of subjects with a COPD diagnosis | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Costs, Resource utilization, Medicaid