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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01615783
Enrollment
40884
Registered
2012-06-11
Start date
2010-11-30
Completion date
2011-03-31
Last updated
2012-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease, Costs, Resource utilization, Medicaid

Brief summary

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.

Interventions

OTHERSubjects with COPD

Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication

OTHERSubjects without COPD

Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incremental costs of COPD1 yearMean 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

Secondary

MeasureTime frameDescription
All-cause resource use1 yearThe 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.
COPD-related costs1 yearMean total, pharmacy, medical and long-term care costs associated with COPD in the cohort of subjects with a COPD diagnosis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026