Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population
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|ClinicalTrials.gov Identifier: NCT01615783|
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 25, 2012
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.
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Other: Subjects with COPD Other: Subjects without COPD|
|Study Type :||Observational|
|Actual Enrollment :||40884 participants|
|Official Title:||Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Medicaid beneficiaries with at least one medical or pharmacy claim during each year in the identification period (2004-2006)
Other: Subjects with COPD
Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication
Other: Subjects without COPD
Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period
- Incremental costs of COPD [ Time Frame: 1 year ]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
- All-cause resource use [ Time Frame: 1 year ]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.
- COPD-related costs [ Time Frame: 1 year ]Mean total, pharmacy, medical and long-term care costs associated with COPD in the cohort of subjects with a COPD diagnosis
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 ClinicalTrials.gov identifier (NCT number): NCT01615783
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|