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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Subjects with COPD; Other: Subjects without COPD

• Registration Number: NCT01615783
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40884

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medicaid beneficiaries	Subjects with COPD	Medicaid beneficiaries with at least one medical or pharmacy claim during each year in the identification period (2004-2006)
Medicaid beneficiaries	Subjects without COPD	Medicaid beneficiaries with at least one medical or pharmacy claim during each year in the identification period (2004-2006)

Primary Outcome Measures

Name	Time	Method
Incremental costs of COPD	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

Secondary Outcome Measures

Name	Time	Method
All-cause resource use	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	1 year	Mean total, pharmacy, medical and long-term care costs associated with COPD in the cohort of subjects with a COPD diagnosis