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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615783
• Other study ID #: 113900
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: June 21, 2012
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40884
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No