Skip to main content
OpenTrials
Completed

NCT Number: NCT01615783

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subjects with COPD

Other

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

Subjects without COPD

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 11, 2012
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.