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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01615783
First received: June 7, 2012
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
Other: Subjects with COPD
Other: Subjects without COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incremental costs of COPD [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • All-cause resource use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean total, pharmacy, medical and long-term care costs associated with COPD in the cohort of subjects with a COPD diagnosis


Enrollment: 40884
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Medicaid beneficiaries
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Medicaid recipients (aged >=40 years) diagnosed with COPD (International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9 CM) codes: 491.xx, 492.x, 496.xx) and newly initiated on Chronic Obstructive Pulmonary Disease (COPD) maintenance medication (maintenance therapies include ipratropium alone/combination ipratropium-albuterol (IPR), tiotropium (TIO), inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and combination product of inhaled corticosteroid and long-acting beta-agonist (ICS/LABA)) will be identified and matched in a 1 to 3 ratio to non-COPD Medicaid recipients on age (exact), gender, race, index year, Medicare dual eligibility, pre-index long-term care use. Index date was defined as the date of the first chronologically-occurring COPD maintenance medication during an identification period (01/01/2004 to 12/31/2006) for COPD patients, and as the date of the first medical or prescription claim during the index year of the corresponding matche

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615783

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01615783     History of Changes
Other Study ID Numbers: 113900
Study First Received: June 7, 2012
Last Updated: June 21, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease
Costs
Resource utilization
Medicaid

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014