Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population
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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 |
- 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
- 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 |
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
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 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013