Last updated: 11/07/2018 06:59:54
Clinical and Economic Burden of Patients with Chronic Obstructive Pulmonary Disease in a Medicaid Population
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Clinical and Economic Burden of Patients with Chronic Obstructive Pulmonary Disease in a Medicaid Population
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incremental costs of COPD
Timeframe: 1 year
Secondary outcomes:
All-cause resource use
Timeframe: 1 year
COPD-related costs
Timeframe: 1 year
Interventions:
Enrollment:
40884
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
D’Souza AO, Shah M, Dhamane AD, Dalal AA. Clinical and Economic Burden of COPD in a Medicaid Population. COPD. 2014;11(2):212-220
- 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
- age less than 40 at index dates
Inclusion and exclusion 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-01-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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