- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Medicaid beneficiaries
Medicaid beneficiaries with at least one medical or pharmacy claim during each year in the identification period (2004-2006)
|
Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication
Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incremental costs of COPD
기간: 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
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
All-cause resource use
기간: 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.
|
1 year
|
|
COPD-related costs
기간: 1 year
|
Mean total, pharmacy, medical and long-term care costs associated with COPD in the cohort of subjects with a COPD diagnosis
|
1 year
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 113900
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