Impact of the Pulmonary and Critical Care Medical(PCCM) Standardized Management on Healthcare Management Among Asthma or COPD or Asthma-COPD Overlap Patients: a Retrospective Descriptive Analysis (PCCM-IMPACTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 288,538
- 试验地点
- 1
- 主要终点
- Proportion of Asthma or COPD or ACO patients(per ICD-10) annually
研究概览
简要总结
A Multi-centre, retrospective study describing the impact of PCCM standardized implementation on healthcare management among Asthma or COPD or Asthma-COPD overlap patients in Tianjin city of China, using real world electronic medical record database collected in local health care settings.
详细描述
This is a multi-center retrospective study to describe the impact of PCCM on healthcare management of Asthma or COPD or ACO patients in Tianjin healthcare big data platform database in China from Jan 01, 2015 to Dec 31, 2020. The impact of PCCM on healthcare management among Asthma or COPD or ACO patients will be explored. Analyses will be performed separately by disease, by hospitals with or without PCCM implementation, by period (pre-PCCM vs post-PCCM period) and by hospital grade. Patients enrolled into pre-PCCM period who also had post-PCCM visit(s) will be counted separately in two periods. The statistical analyses of this study will be primarily descriptive in nature and does not attempt to test any specific a priori hypotheses unless otherwise specified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Of note, the following criteria will be applied separately to the pre-PCCM period and post-PCCM period.
- •Patients were age 18 years and older.
- •Patients had Asthma diagnosis record according to the International Classification of Disease 10th edition (ICD-10) codes J45,J45.x, J46, J46.x.
- •Patients were age 18 years and older.
- •Patients had COPD diagnosis record according to the International Classification of Disease 10th edition (ICD-10) codesJ44 and J44.x (including the other clinical diagnostic records for COPD diagnosis codes: the other clinical diagnostic records will be defined as chronic bronchitis or emphysema or chronic wheeze bronchitis+ at least one of the following prescribed medicine which will be defined as ICS, LABA, LAMA, ICS/LABA, LABA/LAMA, ICS/LABA/LAMA, theophylline (sustained) , systemic glucocorticoids (IV/Oral), SAMA, SABA, SABA/SAMA).
- •Patients were age 18 years and older.
- •Patients had both COPD and Asthma diagnosis in a single record or within one year according to the International Classification of Disease 10th edition (ICD-10) codes J44, J44.x, J45,J45.x, J46 and J46.x.
排除标准
- •Patients with any history of diagnosis of COPD.
- •Patients had new diagnosis of COPD during Asthma follow up period.
- •Patients with any history of diagnosis of Asthma or bronchiectasis, interstitial lung disease(i.e. pulmonary fibrosis).
- •Patients had new diagnosis of Asthma during COPD follow up period.
- •ACO • Patients with any history of diagnosis of bronchiectasis, interstitial lung disease (i.e. pulmonary fibrosis).
结局指标
主要结局
Proportion of Asthma or COPD or ACO patients(per ICD-10) annually
时间窗: Within one year
Prevalence of Asthma or COPD or ACO patients =total numbers with disease(Asthma or COPD or ACO) patients (on/after index date 1)/ total numbers of patients with at least one all-cause visit in respiratory department×100%
Diagnostic accordance rate of admission and discharge
时间窗: Within one year
Diagnostic accordance rate of admission and discharge = total records of accordance of admission and discharge with disease(Asthma or COPD) (on/after index date 1)/ total records of disease(Asthma or COPD) diagnosed in admission or discharge(on/after index date 1)× 100%
Proportion of lung function tested
时间窗: Within one year
Proportion of lung function tested= number of Asthma or COPD or ACO patients with lung function tested(on/after index date 1) /number of Asthma or COPD or ACO diagnosed(on/after index date 1) ×100%
Proportion of prescription of inhaled medicine
时间窗: Within one year
Proportion of prescription of inhaled medicine for outpatient visits and discharges respectively
Incidence rate of newly diagnosed
时间窗: Within one year
Incidence rate of newly diagnosed (annualized) = number of newly diagnosed with disease (Asthma or COPD or ACO) /total person-time(in person-years) of patients with all-cause unique visits in respiratory department free of new Asthma or COPD or ACO diagnosis
Absolute number of Asthma or COPD or ACO patients(per ICD-10) annually
时间窗: Within one year
Absolute number of diagnosis will be defined as the number of patients with Asthma or COPD or ACO (on/after index date 1)
次要结局
- Rate of exacerbations (moderate or severe)(Within one year)
- All-cause mortality(within one year)
- Time to first moderate/severe exacerbation(Within one year)
- Number of OPD, ED or inpatients visits(Within one year)
- To describe clinical characteristics at baseline(Within one year)
- To describe treatment pattern at baseline(Within one year)
- Per capita medical costs of inpatients(Within one year)
- Average daily hospitalization medical costs(Within one year)
- To analyze outcomes of secondary objectives separately(Within one year)
- To describe demographics at baseline(Within one year)
- Proportion of standardized treatment(Within one year)
- Proportion of patients with moderate or severe Asthma or COPD or ACO exacerbation(Within one year)
- Per capita medical costs(Within one year)
- Average length of stay(Within one year)