The Impact of PCCM on Healthcare Among Asthma or Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Asthma, COPD, Asthma-COPD Overlap

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Of note, the following criteria will be applied separately to the pre-PCCM period and post-PCCM period. Asthma: 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. COPD: 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). ACO: 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. Exclusion Criteria: Asthma Patients with any history of diagnosis of COPD. Patients had new diagnosis of COPD during Asthma follow up period. COPD 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of newly diagnosed | 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 | Within one year | 
| Absolute number of Asthma or COPD or ACO patients(per ICD-10) annually | Absolute number of diagnosis will be defined as the number of patients with Asthma or COPD or ACO (on/after index date 1) | Within one year | 
| Proportion of Asthma or COPD or ACO patients(per ICD-10) annually | 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% | Within one year | 
| Diagnostic accordance rate of admission and discharge | 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% | Within one year | 
| Proportion of prescription of inhaled medicine | Proportion of prescription of inhaled medicine for outpatient visits and discharges respectively | Within one year | 
| Proportion of lung function tested | 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% | Within one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe demographics at baseline | To describe demographics among disease(Asthma or COPD or ACO) patients and disease(Asthma or COPD or ACO) patients with exacerbations history | Within one year | 
| To describe clinical characteristics at baseline | To describe clinical characteristics among disease(Asthma or COPD or ACO) patients and disease(Asthma or COPD or ACO) patients with exacerbations history at baseline | Within one year | 
| To describe treatment pattern at baseline | To describe treatment pattern among disease(Asthma or COPD or ACO) patients and disease(Asthma or COPD or ACO) patients with exacerbations history at baseline. | Within one year | 
| Proportion of standardized treatment | Proportion of standardized treatment=number of standardized treatment patients /number of patients with disease(Asthma or COPD or ACO) diagnosed or (disease(Asthma or COPD or ACO) patients with exacerbation history)×100% | Within one year | 
| Proportion of patients with moderate or severe Asthma or COPD or ACO exacerbation | Proportion of patients with moderate or severe Asthma or COPD or ACO exacerbation frequency,Asthma or COPD or ACO exacerbation frequency will be classified as follow: 0 moderate/severe,1 moderate+ 0 severe, 2 moderate+ 0 severe, ≥3 moderate+ 0 severe, 1 severe, 2 severe, ≥3 severe | Within one year | 
| Rate of exacerbations (moderate or severe) | Rate of exacerbations (moderate or severe) within one year after index date | Within one year | 
| Time to first moderate/severe exacerbation | Time to first moderate/severe exacerbation within one year after index date | Within one year | 
| All-cause mortality | All-cause mortality within one year after the index date | within one year | 
| Average length of stay | Average length of stay= total length of Asthma or COPD or ACO -related stay/total number of discharged Asthma or COPD or ACO patients. | Within one year | 
| Number of OPD, ED or inpatients visits | Number of OPD, ED or inpatients visits will be counted in terms of disease(Asthma or COPD or ACO)-related OPD, ED or inpatients visits | Within one year | 
| Per capita medical costs of inpatients | Per capita medical costs of inpatients = total medical costs(medications and non-drug treatments)/ total number of discharges. | Within one year | 
| Per capita medical costs | Per capita medical costs= total medical costs(medications and non-drug treatments) of Asthma or COPD-related OPD, ED or inpatients visits / total number of Asthma or CODP or ACO patients. | Within one year | 
| Average daily hospitalization medical costs | Average daily hospitalization medical costs=total hospitalization costs/ total length of stay of the hospitalization. | Within one year | 
| To analyze outcomes of secondary objectives separately |  | Within one year |