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

AstraZeneca288,538 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

288,538

Conditions

Asthma COPD Asthma-COPD Overlap

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Tianjin Chest Hospital

Tianjin, China

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 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%

Time frame: 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%

Time frame: Within one year

Proportion of prescription of inhaled medicine

Proportion of prescription of inhaled medicine for outpatient visits and discharges respectively

Time frame: 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%

Time frame: Within one year

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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%

Time frame: 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

Time frame: Within one year

Rate of exacerbations (moderate or severe)

Rate of exacerbations (moderate or severe) within one year after index date

Time frame: Within one year

Time to first moderate/severe exacerbation

Time to first moderate/severe exacerbation within one year after index date

Time frame: Within one year

All-cause mortality

All-cause mortality within one year after the index date

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Within one year

Average daily hospitalization medical costs

Average daily hospitalization medical costs=total hospitalization costs/ total length of stay of the hospitalization.

Time frame: Within one year

To analyze outcomes of secondary objectives separately

Time frame: Within one year