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

Asthma Clinical Trial

— PCCM-IMPACTS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905420
• Other study ID #: D589BR00066
• Status: Completed
• Start date: December 8, 2021
• Est. completion date: June 12, 2023

Study information

• Verified date: December 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288538
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Asthma
• Asthma-COPD Overlap
• COPD

Locations

Country	Name	City	State
China	Tianjin Chest Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To describe demographics	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe clinical characteristics	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe treatment pattern	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe clinical outcomes	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe HRU	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe costs	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe demographics	By disease (i.e. Asthma or COPD or ACO) by escalating to triple therapy or initiating triple therapy on definition of different triple therapies ) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe clinical characteristics	By disease (i.e. Asthma or COPD or ACO) by escalating to triple therapy or initiating triple therapy on definition of different triple therapies ) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe treatment pattern	By disease (i.e. Asthma or COPD or ACO) by escalating to triple therapy or initiating triple therapy on definition of different triple therapies ) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe clinical outcomes	By disease (i.e. Asthma or COPD or ACO) by escalating to triple therapy or initiating triple therapy on definition of different triple therapies ) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe HRU	By disease (i.e. Asthma or COPD or ACO) by escalating to triple therapy or initiating triple therapy on definition of different triple therapies ) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To describe costs	By disease (i.e. Asthma or COPD or ACO) by escalating to triple therapy or initiating triple therapy on definition of different triple therapies ) from Jan 01, 2014 to Dec 31, 2020.	Within one year
Other	To analyze outcomes of secondary objectives separately	To analyze outcomes of secondary objectives separately as subgroups within one year after index date	Within one year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Proportion of prescription of inhaled medicine	Proportion of prescription of inhaled medicine for outpatient visits and discharges respectively	Within one year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of exacerbations (moderate or severe)	Rate of exacerbations (moderate or severe) within one year after index date	Within one year
Secondary	Time to first moderate/severe exacerbation	Time to first moderate/severe exacerbation within one year after index date	Within one year
Secondary	All-cause mortality	All-cause mortality within one year after the index date	within one year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Average daily hospitalization medical costs	Average daily hospitalization medical costs=total hospitalization costs/ total length of stay of the hospitalization.	Within one year
Secondary	To analyze outcomes of secondary objectives separately		Within one year

External Links

•   CSR Synopsis