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

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)

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.

Study Overview

• Status: Completed
• Conditions: Asthma; COPD; Asthma-COPD Overlap

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 288538

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Tianjin Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Included in analyses will be patients with at least one diagnosis of Asthma or COPD or ACO identified from the Tianjin healthcare big data platform database from Jan 01, 2015 to Dec 31, 2020. Based on the preliminary assessment, there will be around 90,000 COPD patients, 150,000 Asthma patients and 50,000 ACO patients from 8 tertiary hospitals during Jan 01, 2015 to Dec 31, 2020. In addition, approximately 1,128,890 patients attending hospital respiratory departments for all-causes from Jan 01, 2015 to Dec 31,2020.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe demographics	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
To describe clinical characteristics	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
To describe treatment pattern	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
To describe clinical outcomes	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
To describe HRU	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
To describe costs	By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.	Within one year
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: chuan Yue Li, Dr., Tianjin Chest Hospital

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D589BR00066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No