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NCT Number: NCT04905420

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

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.

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Key information

Conditions

Asthma Asthma-COPD Overlap Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Chest Hospital

Tianjin, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Incidence rate of newly diagnosed

    Time frame: 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

  2. Absolute number of Asthma or COPD or ACO patients(per ICD-10) annually

    Time frame: 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)

  3. Proportion of Asthma or COPD or ACO patients(per ICD-10) annually

    Time frame: 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%

  4. Diagnostic accordance rate of admission and discharge

    Time frame: 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%

  5. Proportion of prescription of inhaled medicine

    Time frame: Within one year

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

  6. Proportion of lung function tested

    Time frame: 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%

Secondary outcomes

  1. To describe demographics at baseline

    Time frame: Within one year

    To describe demographics among disease(Asthma or COPD or ACO) patients and disease(Asthma or COPD or ACO) patients with exacerbations history

  2. To describe clinical characteristics at baseline

    Time frame: Within one year

    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

  3. To describe treatment pattern at baseline

    Time frame: Within one year

    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.

  4. Proportion of standardized treatment

    Time frame: Within one year

    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%

  5. Proportion of patients with moderate or severe Asthma or COPD or ACO exacerbation

    Time frame: Within one year

    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

  6. Rate of exacerbations (moderate or severe)

    Time frame: Within one year

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

  7. Time to first moderate/severe exacerbation

    Time frame: Within one year

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

  8. All-cause mortality

    Time frame: within one year

    All-cause mortality within one year after the index date

  9. Average length of stay

    Time frame: Within one year

    Average length of stay= total length of Asthma or COPD or ACO -related stay/total number of discharged Asthma or COPD or ACO patients.

  10. Number of OPD, ED or inpatients visits

    Time frame: Within one year

    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

  11. Per capita medical costs of inpatients

    Time frame: Within one year

    Per capita medical costs of inpatients = total medical costs(medications and non-drug treatments)/ total number of discharges.

  12. Per capita medical costs

    Time frame: Within one year

    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.

  13. Average daily hospitalization medical costs

    Time frame: Within one year

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

  14. To analyze outcomes of secondary objectives separately

    Time frame: Within one year

Other outcomes

  1. To describe demographics

    Time frame: Within one year

    By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.

  2. To describe clinical characteristics

    Time frame: Within one year

    By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.

  3. To describe treatment pattern

    Time frame: Within one year

    By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.

  4. To describe clinical outcomes

    Time frame: Within one year

    By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.

  5. To describe HRU

    Time frame: Within one year

    By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.

  6. To describe costs

    Time frame: Within one year

    By disease (i.e. Asthma or COPD or ACO) from Jan 01, 2014 to Dec 31, 2020.

  7. To describe demographics

    Time frame: Within one year

    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.

  8. To describe clinical characteristics

    Time frame: Within one year

    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.

  9. To describe treatment pattern

    Time frame: Within one year

    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.

  10. To describe clinical outcomes

    Time frame: Within one year

    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.

  11. To describe HRU

    Time frame: Within one year

    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.

  12. To describe costs

    Time frame: Within one year

    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.

  13. To analyze outcomes of secondary objectives separately

    Time frame: Within one year

    To analyze outcomes of secondary objectives separately as subgroups within one year after index date

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: PCCM-IMPACTS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 27, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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