Clinical trial NCT04905420: The Impact of PCCM on Healthcare Among Asthma or Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap Patients
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Asthma-COPD Overlap
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 288538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence rate of newly diagnosed
timeFrame: Within one year
measure: Absolute number of Asthma or COPD or ACO patients(per ICD-10) annually
timeFrame: Within one year
measure: Proportion of Asthma or COPD or ACO patients(per ICD-10) annually
timeFrame: Within one year
measure: Diagnostic accordance rate of admission and discharge
timeFrame: Within one year
measure: Proportion of prescription of inhaled medicine
timeFrame: Within one year
measure: Proportion of lung function tested
timeFrame: Within one year
Secondary outcomes:
measure: To describe demographics at baseline
timeFrame: Within one year
measure: To describe clinical characteristics at baseline
timeFrame: Within one year
measure: To describe treatment pattern at baseline
timeFrame: Within one year
measure: Proportion of standardized treatment
timeFrame: Within one year
measure: Proportion of patients with moderate or severe Asthma or COPD or ACO exacerbation
timeFrame: Within one year
measure: Rate of exacerbations (moderate or severe)
timeFrame: Within one year
measure: Time to first moderate/severe exacerbation
timeFrame: Within one year
measure: All-cause mortality
timeFrame: within one year
measure: Average length of stay
timeFrame: Within one year
measure: Number of OPD, ED or inpatients visits
timeFrame: Within one year
measure: Per capita medical costs of inpatients
timeFrame: Within one year
measure: Per capita medical costs
timeFrame: Within one year
measure: Average daily hospitalization medical costs
timeFrame: Within one year
measure: To analyze outcomes of secondary objectives separately
timeFrame: Within one year
Other outcomes:
measure: To describe demographics
timeFrame: Within one year
measure: To describe clinical characteristics
timeFrame: Within one year
measure: To describe treatment pattern
timeFrame: Within one year
measure: To describe clinical outcomes
timeFrame: Within one year
measure: To describe HRU
timeFrame: Within one year
measure: To describe costs
timeFrame: Within one year
measure: To describe demographics
timeFrame: Within one year
measure: To describe clinical characteristics
timeFrame: Within one year
measure: To describe treatment pattern
timeFrame: Within one year
measure: To describe clinical outcomes
timeFrame: Within one year
measure: To describe HRU
timeFrame: Within one year
measure: To describe costs
timeFrame: Within one year
measure: To analyze outcomes of secondary objectives separately
timeFrame: Within one year
Locations:
city: Tianjin
country: China
facility: Tianjin Chest Hospital
Study officials:
affiliation: Tianjin Chest Hospital
name: chuan Yue Li, Dr.
role: PRINCIPAL_INVESTIGATOR
References: