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AsthmaPCCM-IMPACTSNCT04905420

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

An observational study of Asthma and COPD, run by AstraZeneca at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma, COPD, Asthma-COPD Overlap
How many people
288,538 participants
Where
1 siteChina
Study dates
8 Dec 2021to 12 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Chest Hospital

    Tianjin

Other trials in China

About this study

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)

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.

Read the 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.

Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within one year

  2. 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)

    Measured: Within one year

  3. 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%

    Measured: Within one year

  4. 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%

    Measured: Within one year

  5. Proportion of prescription of inhaled medicine

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

    Measured: Within one year

  6. 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%

    Measured: Within one year

Secondary outcomes (14)

  1. 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

    Measured: Within one year

  2. 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

    Measured: Within one year

  3. 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.

    Measured: Within one year

  4. 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%

    Measured: Within one year

  5. 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

    Measured: Within one year

  6. Rate of exacerbations (moderate or severe)

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

    Measured: Within one year

  7. Time to first moderate/severe exacerbation

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

    Measured: Within one year

  8. All-cause mortality

    All-cause mortality within one year after the index date

    Measured: within one year

  9. 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.

    Measured: Within one year

  10. 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

    Measured: Within one year

  11. Per capita medical costs of inpatients

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

    Measured: Within one year

  12. 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.

    Measured: Within one year

  13. Average daily hospitalization medical costs

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

    Measured: Within one year

  14. To analyze outcomes of secondary objectives separately

    Measured: Within one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start8 Dec 2021
  3. Primary completion12 Jun 2023
  4. Study completion12 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
288,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905420
Sponsor's protocol ID
D589BR00066
Acronym
PCCM-IMPACTS
Status last verified
Jul 2024
First submitted
30 Apr 2021
Last updated
31 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and COPD, run by AstraZeneca at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of newly diagnosed (time frame: Within one year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04905420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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