Quality Control for Chronic Obstructive Pulmonary Disease

Establishment of Quality Control Index System and Strategy for Chronic Obstructive Pulmonary Disease in China

This is a 1 year longitudinal study to establish a related index system for chronic obstructive pulmonary disease(COPD) quality control.Clinical and economic data of COPD patients will be collected and analyzed.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: Medical quality control intervention strategy

Detailed Description

Sixteen hospitals in Guangdong Province were randomly divided into control group and intervention group.Doctors and nurses of intervention group were trained treat chronic obstructive pulmonary disease according to the GOLD(Global InitiaTive of Chronic Obstructive Lung Disease) guidelines，while those in the control group will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.All patients will be followed and events of acute exacerbation will be recorded.Factors that influence patient prognosis and economic-health benefits will be analyzed.

• Study Type: Observational
• Enrollment (Actual): 1600

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Grade II - III hospital in Guangdong Province

Description

Inclusion Criteria:

• Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.Patients was hospitalized for AECOPD or visiting outpatient department for COPD.

  • A signed and dated written informed consent is obtained prior to participation.
  • Able to comply with the requirements of the protocol and be available for study visits over 1 years.

Exclusion Criteria:

A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:

• Known respiratory disorders, or disorders identified at screening/visit

  1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)

• Having undergone lung surgery (e.g. lung reduction, lung transplant)
• Severe liver and kidney dysfunction
• Have cancer or have had cancer in the 5 years prior to study entry
• Taking part in a blinded drug study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; Doctors and nurses were trained to treat chronic obstructive pulmonary disease according to the GOLD guidelines.Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.
Intervention group; Doctors and nurses will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.	Behavioral: Medical quality control intervention strategy; Training and education for diagnosis, treatment and management of COPD for doctors and nurses; Regular inspection and supervision of medical quality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of exacerbations of COPD (AECOPD)	The rate of exacerbations within 1 year in the intervention group and the control group will be tracked.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of readmission for AECOPD	The rate of readmission for AECOPD within 1 year in the intervention group and the control group will be tracked.	1 year
change of Forced expiratory volume in one second(FEV1)	The difference in FEV1 after bronchodilator between baseline and 1 year later	1 year

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Study Director: Rongchang Chen, MD, Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: COPD; Quality Control
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: C2017050

Drug and device information, study documents

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