A COPD Quality Improvement Program（QIP）

NCT05638646 | Unknown

• 1 other identifier: ESR-21-21293
• Study Type: interventional
• Target: 1,107
• Locations: 1 country
• Sites: 1

Brief Summary

QIP(Quality Improvement Programme) is a COPD quality improvement program in China. The initial step of this program is to set up the Quality Standards(QS) of COPD management in clinical practice, then embed Quality Standards into routine care and uses Quality Control Indicators (QCI)to check the QS implementation. The aim of the QIP program is to standardize COPD management in clinical practice in China, including the standardization of diagnosis, assessment, pharmacological and non-pharmacological intervention, and follow-up. COPD patients can benefit from standardization clinical behaviours, to be identified early, be accessed comprehensively, and be treated correctly according to guidelines, and with an appropriate follow-up to improve adherence.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Time to clinically important deterioration (CID)

  Time to CID, which is defined as the time from the date of enrolment until the date of the first CID.CID defined as any of the following events:1) Trough FEV1 decline ≥100ml;2) CAT increasing ≥ 2 unit;3) one moderate or severe exacerbation.

  48 weeks

Secondary Outcomes (14)

• Annual rate of moderate or severe COPD exacerbation

  1 year

• Annual rate of severe COPD exacerbation

  1 year

• Change from baseline in trough FEV1 over 48 weeks

  48 weeks

• Change from baseline in CAT over 48 weeks

  48 weeks

• Proportion of patients received inhalation technique review at least once during follow-up period

  48 weeks

Study Arms (2)

Intervention group

OTHER

Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease

Other: Intervention group

control group

OTHER

Maintain current treatment

Other: control group

Interventions

Intervention group OTHER

Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease

Intervention group

control group OTHER

Maintain current treatment

control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with COPD
• Aged 40 years or older
• CAT≥10
• With exacerbation history：
• at least 2 moderate or 1 severe exacerbation in the previous year
• or 1 moderate exacerbation in the previous year with FEV1 \<50% predicted value at baseline;
• Must able to sign the informed consent form

You may not qualify if:

• Patients on triple therapy at baseline with a LAMA, LABA, and inhaled corticosteroid (ICS) combination (Including open triple and fix-dose triple)
• Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
• Patients who are currently involved in any other interventional studies

Sponsors & Collaborators

• Shenzhen People's Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rongchang Chen, Professor

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Chen

CONTACT

13428991007; chendandan81@163.com

Rongchang Chen

CONTACT

13902273260; chenrc@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention was delivered at the hospital level. The intervention group will receive QS implementation, including QS training for physicians of respiratory department every 12 weeks; QS implementation check every 12 weeks, and follow-up every 12 weeks, QS-related written COPD clinical procedures will be also suggested to established key QS training requirements are:1) COPD diagnosis and assessment; 2)Therapy prescribed in accordance with national guideline 3)Non-pharmacological interventions; 4)An appropriate follow-up according to QS. The control group will maintain current practice and follow up every 12 weeks.

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 6, 2022
• Study Start: November 25, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 19, 2022

Record last verified: 2022-10

Locations

CN (1)