Clinical trial NCT05638646: A COPD Quality Improvement Program（QIP）
Official title: A Prospective, Multicentre, Cluster Randomised Controlled Trial to Evaluate the Impact of the Implementation of COPD Quality Standards in High Exacerbation Risk Patients------- A COPD Quality Improvement Program（QIP）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2022-12-06
Enrollment: 1107
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Detailed description: Background and Rationale Chronic obstructive pulmonary disease (COPD) is currently the most common chronic respiratory disease in China which causes a huge economic and social burden. Acute Exacerbation is a crucial issue that cannot be ignored in the management of COPD. Patients with frequent exacerbations have been found to have greater airflow limitation, a greater symptom burden, increased mortality, and worsen the quality of life (QoL). However, The COPD management of those patients in clinical practice is poor in China. Patients with a low standard of care, lack of regularly pharmacological and non-pharmacological intervention, and insufficient follow-up and disease education in clinical practice.

Objectives and Outcomes 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.

The objective of QIP study is to address key gaps in management of patients with high-risk through a targeted quality improvement programme in a healthcare system or practice. The aim is to evaluate the impact of QS implementation on target population compared to usual care in a real-world setting, including but not limited to COPD exacerbation, lung function, quality of life, and treatment pattern.

Study design This is a interventional, cluster-randomized, pragmatic clinical study. A total of 41 hospitals will be selected. Among them, 40 eligible hospitals will be selected across China and randomized (stratified by tier and geographic region) to the intervention group or control group at the ratio of 1:1. In addition, the leading site will be assigned to the intervention group without following the randomization procedure. In the intervention group, QS implementation will be performed. The control group will maintain the current practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with COPD
2. Aged 40 years or older
3. CAT≥10
4. With exacerbation history：

   1. at least 2 moderate or 1 severe exacerbation in the previous year
   2. or 1 moderate exacerbation in the previous year with FEV1 \<50% predicted value at baseline;
5. Must able to sign the informed consent form

Exclusion Criteria:

1. Patients on triple therapy at baseline with a LAMA, LABA, and inhaled corticosteroid (ICS) combination (Including open triple and fix-dose triple)
2. 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
3. Patients who are currently involved in any other interventional studies

Primary outcomes:
measure: Time to clinically important deterioration (CID)
timeFrame: 48 weeks
Secondary outcomes:
measure: Annual rate of moderate or severe COPD exacerbation
timeFrame: 1 year
measure: Annual rate of severe COPD exacerbation
timeFrame: 1 year
measure: Change from baseline in trough FEV1 over 48 weeks
timeFrame: 48 weeks
measure: Change from baseline in CAT over 48 weeks
timeFrame: 48 weeks
measure: Proportion of patients received inhalation technique review at least once during follow-up period
timeFrame: 48 weeks
measure: Proportion of patients received long-acting inhaled medicine with percentage of days covered (PDC)≥ 80% over 48 weeks
timeFrame: 48 weeks
measure: Proportion of prescription of inhaled maintenance medicine at 12 weeks
timeFrame: 12 weeks
measure: Proportion of prescription of inhaled maintenance medicine at 24 weeks
timeFrame: 24 weeks
measure: Proportion of prescription of inhaled maintenance medicine at 36 weeks
timeFrame: 36 weeks
measure: Proportion of prescription of inhaled maintenance medicine at 48 weeks
timeFrame: 48 weeks
measure: Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 12 weeks
timeFrame: 12 weeks
measure: Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 24 weeks
timeFrame: 24 weeks
measure: Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 36 weeks
timeFrame: 36 weeks
measure: Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 48 week
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guang Dong
Study officials:
affiliation: Shenzhen People's Hospital
name: Rongchang Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: