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）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,107
- 试验地点
- 1
- 主要终点
- Time to clinically important deterioration (CID)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with COPD
- •Aged 40 years or older
- •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
排除标准
- •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
结局指标
主要结局
Time to clinically important deterioration (CID)
时间窗: 48 weeks
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.
次要结局
- Annual rate of moderate or severe COPD exacerbation(1 year)
- Annual rate of severe COPD exacerbation(1 year)
- Proportion of prescription of inhaled maintenance medicine at 24 weeks(24 weeks)
- Proportion of prescription of inhaled maintenance medicine at 36 weeks(36 weeks)
- Proportion of prescription of inhaled maintenance medicine at 48 weeks(48 weeks)
- Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 36 weeks(36 weeks)
- Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 12 weeks(12 weeks)
- Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 24 weeks(24 weeks)
- Proportion of prescription of inhaled maintenance medicine at 12 weeks(12 weeks)
- Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 48 week(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)
- Proportion of patients received long-acting inhaled medicine with percentage of days covered (PDC)≥ 80% over 48 weeks(48 weeks)
- Change from baseline in trough FEV1 over 48 weeks(48 weeks)