Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study
概览
- 阶段
- 不适用
- 干预措施
- Control group
- 疾病 / 适应症
- COPD
- 发起方
- AstraZeneca
- 入组人数
- 1368
- 试验地点
- 37
- 主要终点
- Time to CID.
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .
详细描述
The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit. Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks. Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated.
研究者
入排标准
入选标准
- •Diagnosed COPD (post- bronchodilator FEV1/FVC \< 0.7)
- •40\~80 years
- •At least two moderate or at least one severe exacerbation history in past 1 year
- •Able to sign informed consent
排除标准
- •Continuous triple inhalation therapy for ≥6 months at baseline (include single inhaler and multiple inhalers)
- •Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
- •Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
- •Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
- •Not living in the healthcare area
- •Patients currently participating in any other interventional studies
研究组 & 干预措施
Control group
The control group will maintain the current usual care practice.
Intervention group
Intervention is implemented at a hospital level and will change overall daily practice. The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks. Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.
结局指标
主要结局
Time to CID.
时间窗: week0-week48
To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).
次要结局
- Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%.(week 12, 24, 36 and 48)
- Inhalation therapy consistency rate with guideline.(week 12, 24, 36 and 48)
- Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare.(week 24 and 48)
- Correct operation rate of inhalation device.(week 24 and 48)
- Patient satisfaction rate with treatment.(week 24 and 48)
- Disease knowledge score of patients.(week 24 and 48)
- Proportion of patients received different categories of long-acting maintenance inhalation.(week 12, 24,36 and 48)
- Rate of moderate or severe exacerbation.(week 12, 24 and 48)
- Rate of severe exacerbation.(week 12, 24 and 48)
- Rate of cardiovascular events.(week 12, 24 and 48)
- Change of CAT score.(week 0 to week 48)
- Percentage change of trough FEV1 and MMEF.(week 0 to week 48)