Clinical trial NCT06646419: Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle
Official title: Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 1368
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population in this study are in the hospital exacerbation COPD patients with high risk of future exacerbation. Exacerbation COPD is defined as an event characterized by dyspnea and/or cough and sputum that worsen over \<14 days. Exacerbation of COPD are often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insults to the lungs.. Screening occurs when AECOPD identified in emergency room, respiratory outpatient clinic or inpatient department. Enrolment occurs when AECOPD treated for several days entering recovery period and transferring to home.

Brief summary: 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 .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed COPD (post- bronchodilator FEV1/FVC \< 0.7)
* 40\~80 years
* CAT≥10
* At least two moderate or at least one severe exacerbation history in past 1 year
* Able to sign informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to CID.
timeFrame: week0-week48
Secondary outcomes:
measure: Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%.
timeFrame: week 12, 24, 36 and 48
measure: Inhalation therapy consistency rate with guideline.
timeFrame: week 12, 24, 36 and 48
measure: Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare.
timeFrame: week 24 and 48
measure: Correct operation rate of inhalation device.
timeFrame: week 24 and 48
measure: Patient satisfaction rate with treatment.
timeFrame: week 24 and 48
measure: Disease knowledge score of patients.
timeFrame: week 24 and 48
measure: Proportion of patients received different categories of long-acting maintenance inhalation.
timeFrame: week 12, 24,36 and 48
measure: Rate of moderate or severe exacerbation.
timeFrame: week 12, 24 and 48
measure: Rate of severe exacerbation.
timeFrame: week 12, 24 and 48
measure: Rate of cardiovascular events.
timeFrame: week 12, 24 and 48
measure: Change of CAT score.
timeFrame: week 0 to week 48
measure: Percentage change of trough FEV1 and MMEF.
timeFrame: week 0 to week 48
Other outcomes:
Locations:
city: Anyang
country: China
facility: Research Site
city: Baise
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Bijie
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chenzhou
country: China
facility: Research Site
city: Chifeng
country: China
facility: Research Site
city: Chuzhou
country: China
facility: Research Site
city: Deyang
country: China
facility: Research Site
city: Fuyang
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Jieyang
country: China
facility: Research Site
city: Jining
country: China
facility: Research Site
city: Jiujiang
country: China
facility: Research Site
city: Kaiyuan
country: China
facility: Research Site
city: Langfang
country: China
facility: Research Site
city: Langzhong
country: China
facility: Research Site
city: Leping
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanchong
country: China
facility: Research Site
city: Neijiang
country: China
facility: Research Site
city: Qiannan
country: China
facility: Research Site
city: Qujing
country: China
facility: Research Site
city: Sanmenxia
country: China
facility: Research Site
city: Shaoyang
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Tengzhou
country: China
facility: Research Site
city: Tieling
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Xiangtan
country: China
facility: Research Site
city: Xiaogan
country: China
facility: Research Site
city: Xinyang
country: China
facility: Research Site
city: Yancheng
country: China
facility: Research Site
city: Yichang
country: China
facility: Research Site
city: Yuling
country: China
facility: Research Site
city: Zaoyang
country: China
facility: Research Site
Study officials:
References: