Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle
BRIDGE-COPD
1 other identifier
observational
1,368
1 country
37
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedStudy Start
First participant enrolled
November 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
May 20, 2026
May 1, 2026
1.8 years
August 29, 2024
May 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to CID.
To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).
week0-week48
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
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.
Control group
The control group will maintain the current usual care practice.
Eligibility Criteria
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.
You may qualify if:
- Diagnosed COPD (post- bronchodilator FEV1/FVC \< 0.7)
- \~80 years
- CAT≥10
- At least two moderate or at least one severe exacerbation history in past 1 year
- Able to sign informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Anyang, China
Research Site
Baise City, China
Research Site
Beijing, China
Research Site
Bijie, China
Research Site
Changsha, China
Research Site
Chenzhou, China
Research Site
Chifeng, China
Research Site
Chuzhou, China
Research Site
Deyang, China
Research Site
Fuyang, China
Research Site
Hangzhou, China
Research Site
Hefei, China
Research Site
Jieyang, China
Research Site
Jining, China
Research Site
Jiujiang, China
Research Site
Kaiyuan, China
Research Site
Langfang, China
Research Site
Langzhong, China
Research Site
Leping, China
Research Site
Nanchang, China
Research Site
Nanchong, China
Research Site
Neijiang, China
Research Site
Qiannan, China
Research Site
Qujing, China
Research Site
Sanmenxia, China
Research Site
Shaoyang, China
Research Site
Suzhou, China
Research Site
Tengzhou, China
Research Site
Tieling, China
Research Site
Wenzhou, China
Research Site
Xiangtan, China
Research Site
Xiaogan, China
Research Site
Xinyang, China
Research Site
Yancheng, China
Research Site
Yichang, China
Research Site
Yuling, China
Research Site
Zaoyang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2024
First Posted
October 17, 2024
Study Start
November 13, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. 'Yes' , indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.