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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to CID. | To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID). | week0-week48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%. | To evaluate the the impact of implementation and audit of transition bundle on treatment compliance. | week 12, 24, 36 and 48 |
| Inhalation therapy consistency rate with guideline. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anyang | China | ||||
| Research Site |
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.
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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.
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.
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To evaluate the the impact of implementation and audit of transition bundle on treatment compliance. |
| week 12, 24, 36 and 48 |
| Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare. | To evaluate the the impact of implementation and audit of transition bundle on treatment compliance. | week 24 and 48 |
| Correct operation rate of inhalation device. | To evaluate the the impact of implementation and audit of transition bundle on treatment compliance. | week 24 and 48 |
| Patient satisfaction rate with treatment. | To evaluate the the impact of implementation and audit of transition bundle on treatment satisfaction. | week 24 and 48 |
| Disease knowledge score of patients. | To evaluate the the impact of implementation and audit of transition bundle on disease knowledge. | week 24 and 48 |
| Proportion of patients received different categories of long-acting maintenance inhalation. | To evaluate the the impact of implementation and audit of transition bundle on treatment pattern. | week 12, 24,36 and 48 |
| Rate of moderate or severe exacerbation. | To evaluate the the impact of implementation and audit of transition bundle on exacerbation. | week 12, 24 and 48 |
| Rate of severe exacerbation. | To evaluate the the impact of implementation and audit of transition bundle on exacerbation. | week 12, 24 and 48 |
| Rate of cardiovascular events. | To evaluate the the impact of implementation and audit of transition bundle on cardiovascular events. | week 12, 24 and 48 |
| Change of CAT score. | To evaluate the the impact of implementation and audit of transition bundle on quality of life. | week 0 to week 48 |
| Percentage change of trough FEV1 and MMEF. | To evaluate the the impact of implementation and audit of transition bundle on PFT. | week 0 to week 48 |
| 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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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