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.
Study Type
OBSERVATIONAL
Enrollment
1,368
Research Site
Anyang, China
Time to CID.
To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).
Time frame: week0-week48
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.
Time frame: week 12, 24, 36 and 48
Inhalation therapy consistency rate with guideline.
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Time frame: 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.
Time frame: 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.
Time frame: week 24 and 48
Patient satisfaction rate with treatment.
To evaluate the the impact of implementation and audit of transition bundle on treatment satisfaction.
Time frame: week 24 and 48
Disease knowledge score of patients.
To evaluate the the impact of implementation and audit of transition bundle on disease knowledge.
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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
...and 27 more locations
Time frame: 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.
Time frame: 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.
Time frame: week 12, 24 and 48
Rate of severe exacerbation.
To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Time frame: week 12, 24 and 48
Rate of cardiovascular events.
To evaluate the the impact of implementation and audit of transition bundle on cardiovascular events.
Time frame: 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.
Time frame: 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.
Time frame: week 0 to week 48