Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646419
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIDGE-COPD
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 21 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 weeksStandardized transition bundle will be implemented once the first round education is completed Clinical audit takes up after first subject enrolled and implemented every 12 weeksThe 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 clinicemergency room and hospitalized due to exacerbation of COPD will be screened including newly diagnosed patients or those who have bee n treated
Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeksStandardized transition bundle will be implemented once the first round education is completed Clinical audit takes up after first subject enrolled and implemented every 12 weeksThe 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 clinicemergency room and hospitalized due to exacerbation of COPD will be screened including newly diagnosed patients or those who have bee n treated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None