Transitional Care Model Evaluation 2020
NCT04212962
CHF - Congestive Heart Failure, COPD
Princeton, New Jersey, United States
View Trial DetailsNCT Number: NCT06646419
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 .
This study is active but is not currently recruiting participants.
40 year–80 year
All sexes
Observational
Research Site, Anyang, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: week0-week48
To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).
Time frame: week 12, 24, 36 and 48
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Time frame: week 12, 24, 36 and 48
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Time frame: week 24 and 48
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Time frame: week 24 and 48
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Time frame: week 24 and 48
To evaluate the the impact of implementation and audit of transition bundle on treatment satisfaction.
Time frame: week 24 and 48
To evaluate the the impact of implementation and audit of transition bundle on disease knowledge.
Time frame: week 12, 24,36 and 48
To evaluate the the impact of implementation and audit of transition bundle on treatment pattern.
Time frame: week 12, 24 and 48
To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Time frame: week 12, 24 and 48
To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Time frame: week 12, 24 and 48
To evaluate the the impact of implementation and audit of transition bundle on cardiovascular events.
Time frame: week 0 to week 48
To evaluate the the impact of implementation and audit of transition bundle on quality of life.
Time frame: week 0 to week 48
To evaluate the the impact of implementation and audit of transition bundle on PFT.
AstraZeneca
Industry
Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study
Acronym: BRIDGE-COPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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