Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02256657
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2014-10-01
Brief Title:
Study of a Quality Improvement Toolkit in Kerala India Among Hospitals Treating Acute Coronary Syndrome Patients
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Acute Coronary Syndrome Quality Improvement in Kerala ACS QUIK Cluster Randomized Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACS QUIK
Brief Summary:
The trial assesses the effect on 30-day major adverse cardiovascular event MACE rate of using a quality improvement toolkit among hospitals in Kerala India The quality improvement toolkit includes standardized admission and discharge sets clinical pathways and an audit and feedback program
Detailed Description:
This study is a cluster randomized stepped wedge clinical trial assessing implementation and effect of a locally-developed quality improvement toolkit for patients with acute coronary syndrome ACS in Kerala India Hospitals will be randomized after stratification for size to one of five cohorts After a four-month baseline period the quality improvement toolkit will be implemented in all hospitals in cohort 1 Through a one-way crossover design these hospitals will continue to use the quality improvement toolkit through the end of the trial for all acute coronary syndrome ACS patients Cohorts 2 through 5 will implement the quality improvement toolkit at time points 8 12 16 and 20 months respectively continuing the use of the toolkits from that time forward to the end of the study The primary outcome is 30-day MACE rates including death reinfarction stroke or major bleeding Rates will be continuously collected and compared at one interim time point for safety and efficacy Final analysis compares MACE rates before and after implementation of the quality improvement toolkits accounting for cluster effects of hospital cohort and time
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R00HL107749-03 | NIH | None | httpsreporternihgovquickSearchR00HL107749-03 |
| 1K99HL107749-01A1 | NIH | None | None |