Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT04381260
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2020-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RUral dispaRities in prehospitAL STEMI
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
RUral dispaRities in prehospitAL STEMI
Status:
COMPLETED
Status Verified Date:
2024-03
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:
None
Brief Summary:
Rural Americans are more likely to be unhealthy, older, living in poverty, uninsured, and medically underserved. The CDC has made achieving health equity and improving cardiovascular health for rural Americans one of their Healthy People 2020 overarching goals. ST-Elevation Myocardial Infarction (STEMI) is a life-threatening cardiovascular emergency that frequently affects people without warning within the communities the Participants live and work. Patients with STEMI have a linear relationship between first medical contact to Percutaneous Coronary Intervention (PCI) time and mortality. Delays are particularly important in STEMI patients with cardiogenic shock, who experience an excess 3.3 deaths per 100 for every 10 minute delay to PCI (for PCI times between 60-180 minutes). Delayed PCI is also associated with a higher rate of long term morbidity, including congestive heart failure and repeat MI. Unfortunately, many rural EMS agencies fail to consistently achieve the recommended 90 minute PCI time goal. Rural agencies are less likely than urban/suburban agencies to meet time goals and this disparity exposes rural patients to excess morbidity and mortality. The American College of Cardiology/American Heart Association (ACC/AHA) endorse the need for prehospital strategies to reduce total ischemic time, particularly in rural settings.
Detailed Description:
Achieving PCI time goals is influenced by multiple factors, such as patient attributes, agency factors and elements of organizational Emergency Medical Services (EMS) culture. Organizational culture is defined as a set of shared values, beliefs, and assumptions within an organization that influences how people within that organization behave. Differences in organizational culture between hospitals have been associated with both cardiovascular mortality and disease-specific outcomes. Although not yet rigorously studied in the prehospital environment, it is likely that organizational culture contributes to differences in tempo and manner of completing interventions. Prehospital performance accountability and culture have been discussed by experts in EMS magazines but have never been formally studied.
EMS STEMI protocols that include direct transportation to a PCI-capable hospital and pre-hospital PCI center activation improve patient outcomes. Unsuccessful EKG transmission, delayed PCI center activation, and cardiogenic shock have been shown to negatively affect PCI time metrics and patient outcomes. The impact of PCI delays in the rural setting has not been specifically studied. In addition, there are agency-level factors, such as ambulances per capita, number of satellite stations, miles of interstate that likely affect the EMS agency's ability to achieve shorter PCI times for the STEMI patients they care for. This proposal will use mixed methods to identify previously unmeasured components of rural EMS agency organizational culture, structure, care processes, and patient environment that likely influence PCI time and patient outcomes. In addition, this project will identify best practices that can be tested as novel interventions and implemented in rural EMS agencies to improve STEMI time metrics and therefore reduce patient morbidity and mortality.
EMS STEMI protocols that include direct transportation to a PCI-capable hospital and pre-hospital PCI center activation improve patient outcomes. Unsuccessful EKG transmission, delayed PCI center activation, and cardiogenic shock have been shown to negatively affect PCI time metrics and patient outcomes. The impact of PCI delays in the rural setting has not been specifically studied. In addition, there are agency-level factors, such as ambulances per capita, number of satellite stations, miles of interstate that likely affect the EMS agency's ability to achieve shorter PCI times for the STEMI patients they care for. This proposal will use mixed methods to identify previously unmeasured components of rural EMS agency organizational culture, structure, care processes, and patient environment that likely influence PCI time and patient outcomes. In addition, this project will identify best practices that can be tested as novel interventions and implemented in rural EMS agencies to improve STEMI time metrics and therefore reduce patient morbidity and mortality.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: