Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
473 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-12-15
Study Completion Date
2022-06-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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ST Elevation Myocardial Infarction
Cardiovascular Diseases
Study Design
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Observational Model Type
OTHER
Study Time Perspective
OTHER
Study Groups
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2016-2019 STEMI Registry
Retrospective data will be collected to develop a well-characterized registry of patients treated from 2016-2019 by any of 14 local rural EMS agencies and transported to a facility capable of performing Percutaneous Coronary Intervention. This registry will be used to determine the time to PCI performance for each of the EMS agencies. Time will be adjusted for patient distance from a PCI center using a linear mixed model with a random effect for center and a fixed effect for distance. This process will allow qualitative methods to identify organizational culture, structure, and clinical processes that impact STEMI care from the two highest and lowest performing rural EMS agencies. (n=750)
No intervention
Intervention Type
OTHER
There is no intervention for patients included in this group as this is a retrospective data registry only.
Key Informant Interviews
After identifying the two highest and lowest performing rural EMS agencies in the 2016-2019 STEMI Registry, key employees from each of those agencies will be recruited to participate in semi-structured key informant interviews. The interviews will assess current clinical care, organizational culture and opportunities for improvement. (n=32)
Interview
Intervention Type
OTHER
Key Informant Interview
Stakeholder Surveys
Employees at all local EMS agencies will be invited to participate in stakeholder surveys to quantify each agency's use of the care strategies identified during Key Information Interviews. (n=240)
Survey
Intervention Type
OTHER
Stakeholder survey
Interventions
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No intervention
There is no intervention for patients included in this group as this is a retrospective data registry only.
Intervention Type
OTHER
Interview
Key Informant Interview
Intervention Type
OTHER
Survey
Stakeholder survey
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Transported to one of four primary PCI centers (Wake Forest Baptist Medical Center (WFBMC), High Point Regional Medical Center (HPRMC), Novant Forsyth Medical Center (FMC), and Moses Cone) by rural agency (county identified rural by 2014 Census) ambulance from 2016-2019
* STEMI identified prior to or upon arrival at hospital
Exclusion:
* None
Key Informant Interviews:
Inclusion:
* Rural agency (county identified rural by 2014 Census)
* Identified as the top or bottom two performing services ranked by overall PCI time by regional STEMI registry patients transported to primary PCI center from 2016-2019
* Hold the position of EMS Director, EMS Medical Director, EMS Training Officer, Paramedic (2), EMT Crew Partner (2) or hold a similar key informant position at a local urban EMS agency (Forsyth county EMS) to allow the interview guide to be field-tested
Exclusion:
* None
Stakeholder Survey:
Inclusion:
* Rural agency (county identified rural by 2014 Census) transported to primary PCI center from 2016-2019
* Hold the position of EMS Director, EMS Medical Director, or EMS Training Officer or be a field provider with a Paramedic or EMT certification
Exclusion:
* None
* Transported to one of four primary PCI centers (Wake Forest Baptist Medical Center (WFBMC), High Point Regional Medical Center (HPRMC), Novant Forsyth Medical Center (FMC), and Moses Cone) by rural agency (county identified rural by 2014 Census) ambulance from 2016-2019
* STEMI identified prior to or upon arrival at hospital
Exclusion:
* None
Key Informant Interviews:
Inclusion:
* Rural agency (county identified rural by 2014 Census)
* Identified as the top or bottom two performing services ranked by overall PCI time by regional STEMI registry patients transported to primary PCI center from 2016-2019
* Hold the position of EMS Director, EMS Medical Director, EMS Training Officer, Paramedic (2), EMT Crew Partner (2) or hold a similar key informant position at a local urban EMS agency (Forsyth county EMS) to allow the interview guide to be field-tested
Exclusion:
* None
Stakeholder Survey:
Inclusion:
* Rural agency (county identified rural by 2014 Census) transported to primary PCI center from 2016-2019
* Hold the position of EMS Director, EMS Medical Director, or EMS Training Officer or be a field provider with a Paramedic or EMT certification
Exclusion:
* None
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jason M Stopyra, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
Countries
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United States
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00064512
Identifier Type: -
Identifier Source: org_study_id
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