RUral dispaRities in prehospitAL STEMI

March 26, 2024 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

473

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Registry: Patients included in the registry data will be an all-comers population of patients suffering from STEMI and transported to a primary PCI by one of 14 identified rural EMS agencies between 2016-2019.

Key Informant Interviews: Participants will be EMS Directors, EMS Medical Directors, EMS Training Officers, Paramedics or EMT Crew Partners at the highest and lowest performing rural EMS agencies as determined by the STEMI registry data.

Stakeholder Surveys: Survey respondents will be EMS Directors, EMS Medical Directors, EMS Training Officers, Paramedics or EMT Crew Partners at any of the 14 local EMS agencies identified as rural.

Description

STEMI Registry:

Inclusion:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Other: No intervention
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)
Other: Interview
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)
Other: Survey
Stakeholder survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the organizational culture, structure, and clinical processes of high and low performing local rural EMS agencies using qualitative methods
Time Frame: 1 day
Aim 1 will be accomplished by developing a 2016-2019 STEMI data registry, which will be utilized to identify high- and low-performing rural EMS agencies. After identifying these agencies, Key Informants will participate in interviews designed to assess facilitators and barriers to achieving STEMI time metrics.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify the association between factors identified in Aim 1 and PCI time among rural EMS STEMI patient encounters.
Time Frame: 1 day
Stakeholder surveys will be utilized to quantify each agency's use of factors identified in Aim 1
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Jason M Stopyra, MD, Wake Forest Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

June 2, 2022

Study Completion (Actual)

June 2, 2022

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00064512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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