University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
NCT Number: NCT04441944
Sepsis is a life-threatening condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. Rural emergency department (ED)-based provider-to-provider telemedicine has been proposed to standardize care and support local clinicians in rural hospitals. The goal of this multicenter observational comparative effectiveness study is to measure the association between tele-ED use and clinical outcomes in a cohort of rural sepsis patients.
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All sexes
Observational
Iowa City, Iowa, 52242, United States
Sepsis is a life-threatening condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. This effect persists even among patients who are transferred between hospitals and who bypass rural hospitals. With 17% of all hospital deaths attributable to sepsis and 19% of Americans living in rural areas, there is a critical need to identify strategies to reduce the disparities in outcomes between rural and urban sepsis care.
Rural ED-based telemedicine has been proposed to standardize care and support local clinicians in rural hospitals. Telemedicine networks provide a real-time, high-definition on-demand video connection between a rural hospital and a tertiary hub 24 h daily. Based in Sioux Falls, South Dakota, Avera eCare is a tele-emergency network that serves as a hub for a 140-hospital network that spans 12 rural Midwestern states. It is the largest rural ED-based telehealth network in North America, and a network the investigators have studied previously.
Our central hypothesis is that telemedicine will improve clinical outcomes through improved adherence with Surviving Sepsis Campaign (SSC) guidelines. Using comparative effectiveness methods and a patient-centered outcomes research (PCOR) approach, this study will test the hypotheses with the following specific aims:
The rationale for this research is that dissemination and implementation of best practices through rural networks remains difficult, but telemedicine offers one potential solution. Sepsis is an ideal model to study the effect of telemedicine because it differs from other acute care conditions treated in rural hospitals (e.g., trauma, myocardial infarction) in that early treatment provided in rural hospitals may be more important than rapid transfer to tertiary centers. Focusing on telemedicine in rural sepsis care will serve as a powerful model for examining strategies for disseminating innovations across rural networks.
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Inclusion criteria
Exclusion criteria
Use of provider-to-provider telemedicine
Time frame: Within 28 days of emergency department presentation
The total number of days in the 28 days after emergency department presentation that a patient is alive and outside the hospital.
Time frame: 6 hours after emergency department arrival
Adherence with all elements of the Surviving Sepsis Campaign 3-hour and 6-hour bundles (dichotomous)
Time frame: Through hospital discharge, an average of 8 days
Did patient die in the hospital?
Time frame: Through hospital discharge, an average of 8 days
Was mechanical ventilation required during admission?
Time frame: Through hospital discharge, an average of 8 days
Was vasopressor therapy required during admission?
Time frame: Through hospital discharge, an average of 8 days
Was dialysis required during this admission (if not on chronic dialysis)?
Time frame: Through hospital discharge, an average of 8 days
Was inter-hospital transfer required from the index hospital?
Time frame: 28 days
The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring a ventilator.
Time frame: 28 days
The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring a vasopressor.
Time frame: 28 days
The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring an ICU bed.
Time frame: Index emergency department duration (1 day)
The total duration of stay in the index emergency department.
Time frame: 24 hours
The time from index emergency department registration to arrival in the inpatient unit
University of Iowa
Other
Acronym: TELEvISED
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