Sepsis Clinical Trial
— TELEvISEDOfficial title:
TELEmedicine as an Intervention for Sepsis in Emergency Departments
NCT number | NCT04441944 |
Other study ID # | 201901748 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2016 |
Est. completion date | October 30, 2022 |
Verified date | November 2022 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1191 |
Est. completion date | October 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (age 18 years or older) - Arrive at participating emergency department between August 1, 2016 and June 30, 2019 - Hospital diagnosis of infection and organ failure - Identification of infection in the emergency department - Presence of organ failure in the emergency department (SOFA score of at least 2) - Presence of systemic inflammatory response syndrome (SIRS) in the emergency department Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 28-day Hospital-Free Days | The total number of days in the 28 days after emergency department presentation that a patient is alive and outside the hospital. | Within 28 days of emergency department presentation | |
Secondary | Surviving Sepsis Campaign Guideline Adherence | Adherence with all elements of the Surviving Sepsis Campaign 3-hour and 6-hour bundles (dichotomous) | 6 hours after emergency department arrival | |
Secondary | Mortality | Did patient die in the hospital? | Through hospital discharge, an average of 8 days | |
Secondary | Mechanical Ventilation | Was mechanical ventilation required during admission? | Through hospital discharge, an average of 8 days | |
Secondary | Vasopressors | Was vasopressor therapy required during admission? | Through hospital discharge, an average of 8 days | |
Secondary | New Hemodialysis | Was dialysis required during this admission (if not on chronic dialysis)? | Through hospital discharge, an average of 8 days | |
Secondary | Inter-hospital Transfer | Was inter-hospital transfer required from the index hospital? | Through hospital discharge, an average of 8 days | |
Secondary | 28-Day Ventilator-Free Days | The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring a ventilator. | 28 days | |
Secondary | 28-Day Vasopressor-Free Days | The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring a vasopressor. | 28 days | |
Secondary | 28-Day ICU-Free 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. | 28 days | |
Secondary | Emergency Department Length-of-Stay | The total duration of stay in the index emergency department. | Index emergency department duration (1 day) | |
Secondary | Time-to-inpatient unit arrival | The time from index emergency department registration to arrival in the inpatient unit | 24 hours |
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