TELEmedicine as an Intervention for Sepsis in Emergency Departments

Sepsis Clinical Trial

— TELEvISED  

Official title:

TELEmedicine as an Intervention for Sepsis in Emergency Departments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441944
• Other study ID #: 201901748
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2022
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. To measure the association between rural ED-based telemedicine use, guideline adherence, and clinical outcomes using an observational cohort comparative effectiveness research study. Rural clinicians choose whether individual sepsis patients will be treated with telemedicine-supplemented care. Medical records will be analyzed from patients with severe sepsis who present to 25 rural hospital EDs that are part of a telemedicine network to estimate the effect of telemedicine on changing early SSC guideline adherence. Guideline adherence has been studied extensively as an outcome of sepsis implementation studies. The study will also analyze the impact of telemedicine on clinical outcomes, such as mechanical ventilation, hospital length-of-stay, and survival, using mediation analysis in a propensity-matched cohort design. Our working hypothesis is that telemedicine consultation will improve SSC guideline adherence and will reduce delays in care, leading to improved clinical outcomes.

2. To measure the effect of ED-based telemedicine on guideline adherence among patients who have telemedicine available but not used. In addition to the effect of use for individual patient care, telemedicine interactions may provide ongoing training for providers and nurses and influence care even for patients for whom telemedicine is not used. This effect may result from a learning effect in which local providers adopt practices they observe in telemedicine-consulted patients. The investigators will use hospital fixed-effects models to measure this association. The working hypothesis is that guideline adherence will increase after telemedicine adoption even in non-telemedicine patients, and adherence will be associated with the number of prior telemedicine sepsis encounters (dose-response).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1191
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• 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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

Other:
• Telemedicine
Use of provider-to-provider telemedicine

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

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