Skip to main content
OpenTrials
Completed

NCT Number: NCT04441944

TELEmedicine as an Intervention for Sepsis in Emergency Departments

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Other

Use of provider-to-provider telemedicine

Primary outcomes

  1. 28-day Hospital-Free Days

    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.

Secondary outcomes

  1. Surviving Sepsis Campaign Guideline Adherence

    Time frame: 6 hours after emergency department arrival

    Adherence with all elements of the Surviving Sepsis Campaign 3-hour and 6-hour bundles (dichotomous)

  2. Mortality

    Time frame: Through hospital discharge, an average of 8 days

    Did patient die in the hospital?

  3. Mechanical Ventilation

    Time frame: Through hospital discharge, an average of 8 days

    Was mechanical ventilation required during admission?

  4. Vasopressors

    Time frame: Through hospital discharge, an average of 8 days

    Was vasopressor therapy required during admission?

  5. New Hemodialysis

    Time frame: Through hospital discharge, an average of 8 days

    Was dialysis required during this admission (if not on chronic dialysis)?

  6. Inter-hospital Transfer

    Time frame: Through hospital discharge, an average of 8 days

    Was inter-hospital transfer required from the index hospital?

  7. 28-Day Ventilator-Free Days

    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.

  8. 28-Day Vasopressor-Free Days

    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.

  9. 28-Day ICU-Free Days

    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.

  10. Emergency Department Length-of-Stay

    Time frame: Index emergency department duration (1 day)

    The total duration of stay in the index emergency department.

  11. Time-to-inpatient unit arrival

    Time frame: 24 hours

    The time from index emergency department registration to arrival in the inpatient unit

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: TELEvISED

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2020
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.