TELEmedicine as an Intervention for Sepsis in Emergency Departments (TELEvISED)

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: Telemedicine

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1191

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will include all adult (age≥18 years) sepsis patients who presented to a participating rural ED between August 1, 2016 and June 30, 2019. Because of poor sensitivity in diagnosis code-based definitions of sepsis, we elected to use a multi-step definition requiring (1) hospital diagnosis of both infection and organ failure, (2) identification of infection in the ED, (3) presence of organ failure in the ED, and (4) presence of systemic inflammatory response syndrome (SIRS) criteria in the ED. To identify hospital diagnosis of infection and organ failure, we used the Fleischmann-Struzek approximation of sepsis using International Classification of Diseases, 10th edition, Clinical Modification (ICD-10-CM) or an explicit sepsis code (R65.20 or R65.21).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Telemedicine Cases; Patients presenting to rural emergency departments who had real-time provider-to-provider telemedicine used to supplement their emergency department care.	Other: Telemedicine; Use of provider-to-provider telemedicine
Non-Telemedicine Cases; Patients presenting to rural emergency departments who did not have real-time provider-to-provider telemedicine used to supplement their emergency department care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	Did patient die in the hospital?	Through hospital discharge, an average of 8 days
Mechanical Ventilation	Was mechanical ventilation required during admission?	Through hospital discharge, an average of 8 days
Vasopressors	Was vasopressor therapy required during admission?	Through hospital discharge, an average of 8 days
New Hemodialysis	Was dialysis required during this admission (if not on chronic dialysis)?	Through hospital discharge, an average of 8 days
Inter-hospital Transfer	Was inter-hospital transfer required from the index hospital?	Through hospital discharge, an average of 8 days
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
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
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
Emergency Department Length-of-Stay	The total duration of stay in the index emergency department.	Index emergency department duration (1 day)
Time-to-inpatient unit arrival	The time from index emergency department registration to arrival in the inpatient unit	24 hours

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Nicholas Mohr, MD, MS, University of Iowa

Publications and helpful links

General Publications

• Mohr NM, Harland KK, Okoro UE, Fuller BM, Campbell K, Swanson MB, Simpson SQ, Parker EA, Mack LJ, Bell A, DeJong K, Faine B, Zepeski A, Mueller K, Chrischilles E, Carpenter CR, Jones MP, Ward MM. TELEmedicine as an intervention for sepsis in emergency departments: a multicenter, comparative effectiveness study (TELEvISED Study). J Comp Eff Res. 2021 Feb;10(2):77-91. doi: 10.2217/cer-2020-0141. Epub 2021 Jan 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): October 30, 2022
• Study Completion (ACTUAL): October 30, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (ACTUAL): June 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: 201901748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate data will be shared with investigators who make a written request to the study team. These data will include aggregate effect sizes, but will not be patient-level data. Because of the sparsely populated region where this study is being conducted, hospital-identifiable data would be sufficient to identify individuals in this region, so fully de-identifying this data set would make it unusable for subsequent independent analyses (e.g., would require removing age, sex, hospital, transfer distance, transport times, comorbidities). The study team will, however, collaborate with other investigators to conduct additional analysis, maintaining the security of the data set.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No