Evaluating Tele-Emergency Care in Costs and Outcomes for Rural Sepsis Patients (TELE-Cost)

Evaluating the Role of Tele-Emergency Care in Health Care Costs and Long-Term Outcomes for Rural Medicare Beneficiaries With Sepsis

Sepsis is a life-threatening emergency for which provider-to-provider telemedicine has been used to improve quality of care. The objective of this study is to measure the impact of rural tele-emergency consultation on long-term health care costs and outcomes through decreasing organ failure, hospital length-of-stay, and readmissions.

Study Overview

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

Detailed Description

Sepsis is responsible for over 1.7 million hospitalizations at a cost of $26 billion annually, making it the most expensive acute care condition in US hospitals. High-quality early sepsis care has been associated with decreased organ failure, shorter ICU and hospital length-of-stay, and improved survival. Rural sepsis patients are more likely to be transferred to tertiary centers, and they also have higher mortality and health care costs. ED-based telemedicine (tele-ED) consultation between a rural provider and a board-certified emergency physician may deliver the expertise to reduce care delays and improve outcomes while avoiding unnecessary costs.

In 2017, the study team partnered with Avera eCARE, the largest tele-ED provider in North America, to implement a standard telemedicine-based sepsis care pathway. Subsequently, the investigators showed (using patient-level primary data collection across several networks) that tele-ED use was associated with improved adherence with international sepsis guidelines.

In addition to its association with short-term clinical outcomes, however, the study team hypothesize that telemedicine may also decrease costs. The investigators have shown that high-quality sepsis care is associated with decreased readmissions and post-discharge mortality. High quality care may also prevent organ failure, avoid ICU admissions, reduce mechanical ventilation and vasopressor use, decrease ICU and hospital length-of-stay, and decrease post-discharge care-primarily through reducing avoidable organ failure. All of these factors are likely to have a significant effect in terms of reducing healthcare cost.

The objective of the proposed project is to measure the effect of tele-ED consultation at reducing healthcare costs and long-term outcomes in sepsis patients in rural EDs. The following primary hypotheses will be tested:

• Total healthcare expenses and 90-day mortality will be lower in patients treated in a tele-ED hospital, with the effect primarily through reduced hospital length-of-stay and fewer readmissions.
• Total expenses and mortality will be lower in cases where tele-ED is used vs. matched controls in non-tele-ED hospitals.

• Study Type: Observational
• Enrollment (Actual): 55772

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: No

• Sampling Method: Non-Probability Sample

Study Population

Age-qualifying Medicare beneficiaries with at least one ED admission for sepsis in a cohort of rural hospitals in the Avera service area between 2017-2019. Hospitals will be stratified as tele-ED capable and a set of 2:1 matched control hospitals in the same regions where tele-ED is not available. Sepsis cases will be identified according to the International (ICD-10), with a discharge diagnosis of [(infection plus organ failure) or explicit sepsis diagnosis], plus an ED diagnosis of infection, as we have done previously.

Description

Inclusion Criteria:

• Sepsis, according to ICD-10 codes

Exclusion Criteria:

• No infection diagnosed in the ED

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-tele-ED hospital; Patients receiving care in an ED that does not provide any tele-ED service
Tele-ED hospital; Patients receiving care in an ED that uses tele-ED services, but patient care did NOT utilize this service
Tele-ED used; Patient care was provided through tele-ED services	Other: Telemedicine; Receiving care in a tele-ED hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total healthcare expenditures	Defined as direct inpatient and outpatient payments to hospitals and physicians, skilled nursing care, home care, durable medical equipment, and ambulance costs from the ED visit until 30 days post-discharge. Drugs are not included.	From hospital admission until 30 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who die within 90 days of hospital admission	90-day mortality	From hospital admission until 90 days after admission
Hospital length-of-stay	Duration of hospitalization	From date of hospitalization through hospital discharge, assessed up to 90 days
Number of participants requiring ICU care	Any admission to the ICU	From the date of hospital admission through hospital discharge or 90 days, whichever comes first, the number of participants who are treated in an intensive care unit
Emergency department costs	Total healthcare expenditures related to emergency department care in current hospitalization	From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all emergency department health care expenditures
Inpatient care costs	Total healthcare expenditures related to inpatient care in current hospitalizations	From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inpatient health care expenditures
Inter-hospital transfer costs	Emergency medical services transfer costs and second emergency department costs (if transferred)	From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inter-hospital transfer health care expenditures
Post-discharge costs	Total healthcare expenditures	From the date of hospital discharge through 30 days after discharge, total health care expenditures health care expenditures
Readmission costs	Total healthcare expenditures during readmission(s) within 30 days after initial hospital discharge	Between hospital discharge and 30 days after hospital discharge, related to inpatient re-hospitalization

Collaborators and Investigators

• Sponsor: Nicholas M Mohr
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Principal Investigator: Nicholas Mohr, MD, University of Iowa

Publications and helpful links

General Publications

• Mohr NM, Schuette AR, Ullrich F, Mack LJ, DeJong K, Camargo CA Jr, Zachrison KS, Boggs KM, Skibbe A, Bell A, Pals M, Shane DM, Carter KD, Merchant KA, Ward MM. An economic and health outcome evaluation of telehealth in rural sepsis care: a comparative effectiveness study. J Comp Eff Res. 2022 Jul;11(10):703-716. doi: 10.2217/cer-2022-0019. Epub 2022 May 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

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: 202011064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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