Evaluating Tele-Emergency Care in Costs and Outcomes for Rural Sepsis Patients

Sepsis Clinical Trial

— TELE-Cost  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072145
• Other study ID #: 202011064
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55772
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sepsis, according to ICD-10 codes

Exclusion Criteria:

• No infection diagnosed in the ED

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

Other:
• Telemedicine
Receiving care in a tele-ED hospital

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Nicholas M Mohr	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants who die within 90 days of hospital admission	90-day mortality	From hospital admission until 90 days after admission
Secondary	Hospital length-of-stay	Duration of hospitalization	From date of hospitalization through hospital discharge, assessed up to 90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post-discharge costs	Total healthcare expenditures	From the date of hospital discharge through 30 days after discharge, total health care expenditures health care expenditures
Secondary	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