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Completed

NCT Number: NCT05072145

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

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.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sepsis, according to ICD-10 codes

Exclusion criteria

  • No infection diagnosed in the ED

Treatment and study plan

Telemedicine

Other

Receiving care in a tele-ED hospital

Primary outcomes

  1. Total healthcare expenditures

    Time frame: From hospital admission until 30 days after discharge

    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.

Secondary outcomes

  1. Number of participants who die within 90 days of hospital admission

    Time frame: From hospital admission until 90 days after admission

    90-day mortality

  2. Hospital length-of-stay

    Time frame: From date of hospitalization through hospital discharge, assessed up to 90 days

    Duration of hospitalization

  3. Number of participants requiring ICU care

    Time frame: 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

    Any admission to the ICU

  4. Emergency department costs

    Time frame: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all emergency department health care expenditures

    Total healthcare expenditures related to emergency department care in current hospitalization

  5. Inpatient care costs

    Time frame: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inpatient health care expenditures

    Total healthcare expenditures related to inpatient care in current hospitalizations

  6. Inter-hospital transfer costs

    Time frame: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inter-hospital transfer health care expenditures

    Emergency medical services transfer costs and second emergency department costs (if transferred)

  7. Post-discharge costs

    Time frame: From the date of hospital discharge through 30 days after discharge, total health care expenditures health care expenditures

    Total healthcare expenditures

  8. Readmission costs

    Time frame: Between hospital discharge and 30 days after hospital discharge, related to inpatient re-hospitalization

    Total healthcare expenditures during readmission(s) within 30 days after initial hospital discharge

Sponsors and collaborators

Lead sponsor

Nicholas M Mohr

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Official study title

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

Acronym: TELE-Cost

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2021
Registry last updated
Jan 11, 2024

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.

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