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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05072145
Recruitment Status : Recruiting
First Posted : October 8, 2021
Last Update Posted : November 9, 2022
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Nicholas M Mohr, University of Iowa

Brief 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.

Condition or disease Intervention/treatment
Sepsis 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.

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Study Type : Observational
Estimated Enrollment : 26000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating the Role of Tele-Emergency Care in Health Care Costs and Long-Term Outcomes for Rural Medicare Beneficiaries With Sepsis
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • Sepsis, according to ICD-10 codes

Exclusion Criteria:

  • No infection diagnosed in the ED

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05072145


Contacts
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Contact: Nicholas Mohr, MD 319-353-6360 nicholas-mohr@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Nicholas Mohr, MD       nicholas-mohr@uiowa.edu   
Sponsors and Collaborators
Nicholas M Mohr
Health Resources and Services Administration (HRSA)
Investigators
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Principal Investigator: Nicholas Mohr, MD University of Iowa
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicholas M Mohr, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT05072145    
Other Study ID Numbers: 202011064
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicholas M Mohr, University of Iowa:
Telemedicine
Additional relevant MeSH terms:
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Sepsis
Toxemia
Emergencies
Disease Attributes
Pathologic Processes
Infections
Systemic Inflammatory Response Syndrome
Inflammation