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

Sponsor
Nicholas M Mohr (Other)
Overall Status
Recruiting
CT.gov ID
NCT05072145
Collaborator
Health Resources and Services Administration (HRSA) (U.S. Fed)
26,000
1
9
2877.7

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated 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 :
Apr 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Total healthcare expenditures [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 [From hospital admission until 90 days after admission]

    90-day mortality

  2. Hospital length-of-stay [From date of hospitalization through hospital discharge, assessed up to 90 days]

    Duration of hospitalization

  3. Number of participants requiring ICU care [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 [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 [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 [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 [From the date of hospital discharge through 30 days after discharge, total health care expenditures health care expenditures]

    Total healthcare expenditures

  8. Readmission costs [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Sepsis, according to ICD-10 codes
Exclusion Criteria:
  • No infection diagnosed in the ED

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242

Sponsors and Collaborators

  • Nicholas M Mohr
  • Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Nicholas Mohr, MD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicholas M Mohr, Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT05072145
Other Study ID Numbers:
  • 202011064
First Posted:
Oct 8, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nicholas M Mohr, Professor, University of Iowa
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022