Clinical trial NCT05072145: Evaluating Tele-Emergency Care in Costs and Outcomes for Rural Sepsis Patients
Official title: Evaluating the Role of Tele-Emergency Care in Health Care Costs and Long-Term Outcomes for Rural Medicare Beneficiaries With Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Telemedicine
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2021-10-08
Enrollment: 55772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Sepsis, according to ICD-10 codes

Exclusion Criteria:

* No infection diagnosed in the ED

Primary outcomes:
measure: Total healthcare expenditures
timeFrame: From hospital admission until 30 days after discharge
Secondary outcomes:
measure: Number of participants who die within 90 days of hospital admission
timeFrame: From hospital admission until 90 days after admission
measure: Hospital length-of-stay
timeFrame: From date of hospitalization through hospital discharge, assessed up to 90 days
measure: Number of participants requiring ICU care
timeFrame: 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
measure: Emergency department costs
timeFrame: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all emergency department health care expenditures
measure: Inpatient care costs
timeFrame: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inpatient health care expenditures
measure: Inter-hospital transfer costs
timeFrame: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inter-hospital transfer health care expenditures
measure: Post-discharge costs
timeFrame: From the date of hospital discharge through 30 days after discharge, total health care expenditures health care expenditures
measure: Readmission costs
timeFrame: Between hospital discharge and 30 days after hospital discharge, related to inpatient re-hospitalization
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Nicholas Mohr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.