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

NCT05072145 | Completed

• 1 other identifier: 202011064
• Study Type: observational
• Target: 55,772
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of participants who die within 90 days of hospital admission

  From hospital admission until 90 days after admission

• Hospital length-of-stay

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

• 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

• Emergency department costs

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

• Inpatient care costs

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

Study Arms (3)

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

Interventions

Telemedicine OTHER

Receiving care in a tele-ED hospital

Tele-ED used

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Sepsis, according to ICD-10 codes

You may not qualify if:

• No infection diagnosed in the ED

Sponsors & Collaborators

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

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 35608080 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Nicholas Mohr, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 8, 2021
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)