SepsisTELE-CostNCT05072145
Evaluating Tele-Emergency Care in Costs and Outcomes for Rural Sepsis Patients
An observational study of Sepsis, run by Nicholas M Mohr at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Telemedicine
- How many people
- 55,772 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Sepsis, according to ICD-10 codes
Who cannot join
- No infection diagnosed in the ED
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Evaluating the Role of Tele-Emergency Care in Health Care Costs and Long-Term Outcomes for Rural Medicare Beneficiaries With Sepsis
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Telemedicine
- Keywords
- Telemedicine
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Receiving care in a tele-ED hospital
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission until 30 days after discharge
Secondary outcomes (8)
Number of participants who die within 90 days of hospital admission
90-day mortality
Measured: From hospital admission until 90 days after admission
Hospital length-of-stay
Duration of hospitalization
Measured: From date of hospitalization through hospital discharge, assessed up to 90 days
Number of participants requiring ICU care
Any admission to the ICU
Measured: 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
Total healthcare expenditures related to emergency department care in current hospitalization
Measured: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all emergency department health care expenditures
Inpatient care costs
Total healthcare expenditures related to inpatient care in current hospitalizations
Measured: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inpatient health care expenditures
Inter-hospital transfer costs
Emergency medical services transfer costs and second emergency department costs (if transferred)
Measured: From the date of hospital admission through hospital discharge or 90 days, whichever comes first, all inter-hospital transfer health care expenditures
Post-discharge costs
Total healthcare expenditures
Measured: From the date of hospital discharge through 30 days after discharge, total health care expenditures health care expenditures
Readmission costs
Total healthcare expenditures during readmission(s) within 30 days after initial hospital discharge
Measured: Between hospital discharge and 30 days after hospital discharge, related to inpatient re-hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55,772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholas M Mohr
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor-investigator, Nicholas M Mohr, University of Iowa
- Investigators
- Nicholas Mohr, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072145
- Sponsor's protocol ID
- 202011064
- Acronym
- TELE-Cost
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35608080
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Tele-Emergency Care in Health Care Costs and Long-Term Outcomes for Rural Medicare Beneficiaries With Sepsis
- ClinicalTrials.gov ID
- NCT05072145
- Acronym / sponsor ID
- TELE-Cost / 202011064
- Conditions
- Sepsis
- Keywords
- Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,772 participants (actual)
- Lead sponsor
- Nicholas M MohrUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: TelemedicinePatient care was provided through tele-ED services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Sepsis, according to ICD-10 codes
Key exclusion criteria (1 listed)
- No infection diagnosed in the ED
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineReceiving care in a tele-ED hospital | Other | Tele-ED used |
Primary outcome
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.
8 secondary outcomes
Number of participants who die within 90 days of hospital admission
Time frame: From hospital admission until 90 days after admission
Hospital length-of-stay
Time frame: From date of hospitalization through hospital discharge, assessed up to 90 days
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
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
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
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
Post-discharge costs
Time frame: From the date of hospital discharge through 30 days after discharge, total health care expenditures health care expenditures
Readmission costs
Time frame: Between hospital discharge and 30 days after hospital discharge, related to inpatient re-hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 35608080Mohr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Mohr, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Nicholas M Mohr at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total healthcare expenditures (time frame: From hospital admission until 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.