SepsisTELEvISEDNCT04441944
TELEmedicine as an Intervention for Sepsis in Emergency Departments
An observational study of Sepsis, run by University of Iowa at 1 site in United States.
Trial summary
Sepsis is a life-threatening condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. 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
- 1,191 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 30 Oct 2022
- 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
- Adult, Older adult
Study population: This study will include all adult (age≥18 years) sepsis patients who presented to a participating rural ED between August 1, 2016 and June 30, 2019. Because of poor sensitivity in diagnosis code-based definitions of sepsis, we elected to use a multi-step definition requiring (1) hospital diagnosis of both infection and organ failure, (2) identification of infection in the ED, (3) presence of organ failure in the ED, and (4) presence of systemic inflammatory response syndrome (SIRS) criteria in the ED. To identify hospital diagnosis of infection and organ failure, we used the Fleischmann-Struzek approximation of sepsis using International Classification of Diseases, 10th edition, Clinical Modification (ICD-10-CM) or an explicit sepsis code (R65.20 or R65.21).
Who may be able to join
- Adults (age 18 years or older)
- Arrive at participating emergency department between August 1, 2016 and June 30, 2019
- Hospital diagnosis of infection and organ failure
- Identification of infection in the emergency department
- Presence of organ failure in the emergency department (SOFA score of at least 2)
- Presence of systemic inflammatory response syndrome (SIRS) in the emergency department
Who cannot join
- None
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
Sepsis is a life-threatening condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. Rural emergency department (ED)-based provider-to-provider telemedicine has been proposed to standardize care and support local clinicians in rural hospitals. The goal of this multicenter observational comparative effectiveness study is to measure the association between tele-ED use and clinical outcomes in a cohort of rural sepsis patients.
Read the detailed description
Sepsis is a life-threatening condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. This effect persists even among patients who are transferred between hospitals and who bypass rural hospitals. With 17% of all hospital deaths attributable to sepsis and 19% of Americans living in rural areas, there is a critical need to identify strategies to reduce the disparities in outcomes between rural and urban sepsis care.
Rural ED-based telemedicine has been proposed to standardize care and support local clinicians in rural hospitals. Telemedicine networks provide a real-time, high-definition on-demand video connection between a rural hospital and a tertiary hub 24 h daily. Based in Sioux Falls, South Dakota, Avera eCare is a tele-emergency network that serves as a hub for a 140-hospital network that spans 12 rural Midwestern states. It is the largest rural ED-based telehealth network in North America, and a network the investigators have studied previously.
Our central hypothesis is that telemedicine will improve clinical outcomes through improved adherence with Surviving Sepsis Campaign (SSC) guidelines. Using comparative effectiveness methods and a patient-centered outcomes research (PCOR) approach, this study will test the hypotheses with the following specific aims:
- To measure the association between rural ED-based telemedicine use, guideline adherence, and clinical outcomes using an observational cohort comparative effectiveness research study. Rural clinicians choose whether individual sepsis patients will be treated with telemedicine-supplemented care. Medical records will be analyzed from patients with severe sepsis who present to 25 rural hospital EDs that are part of a telemedicine network to estimate the effect of telemedicine on changing early SSC guideline adherence. Guideline adherence has been studied extensively as an outcome of sepsis implementation studies. The study will also analyze the impact of telemedicine on clinical outcomes, such as mechanical ventilation, hospital length-of-stay, and survival, using mediation analysis in a propensity-matched cohort design. Our working hypothesis is that telemedicine consultation will improve SSC guideline adherence and will reduce delays in care, leading to improved clinical outcomes.
- To measure the effect of ED-based telemedicine on guideline adherence among patients who have telemedicine available but not used. In addition to the effect of use for individual patient care, telemedicine interactions may provide ongoing training for providers and nurses and influence care even for patients for whom telemedicine is not used. This effect may result from a learning effect in which local providers adopt practices they observe in telemedicine-consulted patients. The investigators will use hospital fixed-effects models to measure this association. The working hypothesis is that guideline adherence will increase after telemedicine adoption even in non-telemedicine patients, and adherence will be associated with the number of prior telemedicine sepsis encounters (dose-response).
The rationale for this research is that dissemination and implementation of best practices through rural networks remains difficult, but telemedicine offers one potential solution. Sepsis is an ideal model to study the effect of telemedicine because it differs from other acute care conditions treated in rural hospitals (e.g., trauma, myocardial infarction) in that early treatment provided in rural hospitals may be more important than rapid transfer to tertiary centers. Focusing on telemedicine in rural sepsis care will serve as a powerful model for examining strategies for disseminating innovations across rural networks.
- 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
Use of provider-to-provider telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Cases | Patients presenting to rural emergency departments who had real-time provider-to-provider telemedicine used to supplement their emergency department care. Receives: Other: Telemedicine | |
| Non-Telemedicine Cases | Patients presenting to rural emergency departments who did not have real-time provider-to-provider telemedicine used to supplement their emergency department care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Hospital-Free Days
The total number of days in the 28 days after emergency department presentation that a patient is alive and outside the hospital.
Measured: Within 28 days of emergency department presentation
Secondary outcomes (11)
Surviving Sepsis Campaign Guideline Adherence
Adherence with all elements of the Surviving Sepsis Campaign 3-hour and 6-hour bundles (dichotomous)
Measured: 6 hours after emergency department arrival
Mortality
Did patient die in the hospital?
Measured: Through hospital discharge, an average of 8 days
Mechanical Ventilation
Was mechanical ventilation required during admission?
Measured: Through hospital discharge, an average of 8 days
Vasopressors
Was vasopressor therapy required during admission?
Measured: Through hospital discharge, an average of 8 days
New Hemodialysis
Was dialysis required during this admission (if not on chronic dialysis)?
Measured: Through hospital discharge, an average of 8 days
Inter-hospital Transfer
Was inter-hospital transfer required from the index hospital?
Measured: Through hospital discharge, an average of 8 days
28-Day Ventilator-Free Days
The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring a ventilator.
Measured: 28 days
28-Day Vasopressor-Free Days
The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring a vasopressor.
Measured: 28 days
28-Day ICU-Free Days
The total number of days in the 28 days after emergency department presentation that a patient is alive and not requiring an ICU bed.
Measured: 28 days
Emergency Department Length-of-Stay
The total duration of stay in the index emergency department.
Measured: Index emergency department duration (1 day)
Time-to-inpatient unit arrival
The time from index emergency department registration to arrival in the inpatient unit
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Aug 2016
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- 1,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Nicholas M Mohr, University of Iowa
- Investigators
- Nicholas Mohr, MD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441944
- Sponsor's protocol ID
- 201901748
- Acronym
- TELEvISED
- Status last verified
- Nov 2022
- First submitted
- 17 Jun 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be shared with investigators who make a written request to the study team. These data will include aggregate effect sizes, but will not be patient-level data. Because of the sparsely populated region where this study is being conducted, hospital-identifiable data would be sufficient to identify individuals in this region, so fully de-identifying this data set would make it unusable for subsequent independent analyses (e.g., would require removing age, sex, hospital, transfer distance, transport times, comorbidities). The study team will, however, collaborate with other investigators to conduct additional analysis, maintaining the security of the data set.
Publications
Mohr NM, Okoro U, Harland KK, Fuller BM, Campbell K, Swanson MB, Wymore C, Faine B, Zepeski A, Parker EA, Mack L, Bell A, DeJong K, Mueller K, Chrischilles E, Carpenter CR, Wallace K, Jones MP, Ward MM. Outcomes Associated With Rural Emergency Department Provider-to-Provider Telehealth for Sepsis Care: A Multicenter Cohort Study. Ann Emerg Med. 2023 Jan;81(1):1-13. doi: 10.1016/j.annemergmed.2022.07.024. Epub 2022 Oct 15.
PubMed 36253295Mohr NM, Harland KK, Okoro UE, Fuller BM, Campbell K, Swanson MB, Simpson SQ, Parker EA, Mack LJ, Bell A, DeJong K, Faine B, Zepeski A, Mueller K, Chrischilles E, Carpenter CR, Jones MP, Ward MM. TELEmedicine as an intervention for sepsis in emergency departments: a multicenter, comparative effectiveness study (TELEvISED Study). J Comp Eff Res. 2021 Feb;10(2):77-91. doi: 10.2217/cer-2020-0141. Epub 2021 Jan 20.
PubMed 33470848
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELEmedicine as an Intervention for Sepsis in Emergency Departments
- ClinicalTrials.gov ID
- NCT04441944
- Acronym / sponsor ID
- TELEvISED / 201901748
- Conditions
- Sepsis
- Keywords
- Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,191 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 22 Jun 2020 (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 condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. Rural emergency department (ED)-based provider-to-provider telemedicine has been proposed to standardize care and support local clinicians in rural hospitals. The goal of this multicenter observational comparative effectiveness study is to measure the association between tele-ED use and clinical outcomes in a cohort of rural sepsis patients.
Detailed description
Sepsis is a life-threatening condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. This effect persists even among patients who are transferred between hospitals and who bypass rural hospitals. With 17% of all hospital deaths attributable to sepsis and 19% of Americans living in rural areas, there is a critical need to identify strategies to reduce the disparities in outcomes between rural and urban sepsis care.
Rural ED-based telemedicine has been proposed to standardize care and support local clinicians in rural hospitals. Telemedicine networks provide a real-time, high-definition on-demand video connection between a rural hospital and a tertiary hub 24 h daily. Based in Sioux Falls, South Dakota, Avera eCare is a tele-emergency network that serves as a hub for a 140-hospital network that spans 12 rural Midwestern states. It is the largest rural ED-based telehealth network in North America, and a network the investigators have studied previously.
Our central hypothesis is that telemedicine will improve clinical outcomes through improved adherence with Surviving Sepsis Campaign (SSC) guidelines. Using comparative effectiveness methods and a patient-centered outcomes research (PCOR) approach, this study will test the hypotheses with the following specific aims:
- To measure the association between rural ED-based telemedicine use, guideline adherence, and clinical outcomes using an observational cohort comparative effectiveness research study. Rural clinicians choose whether individual sepsis patients will be treated with telemedicine-supplemented care. Medical records will be analyzed from patients with severe sepsis who present to 25 rural hospital EDs that are part of a telemedicine network to estimate the effect of telemedicine on changing early SSC guideline adherence. Guideline adherence has been studied extensively as an outcome of sepsis implementation studies. The study will also analyze the impact of telemedicine on clinical outcomes, such as mechanical ventilation, hospital length-of-stay, and survival, using mediation analysis in a propensity-matched cohort design. Our working hypothesis is that telemedicine consultation will improve SSC guideline adherence and will reduce delays in care, leading to improved clinical outcomes.
- To measure the effect of ED-based telemedicine on guideline adherence among patients who have telemedicine available but not used. In addition to the effect of use for individual patient care, telemedicine interactions may provide ongoing training for providers and nurses and influence care even for patients for whom telemedicine is not used. This effect may result from a learning effect in which local providers adopt practices they observe in telemedicine-consulted patients. The investigators will use hospital fixed-effects models to measure this association. The working hypothesis is that guideline adherence will increase after telemedicine adoption even in non-telemedicine patients, and adherence will be associated with the number of prior telemedicine sepsis encounters (dose-response).
The rationale for this research is that dissemination and implementation of best practices through rural networks remains difficult, but telemedicine offers one potential solution. Sepsis is an ideal model to study the effect of telemedicine because it differs from other acute care conditions treated in rural hospitals (e.g., trauma, myocardial infarction) in that early treatment provided in rural hospitals may be more important than rapid transfer to tertiary centers. Focusing on telemedicine in rural sepsis care will serve as a powerful model for examining strategies for disseminating innovations across rural networks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Cases | – | Other: TelemedicinePatients presenting to rural emergency departments who had real-time provider-to-provider telemedicine used to supplement their emergency department care. |
| Non-Telemedicine Cases | – | –Patients presenting to rural emergency departments who did not have real-time provider-to-provider telemedicine used to supplement their emergency department care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will include all adult (age≥18 years) sepsis patients who presented to a participating rural ED between August 1, 2016 and June 30, 2019. Because of poor sensitivity in diagnosis code-based definitions of sepsis, we elected to use a multi-step definition requiring (1) hospital diagnosis of both infection and organ failure, (2) identification of infection in the ED, (3) presence of organ failure in the ED, and (4) presence of systemic inflammatory response syndrome (SIRS) criteria in the ED. To identify hospital diagnosis of infection and organ failure, we used the Fleischmann-Struzek approximation of sepsis using International Classification of Diseases, 10th edition, Clinical Modification (ICD-10-CM) or an explicit sepsis code (R65.20 or R65.21).
Key inclusion criteria (6 listed)
- Adults (age 18 years or older)
- Arrive at participating emergency department between August 1, 2016 and June 30, 2019
- Hospital diagnosis of infection and organ failure
- Identification of infection in the emergency department
- Presence of organ failure in the emergency department (SOFA score of at least 2)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| TelemedicineUse of provider-to-provider telemedicine | Other | Telemedicine Cases |
Primary outcome
28-day Hospital-Free Days
Time frame: Within 28 days of emergency department presentation
The total number of days in the 28 days after emergency department presentation that a patient is alive and outside the hospital.
11 secondary outcomes
Surviving Sepsis Campaign Guideline Adherence
Time frame: 6 hours after emergency department arrival
Mortality
Time frame: Through hospital discharge, an average of 8 days
Mechanical Ventilation
Time frame: Through hospital discharge, an average of 8 days
Vasopressors
Time frame: Through hospital discharge, an average of 8 days
New Hemodialysis
Time frame: Through hospital discharge, an average of 8 days
Inter-hospital Transfer
Time frame: Through hospital discharge, an average of 8 days
28-Day Ventilator-Free Days
Time frame: 28 days
28-Day Vasopressor-Free Days
Time frame: 28 days
28-Day ICU-Free Days
Time frame: 28 days
Emergency Department Length-of-Stay
Time frame: Index emergency department duration (1 day)
Time-to-inpatient unit arrival
Time frame: 24 hours
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 9 Nov 2022.
- Derived from this study: PubMed 36253295Mohr NM, Okoro U, Harland KK, Fuller BM, Campbell K, Swanson MB, Wymore C, Faine B, Zepeski A, Parker EA, Mack L, Bell A, DeJong K, Mueller K, Chrischilles E, Carpenter CR, Wallace K, Jones MP, Ward MM. Outcomes Associated With Rural Emergency Department Provider-to-Provider Telehealth for Sepsis Care: A Multicenter Cohort Study. Ann Emerg Med. 2023 Jan;81(1):1-13. doi: 10.1016/j.annemergmed.2022.07.024. Epub 2022 Oct 15.
- Derived from this study: PubMed 33470848Mohr NM, Harland KK, Okoro UE, Fuller BM, Campbell K, Swanson MB, Simpson SQ, Parker EA, Mack LJ, Bell A, DeJong K, Faine B, Zepeski A, Mueller K, Chrischilles E, Carpenter CR, Jones MP, Ward MM. TELEmedicine as an intervention for sepsis in emergency departments: a multicenter, comparative effectiveness study (TELEvISED Study). J Comp Eff Res. 2021 Feb;10(2):77-91. doi: 10.2217/cer-2020-0141. Epub 2021 Jan 20.
- Individual participant dataSharing planned: No. Aggregate data will be shared with investigators who make a written request to the study team. These data will include aggregate effect sizes, but will not be patient-level data. Because of the sparsely populated region where this study is being conducted, hospital-identifiable data would be sufficient to identify individuals in this region, so fully de-identifying this data set would make it unusable for subsequent independent analyses (e.g., would require removing age, sex, hospital, transfer distance, transport times, comorbidities). The study team will, however, collaborate with other investigators to conduct additional analysis, maintaining the security of the data set.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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, MS 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 University of Iowa 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 6 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 9 Nov 2022. 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?
28-day Hospital-Free Days (time frame: Within 28 days of emergency department presentation). 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 NCT04441944, which also lists 2 linked publications.
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 9 Nov 2022.