Septic ShockNCT03226366
Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
An observational study of Septic Shock and Sepsis, run by Intermountain Health Care, Inc. at 4 sites in United States.
Trial summary
Sepsis is a common syndrome resulting from a dysregulated response to infection. The timing of antibiotic initiation is an important determinant of outcomes for patients presenting to the emergency department with sepsis. The potential effect of care reorganization on very early care for sepsis is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- What is being tested?
- Immediate evaluation by multidisciplinary team
- How many people
- 3,230 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 May 2015to 11 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Adult patients presenting to the ED with sepsis or septic shock
Who may be able to join
- Presented to the ED of study hospital between May 16, 2015 and April 15, 2016 (pre-implementation cohort) or May 16, 2016 and February 15, 2017 (post-implementation cohort).
- Sepsis on presentation to ED, defined as initial Sequential Organ Failure Assessment (SOFA) score ≥2 points above baseline plus antibiotics initiation within 24 hours of ED arrival.
- Overall exclusion criteria:
- Age <18 years
- No antibiotics within 24 hours of ED arrival
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Intermountain Medical Center
Murray, Utah, 84157
Riverton Hospital
Riverton, Utah, 84065
LDS Hospital
Salt Lake City, Utah, 84143
Alta View Hospital
Sandy City, Utah, 84094
About this study
Sepsis is a common syndrome resulting from a dysregulated response to infection. The timing of antibiotic initiation is an important determinant of outcomes for patients presenting to the emergency department with sepsis. The potential effect of care reorganization on very early care for sepsis is unknown. This study will investigate whether multidisciplinary coordination of the initial patient evaluation in the emergency department influences door-to-antibiotic time for septic patients.
Read the detailed description
This is a retrospective cohort study of emergency department sepsis care before versus after implementation of a "swarming" model for simultaneous patient evaluation by multidisciplinary care providers. The analysis will use data from similar hospitals that did not change sepsis care organization during the study period to control for changes in sepsis care not resulting from the "swarming" intervention.
- Conditions
- Septic Shock, Sepsis
- Being tested
- Immediate evaluation by multidisciplinary team
- Keywords
- door-to-antibiotic time, emergency department care, antimicrobial, care reorganization, severe sepsis, swarming
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate evaluation by multidisciplinary teamOther
Also called Swarming
Simultaneous initial evaluation by the ED physician, nurse, and patient care associate
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation (intervention site) | Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016 | |
| Post-implementation (intervention site) | Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017 Receives: Other: Immediate evaluation by multidisciplinary team | |
| Pre-implementation (control site) | Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016 | |
| Post-implementation (control site) | Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From ED Arrival to Administration of First Dose of Antibiotics
Measured: 24 hours
Secondary outcomes (3)
Hospital Mortality
Measured: Up to 1 year
ED Length of Stay
Time (minutes) from ED arrival to ED departure
Measured: Up to 1 week
Door-to-physician Evaluation Time
Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start16 May 2015
- Primary completion31 Jan 2017
- Study completion11 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- 3,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ithan Peltan, Intermountain Health Care, Inc.
- Investigators
- Ithan Peltan, MD, MSc, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226366
- Sponsor's protocol ID
- LDS SWARM
- Status last verified
- Jun 2020
- First submitted
- 19 Jul 2017
- Last updated
- 18 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
Publications
Peltan ID, Bledsoe JR, Brems D, McLean S, Murnin E, Brown SM. Institution of an emergency department "swarming" care model and sepsis door-to-antibiotic time: A quasi-experimental retrospective analysis. PLoS One. 2020 May 5;15(5):e0232794. doi: 10.1371/journal.pone.0232794. eCollection 2020.
PubMed 32369531
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
- ClinicalTrials.gov ID
- NCT03226366
- Acronym / sponsor ID
- LDS SWARM
- Conditions
- Septic Shock, Sepsis
- Keywords
- door-to-antibiotic time, emergency department care, antimicrobial, care reorganization, severe sepsis, swarming
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,230 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 16 May 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 11 Apr 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 18 Jun 2020
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 common syndrome resulting from a dysregulated response to infection. The timing of antibiotic initiation is an important determinant of outcomes for patients presenting to the emergency department with sepsis. The potential effect of care reorganization on very early care for sepsis is unknown. This study will investigate whether multidisciplinary coordination of the initial patient evaluation in the emergency department influences door-to-antibiotic time for septic patients.
Detailed description
This is a retrospective cohort study of emergency department sepsis care before versus after implementation of a "swarming" model for simultaneous patient evaluation by multidisciplinary care providers. The analysis will use data from similar hospitals that did not change sepsis care organization during the study period to control for changes in sepsis care not resulting from the "swarming" intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation (intervention site) | – | –Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016 |
| Post-implementation (intervention site) | – | Other: Immediate evaluation by multidisciplinary teamAdult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017 |
| Pre-implementation (control site) | – | –Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016 |
| Post-implementation (control site) | – | –Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the ED with sepsis or septic shock
Key inclusion criteria (5 listed)
- Presented to the ED of study hospital between May 16, 2015 and April 15, 2016 (pre-implementation cohort) or May 16, 2016 and February 15, 2017 (post-implementation cohort).
- Sepsis on presentation to ED, defined as initial Sequential Organ Failure Assessment (SOFA) score ≥2 points above baseline plus antibiotics initiation within 24 hours of ED arrival.
- Age <18 years
- No antibiotics within 24 hours of ED arrival
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Immediate evaluation by multidisciplinary teamAlso: SwarmingSimultaneous initial evaluation by the ED physician, nurse, and patient care associate | Other | Post-implementation (intervention site) |
Primary outcome
Time From ED Arrival to Administration of First Dose of Antibiotics
Time frame: 24 hours
3 secondary outcomes
Hospital Mortality
Time frame: Up to 1 year
ED Length of Stay
Time frame: Up to 1 week
Door-to-physician Evaluation Time
Time frame: Up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32369531Peltan ID, Bledsoe JR, Brems D, McLean S, Murnin E, Brown SM. Institution of an emergency department "swarming" care model and sepsis door-to-antibiotic time: A quasi-experimental retrospective analysis. PLoS One. 2020 May 5;15(5):e0232794. doi: 10.1371/journal.pone.0232794. eCollection 2020.
- Individual participant dataSharing planned: Yes. In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
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Sepsis
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.
Ithan Peltan, MD, MSc principal investigator
Intermountain Health Care, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Sepsis, run by Intermountain Health Care, Inc. at 4 sites 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 5 inclusion and 0 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time From ED Arrival to Administration of First Dose of Antibiotics (time frame: 24 hours). 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 NCT03226366, 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 18 Jun 2020.