SepsisNCT05213923
ED Tracking Sheet Implementation
A study testing ED Sepsis Tracking Sheet in people with Sepsis and Severe Sepsis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess whether implementation of an ED Sepsis Tracking Sheet effects the percentage of goal-directed sepsis criteria met in a tertiary care academic Emergency Department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Systemic Inflammatory Response Syndrome
- What is being tested?
- ED Sepsis Tracking Sheet
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Over 18 years old
- Initially evaluated in the DHMC Lebanon Emergency Department
- Activated sepsis BPA upon initial presentation (triage history consistent with infection combined with 2 or more SIRS criteria? Are these the criteria that trigger our sepsis BPA?)
Who cannot join
- Patients who are transferred to the DHMC Lebanon Emergency Department from another facility
- Patients with absent data regarding one or more of the goal-directed sepsis criteria
- Patients who did not initially meet criteria to trigger the sepsis BPA, but developed sepsis later in their hospital course
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of this study is to assess whether implementation of an ED Sepsis Tracking Sheet effects the percentage of goal-directed sepsis criteria met in a tertiary care academic Emergency Department.
Read the detailed description
Sepsis remains a common cause of morbidity and mortality in the hospital setting. Accurate diagnosis and timely initiation of therapy are important drivers of patient-centered outcomes in sepsis management. Compliance with the core measures listed in the surviving sepsis campaign guidelines has been variable.
An ED-specific Sepsis Tracking Sheet (STS) - a tool for implementing and documenting critical actions in sepsis management - was created at our institution by a team of physicians, nurses, and ED pharmacists. Dedicated ED pharmacists were instructed to fill this sheet within one hour of the sepsis-specific best practice advisory (BPA) being activated in the ED. Core measures associated with the one hour and three hour sepsis bundles were tracked and outcomes were compared pre- and post-implementation of the STS.
- Being tested
- ED Sepsis Tracking Sheet
- Keywords
- CMS Compliance, ED Pharmacist
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED Sepsis Tracking SheetProcedure or surgery
Implementation of an ED Sepsis Tracking Sheet. This sheet will track time of patient presentation, time of High-Acuity Medical Response (HAMR) page, time of bilateral 18g or larger IV access, time of initial lactate, time two sets of blood cultures were sent, time antibiotics were administered as well as which antibiotics and what dose, time initial IV fluid bolus was completed, time repeat lactate was sent, timing of post-IV-fluid bolus vital signs, as well as the presence of persistent hypotension following this IV fluid bolus and whether or not vasopressors were applied.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Patients presenting to the Emergency Department meeting severe sepsis criteria prior to implementation of an ED Sepsis Tracking Sheet |
| Post-intervention | Experimental | Patients presenting to the Emergency Department meeting severe sepsis criteria following implementation of an ED Sepsis Tracking Sheet Receives: Procedure: ED Sepsis Tracking Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of goal-directed sepsis criteria met
Goal-directed sepsis criteria involve the following: 1) Was an initial lactate obtained? 2) Were two sets of blood cultures sent? 3) Were antibiotics given within one hour of identification of severe sepsis? 4) Was the patient given an initial IV fluid bolus? 5) Was a repeat lactate sent if the initial lactate was elevated? These five criteria will be assessed as "met" or "not met" for each patient. The total of "met" and "not met" criteria will be aggregated across patients. The percentage of goal-directed sepsis criteria met will be calculated as "met" criteria divided by the sum of "met" plus "not met" criteria.
Measured: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Secondary outcomes (2)
Length of hospital stay
Time of ED presentation to the time of in-hospital death or hospital discharge, measured in days.
Measured: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
In-hospital mortality
Death attributed to any cause occurring at any time between the patient's ED presentation and hospital discharge.
Measured: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jul 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harman S. Gill, Dartmouth-Hitchcock Medical Center
- Investigators
- Harman Gill, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213923
- Sponsor's protocol ID
- STUDY02001224
- Status last verified
- May 2023
- First submitted
- 16 Jan 2022
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans for sharing IPD at this time.
Publications
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence. 2014 Jan 1;5(1):4-11. doi: 10.4161/viru.27372. Epub 2013 Dec 11.
PubMed 24335434Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723.
PubMed 25275252Coba V, Whitmill M, Mooney R, Horst HM, Brandt MM, Digiovine B, Mlynarek M, McLellan B, Boleski G, Yang J, Conway W, Jordan J; (The Henry Ford Hospital Sepsis Collaborative Group). Resuscitation bundle compliance in severe sepsis and septic shock: improves survival, is better late than never. J Intensive Care Med. 2011 Sep-Oct;26(5):304-13. doi: 10.1177/0885066610392499. Epub 2011 Jan 10.
PubMed 21220270Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.
PubMed 32572531Schorr C, Odden A, Evans L, Escobar GJ, Gandhi S, Townsend S, Levy M. Implementation of a multicenter performance improvement program for early detection and treatment of severe sepsis in general medical-surgical wards. J Hosp Med. 2016 Nov;11 Suppl 1:S32-S39. doi: 10.1002/jhm.2656.
PubMed 27805796Downing NL, Rolnick J, Poole SF, Hall E, Wessels AJ, Heidenreich P, Shieh L. Electronic health record-based clinical decision support alert for severe sepsis: a randomised evaluation. BMJ Qual Saf. 2019 Sep;28(9):762-768. doi: 10.1136/bmjqs-2018-008765. Epub 2019 Mar 14.
PubMed 30872387
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED Tracking Sheet Implementation
- ClinicalTrials.gov ID
- NCT05213923
- Acronym / sponsor ID
- STUDY02001224
- Keywords
- CMS Compliance, ED Pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Jan 2022 (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.
The purpose of this study is to assess whether implementation of an ED Sepsis Tracking Sheet effects the percentage of goal-directed sepsis criteria met in a tertiary care academic Emergency Department.
Detailed description
Sepsis remains a common cause of morbidity and mortality in the hospital setting. Accurate diagnosis and timely initiation of therapy are important drivers of patient-centered outcomes in sepsis management. Compliance with the core measures listed in the surviving sepsis campaign guidelines has been variable.
An ED-specific Sepsis Tracking Sheet (STS) - a tool for implementing and documenting critical actions in sepsis management - was created at our institution by a team of physicians, nurses, and ED pharmacists. Dedicated ED pharmacists were instructed to fill this sheet within one hour of the sepsis-specific best practice advisory (BPA) being activated in the ED. Core measures associated with the one hour and three hour sepsis bundles were tracked and outcomes were compared pre- and post-implementation of the STS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Patients presenting to the Emergency Department meeting severe sepsis criteria prior to implementation of an ED Sepsis Tracking Sheet |
| Post-intervention | Experimental | Procedure: ED Sepsis Tracking SheetPatients presenting to the Emergency Department meeting severe sepsis criteria following implementation of an ED Sepsis Tracking Sheet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Initially evaluated in the DHMC Lebanon Emergency Department
- Activated sepsis BPA upon initial presentation (triage history consistent with infection combined with 2 or more SIRS criteria? Are these the criteria that trigger our sepsis BPA?)
Key exclusion criteria (3 listed)
- Patients who are transferred to the DHMC Lebanon Emergency Department from another facility
- Patients with absent data regarding one or more of the goal-directed sepsis criteria
- Patients who did not initially meet criteria to trigger the sepsis BPA, but developed sepsis later in their hospital course
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 |
|---|---|---|
| ED Sepsis Tracking SheetImplementation of an ED Sepsis Tracking Sheet. This sheet will track time of patient presentation, time of High-Acuity Medical Response (HAMR) page, time of bilateral 18g or larger IV access, time of initial lactate, time two sets of blood cultures were sent, time antibiotics were administered as well as which antibiotics and what dose, time initial IV fluid bolus was completed, time repeat lactate was sent, timing of post-IV-fluid bolus vital signs, as well as the presence of persistent hypotension following this IV fluid bolus and whether or not vasopressors were applied. | Procedure or surgery | Post-intervention |
Primary outcome
Percentage of goal-directed sepsis criteria met
Time frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
Goal-directed sepsis criteria involve the following: 1) Was an initial lactate obtained? 2) Were two sets of blood cultures sent? 3) Were antibiotics given within one hour of identification of severe sepsis? 4) Was the patient given an initial IV fluid bolus? 5) Was a repeat lactate sent if the initial lactate was elevated? These five criteria will be assessed as "met" or "not met" for each patient. The total of "met" and "not met" criteria will be aggregated across patients. The percentage of goal-directed sepsis criteria met will be calculated as "met" criteria divided by the sum of "met" plus "not met" criteria.
2 secondary outcomes
Length of hospital stay
Time frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
In-hospital mortality
Time frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks
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 19 May 2023.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
- Background: PubMed 24335434Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence. 2014 Jan 1;5(1):4-11. doi: 10.4161/viru.27372. Epub 2013 Dec 11.
- Background: PubMed 25275252Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723.
- Background: PubMed 21220270Coba V, Whitmill M, Mooney R, Horst HM, Brandt MM, Digiovine B, Mlynarek M, McLellan B, Boleski G, Yang J, Conway W, Jordan J; (The Henry Ford Hospital Sepsis Collaborative Group). Resuscitation bundle compliance in severe sepsis and septic shock: improves survival, is better late than never. J Intensive Care Med. 2011 Sep-Oct;26(5):304-13. doi: 10.1177/0885066610392499. Epub 2011 Jan 10.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 32572531Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.
- Background: PubMed 27805796Schorr C, Odden A, Evans L, Escobar GJ, Gandhi S, Townsend S, Levy M. Implementation of a multicenter performance improvement program for early detection and treatment of severe sepsis in general medical-surgical wards. J Hosp Med. 2016 Nov;11 Suppl 1:S32-S39. doi: 10.1002/jhm.2656.
- Background: PubMed 30872387Downing NL, Rolnick J, Poole SF, Hall E, Wessels AJ, Heidenreich P, Shieh L. Electronic health record-based clinical decision support alert for severe sepsis: a randomised evaluation. BMJ Qual Saf. 2019 Sep;28(9):762-768. doi: 10.1136/bmjqs-2018-008765. Epub 2019 Mar 14.
- Individual participant dataSharing planned: No. There are no plans for sharing IPD at this time.
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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.
Harman Gill, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED Sepsis Tracking Sheet in people with Sepsis and Severe Sepsis, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 3 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 19 May 2023. 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?
Percentage of goal-directed sepsis criteria met (time frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks). 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 NCT05213923, which also lists 8 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 19 May 2023.