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| ID | Type | Description | Link |
|---|---|---|---|
| K23GM129661 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-implementation usual care (intervention site) | No Intervention | Adult patients age ≥18 years who receive usual care after presenting to the ED of the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. | |
| Code Sepsis post-implementation (intervention site) | Experimental | Adult patients age ≥18 years presenting to the ED of the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. |
|
| Pre-implementation usual care (control sites) | No Intervention | Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. | |
| Post-implementation usual care (control sites) | No Intervention | Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Code Sepsis protocol (full implementation) | Other | Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis. |
| Measure | Description | Time Frame |
|---|---|---|
| Door-to-antibiotic Time | Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation | Up to 24 hours from ED arrival (an average of 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause 30-day Mortality | Sepsis patient death on or before the 30th day after ED arrival | 30 days after ED arrival |
| All-cause 1-year Mortality | Sepsis patient death on or before the 365th day after ED arrival |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Utilization' | Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival | Up to 24 hours from ED arrival (an average of 6 hours) |
| Adverse Effects of Antibiotics (Sepsis Patients) |
Inclusion criteria (overall):
Exclusion criteria (overall):
(1) Trauma patient
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| Name | Affiliation | Role |
|---|---|---|
| Ithan Peltan, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84107 | United States | ||
| Utah Valley Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38996086 | Derived | Peltan ID, Bledsoe JR, Jacobs JR, Groat D, Klippel C, Adamson M, Hooper GA, Tinker NJ, Foster RA, Stenehjem EA, Moores Todd TD, Balls A, Avery J, Brunson G, Jones J, Bair J, Dorais A, Samore MH, Hough CL, Brown SM. Effectiveness and Safety of an Emergency Department Code Sepsis Protocol: A Pragmatic Clinical Trial. Ann Am Thorac Soc. 2024 Nov;21(11):1560-1571. doi: 10.1513/AnnalsATS.202403-286OC. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-implementation Usual Care (Intervention Site) | Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). |
| FG001 | Code Sepsis Post-implementation (Intervention Site) | Adult patients age ≥18 years exposed to the intervention after presenting to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis. |
| FG002 | Pre-implementation Usual Care (Control Sites) | Adult patients age ≥18 years who received usual care after presenting to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. |
| FG003 | Post-implementation Usual Care (Control Sites) | Adult patients age ≥18 years who receive usual care after presenting to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-implmentation Period |
| |||||||||||||
| Post-implmementation Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-implementation Usual Care (Intervention Site) | Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). |
| BG001 | Code Sepsis Post-implementation (Intervention Site) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Door-to-antibiotic Time | Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. | Posted | Median | Inter-Quartile Range | minutes | Up to 24 hours from ED arrival (an average of 3 hours) |
|
1 year
Reportable adverse events of anaphylaxis or anaphylaxis-like adverse events were defined as events occurring within 72 hours of ED arrival in the subset of subjects who met sepsis criterial in the emergency department. Per protocol, reportable serious adverse events and non-serious adverse events were defined as events possibly, probably, or definitely related to study procedures (or of uncertain relationship). Non-reportable serious and non-serious adverse events were not recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-implementation Usual Care (Intervention Site) | Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | Systematic Assessment | Anaphylaxis or anaphylaxis-like clinical event occurring within 72 hours of hospital arrival among patients meeting sepsis criteria before emergency department departure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Office of Research | Intermountain Health | (801) 408-1991 | officeofresearch@imail.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2023 | Jan 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2023 | Feb 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Patients presenting to the intervention emergency department after implementation of the care reorganization intervention - "Code Sepsis protocol" - will be compared to patients presenting prior to the intervention. Patients presenting to control emergency departments will receive usual care both before and after Code Sepsis implementation and are included in this study to control for changes in intervention-site outcomes over time unrelated to the tested intervention.
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| 1 year after ED arrival |
| All-cause In-hospital Mortality | Sepsis patient death prior to hospital discharge | From the time of admission to hospital discharge (up to 1 year, average 14 days) |
| Hospital Charges | Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization | From the time of admission to hospital discharge (up to 1 year, average 14 days) |
| Hospital Length of Stay | Length of time from sepsis patients' ED arrival until hospital discharge | From the time of admission to hospital discharge (up to 1 year, average 14 days) |
Measured as the fraction of sepsis patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics
| From the time of ED arrival to hospital discharge (up to 1 year, average 14 days) |
| Adverse Effect of Antibiotics (All ED Patients) | Measured as the fraction of all ED patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics | From the time of ED arrival to hospital discharge (up to 1 year, average 14 days) |
| New Onset Clostridium Difficile Colitis Incidence (Sepsis Patients) | Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among ED sepsis patients and (2) all ED patients. | Beginning 72 hours after ED arrival to 90 days after ED arrival |
| New Onset Clostridium Difficile Colitis Incidence (All ED Patients) | Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among all ED patients. | Beginning 72 hours after ED arrival to 90 days after ED arrival. |
| Antibiotic Overtreatment Rate | Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection who received antibiotics in the ED | Up to 24 hours from ED arrival (an average of 6 hours) |
| Antibiotic Spectrum (Sepsis Patients) | Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum. | Up to 24 hours from ED arrival (an average of 6 hours) |
| Antibiotic Spectrum (All ED Patients) | Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum. | Up to 24 hours from ED arrival (an average of 6 hours) |
| Provo |
| Utah |
| 84604 |
| United States |
| Dixie Regional Medical Center | St. George | Utah | 84790 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Adult patients age ≥18 years presenting to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis. |
| BG002 | Pre-implementation Usual Care (Control Sites) | Adult patients age ≥18 years who received usual care after presenting to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. |
| BG003 | Post-implementation Usual Care (Control Sites) | Adult patients age ≥18 years who receive usual care after presenting to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis. |
| OG002 | Pre-implementation Usual Care (Control Sites) - Sepsis Patients | Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. |
| OG003 | Post-implementation Usual Care (Control Sites) - Sepsis Patients | Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. |
|
|
|
| Secondary | All-cause 30-day Mortality | Sepsis patient death on or before the 30th day after ED arrival | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. | Posted | Count of Participants | Participants | 30 days after ED arrival |
|
|
|
|
| Secondary | All-cause 1-year Mortality | Sepsis patient death on or before the 365th day after ED arrival | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. | Posted | Count of Participants | Participants | 1 year after ED arrival |
|
|
|
|
| Secondary | All-cause In-hospital Mortality | Sepsis patient death prior to hospital discharge | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. | Posted | Count of Participants | Participants | From the time of admission to hospital discharge (up to 1 year, average 14 days) |
|
|
|
|
| Secondary | Hospital Charges | Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. Subjects who met sepsis criteria but were missing outcome data (N=80 overall) were also excluded from this analysis. | Posted | Median | Inter-Quartile Range | US dollars * 1000 | From the time of admission to hospital discharge (up to 1 year, average 14 days) |
|
|
|
|
| Secondary | Hospital Length of Stay | Length of time from sepsis patients' ED arrival until hospital discharge | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. | Posted | Median | Inter-Quartile Range | days | From the time of admission to hospital discharge (up to 1 year, average 14 days) |
|
|
|
|
| Other Pre-specified | Antibiotic Utilization' | Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival | Posted | Count of Participants | Participants | Up to 24 hours from ED arrival (an average of 6 hours) |
|
|
|
|
| Other Pre-specified | Adverse Effects of Antibiotics (Sepsis Patients) | Measured as the fraction of sepsis patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. | Posted | Count of Participants | Participants | From the time of ED arrival to hospital discharge (up to 1 year, average 14 days) |
|
|
|
|
| Other Pre-specified | Adverse Effect of Antibiotics (All ED Patients) | Measured as the fraction of all ED patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics | Posted | Count of Participants | Participants | From the time of ED arrival to hospital discharge (up to 1 year, average 14 days) |
|
|
|
|
| Other Pre-specified | New Onset Clostridium Difficile Colitis Incidence (Sepsis Patients) | Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among ED sepsis patients and (2) all ED patients. | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. Patients with a positive stool test for Clostridium difficile colitis at baseline (from 14 days prior to ED arrival to 72 hours after ED arrival) were excluded from analysis. | Posted | Count of Participants | Participants | Beginning 72 hours after ED arrival to 90 days after ED arrival |
|
|
|
|
| Other Pre-specified | New Onset Clostridium Difficile Colitis Incidence (All ED Patients) | Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among all ED patients. | Patients with a positive stool test for Clostridium difficile colitis at baseline (from 14 days prior to ED arrival to 72 hours after ED arrival) were excluded from analysis. | Posted | Count of Participants | Participants | Beginning 72 hours after ED arrival to 90 days after ED arrival. |
|
|
|
|
| Other Pre-specified | Antibiotic Overtreatment Rate | Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection who received antibiotics in the ED | Restricted to patients who had a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection | Posted | Count of Participants | Participants | Up to 24 hours from ED arrival (an average of 6 hours) |
|
|
|
|
| Other Pre-specified | Antibiotic Spectrum (Sepsis Patients) | Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum. | Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. Patients who did not receive antibiotics (i.e., received no antimicrobials or received only antivirals or other non-antibiotic classes of antimicrobials) were excluded from this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 24 hours from ED arrival (an average of 6 hours) |
|
|
|
|
| Other Pre-specified | Antibiotic Spectrum (All ED Patients) | Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum. | Patients who did not receive antibiotics (i.e., received no antimicrobials or received only antivirals or other non-antibiotic classes of antimicrobials) were excluded from this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 24 hours from ED arrival (an average of 6 hours) |
|
|
|
|
| 2,085 |
| 50,437 |
| 0 |
| 50,437 |
| 2 |
| 50,437 |
| EG001 | Code Sepsis Post-implementation (Intervention Site) | Adult patients age ≥18 years presenting to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis. | 1,426 | 33,415 | 0 | 33,415 | 3 | 33,415 |
| EG002 | Pre-implementation Usual Care (Control Sites) | Adult patients age ≥18 years who received usual care after presenting to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. | 2,520 | 56,192 | 0 | 56,192 | 1 | 56,192 |
| EG003 | Post-implementation Usual Care (Control Sites) | Adult patients age ≥18 years who receive usual care after presenting to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. | 1,760 | 40,358 | 0 | 40,358 | 2 | 40,358 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Superiority |
| Superiority |
Change in all-cause in-hospital mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis |
| Superiority |
| Superiority |
| Superiority |
Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients. |
| Superiority |
Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients. |
Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis. |
| Superiority |
Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.
Multiple imputation was employed to account for missing covariate data affecting 3.1% of eligible patients.
| Superiority |
Multiple imputation was employed to account for missing covariate data affecting 2.0% of eligible patients. |