Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures

Study Overview
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Brief Summary
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The goal of this quality improvement study is to measure the impact of incorporation of a manual rapid fluid infuser (RFI) for intravenous crystalloid infusion in patients with suspected sepsis in the prehospital interval. The main question[s] it aims to answer are: Does the intervention affect the timeliness of fluid administration? Does the intervention affect CMS sepsis bundle care measure compliance? Does the intervention affect processes and outcomes of care? Are there any adverse effects? Researchers will compare this intervention to use of more conventional gravity or pressure-infusion bag crystalloid infusion.

Official Title
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Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures

Conditions
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Sepsis, Emergency Medical Services, Quality Improvement, Shock, Septic, Fluid Therapy

Intervention / Treatment
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* Other: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol
* Other: Conventional Prehospital Suspected Sepsis Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients meeting sepsis alert criteria who were transported to the study hospital's emergency department by one of the four rescue units involved in the study. Sepsis alert defined as patient has suspected infection and two or more of the following: (a) temperature > 38° C (100.4° F) or < 36° C (96.8° F), (b) respiratory rate > 20 breaths / minute or end-tidal carbon dioxide (ETCO2) ≤ 25 mmHg, or (c) heart rate > 90 beats / minute Exclusion Criteria: prehospital trauma prehospital cardiac arrest prior to signaling sepsis alert interfacility transfer emergency transport from medical facility (e.g., medical office or clinic) intervention by medical practitioner before emergency medical services arrival do not resuscitate order in place

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-group design with control group enrolled first, then a training period, then a separate intervention group enrolled.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: After-phase: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol<br>Modified protocol specifying intravenous crystalloid infusion Rapid Fluid Infusion Device. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. | Other: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol<br>* Modified protocol specifying intravenous crystalloid infusion Rapid Fluid Infusion Device. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids.<br>|
| Active Comparator: Before phase: Conventional Prehospital Suspected Sepsis Protocol<br>Conventional protocol employing intravenous crystalloid infusion via gravity or pressurized-bag. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. | Other: Conventional Prehospital Suspected Sepsis Protocol<br>* Conventional protocol employing intravenous crystalloid infusion via gravity or pressurized-bag. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis | As defined according to the Centers for Medicare and Medicaid Services (CMS) Specifications Manual for Hospital Inpatient Quality Measures, version 5.9. Time of presentation or time-zero was defined as the time of triage in the Emergency Department. All patients enrolled in the study were assessed for measure compliance, without application of measure inclusion/exclusion criteria. | Assessed at 3 hours after ED arrival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage achievement of 30mL/kg crystalloid infusion for hypotension or lactate level > 4 mmol/L at 1 hour | Dichotomous measure of whether infusion volume was met, based on sum of prehospital and ED-based crystalloid fluid infusion | Assessed at 1 hour after ED arrival | 
| Total volume of intravenous crystalloid infused by time of ED arrival |  | During the 3 hours prior to ED arrival, while under care by EMS. | 
| Total volume of intravenous crystalloid infused by 1 hour after ED arrival |  | Assessed at 1 hour after ED arrival | 
| Total volume of intravenous crystalloid infused by 3 hours after ED arrival |  | Assessed at 3 hours after ED arrival | 
| Total volume of intravenous crystalloid infused, in the ED, by 1 hour after ED arrival |  | Assessed at 1 hour after ED arrival | 
| Total volume of intravenous crystalloid infused, in the ED, by 3 hours after ED arrival |  | Assessed at 3 hours after ED arrival | 
| Percentage of study participants receiving any intensive care unit care |  | Through discharge from index acute-care episode, up to 6 months | 
| Percentage of study participants with admission disposition during index ED visit |  | Through discharge from index acute-care episode, up to 6 months | 
| Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival | Specified life-support interventions were mechanical ventilation, vasopressor use, cardiopulmonary resuscitation, surgical intervention. | Assessed at 24 hours after ED arrival | 
| Percentage of enrollees experiencing in-hospital death |  | Through discharge from index acute-care episode, up to 6 months | 
| Total length of stay in ED | Operationalized as time difference between ED clinician's documented disposition time and the patient's arrival time. | Through discharge from index acute-care episode, up to 6 months | 
| Total length of stay in hospital | Among those admitted to the hospital as the disposition of their index ED visit. | Through discharge from index acute-care episode, up to 6 months | 
| Total length of stay in intensive care unit |  | Through discharge from index acute-care episode, up to 6 months |