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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Shock, Septic; Fluid Therapy; Emergency Medical Services; Quality Improvement
• Intervention / Treatment: Other: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol; Other: Conventional Prehospital Suspected Sepsis Protocol

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orange Park, Florida, United States, 32073
      • Orange Park Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: After-phase: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol; 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; 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.
Active Comparator: Before phase: Conventional Prehospital Suspected Sepsis Protocol; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orange Park Medical Center
• Collaborators: 410 Medical
• Investigators: Principal Investigator: Martin P Wegman, MD, PhD, Orange Park Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Shock; Sepsis; Toxemia; Emergencies; Shock, Septic
• Other Study ID Numbers: 1-1260269-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No