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

Orange Park Medical Center

Status: Completed

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

Treatments: Other: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol; Other: Conventional Prehospital Suspected Sepsis Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05961137

1-1260269-1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

After-phase: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol

Active Comparator group

Description:

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.

Treatment:

Other: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol

Before phase: Conventional Prehospital Suspected Sepsis Protocol

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Prehospital Suspected Sepsis Protocol