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

NCT05961137 | Completed

• 1 other identifier: 1-1260269-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Percentage achievement of 30mL/kg crystalloid infusion for hypotension or lactate level > 4 mmol/L at 1 hour

  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

Study Arms (2)

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

ACTIVE COMPARATOR

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

Before phase: Conventional Prehospital Suspected Sepsis Protocol

ACTIVE COMPARATOR

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

Interventions

Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol OTHER

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.

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

Conventional Prehospital Suspected Sepsis Protocol OTHER

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.

Before phase: Conventional Prehospital Suspected Sepsis Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orange Park Medical Center: lead
• 410 Medical: collaborator

Study Sites (1)

Orange Park Medical Center

Orange Park, Florida, 32073, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Martin P Wegman, MD, PhD

  Orange Park Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-group design with control group enrolled first, then a training period, then a separate intervention group enrolled.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 27, 2023
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)