Clinical trial NCT05961137: Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures
Official title: Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Emergency Medical Services
Quality Improvement
Shock, Septic
Fluid Therapy
Lead sponsor: Orange Park Medical Center
Sponsor class: OTHER
Collaborators: name: 410 Medical
First posted: 2023-07-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group design with control group enrolled first, then a training period, then a separate intervention group enrolled.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis
timeFrame: Assessed at 3 hours after ED arrival
Secondary outcomes:
measure: Percentage achievement of 30mL/kg crystalloid infusion for hypotension or lactate level > 4 mmol/L at 1 hour
timeFrame: Assessed at 1 hour after ED arrival
measure: Total volume of intravenous crystalloid infused by time of ED arrival
timeFrame: During the 3 hours prior to ED arrival, while under care by EMS.
measure: Total volume of intravenous crystalloid infused by 1 hour after ED arrival
timeFrame: Assessed at 1 hour after ED arrival
measure: Total volume of intravenous crystalloid infused by 3 hours after ED arrival
timeFrame: Assessed at 3 hours after ED arrival
measure: Total volume of intravenous crystalloid infused, in the ED, by 1 hour after ED arrival
timeFrame: Assessed at 1 hour after ED arrival
measure: Total volume of intravenous crystalloid infused, in the ED, by 3 hours after ED arrival
timeFrame: Assessed at 3 hours after ED arrival
measure: Percentage of study participants receiving any intensive care unit care
timeFrame: Through discharge from index acute-care episode, up to 6 months
measure: Percentage of study participants with admission disposition during index ED visit
timeFrame: Through discharge from index acute-care episode, up to 6 months
measure: Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival
timeFrame: Assessed at 24 hours after ED arrival
measure: Percentage of enrollees experiencing in-hospital death
timeFrame: Through discharge from index acute-care episode, up to 6 months
measure: Total length of stay in ED
timeFrame: Through discharge from index acute-care episode, up to 6 months
measure: Total length of stay in hospital
timeFrame: Through discharge from index acute-care episode, up to 6 months
measure: Total length of stay in intensive care unit
timeFrame: Through discharge from index acute-care episode, up to 6 months
Other outcomes:
Locations:
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
Study officials:
affiliation: Orange Park Medical Center
name: Martin P Wegman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: