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

Orange Park Medical Center1 site in 1 country66 target enrollmentApril 1, 2021

ConditionsSepsis Emergency Medical Services Quality Improvement Shock, Septic Fluid Therapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sepsis
Sponsor: Orange Park Medical Center
Enrollment: 66
Locations: 1
Primary Endpoint: Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

August 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Orange Park Medical Center

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis

Time Frame: Assessed at 3 hours after ED arrival

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.

Secondary Outcomes

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)
Percentage of study participants receiving any intensive care unit care(Through discharge from index acute-care episode, up to 6 months)
Percentage of enrollees experiencing in-hospital death(Through discharge from index acute-care episode, up to 6 months)
Total length of stay in ED(Through discharge from index acute-care episode, up to 6 months)
Total length of stay in hospital(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)
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, 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 with admission disposition during index ED visit(Through discharge from index acute-care episode, up to 6 months)
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)
Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival(Assessed at 24 hours after ED arrival)