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Completed

NCT Number: NCT05961137

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.

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Key information

Conditions

Sepsis Emergency Medical Services Fluid Therapy Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Quality Improvement Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orange Park Medical Center

Orange Park, Florida, 32073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

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

    Time frame: Assessed at 1 hour after ED arrival

    Dichotomous measure of whether infusion volume was met, based on sum of prehospital and ED-based crystalloid fluid infusion

  2. Total volume of intravenous crystalloid infused by time of ED arrival

    Time frame: During the 3 hours prior to ED arrival, while under care by EMS.

  3. Total volume of intravenous crystalloid infused by 1 hour after ED arrival

    Time frame: Assessed at 1 hour after ED arrival

  4. Total volume of intravenous crystalloid infused by 3 hours after ED arrival

    Time frame: Assessed at 3 hours after ED arrival

  5. Total volume of intravenous crystalloid infused, in the ED, by 1 hour after ED arrival

    Time frame: Assessed at 1 hour after ED arrival

  6. Total volume of intravenous crystalloid infused, in the ED, by 3 hours after ED arrival

    Time frame: Assessed at 3 hours after ED arrival

  7. Percentage of study participants receiving any intensive care unit care

    Time frame: Through discharge from index acute-care episode, up to 6 months

  8. Percentage of study participants with admission disposition during index ED visit

    Time frame: Through discharge from index acute-care episode, up to 6 months

  9. Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival

    Time frame: Assessed at 24 hours after ED arrival

    Specified life-support interventions were mechanical ventilation, vasopressor use, cardiopulmonary resuscitation, surgical intervention.

  10. Percentage of enrollees experiencing in-hospital death

    Time frame: Through discharge from index acute-care episode, up to 6 months

  11. Total length of stay in ED

    Time frame: Through discharge from index acute-care episode, up to 6 months

    Operationalized as time difference between ED clinician's documented disposition time and the patient's arrival time.

  12. Total length of stay in hospital

    Time frame: Through discharge from index acute-care episode, up to 6 months

    Among those admitted to the hospital as the disposition of their index ED visit.

  13. Total length of stay in intensive care unit

    Time frame: Through discharge from index acute-care episode, up to 6 months

Sponsors and collaborators

Lead sponsor

Orange Park Medical Center

Other

Collaborators

  • 410 Medical

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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