search
Back to results

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

Primary Purpose

Sepsis, Emergency Medical Services, Quality Improvement

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol
Conventional Prehospital Suspected Sepsis Protocol
Sponsored by
Orange Park Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Orange Park Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

Before phase: Conventional Prehospital Suspected Sepsis Protocol

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage achievement of 30mL/kg crystalloid infusion for hypotension or lactate level > 4 mmol/L at 1 hour
Dichotomous measure of whether infusion volume was met, based on sum of prehospital and ED-based crystalloid fluid infusion
Total volume of intravenous crystalloid infused by time of ED arrival
Total volume of intravenous crystalloid infused by 1 hour after ED arrival
Total volume of intravenous crystalloid infused by 3 hours after ED arrival
Total volume of intravenous crystalloid infused, in the ED, by 1 hour after ED arrival
Total volume of intravenous crystalloid infused, in the ED, by 3 hours after ED arrival
Percentage of study participants receiving any intensive care unit care
Percentage of study participants with admission disposition during index ED visit
Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival
Specified life-support interventions were mechanical ventilation, vasopressor use, cardiopulmonary resuscitation, surgical intervention.
Percentage of enrollees experiencing in-hospital death
Total length of stay in ED
Operationalized as time difference between ED clinician's documented disposition time and the patient's arrival time.
Total length of stay in hospital
Among those admitted to the hospital as the disposition of their index ED visit.
Total length of stay in intensive care unit

Full Information

First Posted
May 22, 2023
Last Updated
July 17, 2023
Sponsor
Orange Park Medical Center
Collaborators
410 Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT05961137
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orange Park Medical Center
Collaborators
410 Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Emergency Medical Services, Quality Improvement, Shock, Septic, Fluid Therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group design with control group enrolled first, then a training period, then a separate intervention group enrolled.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
After-phase: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol
Arm Type
Active Comparator
Arm 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.
Arm Title
Before phase: Conventional Prehospital Suspected Sepsis Protocol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Conventional Prehospital Suspected Sepsis Protocol
Intervention 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.
Primary Outcome Measure Information:
Title
Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis
Description
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.
Time Frame
Assessed at 3 hours after ED arrival
Secondary Outcome Measure Information:
Title
Percentage achievement of 30mL/kg crystalloid infusion for hypotension or lactate level > 4 mmol/L at 1 hour
Description
Dichotomous measure of whether infusion volume was met, based on sum of prehospital and ED-based crystalloid fluid infusion
Time Frame
Assessed at 1 hour after ED arrival
Title
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.
Title
Total volume of intravenous crystalloid infused by 1 hour after ED arrival
Time Frame
Assessed at 1 hour after ED arrival
Title
Total volume of intravenous crystalloid infused by 3 hours after ED arrival
Time Frame
Assessed at 3 hours after ED arrival
Title
Total volume of intravenous crystalloid infused, in the ED, by 1 hour after ED arrival
Time Frame
Assessed at 1 hour after ED arrival
Title
Total volume of intravenous crystalloid infused, in the ED, by 3 hours after ED arrival
Time Frame
Assessed at 3 hours after ED arrival
Title
Percentage of study participants receiving any intensive care unit care
Time Frame
Through discharge from index acute-care episode, up to 6 months
Title
Percentage of study participants with admission disposition during index ED visit
Time Frame
Through discharge from index acute-care episode, up to 6 months
Title
Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival
Description
Specified life-support interventions were mechanical ventilation, vasopressor use, cardiopulmonary resuscitation, surgical intervention.
Time Frame
Assessed at 24 hours after ED arrival
Title
Percentage of enrollees experiencing in-hospital death
Time Frame
Through discharge from index acute-care episode, up to 6 months
Title
Total length of stay in ED
Description
Operationalized as time difference between ED clinician's documented disposition time and the patient's arrival time.
Time Frame
Through discharge from index acute-care episode, up to 6 months
Title
Total length of stay in hospital
Description
Among those admitted to the hospital as the disposition of their index ED visit.
Time Frame
Through discharge from index acute-care episode, up to 6 months
Title
Total length of stay in intensive care unit
Time Frame
Through discharge from index acute-care episode, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin P Wegman, MD, PhD
Organizational Affiliation
Orange Park Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orange Park Medical Center
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs