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Effect of Automated Real-time Feedback on Early Sepsis Care

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCTP
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sepsis

Eligibility Criteria

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

Inclusion Criteria: Adult patients aged 18 years old and over Who triggered a sepsis best practice advisory that was subsequently acknowledged by a treating clinician as "yes, sepsis possible" Exclusion Criteria: Transfer from an outside hospital Sepsis best practice advisory triggered while the patient is in an intensive care unit Sepsis best practice advisory triggered while the patient is in a perioperative care area

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Received SCTP monitoring and standard of care

Received standard of care only

Outcomes

Primary Outcome Measures

3-hour sepsis bundle order compliance
Overall 3-hour bundle ordering compliance, defined as orders for all 3-hour bundle measures monitored by the study platform completed within the bundle time limits - i.e., orders for antibiotics, blood cultures, and lactate measurement measured from the electronic medical record at the end of the study period

Secondary Outcome Measures

Antibiotic order compliance
Antibiotic ordering compliance, defined as orders for antibiotics placed within 3 hours of timezero
Blood culture order compliance
Blood culture ordering compliance, defined as orders for blood cultures placed within 3 hours of time-zero
Initial lactate order compliance
Initial blood lactate level ordering compliance, defined as orders for initial blood lactate level within 3 hours of time-zero
Repeat lactate order compliance
Repeat blood lactate level ordering compliance, defined as orders for repeat blood lactate level placed within 6 hours of time-zero and within 3 hours of initial lactate measurement, among patients with initial lactate > 2.0mmol/L
3-hour sepsis bundle care delivery compliance
Overall 3-hour bundle care delivery compliance, defined as the implementation of all 3-hour bundle measures monitored by the study platform completed within the bundle time limits - i.e., administration of antibiotics, collection of blood cultures prior to antibiotic administration, and lactate measurement.
Antibiotic delivery compliance
Antibiotic delivery compliance, defined as administration of antibiotics within 3 hours of timezero
Blood culture delivery compliance
Blood cultures delivery compliance, defined collection of blood cultures within 3 hours of timezero and prior to antibiotic administration
Initial lactate delivery compliance
Initial lactate delivery compliance, defined measurement of initial lactate within 3 hours of time-zero
Repeat lactate delivery compliance
Repeat lactate delivery compliance, defined as the measurement of a repeat lactate within 6 hours of time-zero and within 3 hours of initial lactate measurement, among patients with an initial lactate > 2.0mmol/L
Mortality by Day 28
Mortality by Day 28
Early mechanical ventilation
Early mechanical ventilation, defined as the receipt of mechanical ventilation or death within 72 hours of time-zero
Early intensive care unit admission
Early intensive care unit (ICU) admission, defined as ICU admission or death within 72 hours of time-zero
Mechanical ventilation during hospitalization
Mechanical ventilation during hospitalization, defined as receipt of mechanical ventilation or death within 28 days of time-zero
Early antibiotic discontinuation
Early antibiotic discontinuation, defined as discontinuation of all antibiotics for at least 24 hours by 48 hours post-time-zero
Hospital length of stay
Hospital length of stay, defined as hospital days from time-zero through day 28
Blood culture positivity
Blood culture positivity, defined as bacterial growth recovered from any blood culture collected 24 hours before or 7 days after time zero
Non-blood culture positivity
Non-blood culture positivity, defined as bacterial pathogen recovery from any urine, respiratory, peritoneal, pleural, joint, or cerebrospinal fluid culture collected 24 hours before or 7 days after time zero
Any culture positivity
Any culture positivity, defined as a composite of positive results from either the blood or non-blood culture positivity outcome

Full Information

First Posted
November 13, 2022
Last Updated
November 20, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Crico
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1. Study Identification

Unique Protocol Identification Number
NCT05625464
Brief Title
Effect of Automated Real-time Feedback on Early Sepsis Care
Official Title
Effect of Automated Real-time Feedback on Early Sepsis Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Crico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Sepsis is the leading cause of death among US hospitals, accounting for 6% of all hospitalizations and 35% of all inpatient deaths. International guidelines and the CMS SEP-1 bundle stress the importance of adhering to specific steps in the diagnosis and management of sepsis. This can be very difficult, especially in the setting of a busy ED, ward, or ICU where there are multiple simultaneous demands on providers' attention and time. Critical steps can be missed or delayed. The CMS SEP-1 bundle is a measure of compliance with sepsis care that is being tracked nationally across hospitals. Unfortunately, a recent study demonstrated that every hour of delay to the completion of a sepsis bundle, including antibiotic administration, was associated with a 4% increase in risk-adjusted hospital mortality. One strategy to improve the care and outcomes of patients with sepsis is the use of information technology to support our providers in a targeted manner. Technology has already been developed and deployed to help with the early identification of patients with sepsis using a Best Practice Alert (BPA), which has been in place at our hospital since 2017. This pop-up window alerts the team to the possibility of sepsis based on data within the medical record. However, once the alert is accepted or declined, the BPA does not offer ongoing support to clinicians, leaving the clinician to track and execute multiple time-based and inter-dependent sepsis bundle measures in a busy, hectic environment. To augment this existing tool, here we propose to study the efficacy of a novel technology called the Sepsis Care Tracking Platform (SCTP) to provide ongoing support at the bedside to providers, thus improving the care we deliver to patients. SCTP is a monitoring and notification platform that aims to increase the timely delivery of key elements of evidence-based sepsis care. This platform, which was built by clinicians for clinicians, leverages the electronic medical record (EMR) to track real-time compliance with key components of the CMS SEP-1 bundle - timely antibiotics, blood cultures prior to antibiotics, initial lactate, and repeat lactate for those patients with an initially elevated level. SCTP underwent technical validation in Fall 2019 with a pilot in the MGH Emergency Department. The pilot confirmed that SCTP correctly identified missing bundle elements and paged the appropriate team members connected with the patient's care. The pilot also did not find alarm fatigue to be an issue. We hypothesize that SCTP will increase our hospital's compliance with sepsis process metrics and improve patient outcomes. By monitoring real-time data and automatically alerting bedside providers to missing elements within an actionable timeframe, SCTP has the potential to drive improvements in clinical care even in the extremely busy and complex environment of the emergency department and inpatient units.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Received SCTP monitoring and standard of care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Received standard of care only
Intervention Type
Other
Intervention Name(s)
SCTP
Intervention Description
Real-time automated monitoring of the electronic medical record to identify suspected sepsis patients without completion of sepsis bundle measures within 1-hour of the completion deadline and generated reminder pages. Clinicians responsible for patients randomized to the intervention receive reminder pages whereas no pages are sent for control arm patients.
Primary Outcome Measure Information:
Title
3-hour sepsis bundle order compliance
Description
Overall 3-hour bundle ordering compliance, defined as orders for all 3-hour bundle measures monitored by the study platform completed within the bundle time limits - i.e., orders for antibiotics, blood cultures, and lactate measurement measured from the electronic medical record at the end of the study period
Time Frame
Within 3 hours of sepsis BPA trigger (time zero)
Secondary Outcome Measure Information:
Title
Antibiotic order compliance
Description
Antibiotic ordering compliance, defined as orders for antibiotics placed within 3 hours of timezero
Time Frame
within 3 hours of timezero
Title
Blood culture order compliance
Description
Blood culture ordering compliance, defined as orders for blood cultures placed within 3 hours of time-zero
Time Frame
within 3 hours of time-zero
Title
Initial lactate order compliance
Description
Initial blood lactate level ordering compliance, defined as orders for initial blood lactate level within 3 hours of time-zero
Time Frame
within 3 hours of time-zero
Title
Repeat lactate order compliance
Description
Repeat blood lactate level ordering compliance, defined as orders for repeat blood lactate level placed within 6 hours of time-zero and within 3 hours of initial lactate measurement, among patients with initial lactate > 2.0mmol/L
Time Frame
placed within 6 hours of time-zero and within 3 hours of initial lactate measurement
Title
3-hour sepsis bundle care delivery compliance
Description
Overall 3-hour bundle care delivery compliance, defined as the implementation of all 3-hour bundle measures monitored by the study platform completed within the bundle time limits - i.e., administration of antibiotics, collection of blood cultures prior to antibiotic administration, and lactate measurement.
Time Frame
Within 3 hours of sepsis BPA trigger (time zero)
Title
Antibiotic delivery compliance
Description
Antibiotic delivery compliance, defined as administration of antibiotics within 3 hours of timezero
Time Frame
within 3 hours of timezero
Title
Blood culture delivery compliance
Description
Blood cultures delivery compliance, defined collection of blood cultures within 3 hours of timezero and prior to antibiotic administration
Time Frame
within 3 hours of timezero and prior to antibiotic administration
Title
Initial lactate delivery compliance
Description
Initial lactate delivery compliance, defined measurement of initial lactate within 3 hours of time-zero
Time Frame
within 3 hours of time-zero
Title
Repeat lactate delivery compliance
Description
Repeat lactate delivery compliance, defined as the measurement of a repeat lactate within 6 hours of time-zero and within 3 hours of initial lactate measurement, among patients with an initial lactate > 2.0mmol/L
Time Frame
within 6 hours of time-zero and within 3 hours of initial lactate measurement
Title
Mortality by Day 28
Description
Mortality by Day 28
Time Frame
Within 28 days of time zero
Title
Early mechanical ventilation
Description
Early mechanical ventilation, defined as the receipt of mechanical ventilation or death within 72 hours of time-zero
Time Frame
within 72 hours of time-zero
Title
Early intensive care unit admission
Description
Early intensive care unit (ICU) admission, defined as ICU admission or death within 72 hours of time-zero
Time Frame
within 72 hours of time-zero
Title
Mechanical ventilation during hospitalization
Description
Mechanical ventilation during hospitalization, defined as receipt of mechanical ventilation or death within 28 days of time-zero
Time Frame
within 28 days of time-zero
Title
Early antibiotic discontinuation
Description
Early antibiotic discontinuation, defined as discontinuation of all antibiotics for at least 24 hours by 48 hours post-time-zero
Time Frame
at least 24 hours by 48 hours post-time-zero
Title
Hospital length of stay
Description
Hospital length of stay, defined as hospital days from time-zero through day 28
Time Frame
Through day 28 after time zero
Title
Blood culture positivity
Description
Blood culture positivity, defined as bacterial growth recovered from any blood culture collected 24 hours before or 7 days after time zero
Time Frame
24 hours before or 7 days after time zero
Title
Non-blood culture positivity
Description
Non-blood culture positivity, defined as bacterial pathogen recovery from any urine, respiratory, peritoneal, pleural, joint, or cerebrospinal fluid culture collected 24 hours before or 7 days after time zero
Time Frame
24 hours before or 7 days after time zero
Title
Any culture positivity
Description
Any culture positivity, defined as a composite of positive results from either the blood or non-blood culture positivity outcome
Time Frame
24 hours before or 7 days after time zero

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients aged 18 years old and over Who triggered a sepsis best practice advisory that was subsequently acknowledged by a treating clinician as "yes, sepsis possible" Exclusion Criteria: Transfer from an outside hospital Sepsis best practice advisory triggered while the patient is in an intensive care unit Sepsis best practice advisory triggered while the patient is in a perioperative care area
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Automated Real-time Feedback on Early Sepsis Care

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