Effect of Automated Real-time Feedback on Early Sepsis Care

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: SCTP

• Study Type: Interventional
• Enrollment (Actual): 3269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients aged 18 years old and over
2. Who triggered a sepsis best practice advisory that was subsequently acknowledged by a treating clinician as "yes, sepsis possible"

Exclusion Criteria:

1. Transfer from an outside hospital
2. Sepsis best practice advisory triggered while the patient is in an intensive care unit
3. Sepsis best practice advisory triggered while the patient is in a perioperative care area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Received SCTP monitoring and standard of care	Other: SCTP; 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.
No Intervention: Control; Received standard of care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 3 hours of sepsis BPA trigger (time zero)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic order compliance	Antibiotic ordering compliance, defined as orders for antibiotics placed within 3 hours of timezero	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	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	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	placed within 6 hours of time-zero and within 3 hours of initial lactate measurement
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.	Within 3 hours of sepsis BPA trigger (time zero)
Antibiotic delivery compliance	Antibiotic delivery compliance, defined as administration of antibiotics within 3 hours of timezero	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	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	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	within 6 hours of time-zero and within 3 hours of initial lactate measurement
Mortality by Day 28	Mortality by Day 28	Within 28 days of time zero
Early mechanical ventilation	Early mechanical ventilation, defined as the receipt of mechanical ventilation or death within 72 hours of time-zero	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	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	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	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	Through day 28 after time zero
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	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	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	24 hours before or 7 days after time zero

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Crico

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2020P002676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No