Clinical trial NCT05625464: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Crico
First posted: 2022-11-23
Enrollment: 3269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 3-hour sepsis bundle order compliance
timeFrame: Within 3 hours of sepsis BPA trigger (time zero)
Secondary outcomes:
measure: Antibiotic order compliance
timeFrame: within 3 hours of timezero
measure: Blood culture order compliance
timeFrame: within 3 hours of time-zero
measure: Initial lactate order compliance
timeFrame: within 3 hours of time-zero
measure: Repeat lactate order compliance
timeFrame: placed within 6 hours of time-zero and within 3 hours of initial lactate measurement
measure: 3-hour sepsis bundle care delivery compliance
timeFrame: Within 3 hours of sepsis BPA trigger (time zero)
measure: Antibiotic delivery compliance
timeFrame: within 3 hours of timezero
measure: Blood culture delivery compliance
timeFrame: within 3 hours of timezero and prior to antibiotic administration
measure: Initial lactate delivery compliance
timeFrame: within 3 hours of time-zero
measure: Repeat lactate delivery compliance
timeFrame: within 6 hours of time-zero and within 3 hours of initial lactate measurement
measure: Mortality by Day 28
timeFrame: Within 28 days of time zero
measure: Early mechanical ventilation
timeFrame: within 72 hours of time-zero
measure: Early intensive care unit admission
timeFrame: within 72 hours of time-zero
measure: Mechanical ventilation during hospitalization
timeFrame: within 28 days of time-zero
measure: Early antibiotic discontinuation
timeFrame: at least 24 hours by 48 hours post-time-zero
measure: Hospital length of stay
timeFrame: Through day 28 after time zero
measure: Blood culture positivity
timeFrame: 24 hours before or 7 days after time zero
measure: Non-blood culture positivity
timeFrame: 24 hours before or 7 days after time zero
measure: Any culture positivity
timeFrame: 24 hours before or 7 days after time zero
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: