Skip to main content
OpenTrials
Completed

NCT Number: NCT05625464

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

SCTP

Other

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 outcomes

  1. 3-hour sepsis bundle order compliance

    Time frame: Within 3 hours of sepsis BPA trigger (time zero)

    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 outcomes

  1. Antibiotic order compliance

    Time frame: within 3 hours of timezero

    Antibiotic ordering compliance, defined as orders for antibiotics placed within 3 hours of timezero

  2. Blood culture order compliance

    Time frame: within 3 hours of time-zero

    Blood culture ordering compliance, defined as orders for blood cultures placed within 3 hours of time-zero

  3. Initial lactate order compliance

    Time frame: within 3 hours of time-zero

    Initial blood lactate level ordering compliance, defined as orders for initial blood lactate level within 3 hours of time-zero

  4. Repeat lactate order compliance

    Time frame: placed within 6 hours of time-zero and within 3 hours of initial lactate measurement

    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

  5. 3-hour sepsis bundle care delivery compliance

    Time frame: Within 3 hours of sepsis BPA trigger (time zero)

    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.

  6. Antibiotic delivery compliance

    Time frame: within 3 hours of timezero

    Antibiotic delivery compliance, defined as administration of antibiotics within 3 hours of timezero

  7. Blood culture delivery compliance

    Time frame: within 3 hours of timezero and prior to antibiotic administration

    Blood cultures delivery compliance, defined collection of blood cultures within 3 hours of timezero and prior to antibiotic administration

  8. Initial lactate delivery compliance

    Time frame: within 3 hours of time-zero

    Initial lactate delivery compliance, defined measurement of initial lactate within 3 hours of time-zero

  9. Repeat lactate delivery compliance

    Time frame: within 6 hours of time-zero and within 3 hours of initial lactate measurement

    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

  10. Mortality by Day 28

    Time frame: Within 28 days of time zero

    Mortality by Day 28

  11. Early mechanical ventilation

    Time frame: within 72 hours of time-zero

    Early mechanical ventilation, defined as the receipt of mechanical ventilation or death within 72 hours of time-zero

  12. Early intensive care unit admission

    Time frame: within 72 hours of time-zero

    Early intensive care unit (ICU) admission, defined as ICU admission or death within 72 hours of time-zero

  13. Mechanical ventilation during hospitalization

    Time frame: within 28 days of time-zero

    Mechanical ventilation during hospitalization, defined as receipt of mechanical ventilation or death within 28 days of time-zero

  14. Early antibiotic discontinuation

    Time frame: at least 24 hours by 48 hours post-time-zero

    Early antibiotic discontinuation, defined as discontinuation of all antibiotics for at least 24 hours by 48 hours post-time-zero

  15. Hospital length of stay

    Time frame: Through day 28 after time zero

    Hospital length of stay, defined as hospital days from time-zero through day 28

  16. Blood culture positivity

    Time frame: 24 hours before or 7 days after time zero

    Blood culture positivity, defined as bacterial growth recovered from any blood culture collected 24 hours before or 7 days after time zero

  17. Non-blood culture positivity

    Time frame: 24 hours before or 7 days after time zero

    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

  18. Any culture positivity

    Time frame: 24 hours before or 7 days after time zero

    Any culture positivity, defined as a composite of positive results from either the blood or non-blood culture positivity outcome

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Crico

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2022
Registry last updated
Nov 23, 2022

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.

Published trials that share one or more normalized conditions with this study.