An interventional study of SCTP in Sepsis, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 3,269 is above the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Received SCTP monitoring and standard of care
Other: SCTP
Received standard of care only
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.
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
Time frame: Within 3 hours of sepsis BPA trigger (time zero)
Antibiotic order compliance
Antibiotic ordering compliance, defined as orders for antibiotics placed within 3 hours of timezero
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 6 hours of time-zero and within 3 hours of initial lactate measurement
Mortality by Day 28
Mortality by Day 28
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hours before or 7 days after time zero
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Nov 2021, 11 months.
Of 246 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's 11 months is below that.
Counting every sponsor, half of 267 studies reached it within 22 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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