SepsisNCT05625464
Effect of Automated Real-time Feedback on Early Sepsis Care
A study testing SCTP in people with Sepsis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- SCTP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,269 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read more
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.
- Conditions
- Sepsis
- Being tested
- SCTP
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Received SCTP monitoring and standard of care Receives: Other: SCTP |
| Control | No intervention | Received standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 3 hours of sepsis BPA trigger (time zero)
Secondary outcomes (18)
Antibiotic order compliance
Antibiotic ordering compliance, defined as orders for antibiotics placed within 3 hours of timezero
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: within 6 hours of time-zero and within 3 hours of initial lactate measurement
Mortality by Day 28
Mortality by Day 28
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours before or 7 days after time zero
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Dec 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Crico
- Responsible party
- Principal investigator, Kyan Safavi, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625464
- Sponsor's protocol ID
- 2020P002676
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Automated Real-time Feedback on Early Sepsis Care
- ClinicalTrials.gov ID
- NCT05625464
- Acronym / sponsor ID
- 2020P002676
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,269 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Crico
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: SCTPReceived SCTP monitoring and standard of care |
| Control | No intervention | –Received standard of care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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"
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTPReal-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. | Other | Intervention |
Primary outcome
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
18 secondary outcomes
Antibiotic order compliance
Time frame: within 3 hours of timezero
Blood culture order compliance
Time frame: within 3 hours of time-zero
Initial lactate order compliance
Time frame: within 3 hours of time-zero
Repeat lactate order compliance
Time frame: placed within 6 hours of time-zero and within 3 hours of initial lactate measurement
3-hour sepsis bundle care delivery compliance
Time frame: Within 3 hours of sepsis BPA trigger (time zero)
Antibiotic delivery compliance
Time frame: within 3 hours of timezero
Blood culture delivery compliance
Time frame: within 3 hours of timezero and prior to antibiotic administration
Initial lactate delivery compliance
Time frame: within 3 hours of time-zero
Repeat lactate delivery compliance
Time frame: within 6 hours of time-zero and within 3 hours of initial lactate measurement
Mortality by Day 28
Time frame: Within 28 days of time zero
Early mechanical ventilation
Time frame: within 72 hours of time-zero
Early intensive care unit admission
Time frame: within 72 hours of time-zero
Mechanical ventilation during hospitalization
Time frame: within 28 days of time-zero
Early antibiotic discontinuation
Time frame: at least 24 hours by 48 hours post-time-zero
Hospital length of stay
Time frame: Through day 28 after time zero
Blood culture positivity
Time frame: 24 hours before or 7 days after time zero
Non-blood culture positivity
Time frame: 24 hours before or 7 days after time zero
Any culture positivity
Time frame: 24 hours before or 7 days after time zero
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCTP in people with Sepsis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-hour sepsis bundle order compliance (time frame: Within 3 hours of sepsis BPA trigger (time zero)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.