Effect of Automated Real-time Feedback on Early Sepsis Care

NCT05625464 | Completed

• 1 other identifier: 2020P002676
• Study Type: interventional
• Target: 3,269
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Antibiotic order compliance

  within 3 hours of timezero

• Blood culture order compliance

  within 3 hours of time-zero

• Initial lactate order compliance

  within 3 hours of time-zero

• Repeat lactate order compliance

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

• 3-hour sepsis bundle care delivery compliance

  Within 3 hours of sepsis BPA trigger (time zero)

Study Arms (2)

Intervention

EXPERIMENTAL

Received SCTP monitoring and standard of care

Other: SCTP

Control

NO INTERVENTION

Received standard of care only

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Crico: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 23, 2022
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)