Implementation Trial of Predictive Modeling to Enhance Diagnosis and Improve Treatment in Pediatric Septic Shock

NCT05065333 | Completed

• 2 other identifiers: 21-2916K08HS025696
• Study Type: interventional
• Target: 1,345
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, stepped-wedge implementation trial to test the effects of implementing a Clinical Decision Support (CDS) tool for prediction of septic shock in four Emergency Departments within a pediatric healthcare network. The primary outcome will be the proportion of sepsis patients who receive guideline-concordant septic shock care after implementation of the CDS, and the secondary outcome will be time-to-antibiotic after sepsis recognition.

Conditions

Sepsis; Septic Shock; Emergencies

Keywords

pediatric

Outcome Measures

Primary Outcomes (1)

• Number of Patients Receiving Guideline-Concordant Septic Shock Care

  Treatment will be defined as concordant with Surviving Sepsis Campaign guidelines for shock if intravenous antibiotics are initiated within 60 minutes of sepsis recognition and an intravenous fluid bolus is initiated within 60 minutes of sepsis recognition. This will be a binary outcome. Sepsis recognition is defined as the earlier of: sepsis page sent, sepsis orderset use, or intravenous antibiotic order.

  Up to 24 hours after Emergency Department arrival

Secondary Outcomes (1)

• Time to Antibiotics

  Up to 24 hours after Emergency Department arrival

Other Outcomes (3)

• 30-Day In-Hospital Mortality

  30 days after Emergency Department arrival

• Number of Patients Receiving Intravenous Antibiotics during Emergency Department care

  Up to 24 hours after Emergency Department arrival

• Number of Patients With Septic Shock

  Up to 24 hours after Emergency Department arrival

Study Arms (2)

Septic Shock Clinical Decision Support

EXPERIMENTAL

Emergency Department sites in this arm will have Clinical Decision Support (CDS) alerts active in the Electronic Health Record during clinical ED care of patients with suspected sepsis, in addition to following usual institutional standard of care for sepsis. The CDS will alert providers to patients at high risk for developing septic shock.

Other: Septic Shock Clinical Decision Support

Clinical Diagnosis Only

ACTIVE COMPARATOR

Emergency Department sites in this arm will follow the institutional standard for sepsis care without Clinical Decision Support. Standard care includes clinical diagnosis of sepsis supported by institutional sepsis education, a sepsis pathway and orderset.

Other: Clinical Diagnosis Only

Interventions

Septic Shock Clinical Decision Support OTHER

The intervention will be activating a septic shock clinical decision support tool (CDS) in the Electronic Health Record at the site, making it available to trigger and alert Emergency Department providers during clinical care. Patients will be identified when providers suspect sepsis and initiate a sepsis evaluation, using the institutional, clinically-standard, sepsis pathway/orderset. After the CDS is triggered, it will use available Electronic Health Record data to calculate the risk of septic shock, using previously-published predictive models \[Ref 1, 2\]. The CDS will notify providers if the patient is at elevated risk of septic shock and prompt them to follow institutional standard care for septic shock (including close monitoring, complete laboratory evaluation for organ dysfunction, and immediate clinical involvement of an attending Pediatric Emergency Physician). All clinical care decisions will be determined by the providers.

Septic Shock Clinical Decision Support

Clinical Diagnosis Only OTHER

Emergency Department sites in this arm will not have Clinical Decision Support for septic shock visible in the Electronic Health Record for providers at the site. Providers will follow usual institutional standards of sepsis care.

Clinical Diagnosis Only

Eligibility Criteria

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

You may qualify if:

• Children's Hospital Colorado Emergency Care sites
• All providers (physicians, nurse practitioners, physician assistants) at Children's Hospital Colorado Emergency Care sites will be included

You may not qualify if:

• \- None
• Patients whose secondary data will be used to assess the outcomes of the intervention will be 60 days through 18 years old.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80238, United States

Location

Related Publications (2)

• Scott HF, Colborn KL, Sevick CJ, Bajaj L, Kissoon N, Deakyne Davies SJ, Kempe A. Development and Validation of a Predictive Model of the Risk of Pediatric Septic Shock Using Data Known at the Time of Hospital Arrival. J Pediatr. 2020 Feb;217:145-151.e6. doi: 10.1016/j.jpeds.2019.09.079. Epub 2019 Nov 13.

  PMID: 31733815 BACKGROUND

• Scott HF, Colborn KL, Sevick CJ, Bajaj L, Deakyne Davies SJ, Fairclough D, Kissoon N, Kempe A. Development and Validation of a Model to Predict Pediatric Septic Shock Using Data Known 2 Hours After Hospital Arrival. Pediatr Crit Care Med. 2021 Jan 1;22(1):16-26. doi: 10.1097/PCC.0000000000002589.

  PMID: 33060422 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Halden F Scott, MD, MSCS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Emergency Department sites (unit of randomization) cannot be blinded; however patients who are subjects of the intervention are not aware of the arm of the site in the clinical trial.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a stepped wedge cluster randomized trial, with the site as the unit of randomization. There will be five study periods and four sites. In the first period no sites will receive the intervention. During each subsequent period, one site will crossover to receive the intervention.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: March 16, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after publication of study results
• Access Criteria: The study team intends to share study data that may be requested from other research investigators in a data-sharing agreement provided at the individual study's end. The data-sharing agreement will include requirements to protect participants' privacy and data confidentiality. It will prohibit the recipient from transferring the data to other users and will require that the data's security be protected by standard means and be used for research purposes only. The method of distribution will be by request to Dr. Scott, the study PI. After a requestor completes the data-sharing agreement, we will upload data to a secure File Transfer Protocol (FTP) site with the limited dataset to the requestor, or email the data through our University secured email systems that require users to create an account and sign-in with a username and password in order to receive and download any type of sensitive data.

Locations

US (1)