RECRUITING

Assessment for Implementation Methods in Sepsis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Since the introduction of sepsis bundles, there have been multiple published trials that have demonstrated a consistent, strong association between implementation of sepsis "bundles" (3-hour bundle) and improved survival. The current proposal is a Hybrid 2, pragmatic, cluster randomized clinical effectiveness/implementation trial evaluating mortality and respiratory failure-based outcomes, in patients admitted to the emergency department with sepsis, comparing the effectiveness of implementation of the hour-1 bundle to 3-hour bundle, while facilitating adherence to both bundles. In addition, 4 distinct sepsis phenotypes will be derived from routine clinical data to identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles in future studies.

Official Title

Assessment for Implementation Methods in Sepsis

Quick Facts

Study Start:2022-07-15
Study Completion:2027-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05491941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults \>=18
  2. * Patient meets criteria for time zero (sepsis within 6 hours of ED triage and the 3 criteria-infection, 2 SIRS and 1 or more organ dysfunctions, must be met within 3 hours of each other.
  1. * Last admission for patients admitted to same hospital once
  2. * Pregnant women
  3. * All transfers from another hospital
  4. * Individuals who are made comfort care only within 6 hours of admission to ED
  5. * Moribund patients

Contacts and Locations

Study Contact

Mitchell Levy, MD
CONTACT
401-444-4000
mitchell_levy@brown.edu
Lori Harmon, RRT, MBA, CPHQ
CONTACT
847-493-6403
lharmon@sccm.org

Principal Investigator

Mitchell Levy, MD
PRINCIPAL_INVESTIGATOR
Rhode Island Hospital

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Mitchell Levy, MD, PRINCIPAL_INVESTIGATOR, Rhode Island Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-15
Study Completion Date2027-07-15

Study Record Updates

Study Start Date2022-07-15
Study Completion Date2027-07-15

Terms related to this study

Additional Relevant MeSH Terms

  • Sepsis Severe
  • Septic Shock