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AIMS Study

Determine the safest, most effective approach to sepsis intervention.

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The Assessment of Implementation of Methods in Sepsis and Respiratory Failure (AIMS) study seeks to determine the safest and most effective approach to sepsis intervention using the evidence-based Surviving Sepsis Campaign guidelines. The five-year prospective multicenter study is being funded by a $3.2 million grant from the National Heart, Lung, and Blood Institute to Rhode Island Hospital in Providence, Rhode Island. The Society of Critical Care Medicine (SCCM) serves as the data and clinical coordinating center for the study.

The goal of the AIMS study is to determine whether the Hour-1 or 3-Hour Bundle is most effective when implemented in emergency departments. The AIMS study compares both bundles head to head for the first time since they were developed by the SSC. The study is being conducted at 18 U.S. hospitals, including both community and academic hospitals. It will ultimately include about 10,000 patients eligible for sepsis care who will receive either the Hour-1 or 3-Hour Bundle.

The steps of the 3-Hour Bundle should be completed within three hours. The steps of the Hour-1 Bundle should be started within the first hour. While the Hour-1 Bundle has been adopted by some hospitals, the 3-Hour Bundle is the current standard of care in the United States and is mandated by the Centers for Medicaid and Medicare.

The National Institutes of Health funding is a T3 translational research grant, which seeks to ensure that evidence-based interventions and treatments are delivered effectively. Staff in both the Hour-1 and 3-Hour Bundle arms will be trained in techniques for enhancing integration of either bundle into practice by implementation scientists from Brown University.

The study’s primary outcome is hospital mortality. Secondary outcomes include:

  • Respiratory failure
  • Need for mechanical ventilation
  • Hospital length of study
  • Discharge status (e.g., to home, rehabilitation, or skilled nursing facility)
  • Which bundle is most appropriate for various phenotypes
Mitchell M. Levy, MD, MCCM

Mitchell M. Levy, MD, MCCM

Principal Investigator

Professor of Medicine
System-wide Director, Critical Care, Lifespan Systems
Rhode Island Hospital
Providence, Rhode Island

Project Manager: Lori Harmon, RRT, MBA, CPHQ
Data Managers: Karen Boman and Humera Moulvi

Assessment of Implementation Methods in Sepsis and Respiratory Failure: Study Protocol for a Cluster-Randomized Hybrid Type 2 Trial

September 29, 2023
A recent article published in Trials outlined the Assessment of Implementation Methods in Sepsis and Respiratory Failure (AIMS) study, a cluster-randomized trial of 18 emergency departments in the United States comparing the Surviving Sepsis Campaign Hour-1 and 3-Hour bundles. The trial, funded by the National Heart, Lung, and Blood Institute, is now in year two and entering the implementation phase. The Society of Critical Care Medicine (SCCM) is serving as the clinical and data coordinating centers. It is anticipated that results will be published in 2027.

Additional Resources

SCCM Pod-489: The AIMS Trial: Battle of the Bundles, Hour-1 Versus 3-Hour

Podcast

SCCM Pod-489: The AIMS Trial: Battle of the Bundles, Hour-1 Versus 3-Hour

The Assessment of Implementation of Methods in Sepsis and Respiratory Failure (AIMS) Study seeks to determine the safest and most effective approach to sepsis intervention using the evidence-based Sur...

NIH Funds SCCM Discovery Study on the Use of Sepsis Bundles in the Emergency Department

Blog

NIH Funds SCCM Discovery Study on the Use of Sepsis Bundles in the Emergency Department

In funding a five-year prospective multicenter study to determine the safest and most effective approach to sepsis intervention, the National Heart, Lung, and Blood Institute (NHLBI) is recognizing th...

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