Assessment for Implementation Methods in Sepsis

NCT05491941 | Recruiting DMC

• 1 other identifier: 1R01HL162954-01
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis Severe; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality associated with death from sepsis.

  28 days

Study Arms (2)

Hour-1 Bundle

ACTIVE COMPARATOR

If the patient meets 2+ SIRS and chief complaint criteria, a second BPA may be triggered, which displays to the provider. The second alert identifies patients who progress to organ failure based on lab results, or who have a recorded instance of hypotension. When this alert appears, an automatic counter will begin and serve as our Sepsis Time Zero. The provider will receive sepsis order sets and guided to the Sepsis Navigator. The navigator will allow them to review relevant patient data, reference sepsis guidelines, and keep tabs on a live-updating sepsis checklist to ensure they complete each element in order and on time. Following identification in the ED, both study arms will receive the same bundle (see below). The only difference will be the timing: For the Hour-1 bundle, all interventions in the bundle must be initiated within 1 hour.

Other: Sepsis Bundle

3-Hour Bundle

ACTIVE COMPARATOR

If the patient meets 2+ SIRS and chief complaint criteria, a second BPA may be triggered, which displays to the provider. The second alert identifies patients who progress to organ failure based on lab results, or who have a recorded instance of hypotension. When this alert appears, an automatic counter will begin and serve as our Sepsis Time Zero. The provider will receive sepsis order sets and guided to the Sepsis Navigator. The navigator will allow them to review relevant patient data, reference sepsis guidelines, and keep tabs on a live-updating sepsis checklist to ensure they complete each element in order and on time. Following identification in the ED, both study arms will receive the same bundle (see below). The only difference will be the timing: For the 3-hour bundle, all elements must be completed by 3 hours.

Other: Sepsis Bundle

Interventions

Sepsis Bundle OTHER

Intervention initiated within 1 hour or 3 hours of presentation depending on the Arm: 1. Measure lactate level. 2. Obtain blood cultures before administering antibiotics. 3. Administer broad-spectrum antibiotics. 4. Begin rapid administration of 30ml/kg crystalloid for hypotension or lactate greater than or equal to 4mmol/L. 5. Apply vasopressor if hypotensive during or after fluid resuscitation to maintain a mean arterial pressure greater than or equal to 65 mm Hg.

3-Hour Bundle; Hour-1 Bundle

Eligibility Criteria

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

You may qualify if:

• Adults \>=18
• 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.

You may not qualify if:

• Last admission for patients admitted to same hospital once
• Pregnant women
• All transfers from another hospital
• Individuals who are made comfort care only within 6 hours of admission to ED
• Moribund patients

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

• Frank HE, Evans L, Phillips G, Dellinger R, Goldstein J, Harmon L, Portelli D, Sarani N, Schorr C, Terry KM, Townsend SR, Levy MM. Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial. Trials. 2023 Sep 29;24(1):620. doi: 10.1186/s13063-023-07644-y.

  PMID: 37773067 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Mitchell Levy, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Levy, MD

CONTACT

401-444-4000; mitchell_levy@brown.edu

Lori Harmon, RRT, MBA, CPHQ

CONTACT

847-493-6403; lharmon@sccm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Critical Care Medicine at Lifespan, and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine

Model Details: Hybrid 2 implementation effectiveness trial with a cluster randomized control trial

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)