Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection

ConditionInfection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrustees of Dartmouth College

About this trial

Surgical site infections (SSIs) are associated with increased patient morbidity, mortality, and healthcare costs. ESKAPE (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) pathogens are particularly pathogenic because they have increased capacity to acquire resistance and virulence traits. The investigators have proven that a multifaceted program involving improved basic perioperative preventive measures can generate substantial reductions in S. aureus transmission and significant reductions in SSIs (88% reduction as compared to usual care). In this study, the investigators aim to examine the relative effectiveness of each component of this program in controlling ESKAPE transmission and reducing SSIs and to identify an optimal implementation strategy for national dissemination. Randomization occurs at the site level, and sites adopt preventative programs. This work will improve perioperative patient safety for the 51 million patients who undergo surgery each year.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

250 patients (125 case pairs) per site in the active phase (N=3,000)

250 patients (125 case pairs) per site in the sustainability phase (N=3,000)

Total N=6,000

orthopedic total joint and spine procedures

Trial design

Design model

Factorial

Treatments tested in this trial

  • Technical assistance or team-based coaching

    Behavioral

    Main comparison in delivering peri-operative preventive strategies against transmission and infection is one on one technical assistance or team-based coaching.

Treatment groups

6,000 Participants
are divided into 4 treatment groups
Group A: Surveillance with Technical AssistanceActive comparator 1 intervention
Group B: Surveillance with EBIP CoachingActive comparator 1 intervention
Group C: Technical Assistance No SurveillanceActive comparator 1 intervention
Group D: EBIP Coaching No SurveillanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ESKAPE Transmission Events

One or more epidemiologically related ESKAPE pathogen transmission events (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, Enterobacter spp.) occurring in a perioperative observational unit. ESKAPE transmission will be defined as ≥ 2 ESKAPE isolates of the same class obtained from ≥ 2 distinct, temporally-associated reservoirs and/or the isolation of ≥ 1 ESKAPE pathogen from a reservoir at case end that was not present at case start, a definition tightly associated with SSI.

Time frame
Peri-operative

Secondary outcomes

1

Surgical Site Infection

90 postoperative day SSIs according to the NHSN SSI checklist. SSI tracking will initially involve chart review for fever, leukocytosis, culture (type/source), anti-infective order, office documentation of infection, and up to 3 calls in the 90-day postoperative period. If 1 or more of the 5 criteria are flagged and/or documentation by phone call as recorded in the microEMR, the site PI reviews the information and applies to NHSN checklist criteria for SSIs. Superficial incisional, deep incisional, and organ/space SSIs will be tracked. Information will be compiled in a separate spreadsheet without treatment group identifiers for blinded review.

Time frame
90-day postoperative

Other outcomes

Sponsors and contacts

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Trustees of Dartmouth College

Lead sponsor

Mayo Clinic

Collaborator

Georgetown University

Collaborator