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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The 'Bekele Afessa Scan-Teach-Treat Approach'

NCT02697513

Infection Sepsis

UNKNOWN NA

Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes

NCT01562769

Patients Hospitalized in Infectious Disease

TERMINATED

Reducing Intraoperative Infection Transmission in the Pediatric Operating Room

NCT03992209

Health Care Associated Infection Hand Hygiene

COMPLETED NA

Effect of Daily Chlorhexidine Bathing and Antibiotic/PPI Stewardship on Prevention of CPE Transmission and Infection

NCT07039955

Carbapenemase-Producing Enterobacteriaceae (CPE) Healthcare-Associated Infections (HAIs)

ENROLLING_BY_INVITATION NA

Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.

NCT00151606

Nosocomial Infections MRSA Colonization

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators propose to test the implementation of a multifaceted, evidence-based, peri-operative surgical site infection (SSI) preventive program that leverages basic preventive measures optimized by pathogen cluster detection software (surveillance) to reduce ESKAPE (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission and SSIs. SSIs increase patient morbidity, prolong hospitalization, and increase the risk of death. ESKAPE pathogens are particularly problematic because they have increased capacity to acquire resistance and virulence traits. For example, S. aureus explains a significant proportion of SSIs. S. aureus transmission can be detected in 39% of surgical cases, has been directly linked to up to 50% of S. aureus SSIs by single nucleotide variant analysis, and is tightly associated with SSI development across a variety of surgical specialties. The isolation of ≥ 1 KAPE isolate from ≥ 1 intraoperative reservoir is associated with increased risk of infection development. The investigators have proven that improvements in basic perioperative preventive measures can generate substantial and sustained reductions in perioperative S. aureus transmission and SSIs, with the magnitude of the effect exceeding that of SSI preventive efforts focused on host optimization and inhibition of bacterial virulence strategies, the status quo. However, perioperative application of these basic preventive measures has been inconsistent, and some evidence suggests that S. aureus explains 20% of SSIs. Thus, there remains room for further advancement in perioperative infection control by addressing other ESKAPE organisms and by delineating an implementation approach that will yield effective, national dissemination of these proven measures. The investigators planned approach to address these pathogens mirrors our approach for perioperative S. aureus control, integrating evidence-based provider hand hygiene, intravascular catheter design/handling, environmental cleaning/organization, and patient decolonization improvement strategies with surveillance. The investigators surveillance approach maps the epidemiology of transmission of each pathogen, identifying for example, reservoirs of origin that become improvement targets for sustainability. While this approach is proven effective in preventing perioperative S. aureus transmission and SSIs, the relative effectiveness of the various components of the multi-faceted approach in reducing ESKAPE transmission and associated SSIs, as well as an effective national dissemination strategy, remain unknown. Therefore, the overall objectives for this study are to examine the relative effectiveness of each programmatic component in controlling ESKAPE spread and associated SSIs and to identify the best approach for national dissemination of this technology. The investigators will use a cluster-randomized design to evaluate the implementation and sustainability of each approach guided by RE-AIM framework. More broadly, these findings will be relevant to supporting hospital's implementation of a wide array of preventive interventions and has potential for vastly improving patient care and outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 Factorial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surveillance with EBIP Coaching

Surveillance will be offered to 3 teams with Evidence-Based Infection Prevention Bundle (EBIP) coaching in block randomization. Surveillance tool will execute regularly updated reports (continually updated with laboratory data entry of ESKAPE pathogen isolation results), which generates a set of data that will populate series of tables and graphs for each site based on data collection form as previously reported. EBIP involves evidence-based improvements in perioperative hand hygiene, environmental cleaning, vascular care, and patient decolonization. Each participating site will receive monthly team-based coaching to establish a multidisciplinary team charged with continuously improving transmission and infection prevention.

Group Type ACTIVE_COMPARATOR