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

Infection Clinical Trial

— BASIC  

Official title:

The BASIC Trial: Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600973
• Other study ID #: STUDY00032185
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Trustees of Dartmouth College
• Contact: Jeremiah R Brown, PhD
• Phone: 603-646-5409
• Email: jbrown[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Site Inclusion and Exclusion Criteria.

• 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

Site Inclusion Criteria:

• operating room conducting orthopedic total joint and spine

• Surgeons performing orthopedic total joint or spine

Site Exclusion Criteria:

• medical centers actively enrolling patients in a bacterial transmission or infection prevention trial

Patient Inclusion Criteria:

• all elective patients undergoing orthopedic total joint and spine

Exclusion Criteria:

• no requirement for anesthesia and/or placement of a peripheral intravenous catheter

• lack of incision or informed, written consent

• an allergy to chlorhexidine

• povidone iodine or isopropyl alcohol

• ASA health classification status>5

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections

Intervention

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

Locations

Country	Name	City	State
United States	Trustees of Dartmouth College	Hanover	New Hampshire
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Trustees of Dartmouth College	Georgetown University, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Peri-operative
Secondary	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.	90-day postoperative