Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection
BASIC
The BASIC Trial: Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection
1 other identifier
interventional
6,000
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 3, 2025
December 1, 2025
5 years
October 19, 2020
December 2, 2025
Conditions
Keywords
Outcome Measures
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.
Peri-operative
Secondary Outcomes (1)
Surgical Site Infection
90-day postoperative
Study Arms (4)
Surveillance with Technical Assistance
ACTIVE COMPARATORSurveillance will be offered to 3 teams with Technical Assistance (TA) 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.
Surveillance with EBIP Coaching
ACTIVE COMPARATORSurveillance 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.
Technical Assistance No Surveillance
ACTIVE COMPARATORTA will be offered to 3 teams. TA will have monthly scheduled TA calls (60 minutes each) with each team individually to review and discuss the protocol interventions (as is done in the EBIP group) and allow for a consultation with experts on the peri-operative interventions. Surveillance toolkit will only be used for transmission data collection.
EBIP Coaching No Surveillance
ACTIVE COMPARATOREBIP will be offered to 3 teams. Each participating site will receive monthly team-based coaching to establish a multidisciplinary team charged with continuously improving transmission and infection prevention. EBIP involves evidence-based improvements in perioperative hand hygiene, environmental cleaning, vascular care, and patient decolonization. Surveillance toolkit will only be used for transmission data collection.
Interventions
Main comparison in delivering peri-operative preventive strategies against transmission and infection is one on one technical assistance or team-based coaching.
Eligibility Criteria
You may not qualify if:
- patients (125 case pairs) per site in the active phase (N=3,000)
- patients (125 case pairs) per site in the sustainability phase (N=3,000)
- Total N=6,000
- orthopedic total joint and spine procedures
- operating room conducting orthopedic total joint and spine
- Surgeons performing orthopedic total joint or spine
- \- medical centers actively enrolling patients in a bacterial transmission or infection prevention trial
- \- all elective patients undergoing orthopedic total joint and spine
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trustees of Dartmouth Collegelead
- Mayo Cliniccollaborator
- Georgetown Universitycollaborator
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Trustees of Dartmouth College
Hanover, New Hampshire, 03755, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremiah R Brown, PhD
Trustees of Dartmouth College
- PRINCIPAL INVESTIGATOR
Randy Loftus, MD
Mayo Clinic
- STUDY DIRECTOR
Ib en K Sullivan, PhD
Trustees of Dartmouth College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
July 1, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 3, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 12 months of study ending
- Access Criteria
- Follow institutional regulations for access
The investigators agree to follow all applicable NIH policy and guidance on sharing of resources. The hyper resistant and transmissible strains identified during the course of these studies and for the registry period to follow will be made known via publications and will be shared freely with any scientists who request them. The request process will require submission and review of a research proposal for specimen use by the MPIs. In addition to resource sharing, we will provide relevant protocols and other data sets upon request following review. Should any intellectual property arise during the study period which requires a patent, the investigators will ensure that the technology (materials and data) remains widely available to the research community in accordance with the NIH Principles and Guidelines document.