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

July 6, 2026 updated by: Trustees of Dartmouth College

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Hampshire
      • Hanover, New Hampshire, United States, 03755
        • Trustees of Dartmouth College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Surveillance with Technical Assistance
Surveillance 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.
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.
Active Comparator: 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.
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.
Active Comparator: Technical Assistance No Surveillance
TA 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.
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.
Active Comparator: EBIP Coaching No Surveillance
EBIP 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ESKAPE Transmission Events
Time Frame: Peri-operative
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgical Site Infection
Time Frame: 90-day postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trustees of Dartmouth College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mayo Clinic
Georgetown University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeremiah R Brown, PhD, Trustees of Dartmouth College
  • Principal Investigator: Randy Loftus, MD, Mayo Clinic
  • Study Director: Iben Sullivan, PhD, Trustees of Dartmouth College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00032185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

12 months of study ending

IPD Sharing Access Criteria

Follow institutional regulations for access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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