R01AI155752

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

We propose to establish a best practice for implementation of a multifaceted approach designed to attenuate perioperative ESKAPE (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, Enterobacter spp.) transmission and associated surgical site infection (SSI) development.

Perioperative ESKAPE transmission (inoculum) contributes to the development of surgical site infections (SSIs) which affect 3-5% of patients undergoing surgery. SSIs increase patient morbidity, prolong hospitalization, increase the risk of intensive care unit admission, and increase the risk of death 2-fold. ESKAPE pathogens are particularly problematic.

Sustained reductions in epidemiologically-related, perioperative S. aureus transmission events achieved via a multifaceted approach including surveillance feedback optimization resulted in substantial SSI reductions (88% decrease). An evidence-based approach for attenuation of the perioperative bacterial inoculum must integrate improvements in provider hand hygiene, intravascular catheter design/handling, environmental cleaning/organization, and patient decolonization.

In this application, we propose a type 1 hybrid effectiveness-implementation using a 2x2 factorial cluster-randomized design guided by RE-AIM. We aim to identify a best practice for addressing the perioperative ESKAPE inoculum. We will examine the relative effectiveness of increased site awareness and commitment to generating improvements via technical assistance (TA), team coaching implementation of an evidence-based set of interventions (EBIP), and TA or EBIP with ESKAPE transmission surveillance feedback.

Our strong preliminary data from a randomized trial implementing a multifaceted program with surveillance has demonstrated substantial and statistically significant reductions in transmission of S. aureus and 90-day SSIs and recently reproduced our randomized trial findings in an additional external site. Therefore, our prior research strongly suggests that the proposed research should be done and justifies scaling up to dissemination and implementation.

Our exceptional multidisciplinary team is well equipped to successfully complete the proposed trial and aims. In the proposed trial guided by RE-AIM, we will advance scientific knowledge and inform future dissemination and implementation by investigating how best to scale-up an already successful multifaceted approach to national dissemination through either TA or EBIP with or without surveillance. We will conduct a rigorous cost-effectiveness analysis including evaluation of net cost savings.

The proposed trial guided by RE-AIM (Aim 1), the addition of 1-year follow-up for sustainability (Aim 2), and cost-effectiveness analysis (Aim 3) will provide the essential scientific knowledge to adopters and organizers to be able to reproduce the most effective delivery method of our interventions to their local setting in addition to informing our investigative team which approach to scale-up to reach national dissemination.

Trustees Of Dartmouth College

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Hanover, New Hampshire 037551421 United States

Single Zip Code

Dissemination and Implementation Research in Health (R01 Clinical Trial Optional) (PAR-19-274)

Amendment Since initial award the total obligations have increased 375% from $843,141 to $4,005,071.