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Completed

NCT Number: NCT05319561

Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team

Antimicrobial-resistant and healthcare-associated pathogens are a global health threat. The goals of antimicrobial stewardship are to minimize unnecessary and inappropriate antimicrobial use as a means to combat antimicrobial resistance. Previously, the investigators implemented a Videoconference Antimicrobial Stewardship Team (VAST) at 2 VA Medical Centers (VAMCs), using telehealth to connect clinicians at a rural VAMC to a geographically distant infectious disease expert Both VASTs successfully decreased overall antibiotic use in acute and long-term care units. This project will expand the VAST approach to other VAMCs and test the hypothesis that quarterly reports that quantify facility-level antibiotic use will enhance the efficacy of VASTs to support antimicrobial stewardship. This work will directly increase access to antimicrobial stewardship consultation at rural VA facilities, which are often underserved by infectious disease expertise.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States

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About this study

Background: Antimicrobial stewardship guidelines call for a multidisciplinary team with an infectious disease (ID) physician and ID-trained clinical pharmacist as core members. Unfortunately, there are insufficient ID-trained specialists to staff on-site antimicrobial stewardship programs throughout VA.

Significance: This proposal is highly significant for Veterans and the goals of VA. Veterans experience many of the risk factors associated with development of antimicrobial resistant and healthcare-associated infections. The unprecedented effects of the novel Coronavirus disease 2019 (COVID-19) on the health of Veterans and on the entire healthcare system makes the demand for ID expertise even more apparent, especially in long-term care. Also, this study directly addresses the VA MISSION ACT to improve access to care, timeliness and quality of care, using telehealth services. Finally, this project is aligned with the priorities of operation partners: VA Antimicrobial Stewardship Taskforce (ASTF), the VA National Infectious Disease Service (NIDS), VA Pharmacy Benefits Management (PBM) Services, and the Office of Rural Health.

Innovation and Impact: The design is innovative because the investigators will systematically test and assess implementation barriers to telehealth for antimicrobial stewardship, a novel approach that has not been implemented in VA facilities, other than in the investigators' previous pilot study. Further, the Antibiotic Use Reports (AURs) are an innovative adaptation of peer-comparison, an antibiotic stewardship strategy successful in outpatient settings. This project will provide findings for a scalable model that could be deployed nationally to all applicable VAMCs, continuing the role of VHA as a leader in implementing large-scale interventions focused on prevention and management of ID and stewardship.

Specific Aims: The goal is to implement a multidisciplinary videoconference antimicrobial stewardship team (VAST) in VAMCs using SCAN-ECHO. The central hypothesis is that feedback reports that quantify facility-level antibiotic use will enhance the efficacy of VASTs to support antimicrobial stewardship. The investigators propose a Type 2 hybrid effectiveness-implementation design, comparing clinical effectiveness in sites that implement the VAST alone (VAST-) to sites that implement the VAST augmented by facility-level Antibiotic Use Reports (VAST+). Aims are: 1) Identify and test effective strategies for implementing the VAST; 2) Determine the influence of the VAST overall and VAST+ on the care of Veterans with suspected infections; 3) Determine the influence of the VAST overall and VAST+ on antibiotic use at each VAMC.

Methodology: The investigators will randomize rural VAMCs that do not have ID-trained professionals on staff to implement the VAST alone (VAST-) versus VAST + antibiotic use feedback (VAST+). Aim 1: The investigators will assess modification and adaptations at the intervention sites and by the infectious disease experts. Methods will include process maps and semi-structured interviews to gather qualitative data about what key VAST members perceive as facilitators, barriers and burden to VAST implementation. The investigators will also evaluate costs of implementation. Aim 2: The investigators will evaluate the Veteran population served, clinical activities, and user perceptions of the VAST. The investigators will assess the concordance of clinical care with recommendations from evidence-based clinical practice guidelines. VAST members' perceptions of the quality and timeliness of care will be evaluated. Aim 3: The primary outcome measure will be overall rates of antibiotic use. Secondary outcomes will be changes in the rates of broad-spectrum antibiotic use, antibiotic starts, and length of antibiotic therapy.

Next steps/Implementation: Testing effective implementation of the VAST at additional VAMCs is an important step toward augmenting antimicrobial stewardship in both acute- and long-term care settings. In collaboration with VA clinical operation partners, outcomes from this trial will be used to roll-out an implementation playbook to be used by other VAMCs, as well as non-VA settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • VA medical centers without local ID expertise that pair with an ID-expert from another VA medical center.

Exclusion criteria

  • (none)

Treatment and study plan

Antibiotic Use Report

Other

The Antibiotic Use Report uses both text and graphics to communicate successes and improvement opportunities specific to the VAMC for which it is prepared. The graphs summarize overall antibiotic use over the previous year, with additional information regarding use of broad- and narrow-spectrum agents. Further, each Antibiotic Use Report compares or "benchmarks" the individual VAMC for which it is prepared to other VAMCs in the same Medical Complexity Group. This approach adapts and expands peer comparison, which has proven effective at reducing inappropriate antibiotic use in outpatient settings.

Primary outcomes

  1. Days of Antibiotic Therapy Per 1000 Days of Care

    Time frame: The study period was 15 months following each the first meeting held by each VAST. The first 3 months were considered a wash-in period. Data analysis focused on the subsequent 12 month period.

    Days of antibiotic therapy per 1000 days of care (DOT/1000 DOC) measures the overall rate of antibiotic use and is a common metric that accounts for dose adjustments, such as for people who receive dialysis. Administration of any dose of an antimicrobial on a given day represents a single DOT for that agent, regardless of the number of times the doses are administered or the dose strength. This metric gauges overall antibiotic use, capturing both the number of prescriptions as well as the length of prescriptions issued. It also helps benchmark use across facilities, tracks prescribing trends, and assesses the impact of stewardship efforts.

Secondary outcomes

  1. Days of Broad-spectrum Antibiotic Therapy Per 1000 Bed Days of Care

    Time frame: The study period was 15 months following each the first meeting held by each VAST. The first 3 months were considered a wash-in period. Data analysis focused on the subsequent 12 month period.

    Antibiotic Spectrum Index (ASI) scores range from 1 (narrowest spectrum) to 13 (broadest spectrum). As an example, the ASI scores for penicillin, doxycycline, ciprofloxacin, and ertapenem are 2, 5, 8 and 9, respectively. Broad-spectrum was defined as an ASI of ≥8. The rate of broad-spectrum antibiotic use is determined as the days of broad-spectrum antibiotic therapy per 1000 bed days of care. When compared to overall antibiotic use, this metric helps assess the proportion of antibiotic use comprised by broad-spectrum agents. Normalizing to 1000 bed days of care helps benchmark use across facilities, tracks prescribing trends, and assesses the impact of stewardship efforts.

  2. Antibiotic Starts (New Prescriptions)/1000 Bed Days of Care

    Time frame: The study period was 15 months following each the first meeting held by each VAST. The first 3 months were considered a wash-in period. Data analysis focused on the subsequent 12 month period.

    An antibiotic start is recorded whenever a patient is newly prescribed an antibiotic. The rate of antibiotic starts is determined as the Number of Antibiotic Starts per 1000 Bed Days of Care. This metric gauges overall antibiotic prescribing frequency, helps benchmark use across facilities, tracks prescribing trends, and assesses the impact of stewardship efforts.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team (VAST)

Acronym: VAST

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 8, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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