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Common InfectionsVASTNCT05319561

Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team

A study testing Antibiotic Use Report in people with Common Infections and Urinary Tract Infections, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
Antibiotic Use Report
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesUnited States
Study dates
28 Mar 2022to 31 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • (none)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Antibiotic Use Report
Keywords
antimicrobial stewardship, telehealth
Medical subject headings
Urinary Tract Infections, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antibiotic Use ReportOther

    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.

Study groups in NCT05319561
Study groupRoleWhat they receive
VAST+ExperimentalSites are rural VA Medical Centers that work with an ID physician at different VA to conduct regular discussions about infectious diseases and antimicrobial use for Veterans receiving care at the rural VAMC. These dyads formed the Videoconference Antimicrobial Stewardship Teams or VASTs. VAST+ sites received a brief (2 page) Antibiotic Use Report that described summarized the antibiotic use at the rural VAMC acute care and CLC over the previous month, including a comparison to the average antibiotic use among other rural VAMCs in the same Medical Complexity Group. The Antibiotic Use Reports were distributed quarterly during the intervention period.
Receives: Other: Antibiotic Use Report
VAST -No interventionSites are rural VA Medical Centers that work with an ID physician at different VA to conduct regular discussions about infectious diseases and antimicrobial use for Veterans receiving care at the rural VAMC. These dyads formed the Videoconference Antimicrobial Stewardship Teams or VASTs. VAST- sites received no additional information about antibiotic use at their rural VAMC.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days of Antibiotic Therapy Per 1000 Days of Care

    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.

    Measured: 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.

Secondary outcomes (2)
  1. Days of Broad-spectrum Antibiotic Therapy Per 1000 Bed Days of Care

    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.

    Measured: 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.

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

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start28 Mar 2022
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Practical, Robust Implementation and Sustainability Model (PRISM) is an expansion of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model. Briefly, PRISM expands RE-AIM to further consider key contextual factors related to implementation, evaluation and dissemination of health services programs. The investigators will use PRISM and RE-AIM to inform implementation, evaluation and maintenance of the intervention as the investigators seek to disseminate the VAST beyond the 2 pilot sites
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05319561
Sponsor's protocol ID
IIR 20-246
Other IDs
HX003364
Acronym
VAST
Status last verified
Apr 2026
First submitted
31 Mar 2022
Last updated
1 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Final data sets underlying all publications resulting from the proposed research will not be shared outside VA, except as required under the Freedom of Information Act (FOIA). Reasons for this are (i) the sample size will be too large to obtain informed consents and HIPAA authorizations and (ii) public disclosure of the final study data containing protected health information (PHI) is inconsistent with the IRB approved waiver of informed consent and waiver of HIPAA authorization that will be sought.

Publications

  • Fabre V, Davis A, Diekema DJ, Granwehr B, Hayden MK, Lowe CF, Pfeiffer CD, Sick-Samuels AC, Sullivan KV, Van Schooneveld TC, Morgan DJ. Principles of diagnostic stewardship: A practical guide from the Society for Healthcare Epidemiology of America Diagnostic Stewardship Task Force. Infect Control Hosp Epidemiol. 2023 Feb;44(2):178-185. doi: 10.1017/ice.2023.5.

    PubMed 36786646
  • Jump RLP, Bej TA, Vivo A, Wilson BM, Kowal C, Song S, Abdelrahim S, Wilson G, Milner A, Nguyen A, Rodriguez KL, Beyer N, Michaels Z, Amundson C, Bajema KL, Beck A, Burnham JP, Crnich CJ, Drekonja DM, Epstein L, Ewers T, Livorsi DJ, Narayan M, Perez F, Pfeiffer CD, Sabzwari RW, Salti AM, Tate D, Walkner T, Webster AS, Evans CT. Dissemination and Implementation of a Telehealth-Enabled Program for Providing Infectious Disease Expertise in Rural Settings. Open Forum Infect Dis. 2025 Aug 11;12(8):ofaf485. doi: 10.1093/ofid/ofaf485. eCollection 2025 Aug.

    PubMed 40860515

Questions about this trial

What is this clinical trial studying?

A study testing Antibiotic Use Report in people with Common Infections and Urinary Tract Infections, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05319561, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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