NCT05319561

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

March 31, 2022

Results QC Date

March 4, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

antimicrobial stewardshiptelehealth

Outcome Measures

Primary Outcomes (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.

    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)

  • Days of Broad-spectrum Antibiotic Therapy Per 1000 Bed Days of Care

    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 Starts (New Prescriptions)/1000 Bed Days of Care

    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.

Study Arms (2)

VAST+

EXPERIMENTAL

Sites 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.

Other: Antibiotic Use Report

VAST -

NO INTERVENTION

Sites 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.

Interventions

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.

VAST+

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • (none)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (2)

  • 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.

    PMID: 36786646BACKGROUND
  • 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.

MeSH Terms

Conditions

Urinary Tract InfectionsPneumonia

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Not all the VASTs were robust or sustained. In general, those with a higher volume of consults tended to continue, sometimes connecting with an ID expert within the same VISN. Those with fewer cases may not have had sufficient volume to sustain engagement or did not cultivate the informal professional relationships that often facilitate trust and open communication. We elected to defer assessment of VAST on overall antibiotic use pending analysis of data from the sustainment period.

Results Point of Contact

Title
Robin L. P. Jump, MD, PhD
Organization
VA Pittsburgh Healthcare System

Study Officials

  • Robin Lynn Paige Jump, MD PhD

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR
  • Charlesnika Tyon Evans, PhD MPH BS

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 8, 2022

Study Start

March 28, 2022

Primary Completion

March 31, 2025

Study Completion

March 31, 2026

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations