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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia; Urinary Tract Infections; Common Infections
• Intervention / Treatment: Other: Antibiotic Use Report

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Louis Stokes VA Medical Center, Cleveland, OH
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• (none)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VAST+; Sites that implement the VAST augmented by quarterly facility-level Antibiotic Use Reports (VAST+).	Other: Antibiotic Use Report; 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.
No Intervention: VAST -; to sites that implement the VAST and do NOT receive a quarterly facility-level Antibiotic Use Reports (VAST-).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of Antibiotic Therapy / 1000 Bed 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, including 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.	2.25 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of broad-spectrum antibiotics	The investigators will specifically examine the rate of broad-spectrum antibiotics, defining broad-spectrum agents as those with an Antibiotic Spectrum Index score of 8. This scale ranges from 1 to 13; the ASIs for penicillin, doxycycline, ciprofloxacin, and ertapenem are 2, 5, 8 and 9, respectively.	2.25 years
Antibiotic Starts	The investigators will measure the rate of antibiotic starts (new prescriptions), calculated as the number of starts per 1000 DOC. The fourth metric is the length of antibiotic therapy in days. For people on hemodialysis, up to 72 hours may occur between doses of specific agents (e.g. vancomycin, aminoglycosides, several cephalosporins); these will be considered as a single course.	2.25 years

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: antimicrobial stewardship; telehealth
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: IIR 20-246; HX003364 (Other Grant/Funding Number: HSR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No