Clinical trial NCT05319561: Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team
Official title: Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team (VAST)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Common Infections
Urinary Tract Infections
Pneumonia
Keywords: antimicrobial stewardship
telehealth
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-04-08
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* (none)

Primary outcomes:
measure: Days of Antibiotic Therapy / 1000 Bed Days of Care
timeFrame: 2.25 years
Secondary outcomes:
measure: Rate of broad-spectrum antibiotics
timeFrame: 2.25 years
measure: Antibiotic Starts
timeFrame: 2.25 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Robin Lynn Paige Jump, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Charlesnika Tyon Evans, PhD MPH BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.