VAST: Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05319561

Collaborator

(none)

Enrollment

Locations

Arms

48.1

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Infections Urinary Tract Infections Pneumonia	Other: Antibiotic Use Report	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 sitesThe 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)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

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-).

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-).

Outcome Measures

Primary Outcome Measures

Days of Antibiotic Therapy / 1000 Bed Days of Care [2.25 years]
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.

Secondary Outcome Measures

Rate of broad-spectrum antibiotics [2.25 years]
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.
Antibiotic Starts [2.25 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

(none)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio	United States	44106
2	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240