PIVO-ED: Protocol for Intermountain Venous Access Optimization for Blood Cultures in the Emergency Department

This prospective implementation and efficacy study will be conducted with primary implementation at three Intermountain Health emergency departments: Park City Hospital (Park City, Utah), Primary Children's Hospital (Salt Lake City, Utah), and Utah Valley Hospital (Provo, Utah). These three sites have a combined annual emergency department visit volume exceeding 100,000 visits, ensuring a robust implementation setting for the evaluation of blood culture practices. The investigators will seek to expand the protocol to three secondary sites, pending the results of the initial data regarding blood culture contamination rates from the primary sites. These secondary sites include the emergency departments at Intermountain Medical Center (Murray, Utah). LDS Hospital (Salt Lake City, Utah), and McKay-Dee Hospital (Ogden Utah). These sites have combined annual emergency department volumes exceeding 150,000 patients per year.

The study will launch on October 1, 2025, following the system-wide Epic EHR deployment in September 2025. During October, each ED will undergo a structured training program for clinical staff, including ED nurses, physicians, and phlebotomists. This training will focus on the indications for PIVO use, technical instructions, workflow integration, and documentation standards within Epic. After training, the PIVO protocol will be implemented for a total study duration of 13 months, with data collection occurring between November 2025 and October 2026. The investigators will perform interim analyses at three, six, and nine months to assess PIVO utilization and any need for site-specific re-training, feedback, and intervention. The study team will perform a REDCap-based survey of relevant practitioners (phlebotomists, laboratory technicians, and nurses) who have utilized the device at ten months to assess their comfort with use and willingness to recommend the device. All individuals who have performed at least one blood culture draw utilizing the PIVO will be eligible to participate. The study team will distribute the survey link through site clinical leaders to relevant groups who perform these draws, and they will be asked to participate if they have utilized the PIVO. Investigators will obtain informed consent for participation per Intermountain IRB procedures.

After the review of blood culture results and contamination rates at three months, as well as feedback from the primary site clinical leaders regarding the efficacy and ease of use of the PIVO, the study team will work with clinical leaders at the secondary sites of Intermountain Medical Center, LDS Hospital, and McKay-Dee Hospital to expand the protocol to these emergency departments. Currently, Intermountain Medical Center and LDS Hospital do not utilize the PIVO; the team will provide training and take necessary steps for implementation pending approval from clinical leaders within these sites. McKay-Dee Hospital is currently using the PIVO but will also likely require training specific to its use within this protocol in the emergency department setting. The investigators will aim to have implementation of the protocol within these sites at the six-month mark with ongoing data collection related to blood culture contamination rates across all sites over the entire study period.

Based on historical data and protocol-defined inclusion criteria, the investigators estimate that approximately 5,000 total blood cultures will be collected across the three primary EDs during the one-year study period. Pending adoption of the protocol at the secondary sites, the team would anticipate an additional 5,000 total blood cultures performed in these emergency departments over six months. The investigators anticipate that approximately 40% (4,000 blood cultures) will involve the PIVO device. The remaining 6,000 cultures will be collected via standard venipuncture practices. The investigators expect that for the large majority of the cultures obtained with the PIVO device, patients will have also had a blood culture performed using standard procedures.

The PIVO utilization protocol involves three scenarios. In all three scenarios, blood culture draws using PIVO will occur within 24 hours of IV placement, which is in line with the FDA approval for this indication and per guidance from the manufacturer (BD) regarding this approval.