La Plata

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating two new clinical decision support tools designed to predict the risk of sepsis and patient deterioration within four hours in hospitalized adult patients. The study aims to improve healthcare providers awareness of these risks by introducing the SEPSys Score for sepsis prediction and the RESCUE Score for deterioration prediction. This trial is a multi-site, cluster-randomized, factorial stepped-wedge pragmatic clinical trial conducted within the University of Maryland Medical System. The study involves hospitals transitioning through different phases where initially no risk scores are available, then one risk score either SEPSys or RESCUE is visible to clinicians, followed by both scores being available. These scores produce color-coded risk levels from 1 to 4, with higher numbers indicating greater risk. Clinicians use their judgment to recommend treatments and care plans regardless of the availability of the scores. Participants are hospitalized adults in inpatient units of member hospitals who meet specific criteria for score calculation. The study measures the time from an elevated risk score to the recording of vital signs, aiming to assess increased clinical awareness. Other assessments include sepsis diagnosis, treatment timing, deterioration events, and laboratory order frequency. Data collection occurs continually during hospital stays, with an average duration of about five days.