La Plata

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating two new risk scores designed to predict a patient's risk over the next four hours: one for developing sepsis and one for clinical deterioration events such as cardiac arrest, death, unplanned ICU transfer, or rapid response team calls. The study aims to improve healthcare providers' awareness of these risks by showing these scores, hoping this will lead to quicker vital sign monitoring. The trial is a multi-site, cluster-randomized, stepped-wedge study conducted at the University of Maryland Medical System. The study involves hospitals transitioning in phases from having no risk scores visible, to having one of the two risk scores (SEPSys or RESCUE) visible, and finally to having both scores available for inpatient care. Each score produces a 1-4 color-coded risk level, where 4 indicates the highest risk. Providers will see these scores but will continue to manage patient care using their own judgment, without any mandated treatment changes from the study. Participants are adult inpatients in participating hospital units who meet specific criteria for score availability. Researchers will track the time from when a patient’s risk score rises to when vital signs like heart rate and blood pressure are measured, reflecting provider awareness. Monitoring will continue throughout hospitalization, up to 24 hours after risk elevation, to assess if displaying the scores leads to faster patient monitoring and potentially closer care.