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Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating a stepped care approach called STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) to reduce suicide risk among youth aged 12 to 17 years who receive pediatric primary care. Suicide is a leading cause of death in this age group, and many at-risk youth are not identified or treated. This five-year study tests the effectiveness of STARRS-PC compared to usual care (treatment as usual, TAU) across 14 pediatric primary care clinics. The study also examines factors affecting the implementation and sustainability of this suicide prevention approach using the Practical, Robust Implementation, and Sustainability Model (PRISM).