Ashtabula

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 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 receiving primary care. This study aims to compare the effectiveness of STARRS-PC against usual treatment TAU in lowering suicide attempts, suicidal thoughts, and self-injury over a 12-month period. The study also explores factors that affect how well the clinical pathway can be put into practice and sustained in primary care settings. The study is conducted over five years at 14 pediatric primary care clinics. It includes three phases treatment as usual TAU, intervention, and sustainability. During TAU, usual depression and suicide risk screening is performed. In the intervention phase, STARRS-PC is implemented, which involves universal suicide risk screening with a brief questionnaire, followed by a detailed risk assessment and care decisions based on risk level. Providers receive training and participate in interviews to identify challenges and supports for implementing the clinical care pathway. The final sustainability phase focuses on maintaining improvements without enrolling new participants. Participants include 2,572 adolescents identified at risk for suicide along with their parents or guardians. They complete interviews and questionnaires at baseline, 3, 6, and 12 months. Medical records are reviewed throughout the study. Youth outcomes measured include suicide attempts, suicidal thoughts, and non-suicidal self-injury, while family satisfaction is also assessed. Providers are evaluated on knowledge and attitudes about suicide risk management. The study includes ongoing monitoring, data collection, and a 6-month follow-up after the intervention phase for sustainability analysis.