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Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Pain is a frequent issue affecting 30% to 80% of older adults living with dementia in nursing homes, yet it is often not properly assessed or treated. Untreated or over-treated pain can worsen quality of life, function, sleep, and behavior. This trial evaluates a new approach called PAIN-CPG-EIT, which combines a Pain Management Clinical Practice Guideline with a theory-based method to improve pain assessment, diagnosis, and management among nursing home residents with dementia. The study also examines differences in pain treatment and outcomes by sexgender and race. The PAIN-CPG-EIT intervention involves a research nurse facilitator working with community champions and stakeholder teams for 12 months. This includes monthly stakeholder meetings, staff education on pain management, mentoring and motivating staff to address pain, and ongoing monitoring of pain outcomes. Twelve nursing home communities are randomized to receive either PAIN-CPG-EIT or Education Only, where staff receive the same educational component without the additional mentoring and monitoring. Participants include nursing home residents living with dementia and pain. Researchers will collect pain assessments at baseline, 4 months, and 12 months, along with monitoring pain management plans and opioid use. The study measures treatment fidelity and evaluates pain using tools like the Pain in Alzheimers Disease PAIN-AD scale. The trial aims to improve pain care, understand health disparities, and enhance equity among older adults with dementia. The study is expected to continue until the end of 2028.