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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.

Age: 18Years +All Genders
2284 locations
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Actively Recruiting

Pain is a common issue among older adults living with dementia in nursing homes, often going unassessed and untreated, which can lead to lower quality of life and increased behavioral symptoms. This research evaluates the effectiveness of 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 in nursing home residents with dementia. The study also explores differences in pain treatment and response between male and female residents and between Black and White residents to address health equity. The study includes 12 nursing home communities, each recruiting 25 residents with dementia experiencing pain. Six communities receive the PAIN-CPG-EIT intervention, where a research nurse facilitator works with a stakeholder team and community champions over 12 months, providing monthly meetings, staff education, mentoring, motivation, and ongoing pain outcome evaluation. The other six communities receive only education similar to the PAIN-CPG-EIT education component, delivered in various formats based on community preference. Participants will undergo pain assessments at baseline, four months, and twelve months. Researchers will monitor pain management practices, including appropriate opioid use, and assess treatment fidelity by tracking delivery, receipt, and enactment of the intervention. The study will help improve pain care for older adults with dementia in nursing homes and provide insights into treatment differences across gender and race, contributing to better health equity.

Age: 60Years +All GendersPhase 2
11 locations
Medical trials in Havre de Grace | DecenTrialz