Shrewsbury

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.

Mental health conditions during pregnancy and up to one year postpartum affect about one in five individuals, making them a leading cause of death in this period in the United States. This research aims to compare two approaches to improving care for mood and anxiety disorders among pregnant and postpartum individuals. The study involves 32 perinatal care settings across the U.S. to determine whether healthcare systems should invest in a healthcare-only model or a combined healthcare-community partnership model for mental health care during the perinatal period. The study compares two approaches the healthcare system-focused approach, which integrates screening, assessment, and treatment of mood and anxiety disorders into prenatal and postpartum care through the Program in Support of Moms PRISM, and the healthcare-community partnership approach, which adds Postpartum Support International PSI Peer Support to the PRISM model. The PSI Peer Support pairs individuals with trained volunteers who have experienced and recovered from perinatal mood and anxiety disorders. Both models will be implemented in perinatal care settings, with half assigned to each approach. Participants will be pregnant or postpartum individuals receiving care at the study sites, along with care providers and peer mentors. Researchers will review patient charts to assess treatment initiation and symptom changes in depression and anxiety using recognized scales such as the Edinburgh Postnatal Depression Scale and Patient Health Questionnaire. The study also examines the implementation of mental health screening and support services, professional and mentor experiences, and racial bias and burnout through surveys. The study includes ongoing engagement with advisory councils to gather feedback and identify factors influencing broader adoption of these approaches. The study runs through 2030 with assessments up to 13 months postpartum.

Researchers are evaluating DeafMET, a specially adapted version of Motivational Enhancement Therapy MET designed for Deaf adults who have high-risk alcohol use. This pilot study addresses the unique challenges faced by Deaf individuals, such as limited English literacy and lack of accessible behavioral health resources, by creating materials and sessions tailored to American Sign Language ASL users. The study aims to assess the feasibility, acceptability, and initial effects of DeafMET in motivating change around alcohol use. Participants will receive the DeafMET intervention delivered by a Deaf therapist fluent in ASL, either in-person or through telehealth via Zoom. The program includes six one-hour sessions held every two weeks, featuring Deaf-friendly handouts, ASL educational content, and interactive activities. Sessions are structured to build motivation and commitment to change drinking behaviors, with options for support persons to join later sessions. All sessions are recorded for quality review, with only a portion analyzed for therapy fidelity. During the 13-week participation, individuals complete assessments before, during, and after the intervention using measures translated into ASL and written English. These include surveys on motivation, alcohol use, craving, social support, and therapy alliance. The study also collects feedback through interviews with participants to refine the DeafMET approach. Researchers will monitor recruitment, retention, satisfaction, and changes in participants readiness for change as key outcomes.