Pleasanton

Researchers are evaluating two current approaches to address social needs among adults with multiple chronic conditions. This randomized clinical trial compares higher intensity telephonic navigation against lower intensity virtual outreach to see which strategy better helps patients access social services, meet social needs, and close clinical care gaps. The study also explores how different patient groups may respond to these interventions and investigates the pathways linking social support to improved health outcomes. Participants will be assigned to one of two groups the higher intensity arm involves active telephonic outreach from a health navigator with follow-up contacts for up to three months, while the lower intensity arm consists of outreach via text, email, or letter providing information about available governmental benefits and services. The trial includes qualitative assessments through patient focus groups and navigator interviews to understand the impact and mechanisms of each intervention. During the study, participants will be monitored for receipt of social services and reduction in social needs approximately six months after enrollment, as well as clinical care gap closure around 12 months. Outcomes will be assessed through patient reports and health records. The study plans to provide evidence to guide healthcare systems on effective strategies to support patients with multiple chronic conditions by addressing their social needs over time.

Researchers are evaluating whether managing heart failure patients using the CardioMEMS HF System, which monitors pulmonary artery PA pressure, improves long-term health outcomes compared to usual care without PA pressure monitoring. This observational study focuses on heart failure patients and aims to determine the impact on hospitalization rates and survival over two years in a real-world setting. Abbott Medical Devices leads this research to better understand the benefits of PA pressure-guided management. Participants include heart failure patients either implanted with the CardioMEMS PA pressure sensor or managed without PA pressure monitoring as a control group. The study compares two groups those with the device and those without it. The CardioMEMS HF System continuously monitors PA pressure to guide heart failure management decisions. During the study, researchers will track heart failure hospitalizations and overall survival for two years. They will review hospitalization rates related to heart failure and survival from any cause to assess differences between the groups. Participants will be monitored regularly, and their health outcomes will be recorded to evaluate the effectiveness of PA pressure-guided management over standard care.

Adolescent alcohol and other drug use is a major public health problem that leads to serious health, social, and economic consequences for young people. Early identification and intervention are crucial to improving outcomes. This study evaluates whether a centralized, virtually delivered version of Screening, Brief Intervention and Referral to Treatment SBIRT can be implemented cost-effectively in pediatric primary care to better identify and treat adolescents at high or severe risk of substance use and related mental health problems. It compares this virtual model to the traditional in-person SBIRT approach in a large, diverse health system. The trial involves two groups of pediatric primary care clinics one where behavioral health clinicians provide brief interventions in person by appointment Traditional SBIRT, and another where interventions are delivered virtually by video or telephone through a centralized behavioral health clinician Centralized Virtual SBIRT. This approach aims to overcome barriers like lack of trained staff and time constraints in busy clinics. Both methods focus on adolescents aged 12 to 17 identified as at risk during routine Well Visits. Participants will be monitored over a two-year intervention period. Researchers will track referrals to behavioral health clinicians, brief interventions delivered, initiation and engagement in specialty treatment, diagnoses related to substance use and mental health, substance use behaviors, depressive symptoms, suicidality, and health services utilization. These assessments occur at 1- and 2-year follow-ups, with specialty treatment monitored within specific timeframes after screening. The study seeks to understand which SBIRT delivery method best supports early intervention and care for adolescent substance use and mental health issues.

Researchers are evaluating whether reminding doctors about treatment guidelines for iron deficiency in adults with heart failure who are hospitalized and have iron deficiency affects how often intravenous IV iron treatment is used. This study compares two groups of hospitalized adult patients with heart failure and iron deficiency one group where doctors receive notifications with their patients iron test results and guideline recommendations, and a control group where doctors continue usual care without such notifications. The study also looks at whether increased IV iron use leads to fewer hospital visits and lower risk of death. The trial involves up to 21 medical centers randomly assigned to either an intervention group, where physicians receive a one-time notification about their patients iron deficiency and guideline information about IV iron therapy, or a control group, where physicians receive no such notifications and follow usual care. The study team does not directly contact patients or make clinical decisions care decisions remain with each patients physician. Participants include adults hospitalized for any reason with diagnosed heart failure and iron deficiency. Researchers will observe the use of IV iron within 7 days of hospital admission and track health outcomes including death and heart failure-related hospitalizations for 12 months after randomization. The study uses medical records to analyze outcomes without additional patient contact, focusing on how provider notifications impact treatment use and patient health over time.

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.

This research aims to evaluate an investigational noninvasive neuromodulation device for treating Restless Legs Syndrome RLS. The study focuses on assessing how well participants tolerate the device, its safety, and its effects on RLS symptoms, including the number of awakenings related to RLS during the night. The device has been designated as non-significant risk by the institutional review board IRB. The study lasts 12 weeks, beginning with a 1-week baseline period without intervention, followed by 1 week of Tonic Motor Activation TOMAC therapy involving 30-minute stimulation sessions. After this, participants undergo 4 weeks of Extended Duration XD- TOMAC therapy nightly. In the final 6 weeks, participants use the investigational device with different therapy settings in a pseudo-randomized order across three 2-week periods to assess varying stimulation waveforms. During the study, participants set up and use the device at bedtime as instructed. Researchers monitor sleep quality and RLS symptoms through various measures, including nightly awakenings, symptom severity scales, sleep efficiency, and patient-reported improvement. Participants complete electronic questionnaires and communicate with the study staff remotely throughout the home-based study. The primary measure is the number of RLS-related awakenings over 12 weeks, with secondary measures assessing symptom changes and sleep quality.

The Vanguard Study is exploring the use of blood tests called multi-cancer detection MCD tests to screen for multiple cancers at once in adults aged 45 to 75 without cancer. The study aims to understand how these tests perform as cancer screening tools and how patients and doctors respond to test results. It also seeks to assess the feasibility of recruiting participants and collecting necessary data for a future larger trial. Participants are randomly assigned to one of three groups two groups receive different MCD tests Shield or Avantect with blood samples collected at enrollment and after one year, while a control group undergoes blood collection without MCD testing. Some sites provide test results to participants, and those with abnormal results are advised to follow up with their clinicians. After the one-year intervention period, all participants are monitored passively for up to 10 years. Throughout the study, participants complete questionnaires and provide blood samples as scheduled. Researchers collect medical record information and track follow-up adherence, test result return times, and diagnostic outcomes for abnormal results. The study measures feasibility outcomes, cancer detection accuracy, participant anxiety, and other effects related to the screening process. Participant follow-up and data collection may continue for up to 10 years after the intervention period ends.