Pleasanton

Researchers are evaluating two usual care strategies for addressing social needs in adults with multiple chronic conditions. This randomized clinical trial compares a higher intensity telephonic navigation approach with a lower intensity virtual outreach method. The study aims to provide evidence on which strategy better supports patients in managing their social needs and improving health outcomes, including closing clinical care gaps. Participants will be randomly assigned to one of two groups. The higher intensity group receives active telephonic outreach from a health navigator with follow-up contacts lasting up to three months. The lower intensity group receives outreach through text, email, or letters containing information about local, state, and federal benefits and services. The study also includes qualitative assessments through patient focus groups and navigator interviews to explore the intervention's impact and mechanisms. During the study, researchers will measure receipt of social services and reduction in social needs approximately six months after enrollment, and clinical care gap closure around twelve months after enrollment. Participants will be assessed for engagement with the interventions, social needs met, and changes in clinical care. The study seeks to understand outcomes across different patient groups based on age, education, social needs, and chronic condition burden to guide future healthcare approaches.

This research aims to evaluate whether managing heart failure using the CardioMEMS HF System, which guides treatment based on pulmonary artery pressure, improves long-term health outcomes for heart failure patients in real-world settings. The study focuses on comparing heart failure hospitalization rates and overall survival over two years between patients using the CardioMEMS system and those managed without pulmonary artery pressure guidance. Participants are divided into two groups: those implanted with the CardioMEMS pressure sensor and managed using this system, and a control group managed without this device. The study observes heart failure patients over a two-year period to assess the impact of pulmonary artery pressure-guided management on their health outcomes. Throughout the study, researchers track hospitalizations related to heart failure and measure survival rates over two years. Data from patients using the CardioMEMS system are compared to those from patients not using the device to evaluate differences in hospitalization and mortality. The study includes monitoring and data collection to understand the effectiveness of this management approach in routine clinical practice.

Adolescent alcohol and other drug (AOD) use is a significant public health issue linked to serious health, social, and economic problems. Early detection and intervention are critical to improving outcomes for young people. This research evaluates whether a centralized, virtually delivered method of Screening, Brief Intervention and Referral to Treatment (SBIRT) can be effectively implemented in pediatric primary care to identify and treat AOD use and related mental health problems in adolescents aged 12 to 17 years at high or severe risk. The study compares two approaches in pediatric clinics: 1) Centralized Virtual SBIRT, where brief interventions are delivered remotely via video or telephone by a centralized behavioral health clinician, and 2) Traditional SBIRT, where interventions are provided in person by a behavioral health clinician assigned to the clinic. This pragmatic comparative effectiveness study includes approximately 22,320 adolescents across busy, general pediatric clinics within a large health system. Participants will be monitored over a two-year intervention period with assessments including referrals to behavioral health clinicians, brief interventions, specialty treatment initiation and engagement, diagnoses of AOD and mental health conditions, alcohol and drug use, depressive symptoms, suicidality, and healthcare services use. The study aims to measure cost-effectiveness, early identification, and treatment outcomes through these evaluations and follow-ups.

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.

Researchers are investigating multi-cancer detection (MCD) tests as a new way to screen for multiple cancers at once in adults aged 45 to 75 without cancer. This study is a feasibility trial called the Vanguard Study designed to explore how well these MCD tests work as cancer screening tools and to understand how patients and doctors decide on care based on the test results. The study will compare two different MCD tests to a control group, aiming to provide early information on their performance and impact. Participants are randomly assigned to one of three groups: one group will have blood collected for the Shield MCD test, another for the Avantect MCD test, and a control group will have blood collected without MCD testing. Blood samples are collected at enrollment and again after one year. Some sites will share test results with participants, while others will keep results blinded. After the intervention period, participants will be followed passively for up to 10 years. During the study, participants complete baseline and follow-up questionnaires within 60 days, provide blood samples for MCD testing within 90 days, and allow researchers to collect health data from medical records. The study measures enrollment feasibility, follow-up completion, diagnostic resolution of abnormal results, test accuracy, and participant anxiety related to the testing process. Safety and long-term outcomes such as cancer incidence and mortality are also monitored throughout the study period.