Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 2)
To drive change, OASAS will invest in a quality measurement and management (QM2) strategy that provides performance feedback to activate leadership and staff of clinics to improve practice as well as publicizes quality measures to ensure public accountability. Using the Donabedian framework as a guide, the OASAS QM2 strategy will include a suite of structural (e.g., client/counselor ratios), process (e.g., use of medications for OUD), and outcome (e.g., hospitalization for detoxification) quality measures. In support of the strategy, OASAS will also provide funding to ensure all clinics have electronic health records (EHR) that have capacity to capture and report on quality measures. The OASAS strategy will address common barriers to QM2 efforts, including: inadequate technological capacity at clinics, dearth of validated quality measures for SUD treatment, limited data literacy in the workforce, insufficient expertise in change management among staff, and clinic leadership resistance due to concerns about fairness in accounting for the clinical complexity of their clients. In addition, OASAS recognizes that gathering data directly from patients is essential to assessing whether their goals and needs are addressed in a person-centered system of care. OASAS will work with academic partners to develop measures and provide support to clinics to address these barriers. This QM2 research center (QM2-RC) proposal comes from an academic-government partnership that has a longstanding history of collaborating on studies to improve treatment for SUD. The broad aim is to build then test a science-based QM2 strategy for person-centered treatment. The project will leverage OASAS’s investment in its new QM2 strategy and policy leadership. The academic partners will offer expertise in statistical methods for measurement validation, risk adjustment, and causal inference that will address some obstacles to QM2 as well as build the evidence base for the benefits of the strategy. The team will also assess how clinics and other stakeholders—e.g., patients, payers—incorporate the QM2 strategy into practice improvement, contract negotiations, and choosing clinics.
Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 3)
To drive change, OASAS will invest in a quality measurement and management (QM2) strategy that provides performance feedback to activate leadership and staff of clinics to improve practice as well as publicizes quality measures to ensure public accountability. Using the Donabedian framework as a guide, the OASAS QM2 strategy will include a suite of structural (e.g., client/counselor ratios), process (e.g., use of medications for OUD), and outcome (e.g., hospitalization for detoxification) quality measures. In support of the strategy, OASAS will also provide funding to ensure all clinics have electronic health records (EHR) that have capacity to capture and report on quality measures. The OASAS strategy will address common barriers to QM2 efforts, including: inadequate technological capacity at clinics, dearth of validated quality measures for SUD treatment, limited data literacy in the workforce, insufficient expertise in change management among staff, and clinic leadership resistance due to concerns about fairness in accounting for the clinical complexity of their clients. In addition, OASAS recognizes that gathering data directly from patients is essential to assessing whether their goals and needs are addressed in a person-centered system of care. OASAS will work with academic partners to develop measures and provide support to clinics to address these barriers. This QM2 research center (QM2-RC) proposal comes from an academic-government partnership that has a longstanding history of collaborating on studies to improve treatment for SUD. The broad aim is to build then test a science-based QM2 strategy for person-centered treatment. The project will leverage OASAS’s investment in its new QM2 strategy and policy leadership. The academic partners will offer expertise in statistical methods for measurement validation, risk adjustment, and causal inference that will address some obstacles to QM2 as well as build the evidence base for the benefits of the strategy. The team will also assess how clinics and other stakeholders—e.g., patients, payers—incorporate the QM2 strategy into practice improvement, contract negotiations, and choosing clinics.
PERSPECTIVES OF PROVIDERS ON HIGH QUALITY CARE OF LGBTQIA+ PATIENTS WITH INFLAMMATORY BOWEL DISEASE
This is a qualitative interview study to better understand provider attitudes and perspectives for providing high quality care in sexual and gender minorities (SGM) patients with inflammatory bowel disease (IBD).
PET/CT Scans | NYU Langone Health
NYU Langone offers PET/CT scans to diagnose illness, evaluate treatments, and assess recurrences of many conditions, including cancer.
Phase 1 Dose-Escalation Study of KTX-2001 (an NSD2 Inhibitor) Alone and in Combination with Darolutamide for Metastatic Castration-Resistant Prostate Cancer
This is a multicenter, open-label Phase 1 study in participants with metastatic castration-resistant prostate cancer (mCRPC) to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of KTX-2001 monotherapy (Part A) and KTX-2001 in combination with darolutamide 600 mg twice daily (BID) (Part B), and to establish a recommended Phase 2 dose(s) of KTX-2001 for future study.
Phase 1 study of intratumoral administration of JNJ-87704916 an oncolytic virus as monotherapy and in combination for advanced solid tumors
This is a phase 1 study, testing the study medicine JNJ-87704916 (an oncolytic herpes simplex virus type 1, HSV-1) alone or in combination with another medicine, cetrelimab (a PD-1 antibody), in patients with advanced solid tumors. This study has two parts. In part 1 of the study, the study team will gradually increase the dose of the study medicine to find out the most effective dose that works well with fewer side effects. In part two, the patients will be divided into two groups. Group A will include patients whose lung cancer has spread from the primary location and the tumor has no PDL-1 expression (PD-L1
Phase 1/2 Multi-Center Open-Label Study to Evaluate the Safety Tolerability and Preliminary Anti-tumor Activity of TNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors
Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, andPreliminary Anti-tumor Activity of TNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors
Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination with Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
This is a Phase 1/2 study testing a new drug called mRNA-4359 in people who have solid tumors: a type of cancer that can be measured, has gotten worse, or has spread to other parts of the body. The study will look at how safe mRNA-4359 is, how well people can tolerate it, and what the highest safe dose is when given alone or with other cancer treatments that boost the immune system. Adding a PD-1 inhibitor, like pembrolizumab or nivolumab, to mRNA-4359 might help the body’s immune system fight cancer better. This combination could work better at controlling the disease than just using one of the treatments by itself. Patients will be divided into different groups (called arms) based on what type of cancer they have, whether they have tried other treatments and how much PD-L1 protein their cancer has. Arm 1a will test different doses of mRNA-4359 in patients with advanced or metastatic cancer. Arm 1b will include patients with advanced melanoma or lung cancer that did not respond to other treatments. They will be given a combination of mRNA-4359 and pembrolizumab to determine what dose works best. Arm 2a will include patients with advanced melanoma who have not had any other treatments yet. They will be given both mRNA-4359 and pembrolizumab. Arm 2b will include both mRNA-4359 and pembrolizumab in adults with advanced lung cancer (NSCLC) who have have not had any other treatments for their cancer. Arm 2c will treat adults with advanced melanoma using mRNA-4359 along with two other treatments: ipilimumab and nivolumab. Arm 2d will include patients 12 years or older with advanced melanoma that did not respond to previous treatments, using mRNA-4359 and pembrolizumab. They must have had at least one treatment that did not work before and also their PD-L1 score must be 1% or higher. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.
Phase 1/2 Study of PARG Inhibitor ETX-19477 in Patients with Advanced Solid Malignancies
This study is designed to test how the drug moves through the body (pharmacokinetics), how it works (pharmacodynamics), and how well it fights tumors. The drug being tested is ETX-19477, which targets a specific protein in cancer cells. The study has two parts: Phase 1 will test different doses of the drug to find the dose with the least amount of side effects that works, and Phase 2 will look at how well that dose works for treating cancer. In Phase 1, patients will be given different amounts of the drug to see which dose is best tolerated, starting with small doses and increasing them if it’s safe. Researchers will keep track of patients’ health and any side effects, and check how well the drug helps shrink the tumors. The goal is to find the best dose and learn how well ETX-19477 works against advanced cancers.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2 (HER2)-negative locally advanced and unresectable or metastatic breast cancer expressing somatostatin receptors (SSTRs) and progressed after antibody-drugconjugates and/or chemotherapy (TRACY-1)
This is a phase 1b/2 study testing whether the study medicine RYZ101 (targeted radiopharmaceutical therapy) will be a safe and better option for treating patients with ER+, HER2-negative breast cancer. This study will be done in two parts. In the first part, patients will be sequentially enrolled and divided into groups to receive study medicine at different dose levels. The study team will find out the dose that works well and has fewer side effects. In the second part of the study, more patients will be included to receive the study medicine that was effective and had fewer side effects for patients in the first part. All patients will have blood samples taken to see how their bodies are handling the study medicine. Special scans will be taken for all patients to see how the study medicine is changing their cancer. The study team will monitor all patients for side effects and safety.