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NCT ID: NCT05390411 Enrolling by invitation - Decision Making Clinical Trials

Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial

SOCIAL HF
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to achieve equity in the allocation rate of advanced heart failure therapies, heart transplants and ventricular assist devices. This study proposes to implement evidence-based strategies that reduce bias, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. This rigorously designed trial may inform national guidelines for advanced heart failure therapy allocation, and data are likely to be generalizable to other organ replacement treatments and advanced chronic disease decision-making processes.

NCT ID: NCT05388786 Enrolling by invitation - Clinical trials for Consensus Development

Complications and Adverse Events in Lymphadenectomy in the Inguinal Area

Start date: June 1, 2023
Phase:
Study type: Observational

The investigators aim to create an effective and accurate method to report, define, and classify complications and adverse events during and after Inguinal lymph node dissection (ILND) as part of the staging and treatment for penile cancer, vulvar cancer, and melanoma. In turn, this will become an objective, efficient, and reproducible tool to facilitate comparisons across surgical approaches, techniques, and surgeons.

NCT ID: NCT05388045 Enrolling by invitation - Clinical trials for Substance Use Disorders

Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting

RecoveryPROM
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

Performance measure can improve quality of care at the patient, provider, and systems level of care, and patient-reported outcome measures bring a needed patient-centered focus. Recovery has been difficult to measure for people with substance use disorders, and is more challenging in the context of opioid use disorders (OUD) and treatment medications. This study will examine a recovery patient-reported outcome measure to determine if patients and clinicians find it useful and acceptable in the clinical context, and if it leads to improved outcomes.

NCT ID: NCT05388019 Enrolling by invitation - Heart Failure Clinical Trials

Multidisciplinary Ventricular Assist Device Clinic

MultiVAD
Start date: May 2022
Phase: N/A
Study type: Interventional

Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements. This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.

NCT ID: NCT05386316 Enrolling by invitation - Health Disparities Clinical Trials

The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project

MIRACLE
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This community-partnered study will scale a community, provider, and system-level implementation intervention to reduce African American maternal morbidity and mortality disparities in two Michigan counties (Genesee and Kent). This project will test the intervention using data from Medicaid insured women who deliver in Michigan from 2016-2019 and 2022-2025 (approximately 540,000 births, including 162,000 births to African American women).

NCT ID: NCT05382455 Enrolling by invitation - Clinical trials for Consensus Development

Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Artificial Intelligence Extension

PRISMA-AI
Start date: June 15, 2022
Phase:
Study type: Observational

The investigators aim to develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Artificial Intelligence Extension (PRISMA-AI) guideline as a stand-alone extension of the PRISMA statement, modified to reflect the particular requirements for the reporting of AI and its related topics (namely machine learning, deep learning, neuronal networking) in systematic reviews.

NCT ID: NCT05382221 Enrolling by invitation - Smoking Cessation Clinical Trials

Breathe 2 Project 3: Comprehensive Chronic Care

Start date: August 8, 2022
Phase: N/A
Study type: Interventional

This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.

NCT ID: NCT05381480 Enrolling by invitation - Healthy Aging Clinical Trials

Elders Preserving Independence in the Community

EPIC
Start date: November 22, 2022
Phase: N/A
Study type: Interventional

Twenty percent of the US population will be age 65 or older by 2050, a surge from 8 percent in 1950 and 12 percent in 2000. The proportion of low-income older adults is also growing. Approximately 70 percent of people 65 and older are expected to need some level of long-term care, which may burden the nation's health and caregiver systems. While there are many models to care for chronically ill older adults, there is less agreement on how to support healthier, low-income older adults to stay independent in their communities. This study will compare the effectiveness of an in-home preventive healthcare program delivered by nurses to on-site health and wellness classes for older adults living in low-income independent housing. We also want to understand adherence and preferences of older adults for these two options. The three-year study will take place in up to 18 low-income independent older adult apartment buildings in Los Angeles. Half of buildings will be randomized to offer the health and wellness classes, and the other half will offer the in-home preventive healthcare program. All study activities will be provided on-site at the building locations, and individuals living in the buildings will be invited to participate. A total of 480 participants will be recruited to participate, 240 in each group. Residents from participating buildings will meet with the research team to provide feedback throughout the study. Other stakeholders, including doctors, housing services, social agencies, hospital leaders, professional societies, advocacy groups, and city policymakers will also meet with the team as an advisory group to share input and concerns. This project seeks to compare how each option maintains or improves health and functional independence in low-income older adults, with the goal of limiting dependency, moves to nursing homes, and the use of costly health services, while improving health behaviors and promoting the use of preventive health and appropriate community services.

NCT ID: NCT05381441 Enrolling by invitation - Patient Safety Clinical Trials

Safety Action Feedback and Engagement (SAFE) Loop

Start date: February 17, 2022
Phase: N/A
Study type: Interventional

This trial will test whether a new intervention, the Safety Action Feedback and Engagement (SAFE) Loop, enhances nurse incident reporting practices, improves nurses' perceptions of incident reporting, and lowers rates of high-priority medication events, as compared with using an existing incident reporting system. The trial will be performed in 20 acute care nursing units at Cedars-Sinai Medical Center.

NCT ID: NCT05380921 Enrolling by invitation - Epilepsy Clinical Trials

Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This study will improve access of Veterans with epilepsy living in rural areas to the most important diagnostic procedure for the care of patients with epilepsy: the routine electroencephalogram (EEG). The investigators will test a new method for recording EEG which uses a novel dry electrode system headset that does not require an EEG technologist to operate. The headset integrates the EEG electrodes and amplifier into a compact system which is easily placed on the head. This approach could make it possible for a nurse or nurse assistant with minimal training to record an EEG in a rural community based outpatient clinic (CBOC) as part of an epilepsy telemedicine outreach program along with clinical interviews. The investigators will compare performance of this dry electrode system to standard EEG when it is used by EEG technologists in three VA medical centers. This project has the potential to improve access of Veterans to the EEG procedure and decrease cost to the Veterans Health Care System.