57 Clinical Trials for Various Conditions
This work aims to evaluate an approach for improving federal legislators' use of evidence-known as the Research-to-Policy Collaboration (RPC) - which seeks to address known barriers to policymakers' use of research, including a lack of personal contact between researchers and policymakers and limited relevance of research translation efforts to current policy priorities. The RPC involves structured processes for identifying policymakers' priorities, building researchers' capacity for nonpartisan responses to current policy priorities, and facilitating ongoing and productive researcher-policymaker interactions. This implementation of the RPC will focus on child and family policies relevant to child maltreatment. This study assesses both processes for collaboration and policymakers' use of research within a randomized controlled trial (RCT) employing a mixed methods approach-including quantitative and qualitative evaluation of impact. The proposed project will be guided by three overarching questions: 1. How does the RPC impact researchers and legislative staff? 2. How does the RPC impact legislative activity? 3. How might perceptions and experiences of collaboration through the RPC relate to different forms of evidence use among researchers and policymakers? The RPC's effectiveness will be tested through experimental design (randomization) using qualitative and quantitative assessments of researcher-policymaker interactions and impact. This includes surveying congressional staff and researchers, reviewing records of policymaker's public statements and introduced legislation, and conducting qualitative interviews around researchers' and legislative staffs' experiences with researcher-policymaker collaboration prior to and during the RPC.
The primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (PWID).
Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.
Sickle cell disease affects 100,000 people and 2,000 newborns each year; 50% of these children have a developmental deficit (\>2 SD) before the age of 3. Early identification of developmental deficit supports timely intervention, but children with sickle cell disease are grossly underdiagnosed and undertreated. The goal of the proposed study is to determine the incidence and severity of developmental deficit at 9, 18 and 30 months of age among children with sickle cell disease and test a 12-month, home-based caregiver intervention with this disproportionately affected population.
This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population.
Hypertension is a significant contributor to poor cardiovascular outcomes. Self-management support tools can increase patient behaviors to improve blood pressure. The investigators created a clinical decision support app, called COACH, to integrate home blood pressure data and goals into EHR reporting and workflow with communications informed by behavioral economics principles to support shared decision-making. The study aims to measure the effectiveness of the COACH intervention in a pragmatic multi-site randomized trial in a primary care setting.
This project includes an intervention in five Michigan Medicine family medicine clinics which is designed to improve staff collaboration across different job roles.
The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.
We will conduct and evaluate the impact of two week-long Innovation Labs on collaboration attitudes and behavior among early career scholars. Applicants to each Innovation Lab will be screened and then randomized to either the Innovation Lab group or a control group.
The study is one part of a "bundle" of experiments that constitute Project Three of a National Eye Institute grant. Project Three includes a series of experiments that investigate how changing the input from a simulated AI can affect the decisions made by human observers in a two-alternative forced choice task (like the decision to recall a woman for further examination in mammography). HAICT 7, the experiment described here, investigates how changing prevalence affects human performance when AI is used as a Second Reader.
To date, little knowledge exists related to the use of hemodialysis (HD) in infants and has been limited to mainly single center studies. The CARPEDIEM (CArdio-Renal PEdiatric Dialysis Emergency Machine) device, which can be used to provide hemodialysis in infants, has been launched in the United States. This study/registry is designed to obtain data on critically ill infants who require HD using the CARPEDIEM device to understand the indications for initiation, best practice in prescribing and performing treatment, expected treatment course, and outcomes of a dedicated infant continuous renal replacement therapy (CRRT) machine.
Background: Inequalities in COVID-19 infection, hospitalization, and death in under-studied, under-represented, and under-reported groups of people are severe. A growing number of studies have assessed the impact of individual risk factors. But few studies have assessed which factors are the greatest drivers of COVID-19 disparities from a wider perspective. Objective: To understand the long-term impacts of COVID-19 on minority women and their families to assist in developing community-based programs to help in recovery. Eligibility: Healthy people aged 18 and older who reside in North Carolina. Design: Participants will take a 45-minute online survey. The survey will cover their demographics, community, health, lifestyle, household, and environment. Participants may choose to have tests. They may visit the Clinical Research Unit. They may also have a home visit for these tests. In some cases, they may mail samples to the study team in prepaid envelopes. Participants may take an optional 15 minute survey about their reproductive history. Participants may give a blood sample. Participants may give a urine sample. They will fill out a log and return with their sample. Participants may give saliva samples. Participants may give toenail samples from each toe. Participants may give dust samples. They will be given 8 alcohol swabs. Two will be for testing. They will be asked to swipe a total of 3 door frames. Each door frame should be in a different room of the house. Participants may be given silicone wristbands to wear for 1 week. This is to measure their exposure to air pollutants. Participants may be contacted in the future for follow-up. They may be contacted by phone, email, or letter.
This is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing.
The purpose of this study is to develop and then test an enhanced version of the parent study's collaborative care intervention for co-occurring disorders (CC-COD) to reduce the risk of suicide and overdose among individuals with opioid use disorder (OUD) in combination with PTSD/depression. The parent study is CLARO, Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (NCT04559893).
Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO) is a five-year project that tests whether delivering care using a collaborative model helps patients with both opioid use disorders and mental health disorders.
The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.
This is a novel project which incorporates clinic and community pharmacists in three aspects of the Patient-Centered Medical Home: pre-visit planning, pre-visit care team huddles, and chronic care management (CCM). Patients for the project are enrolled in the NEIFPC CCM program and have Greenwood pharmacy as their primary pharmacy. Community and clinic pharmacists will contribute to pre-visit medication reviews and document their drug therapy recommendations in a shared, templated note in the clinic EHR. NEIFPC pharmacists will attend pre-visit team huddles to relay drug therapy recommendations to the physician. Revenue from CCM services will be prorated and shared between Greenwood pharmacy and NEIFPC. The project will last 9 months. Primary aims are to describe the pharmacist pre-visit planning service, summarize the billing experience of a community pharmacist providing this service, and to describe the drug therapy interventions made by pharmacists.
The overarching goal of this pilot study is to explore the feasibility, acceptability, and patient/provider satisfaction of pharmacy-based administration and dispensing of methadone for opioid use disorder. The results gained will inform the development of a future multisite randomized clinical trial.
Collaboration Live is a prospective, single-arm clinical study of subjects who provide written consent. Subjects are scanned using a Philips EPIQ 5 or EPIQ 7 Ultrasound System equipped with Collaboration Live software. The study investigator will evaluate performance of the Collaboration Live tool with regard to performance of conferencing, sharing and control capabilities. Adverse events will be reported and the study investigator will assess potential relationship to the study device or study procedure. Additionally, the utility of Collaboration Live in remote consult of study patients will be evaluated. No patient follow-up beyond the initial consultation will be conducted with the Collaboration Live software solution.
The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention on the distribution and variability of pain level before and after intervention receipt among people with co-occurring chronic pain and Substance Use Disorders (SUDs) over a three-month follow-up period.
The purpose of this study is to help us learn what are the best services to promote young children's healthy development for families who are experiencing homelessness. Participants may participate in three programs: 1. Healthy Home: four weekly, one-hour group sessions on health topics; 2. Attachment and Biobehavioral Catch-up (ABC): 10, one-hour parenting with parent and child; 3. Healthy Steps: helps families identify, understand and manage parenting challenges completed at well child visits. Participants will be asked to complete surveys, participate in focus groups, and interviews about the experiences with the services offered. Questionnaires about understanding health issues and surveys about parenting behaviors and self-efficacy will also be completed. Study duration is approximately 10 - 12 weeks. Programs may be continued once families move into permanent housing.
The purpose of this study is to follow a cohort of HIV-infected adults who have alcohol and/or drug use to: 1) test the associations between alcohol (and illicit drugs and polypharmacy (multiple prescribed medications)) and falls (fractures secondarily), and whether frailty mediates these associations; and 2) test the associations between alcohol (and illicit drugs and polypharmacy) and utilization (emergency department use and hospitalization for falls and fractures), and whether frailty mediates them. To achieve the stated aims the investigators will expand (to 400) and continue to follow an existing prospective cohort (The Boston ARCH Cohort) of adults with HIV infection and a high prevalence of exposure to alcohol, other drugs, and polypharmacy. The Boston ARCH Cohort is a longitudinal cohort (1-3.5 years of follow-up) of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use.
Spatial neglect may occur in patients who have had a stroke. People with spatial neglect often pay much more attention to one side of the body while ignoring the other side, even though they have no difficulty seeing. The purpose of this study is to evaluate the impact on stroke recovery, including spatial neglect, of the Family-Clinician Collaboration program, where a family member of a stroke survivor actively interacts with clinical staff members providing inpatient rehabilitation services to the stroke survivor.
National Jewish Health and The University of Arizona worked with Navajo Nation organizations to develop this program to improve the health of children with asthma. The Navajo Community Asthma Program will have two main parts. One will train doctors and health care professionals to improve the diagnosis and treatment of asthma. The second part will work with area schools to provide education to school nurses, teachers, and children to help them better understand asthma. The project also works with families to help them know how to best take care of their child's asthma. A major project aim is to make sure that doctors, teachers, and families work together to manage asthma.
The goal of this study is to evaluate a sustainable, community-engaged program to reduce asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban center, has been named the Asthma Capital, or "most challenging place to live in the U.S. with asthma," by the Asthma and Allergy Foundation three times in the last 5 years. To date, however, the city has no comprehensive, community-engaged asthma care program for those children at highest risk for poor asthma outcomes. To address this disparity, the study team engaged with community partners and completed a mixed-methods needs assessment to enhance understanding of the barriers and supports to asthma care for children and their families living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the home as a system, increased school nurse education, and coordination with schools and providers. Working together, the community-engaged team translated needs assessment findings to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home, community, and medical care.
The Institute of Medicine's (IOM) ambitious goal for at least 90% of clinical decisions to be evidence-based includes nursing interventions and practice. Models and frameworks have been developed to meet the demand for practice transformation. While magnet facilities require a commitment to evidence-based nursing practice, military facilities currently lack such a requirement but are instituting evidence-based practice (EBP) initiatives in a purposeful path toward developing high-reliability organizations. Currently, little is known regarding the effectiveness of specific EBP models and frameworks within the military culture. The purpose of this investigation is to determine the effectiveness of the Advancing Research and Clinical Practice through Close Collaboration (ARCC) model in an Air Force Medical Treatment Facility (MTF) beginning with nursing services. Research questions: 1. What is the current state of organizational culture and readiness for EBP within the MTF's nursing services? 2. Will utilization of the ARCC model significantly improve EBP beliefs, knowledge, and practice in MTF nurses over a two-year period? 3. Is the ARCC model feasible for implementation in Air Force MTF's? This study includes an intervention group (n=70) of active duty nurses and technicians who attend an intensive 5-day EBP Immersion Workshop and a control group (n=70) who do not. The intervention group will have access to specialized resources such as: a) Center for Transdisciplinary Evidence-Based Practice (CTEP) expert EBP mentors, b) EBP toolkit and resources, c) one year of free access to the Ohio State University (OSU) virtual library. Control group participants will have standard MTF education opportunities. Established valid and reliable survey measures (EBP attitudes, knowledge, beliefs) will be hosted electronically by CTEP at baseline, three, and twelve months. Online measures include institutional and nursing process measures (EBP implementation, policy changes, and publications) over the two-year study period. De-identified data from the anonymous survey measures will be shared by CTEP with this study team. Data analysis will include Student's t-tests to explore differences between groups. Repeated measures ANOVA or the nonparametric equivalent (Friedman's test or Skillings-Mack test) will be used to compare three time points within groups. Feasibility metrics and demographics will be reported with descriptive statistics.
This pilot study examines the feasibility and acceptability of transitioning office-based buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from this study will inform the development of a future multi-site randomized clinical trial.
This study will explore provider's screening and management practices for eligibility for neoadjuvant therapy from baseline to following the project intervention (use of a novel existing technology, the Carevive Care Planning System at the point of care plus provider continuing medical education.
This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition. The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled. This protocol covers the procurement of biological samples from patients undergoing any cerebrovascular surgery and/or neurointerventional clinical procedure at University of Kentucky. Control participants will include patients undergoing non-emergent, elective diagnostic cerebral angiography as well as patients undergoing emergent angiogram cases. This study represents the first time that tissue, clot and blood will be evaluated for the markers, proteins, and cytokines in human subjects undergoing cerebrovascular procedures. By starting with the human condition, the investigators aim to minimize this loss in translation. Overall, this study will have a great impact on our knowledge of stroke pathology. In essence, this could fundamentally change not only how the investigators develop treatment strategies for the stroke patient population but allow us to individualize the treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques that are impractical when delivered systemically could be delivered locally to impede the early inflammation. This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies.
The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt". In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions. Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care. The study's 4 arms are: 1. Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care 2. Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques 3. Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction 4. Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.