69 Clinical Trials for Various Conditions
Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.
The goal of this study is to evaluate the effectiveness of a mind-body medicine training program on parole services staff. The main questions it aims to answer are: * Will participation in the training increase resilience; empathy; the belief that one can cope with difficult situations; and decrease symptoms of depression, stress, anxiety, and burnout? * What is the personal and professional impact of the training program? Sixty staff members of the Indiana Department of Correction Parole Services Division will do the following: * Attend an initial 4-day mind-body medicine training. Mind-body techniques taught in the training include: meditation; a breathing exercise; biofeedback; guided imagery; expressing oneself through drawings and writing; movement to reduce stress; and family trees to explore family dynamics. * Attend a 2-day practicum. The 2-day practicum will teach staff the ways in which they can share the skills they have learned one-on-one with parolees and families of parolees. * Attend 4 biweekly sessions of 2-hour group consultation sessions. The consultations will support the use of the mind-body skills with the parolees. Participants will also do the following: * Fill out standardized questionnaires online before and after the training program in order to measure changes in resilience; empathy; the belief that one can cope with difficult situations; and symptoms of depression, stress, anxiety, and burnout. * Fill out an additional online questionnaire three months after the consultation sessions to determine how trainees are using the mind-body skills in their work. * Participate in an online group interview to determine how trainees are using the skills and how the training has affected them personally and professionally.
The 2021-2022 Study of Family and Staff Well-Being in Head Start Family and Child Experiences Survey (FACES) Programs (the 2021-2022 Study) builds on FACES 2019, a national study of children and families participating in Head Start programs. In the year following the start of the COVID-19 pandemic, there was a need to understand how children, families, and Head Start staff were faring. The 2021-2022 Study explores child, family, and staff well-being, primarily in the programs that participated in FACES 2019.
The 2021-2022 Study of Family and Staff Experiences in American Indian and Alaska Native Head Start Family and Child Experiences Survey Programs (the 2021-2022 Study) builds on AIAN FACES 2019, a national study of children and families participating in Head Start programs funded through grants to federally recognized tribes and consortia. In the year following the start of the COVID-19 pandemic, there was a need to understand how children, families, and Head Start staff were faring. The 2021-2022 Study explores this with some of the programs that participated in AIAN FACES 2019.
The overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.
This quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. The Google form questionnaire will ask the high schoolers and staff for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.
Child Trends, funded by the Office of Planning, Research, and Evaluation, Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services (HHS) will collect descriptive information for The Role of Licensing in Early Care and Education (TRLECE): Front-Line Licensing Staff project. The goal of this information collection is to deepen the field's understanding of child care and early education licensing systems, which play a critical role in supporting positive outcomes for providers, families, and children. The investigators will conduct one round of survey data collection with front-line child care licensing staff in all states.
The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. The main questions it aims to answer are: * Is IRTTS superior to WILC in improving residential care worker (RCW) resiliency; stress management and burnout; depression and anxiety; and positive health behaviors? * Is IRTTS superior to WILC in improving RCW turnover/retention; RCW sick days/absenteeism; and group home safety and resident incidents? * What are the barriers, facilitators, and resources required to successfully implement IRTTS and WILC? Participants may engage in training sessions, collaborate with residents and other RCWs in their group homes, attend meetings with RCWs from other group homes, complete surveys, participate in focus groups, and/or give qualitative interviews. Researchers will compare IRTTS to WILC to see which intervention should be implemented to achieve the greatest improvement in RCW resiliency and greatest reduction in burnout and turnover in group homes for adults with serious mental illness and/or developmental and intellectual disabilities.
The goal of this 12-month cluster clinical trial is to evaluate if improving child care providers' health behaviors using an online provider weight management program elicits meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment. The study sample will include 84 child care centers. Including: 84 center directors, 168 2-5-year-old classroom teachers, 672 2-5-year old children. Some centers will do only the online Nutrition and Physical Activity Self-Assessment for Child Care (Go NAPSACC) program. This program works with child care center directors to make changes to their center around child nutrition and physical activity to foster healthier habits for the children enrolled in their care. Other centers will do Go NAPSACC Enhanced. This will include center directors doing Go NAPSACC and 2-5 year old teachers doing an online weight management program with support. Researchers will compare centers in Go NAPSACC with centers in Go NAPSACC Enhanced to see if there are greater improvements in children's diet quality and physical activity, as well as the nutrition and physical activity environment of centers in the Go NAPSACC Enhanced group. Additionally, they will see if there are greater improvements in teachers' weight, diet quality, and physical activity in centers using Go NAPSACC Enhanced.
The specific aims of this pilot study are: Aim 1) To identify whether no prep ready to eat meals (intervention) or ingredient bundles (control) have higher client acceptability, liking, satisfaction, and perceived diet quality ratings. Aim 2) To identify whether no prep ready to eat meals (intervention) or ingredient bundles (control) have higher feasibility ratings with food pantry staff. Exploratory Aim) To identify whether no prep ready to meals (intervention) or ingredient bundles (control) lead to greater improvements in food security, perceived diet quality, and fruit and vegetable consumption.
This study looks at school employees' mental health, well-being, and effectiveness before and after completing a professional development workshop. The participants' schools are offering the Cultivating Awareness and Resilience in Education (CARE) professional development workshop to all teachers, staff, and administrators. CARE will be presented in three in-person training sessions over two to three months during the school year. People who participate in CARE are asked to answer questions about their demographic information, mental health, well-being, and effectiveness before the workshop and two times after completing the workshop. This consent form provides the necessary information for people interested in answering these questions to make an informed decision. This consent form is not for the professional development workshop. Taking part in the workshop and questionnaires is optional. This study is being conducted because teachers, school staff, and children's mental health has declined since the beginning of the COVID-19 pandemic. The investigators hope to use information collected in this study to tell schools, local public health officials, and state leaders how best to support teachers' mental health and well-being. There are minimal risks associated with this study. The greatest risk of this study is loss of confidentiality.
The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities that will test a communication and engagement strategy for increasing COVID-19 booster vaccination rates against an enhanced usual care comparator (Centers for Disease Control and Prevention or other national organization vaccine education and communication materials) among facility staff. The communication and engagement strategy being tested includes (1) the development of materials co-designed with and tailored to facility staff whose primary language is a language other than English or who are from certain cultural affinity groups and (2) the distribution of the developed materials by members of the language/cultural affinity groups with peer advocacy activities (full intervention). The study is being conducted in Washington state and Georgia. Long-term care/residential facilities will be asked to furnish their staff booster rate at 4 timepoints: pre-intervention, and one month (timepoint 1), 3 months (timepoint 2), and 6 months (timepoint 3) post-intervention. Staff at participating long-term care facilities will be invited to complete three online surveys at 3 timepoints: pre-intervention, 3 months post-intervention and 6 months post-intervention. Long-term care facilities will be randomized to a trial arm following the pre-intervention data collection.
The University of Iowa in collaboration with the Cedar Rapids Community School District (CRCSD) conducted an effectiveness study to test a theory-based system, called Link, that trained school staff to provide a sustainable infrastructure of support for youth at-risk of violence. Our purpose was to prevent and intervene in violence that impacts students, and to adopt cost-effective school-based violence prevention strategies. The research team conducted a randomized intervention trial with three "clusters" of within the CRCSD using the procedures described in the following paragraph. Each cluster consisted of a middle school and three "feeder" elementary schools. Implementation of the program began in Fall 2017 at Cluster 1, Fall 2018 at Cluster 2, and Cluster 3 remained a control site and received no intervention. Program Implementation, by Cluster: A series of videos were produced by the University of Iowa team in conjunction with the CRCSD, and were offered as a training opportunity to school staff. The series of video trainings include: Trauma Informed Care (TIC) video to be viewed by all staff; and a Link Program training video for select staff. TIC video instructions was required of all staff during a workshop session. Participants were invited to complete a post-training evaluation survey following the viewing of the TIC video, for research. Concurrent with the delivery of the Trauma Informed Care video training, select staff were identified by the CRCSD research team to become Link interventionists, by participating in specialized training of the Link system using the Link Program video and in-person trainings. These interventionists had a dual role as a study participant and as a member of the research team. These interventionists were provided 4 in-person trainings throughout the school year that included training in child assent procedures, and Link Program training. These interventionists were invited to complete pre/post evaluation surveys at each training session, for research. Targeted Research Intervention: Following the Link Program Training, the CRCSD research team randomly assigned a case load of students to the Link interventionists with whom they used the Link Program skills. Following each student encounter, the interventionist completed a Link Case Management Tool for process evaluation. Link interventionists were also invited to complete a pre-evaluation survey prior to Link Program training, and post-evaluation surveys following training sessions. Data collected for the targeted student intervention included: primary data in the form of a Link Case Management Tool completed by a Link interventionist following each student encounter; secondary data in the form of existing school administrative data sources (i.e., enrollment and office referrals).
Stigma is one of the most pervasive barriers to addiction care in the U.S. criminal justice (CJ) system. However, there have been no stigma reduction interventions developed for this context. This project addresses this gap with a new multi-level stigma intervention, Combatting Stigma to Aid Reentry and Recovery (CSTARR), for justice-involved people with addiction and criminal justice staff. This intervention will be implemented in 6 (mostly rural) counties in TN for clients and staff in the Tennessee Recovery Oriented Compliance Strategy (TN-ROCS) program, which coordinates multiple CJ sectors (i.e., courts, corrections, probation, treatment) to divert and treat people with addiction. This project aims to 1) examine the feasibility, acceptability, and implementation considerations of integrating CSTARR in the TN-ROCS program, and 2) determine whether CSTARR impacts individual, staff, and program-level outcomes. We aim to recruit 25 stakeholders, 80 clients, and 75 staff over the course of this 18-month project to participate in our intervention and evaluation efforts. Staff and clients will be asked to complete online surveys before and after the intervention, as well as 1- and 3-month follow ups, for which they will receive gift-cards. The overall goal of this project is to examine the feasibility and utility of stigma reduction efforts in the criminal justice system to determine whether they can help facilitate engagement with evidence-based addiction care and improve client and staff outcomes.
The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, is a worldwide pandemic that has resulted in large-scale quarantines in cities, states, and countries throughout the world. SARS-CoV-2 is a respiratory virus that is most commonly spread via contact with infective respiratory droplets and aerosols produced by coughing, sneezing, talking, and singing. Children with medical complexity (CMC), i.e., children with multiple severe chronic conditions, high resource use, severe functional limitations, and substantial family-identified service needs, are a medically vulnerable population for the development of severe COVID-19. Deciding to send CMC to school poses a major dilemma to families wanting to minimize severe COVID-19 risk. School personnel also face risks when CMC attend school. Despite these challenges, achieving in-person school attendance is critical for CMC. Compared to non-CMC, academic and social development for most CMC hinges on being at school. Severe intellectual and developmental disability impairs one's ability to engage with online platforms. Health-promoting services delivered at school, e.g., physical, occupational, and speech therapy, are likely less effective when delivered virtually. Parents of CMC, already disproportionately unemployed due to their child's care needs, experience added employment strain when their child is out of school. The study objective is to increase the safe return to school for CMC by 1) evaluating the feasibility of school-based COVID-19 testing strategies and 2) identifying parent and staff perceptions of testing and school attendance. A related study (ReSET Aim 1a, NCT04895085) will evaluate the same factors in home-based testing strategies in CMC exclusively.
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings is a research study aimed at developing, implementing, and evaluating a package of interventions specifically designed to reduce COVID-19 and other infectious-disease incidence, hospitalizations, and mortality among staff and adults with Serious Mental Illness and Intellectual and Developmental Disabilities in congregate-living settings.
The Mental Health Among Patients, Providers, and Staff (MHAPPS) Study is designed to study how the COVID-19 pandemic has affected mental health and wellbeing, and how to support mental health while minimizing the burden on the healthcare system. The study will enroll adults and adolescents who have had a primary care visit in the last 12 months, as well as healthcare providers and staff from a large health system in Idaho. The study will include: Aim 1: a cross sectional survey to measure the prevalence of various measures of mental distress and how they are associated with COVID-19-related factors; and Aim 2: a randomized controlled trial comparing the effectiveness of two versions of a Caring Contacts intervention to reduce loneliness and mental distress.
The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
Given the critical role of sleep in enhancing neural recovery, motor learning, neuroprotection, and neuroplasticity, interventions to enhance sleep that target sleep could improve recovery and rehabilitation outcomes for stroke patients. In this proposal, a multidisciplinary group of researchers with expertise in rehabilitation medicine, sleep medicine, nursing, physical therapy, wearable technologies, and implementation science will adapt, implement and evaluate a state-of-the-art intervention to promote sleep for stroke patients undergoing acute rehabilitation. SIESTA-Rehab, adapted from a previous unit-based intervention, bundles two sleep-promoting interventions to address the unique sleep challenges stroke patients face during acute rehabilitation: (1) nursing education and empowerment to reduce unnecessary disruptions; (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing if present during acute stroke rehabilitation.
Evidence-based VA care is best for meeting Veterans' mental health needs, such as depression, PTSD and opioid use disorder, to prevent suicide or overdose. But some key evidence-based practices only reach 3-28% of patients. Participatory system dynamics (PSD) helps improve quality with existing resources, critical in mental health and all VA health care. PSD uses learning simulations to improve staff decisions, showing how goals for quality can best be achieved given local resources and constraints. This study aims to significantly increase the proportion of patients who start and complete evidence-based care, and determine the costs of using PSD for improvement. Empowering frontline staff with PSD simulation encourages safe 'virtual' prototyping of complex changes to scheduling, referrals and staffing, before translating changes to the 'real world.' This study determines if PSD increases Veteran access to the highest quality care, and if PSD better maximizes VA resources when compared against usual trial-and-error approaches to improving quality.
Compassion-Centered Spiritual Health (CCSH) at Emory University was launched as a joint creation by Spiritual Health and the Center for Contemplative Science and Compassion-Based Ethics in 2018. The program enhances the practice of spiritual health through CCSH Interventions, which are a Cognitively-Based Compassion Training (CBCT)-based approach to support the practices of spiritual health clinicians. CBCT is a research-based contemplative program developed at Emory University in 2004. CCSH Interventions are provided by spiritual health clinicians across Emory's inpatient and outpatient facilities and beyond, and offer a method to alleviate distress in patients and families and to mitigate burnout in healthcare professionals. While the intervention will be required for some staff and provider populations, Spiritual Health proposes to pilot a voluntary systematic implementation of CCSH Interventions for Teams (CCSH-TI) to clinical research teams at Winship Cancer Institute. Clinical Research Coordinators (CRCs) experience significant emotional and spiritual burden through exposure to patients living with cancer and undergoing clinical trials for cancer treatment. As individuals and teams, CRCs face multiple work-related challenges known to cause distress, including experiences of secondary trauma, exposure to emotional and spiritual suffering of patients and families, and experiences of loss of patients. The researchers of this study hope that offering CCSH Interventions for Teams to CRCs will increase their resilience, wellbeing and compassion toward self and others, with a secondary benefit that burnout will be reduced. By conducting this pilot project, the researchers hope to gain a better understanding of how to optimally implement CCSH for CRC teams at the Winship Cancer Institute.
The investigators propose to develop and evaluate Link for Equity, a trauma-informed system of care. Link, a system of support for ACE-affected children, is composed of universal school Trauma-Informed Care. Preventing Racism through Awareness and Action (PRAA) is a perspective-taking racism/discrimination prevention intervention for school staff that increases awareness of racism and how it impacts students and promotes empathy for students of color. Link for Equity will be translated to be culturally responsive for 12 secondary public schools in metropolitan and rural Minnesota with substantial racial/ethnic minority students and racial/ethnic disparities in school discipline and violence. Using a nested, rigorous, and ethically acceptable randomized waitlist control design, the investigators will implement and evaluate Link for Equity sequentially for two years in each school. The overall goal is to evaluate if Link for Equity can reduce school violence disparities.
The objective of this randomized safety and observational study is to demonstrate CorPath GRX chronic total occlusion PCI is safe, and that Cardiac Catheterization Laboratory staff have no additional exposure to radiation when compared to conventional manual chronic total occlusion PCI procedures without added procedure time.
The purpose of this study is to establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian Nutritionist (RDN) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. Sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. The total number of participants enrolled across the 120 facilities will be between 2400-9600. The aims of the study include: 1. Assess the interrater reliability of the MCC. 2. Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes. 3. Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients. 4. Identify the utility of BIA for body composition analysis in clinical settings. 5. Estimate the level of RDN care necessary to improve patient outcomes within the portfolio of outcomes. Specifically: quantify the dose (minutes of care and frequency of encounters) of RDN care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders. 6. Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.
The overall goal of the Connect Through Positive Leisure Activities for Youth (PLAY) Project is to improve staff capacity for implementing effective physical activity (PA) programming within middle school after school programs serving high-risk youth. All components of the 'Connect' intervention (health promotion initiative, comprehensive training, and tailored physical activity curriculum) aim to support staff cohesion, motivation and efficacy in facilitating a PA context that supports youth social goals and meaningful connections. To this end, the investigators will be implementing a 5-year randomized controlled trial with 30 ASPs. Compared to control programs, after school programs receiving the 'Connect' program are expected to show greater improvements from baseline to post- and 6 mo follow-up in social mechanisms, youth PA, and staff PA. The Connect through PLAY project will provide important insights into what supports are needed (and efficacious) for after school program staff to create a positive social climate to promote increases in youth motivation and participation in physical activity.
The purpose of this study is learn more about how being treated for breast cancer affects patients' employment. Researchers are testing an early version of a mobile app designed to help breast cancer patients keep their jobs during and after treatment. The app provides advice for patients to use when having conversations about breast cancer with their employers and their doctors. The app is called TEAMWork (Talking to Employers And Medical staff about Work). In this study, the investigators are asking breast cancer patients who are about to receive treatment or who are currently receiving treatment to tell us what aspects of the app work well, so that they can learn how to improve it.
The primary goal of this PCORI proposal is to evaluate the impact of enhanced provider and clinical staff training to address the health disparities of SGM CHC patients to ultimately improve their health outcomes because CHCs are a key part of the U.S. health care delivery system for underserved populations. The current application proposes to test an intervention designed to understand how CHCs, including front line staff and safety net clinical providers, can identify and provide optimal care for their SGM patients, and will determine whether enhanced training of CHC staff in best practices for the provision of primary care for SGM patients will improve their clinical outcomes. The time is right for routinization of SOGI measures in EHRs and evaluation of the optimal methods to train primary care providers in the best practices for the care of SGM patients.
The purpose of this study is to assess subjects' perceptions of environmental conditions and their preferences, and to expose subjects to varied environmental conditions as well as to assess their perception and feedback to these conditions. Another aim of this study is to explore potential patterns, factors of influence, and factors of reference in relation to the objectively assessed quality of the imagining examination and/or the perception of the patient. Finally, another aim of this study is to explore the feasibility of innovative biofeedback response capturing methodologies and technologies to guide the design of specific clinical investigations or trials.
The main purpose of this pilot study is to investigate the safety, effectiveness and tolerability of the study medication in the treatment of people with chronic hepatitis C virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction treatment.