57 Clinical Trials for Various Conditions
The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based behavioral intervention for students with ADHD, to make the program accessible to schools that serve students from low-socioeconomic (SES) backgrounds. Existing evidence-based interventions for students with ADHD are often inaccessible in schools with limited resources to support implementation. By adapting CLS to include a dHealth tool-CLS-D-investigators aim to improve the feasibility of intervention implementation in schools with limited resources and mitigate disparities in access to evidence-based interventions among students with ADHD who are from low-SES backgrounds.
This study develops a web-based PD (CLS-R) to provide SSWs with remote training in EBPs for attention and behavior problems. CLS-R is designed to be usable, feasible, portable, accessible, and acceptable - ingredients which have been identified as necessary for the sustainability of school-based programs. The study evaluates the usability, feasibility, acceptability, fidelity of implementation, and preliminary effects on student outcomes.
The study evaluates the implementation of evidence-based practice for the management of patients with dizziness in the emergency department (ED) within a large integrated health care system. The clinical focus is on benign paroxysmal positional vertigo (BPPV), unilateral vestibulopathy (e.g., vestibular neuritis), and stroke - which are disorders with established evidence-base practices for evaluation and management. Evidence-based practices for these clinical topics have not properly disseminated regarding dizziness visits, and this results in missed opportunities for effective and efficient care delivery. The investigators propose a hybrid type 3 effectiveness-implementation trial to evaluate an enhanced BPPV-centric implementation strategy and clinical intervention. The overall strategy, initially developed in Dizziness Treatment through Implementation \& Clinical strategy Tactics-1 (DIZZTINCT-1), will be improved to increase generalizability, convenience, exposures, sustainability, and dissemination. We use an innovative design of a stepped-wedge trial for the ED-level implementation strategy and an embedded randomized patient-level dissemination strategy. As a result, we can closely assess the individual and additive impact of study components. We will evaluate effectiveness of the implementation strategy and also confirm clinical outcomes.
The purpose of the proposed study is to evaluate the feasibility and acceptability of a brief educational intervention (TEACH) that includes evidence-based strategies designed to improve task-specific teamwork and its impact (vs. standard practice) on teamwork among primary care team members and on evidence-based suicide prevention care provided to Veterans in Primary Care.
The objective of this trial is to demonstrate early proof-of-concept for My Healthy Brain, an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of cognitive decline. The investigators will explore the feasibility, acceptability, and effect sizes of improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being.
This study will compare training as usual to automated training using an intelligent tutoring system in training bachelors (BA) level social workers in cognitive behavioral therapy (CBT). The purpose of the study is to determine if time and cost of training front line clinicians in evidence-based treatments can be shortened, and if this new training model can reduce the need for clinicians to seek advice from experts.
The overarching objective of this study is to close clinical knowledge and performance gaps by providing oncology clinicians with the latest advances and emerging research in the evidence-base and personalized treatment of advanced NSCLC patients. In addition, the research team seeks to meet quality measures relevant to value-based care delivery through IT infrastructure and clinical workflow processes. The research team also hopes to gain insights on clinician practice patterns related to advanced NSCLC, and the correlation between advanced NSCLC patients reported goals of care and advanced NSCLC patients' fit/frailty status and treatment decisions.
In this study, a computer-assisted adaptation of SafeCare, an evidence-based home visiting program, will be developed and tested in child welfare. This approach will assist home visitors with the delivery of SafeCare to families, with the goal of improving provider fidelity and implementation success. In the computer-assisted SafeCare sessions, a portion of the session will be delivered on a tablet computer that the home visitor brings to the family's home. The computer software will deliver the educational piece, or explain a piece of each session, along with modeling videos of the skills. The home visitor will follow up with the practice and feedback portions of the session. A randomized feasibility trial will be conducted to test the technology-based approach against the standard SafeCare implementation approach in terms of feasibility of implementation, provider job demands, and resources, as well as client outcomes such as skill acquisition and mental health.
Although numerous studies have demonstrated that a high percentage of primary care providers (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing ADHD, many fail to implement these guidelines correctly. The goal of this project is to increase the use of evidence-based practices (EBP) for assessing and treating children with ADHD between 5 and 12 years in the context of primary care practice. This randomized controlled trial will evaluate the whether a 3-part intervention (education about ADHD management and communication training, collaborative consultation, and performance feedback regarding use of EBPs) is effective in improving EBP use among primary care providers.
The objective of this Implementation Trial is to evaluate the implementation of evidence based practices for Bipolar Disorder and Treatment Resistant Depression in small rural Federally Qualified Health Centers. The evidence based practices chosen and adapted by Health Center providers and patients in consultation with clinical experts include: screening for and diagnosing Bipolar Disorder, prescribing mood stabilizers, on-line cognitive behavioral therapy, on-line peer support, collaborative care management and tele-psychiatry consultation. A quasi-experimental study design will be used, with each of the six participating Federally Qualified Health Centers choosing one implementation clinic and one control clinic. Implementation outcomes include: reach, adoption, implementation-fidelity and effectiveness. Providers and patients may choose to use all, any or none of the evidence based practices based on their needs and preferences. Data will be collected from chart review and patient surveys will be administered by an Interactive Voice Response telephone system.
Juvenile drug courts were developed in response to a perceived need to intervene more effectively with youth with substance abuse problems. Close collaboration between the court and substance abuse treatment provider is a defining component of the drug court model and is critical to helping youth achieve positive outcomes. Despite the proliferation of juvenile drug courts in recent years, however, evaluation of their capacity to reduce offender substance use and criminal activity has lagged. Moreover, the Institute of Medicine (IOM, 1998) and leading experts (McLellan, Carise, \& Kleber, 2003) have presented a bleak picture of the nation's capacity to meet the treatment needs of substance abusing individuals. Although community-based programs provide the backbone of substance abuse treatment in the nation, their capabilities have not kept up with major scientific advances in the development and validation of evidence-based substance abuse interventions. Building on our research findings and experience regarding juvenile drug court outcomes as well as the transport of evidence-based practices to community treatment settings, the purpose of this study is to develop and test a relatively flexible and low cost strategy for enhancing the outcomes of juvenile drug courts by integrating components of evidence-based treatments into existing substance abuse services. Specifically, this project aims to: Aim 1: Adapt existing intervention and training protocols from evidence-based practices (i.e., Contingency Management for adolescent substance abuse; family engagement strategies from evidence-based treatments of juvenile offenders) for integration into juvenile drug court sites. Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and system level (e.g., intervention adherence, feasibility, retention and completion rates, consumer satisfaction, cost estimates) effects of implementing the intervention protocols in juvenile drug courts. Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if findings are supportive.
This administrative supplement capitalized on the preliminary positive outcomes from the primary parent grant award (R01DA040416), and lessons learned from the implementation of the R3 Supervisor Strategy (R3) throughout the participating four regions (12 counties) in Tennessee. This project aimed to pilot the implementation of R3 with a new sample, a cohort of counties in Oregon particularly affected by the current opioid epidemic, for potential scale-up.
This research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in a new setting that increases access to mental health care - schools (Aim 1); test the cost effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (Aim 2c).
This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize "technology-based approaches" for "implementing large-scale change." Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.
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.
The goal of this study is to develop a targeted virtual training program (Simulated Exposure Trainer; SET) for exposure therapy. Two platforms with differing levels of immersion (low - mobile device; high - head mounted display) will be evaluated based on their usability and engagement of an empirically-derived training target (i.e., therapist negative beliefs). Target engagement will be evaluated by applying an experimental therapeutics framework during a brief training trial.
The goal of this pilot randomized clinical trial is to learn if a music therapy treatment, called AMUSED, can improve engagement and reduce behavioral symptoms in older adults with severe dementia who live in care facilities. The main questions it aims to answer are: * Is it feasible to conduct a full-scale trial of AMUSED? * Can investigators identify the best outcome measures to assess impact on behavioral symptoms of dementia? * Does speech offer a useful indicator of treatment effectiveness? Researchers will compare a group-based music therapy treatment to a reading activity to learn if music therapy leads to greater improvements in behavioral symptoms and speech patterns. Participants will: * Participate in either music therapy (includes live music, singing, and rhythmic instrument playing) or a reading group with stories about life and nature and talk about memories. * Attend small group sessions twice a week for 12 weeks, with each session lasting 40 minutes between lunch and dinner. * Be observed and assessed for behavioral symptoms, cognition, and speech several times during treatment and at a 4-week follow-up.
This study investigates the benefits of using telehealth services, specifically a combination of music therapy and social work support, to improve the well-being of older adults. Investigators are focusing on outcomes such as reduced loneliness, improved cognition, and how well older adults with and without dementia perceive the quality of the services received. This research is crucial because as the population ages and conditions like Alzheimer's become more prevalent, effective psychosocial interventions are needed. The collaborative telehealth approach of the intervention in this study strives to connect older adults to community and health-related services. Older adults experience challenges in accessing services related to transportation, social support, and finances. While the pandemic prompted a rapid shift of healthcare services online, including music therapy and social work, questions remain about the quality of this transition, especially for older adults who may not be familiar with or have the resources for telehealth. In this pilot study, investigators are studying music therapy and social work support through telehealth to understand how this approach can impact the well-being, cognition, and service quality for older adults, both with and without dementia. Social workers, who focus on improving well-being and addressing various needs, can leverage the therapeutic relationship built by music therapists to better identify and meet service needs. This pilot study builds on a feasibility project, which indicated that this collaborative framework is acceptable, valuable, and of interest to older adults, facilitating remote community connection. Through this research, investigators aim to evaluate the effectiveness of telehealth services for older adults to inform a future larger trial.
The goal of this randomized controlled clinical trial is to determine the feasibility, acceptability, and preliminary efficacy of an artificial intelligence platform )שׁ( for behavioral health in facilitating better clinical outcomes for adult patients receiving outpatient therapy. The main question\[s\] it aims to answer are: * whether an AI platform designed for behavioral healthcare would be feasible and acceptable to patients and therapists. * whether the depression and anxiety outcomes of adults receiving outpatient cognitive-behavioral therapy (CBT) in a community-based clinic would be superior among patients whose therapists used an AI-based platform to support clinical decision making and administrative tasks compared to patients receiving treatment-as-usual (TAU). Participants will receive CBT for depression or anxiety and complete standardized assessments. Participants will be followed for the first two months of therapy.
This is a pilot and feasibility study of a pragmatic cluster randomized trial that utilizes health information technology and practice facilitation to address referral barriers and increase clinician awareness and motivation to refer patients with diabetes to diabetes self-management education and services (DSMES).
An increasing number of schools in rural settings are employing the multi-tier positive behavioral interventions and supports (PBIS) framework to improve school-climate. PBIS can also be used as a framework for the adoption and integration of evidence-based practices (EBPs) for children's mental health concerns. A key challenge is that school personnel need technical assistance (training plus ongoing consultation) in order to implement EBPs with fidelity. In urban and suburban schools, this support can be provided to school staff on site. However, providing ongoing on-site support is not feasible or sustainable in the majority of rural schools, due to their remote physical location. For this reason, video technology has been recommended for the training of behavioral health staff (BHS) in under-served rural communities.
Rural areas have fewer, and less well trained, health care providers than non-rural areas. Schools have become more involved in the delivery of mental health services and hold great potential for increasing access to children and adolescents. Innovations in training and service delivery are needed to improve mental health care quality and availability in rural schools. Evidence-based practices (EBPs) can be incorporated into school-wide multi-tiered systems that are currently used to improve school climate and safety. School-wide Positive Behavioral Interventions and Supports (PBIS), a service-delivery strategy based on the public health model is one example. Investigators will use an iterative process (Rapid Prototyping) to develop and evaluate the appropriateness, feasibility, acceptability, and preliminary efficacy of a remote training strategy that provides resources to support use of Tier 2 EBPs and effective support for care coordination practices in rural schools.
Despite research identifying effective treatments for youth anxiety, parents (and other primary caregivers) are unaware that some treatments are more effective than others. This study investigates whether having a local parent key opinion leader co-facilitate an educational outreach presentation on effective treatment for youth anxiety will increase parent demand for evidence-based practices (EBPs). It is hypothesized that participants who receive a presentation co-presented by a key opinion leader will be more likely to have sought cognitive behavioral therapy for their child at the three-month follow up, relative to participants who receive a presentation presented by two researchers.
The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide.
The pandemic caused by the novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has resulted in substantial global morbidity and mortality including in Oklahoma and caused unprecedented interruptions in nearly all aspects of our lives. The population of the state of Oklahoma is at particular risk to SARS-CoV-2 due to its large rural population, strained healthcare system, and poor overall health. The Community-Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations (CATCH-UP) program will involve both practice-based and community-based approaches to maximize the reach of the Rapid Acceleration of Diagnostics - Underserved Populations (RADx-UP) consortium, broaden the potential perspectives that could be captured, and compare the effectiveness of strategies. The interventions will be pragmatic to allow CATCH-UP to respond to changing attitudes, barriers, and environments as the pandemic progresses as well as expected technology developments to produce more effective viral testing that can provide rapid results to patients. The investigators will assist 50 small primary care practices to implement guidelines-based testing and patient education about Coronavirus Disease 2019 (COVID-19) and risk mitigation strategies. The project's community-based approach is designed to rapidly respond to community testing needs by deploying mobile testing sites that will provide operational support to increase the efficiency and the existing capacity for state-wide testing by Oklahoma's public health authorities. Together, the investigators estimate that the CATCH-UP program will result in at least 105,000 SARS-CoV-2 tests performed during the first year of implementation. A comprehensive, ongoing evaluation will be performed to analyze patient and provider attitudes, barriers and facilitators of viral testing, identified health disparities caused by COVID-19, effectiveness of the intervention in both settings, and to allow robust collaboration with other RADx-UP consortium sites.
Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity. However, new statistical techniques make it possible to study small samples of heterogeneous populations. We propose to study the palliative care needs of family caregivers of children with ultra-rare diseases and to pilot test a palliative care needs assessment and advance care planning intervention to facilitate discussions about the future medical care choices families are likely to be asked to make for their child.
This study will test the impact of implementing the Communities That Helping to End Addiction Long-term (HEAL) intervention on opioid overdose deaths within 67 highly affected communities with the goal of reducing opioid overdose deaths by 40%.
This study will investigate the effects of an organizational implementation strategy called Leadership and Organizational Change for Implementation (LOCI), relative to training and technical assistance only, on fidelity to, and youth service outcomes of, a well-established digital measurement-based care intervention called the Outcomes Questionnaire-Analyst in outpatient community mental health clinics.
This study will pilot test three strategies designed to speed implementation of preventive post-extubation noninvasive ventilation (NIV): one control strategy (traditional online continuing medical education) and two novel strategies (interprofessional education and just-in-time education).
Research shows that the majority of all mental health (MH) treatment for children is delivered in schools. Unfortunately, however, school mental health (SMH) providers rarely use evidence-based approaches and are often poorly integrated into the school context. Given the high (\>20%) and increasing rates of MH disorders among children and youth, MH clinicians working in schools need effective and efficient ways to address student emotional and behavioral problems. The Brief Intervention Strategy for School Clinicians (BRISC) is a four-session, flexible, and research-informed "Tier 2" intervention tailored to high school students and designed to fit the school context. Findings from initial research funded by an IES Development and Innovation grant, including a small (n=66) comparison study, indicate positive, small to large sized effects (ES = .30- 1.33) in favor of BRISC for MH impairment, emotional symptoms, therapeutic alliance, coping skills, and client satisfaction. Moreover, even though the majority of students who were referred to BRISC were in the clinical range for functional impairment due to MH problems, over 50% were able to step down to lower levels of intervention after four sessions of BRISC, demonstrating promise for efficiency and reach. Given potential for public health impact, the purpose of the current study is to further examine the efficacy of BRISC by assessing its impact on mental health and academic outcomes - as well as feasibility, acceptability, and efficiency - in a larger, multi-site trial.