Clinical Research Directory

Healthy Options At Pantries (HOAP) Study

This study will evaluate a digital nudge intervention, Healthy Options At Pantries (HOAP), in the online food pantries of three large charitable food organizations. The study will use a hybrid effectiveness-implementation design, meaning it will evaluate whether the intervention works and how it can best be rolled out in an online food pantry setting. Intervention effectiveness will be evaluated using an interrupted time series analysis to identify changes in how healthy foods ordered by shoppers are (primary outcome) by comparing food ordering data over time before and after HOAP is introduced. The study will also evaluate the possibility of collecting dietary and clinical outcomes in a small subgroup of online pantry shoppers over time comparing both in-person and at-home approaches.

Parents Helping Parents for Youth Vaping Cessation

The goal of this randomized controlled study is to test if this new intervention works to help adolescents quit vaping. A key feature of the program is the use of peer support for parents, delivered by trained parent coaches. Participants will complete baseline and follow up surveys. Parents in the intervention arm will receive peer support as part of the program.

Pilot Implementation Trial of Implementation Toolkits for Diabetes Coaching

The goal of this study is to learn if toolkits of implementation strategies (e.g., provider and staff education, clear plan for how to refer and bill) help pediatric type 1 diabetes medical and psychology providers deliver a behavioral intervention (Diabetes Coaching) to more families. The main questions this study aims to answer are: * Is it possible to put these toolkits of implementation strategies into place in one pediatric hospital? * Do providers and staff find these toolkits of implementation strategies acceptable? Participants will be type 1 diabetes professionals (endocrinologists, nurse practitioners, psychologists, scheduling and billing staff) at Nemours Children's Hospital Delaware. Participants will: * Attend educational and/or planning meetings * Receive email updates on referral data * Complete surveys * Complete an interview

Evaluation of Choose to Move Replacement Ready (CTM-RR)

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

REmote Virtual Inspiration: Vitality and Energy

REVIVE is a randomized controlled trial designed to evaluate the effects of a remotely delivered seated Tai Chi/Qigong (TCQ) intervention on cardiometabolic health, stress, sleep, and psychological well-being among women with mobility impairments. Women with mobility impairments experience higher rates of obesity, cardiometabolic disease, chronic stress, sleep disturbances, and mental health concerns compared with women without disabilities. Limited access to accessible physical activity programs and barriers to participation in traditional exercise interventions contribute to these health disparities. Tai Chi and Qigong are gentle mind-body practices that may improve physical and psychological health through movement, breathing, and mindfulness techniques and can be adapted for individuals with limited mobility. Participants will be randomized to either a seated Tai Chi/Qigong intervention or a health education video control condition. During the 12-week intervention phase, participants will receive daily video-based content delivered remotely. Participants assigned to the Tai Chi/Qigong group will engage in seated meditative movement practices, while participants assigned to the control group will receive health and wellness education videos unrelated to physical activity or nutrition behavior change. Outcomes will be assessed remotely at baseline, post-intervention, and follow-up. Primary outcomes include waist circumference and indicators of physiological stress regulation, including heart rate variability and salivary cortisol. Secondary outcomes include perceived stress, emotion regulation, depression, anxiety, emotional eating, sleep quality, and sleep disturbance. Additional measures collected through wearable technology, sleep diaries, questionnaires, and biological samples will be used to examine potential behavioral, psychological, and physiological mechanisms underlying intervention effects. The findings from this study will contribute to the development of accessible, scalable, and evidence-based health promotion interventions designed to improve cardiometabolic health and overall well-being among women with mobility impairments.

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

The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to reduce disparities 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 unequal and unethical decision-making towards patients, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. Our rigorously designed trial will 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 across populations.

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.

Clinical Surveillance Tool to Screen for Unmet Palliative Needs Among Patients in the Final Year of Life

One of the most important obstacles to improving end-of-life care is the inability of clinicians to reliably identify those who are approaching the end-of-life. Every aspect of a palliative approach to care - screening for unmet needs, treating symptoms, discussing goals of care, and developing a palliative management plan - depends on the reliable and accurate identification of patients with palliative needs. The investigators developed an accurate and reliable mortality prediction tool that automatically identifies patients in hospital at elevated risk of death in the coming year. In previous studies it has been shown that these patients also frequently have unmet palliative care needs at the time they are identified by the tool. This tool has been demonstrated feasible, acceptable to patients and providers, and effective for changing physician behaviour in an inpatient clinical context. In this project, this tool is implemented as part of an integrated knowledge translation project to facilitate reliable and timely identification of unmet palliative needs across multiple hospitals with different clinical settings and contexts. The investigators have partnered with 12 hospitals to improve the quality of palliative and end-of-life care provided to patients and families. With each partner site the investigators will develop a comprehensive implementation plan, including stakeholder engagement, education, and feedback. Process measures will be collected at each site to determine whether the tool was effective for promoting the identification and documentation of unmet palliative needs. Patients who were identified by the tool will also be followed over time to collect outcome and impact measures to see if their end-of-life care was affected by the intervention compared to control groups.

Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.

Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana

The investigators propose to develop and/or adapt implementation strategies and a structured implementation plan to translate the HOPE intervention into existing healthcare practice in Ghana. These "implementation support strategies (ISS)" are implementation strategies relevant to implementation support, which is concerned with moving (implementation) research into (implementation) practice. The ultimate goal is to facilitate health system adoption and sustainment.

Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD

The proposed project aims to integrate team-based implementation strategies with an established school-based intervention for children with ADHD, the Collaborative Life Skills Program (CLS), to enhance its implementation and optimize its effectiveness. The investigators will tailor three empirically-supported team development interventions, Team Charters, Team Communication Training (Student Handoff Protocols), and Team Performance Monitoring, and integrate them into a team-enhanced CLS implementation protocol (CLS-T). Team Charters are a written document developed collaboratively by the team at the outset of their work together outlining expectations, goals, roles and responsibilities, and relevant policies and procedures for team collaborative operations. Research shows that Team Charters strengthen affective emergent states, such as trust and cohesion among team members, as well as cognitive emergent states, such as shared mental models. They also strengthen team processes, such as goal specification, communication, and coordination to optimize team effectiveness. Handoff protocols are widely used interventions for ensuring continuity in patient care and minimizing errors in medical settings. They have also been found to improve affective (e.g., trust, cohesion) and cognitive (e.g., shared mental models, situation awareness) emergent states among team members, enhancing team communication and coordination. Finally, Team Performance Monitoring provides feedback to teams that can motivate performance, provide opportunities for adaptation in the event of challenges, and prompt communication among team members. The investigators will conduct a Hybrid Type III cluster randomized trial in 24 schools in two large urban school districts, to evaluate whether CLS-T implementation results in improved implementation outcomes and child outcomes in comparison to standard CLS implementation.

K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions

This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention.

Evaluation of a Multi-Component Intervention to Support HIV Testing and Linkage to Services Among MSM in Peru

This study is testing a new program designed to improve access to HIV testing and help connect people with available treatment or prevention services, based on their test result. The version of the program being tested in this study was designed for men who have sex with men (MSM) in Lima, Peru. The program has two main parts: 1) offering HIV testing at venues where people go for sex (called "sex-on-premises venues" or SOPVs), and 2) a text messaging app that shares useful information about HIV treatment/prevention; users can also message back to get support from a healthcare worker. Before doing this study, the researchers worked with community members and healthcare providers in the area to make sure that the HIV testing approach and mobile app were designed in a way that would be engaging and meet their needs. Every Thursday, Friday, and Saturday night during recruitment, the researchers will go to SOPVs popular among the MSM community in Lima and invite people to take an HIV test. On each recruitment date, they will offer one of the following HIV testing options: 1. A rapid HIV test done on-site (participants will get their result right away) 2. An HIV self-testing kit to take home 3. A coupon for a free HIV test at a participating health center 4. Their choice of any one of the previous three options Only one of these options will be offered at a time, depending on the date. The specific HIV testing option offered on each date will be randomly assigned. All participants will receive the mobile app, which will send weekly messages with links to different types of online content (infographics, maps, videos) over the next 3 months. The specific sequence of messages and content will be different depending on the type of HIV test the person received and their HIV test result, once it is known. The study will measure two main outcomes related to the acceptability and feasibility of the program: * The number and percentage of people who accept the program when offered * The number and percentage of participants who continue to engage with the mobile app after 3 months The study will also measure: * overall satisfaction with the app (based on a questionnaire sent at 3 months) * the number and percentage of participants who completed any form of HIV testing after 3 months * the number and percentage of participants who started HIV treatment (out of those with a positive HIV test) * the number and percentage of participants who started HIV pre-exposure prophylaxis, or "PrEP" (out of those with a negative HIV test) All follow-up will be done remotely. Participants will have the app for 3 months. After 3 months, they will get a follow-up questionnaire asking about their experiences with the program. The researchers will keep tracking results related to the HIV treatment/prevention services that people receive for up to 6 months.

Cardiac point-of Care Ultrasound Training Pathway for Emergency Department Advanced Practice Providers

The aim of this study is to assess emergency medicine physician and advanced practice provider (APP) knowledge and technical skill in performance of a point-of-care ultrasound simulation and just-in-time training pathway to determine the feasibility, acceptability, and usability of the ultrasound training program. By performing this study, we hope to create a standardized training model which could potentially facilitate point-of-care ultrasound (POCUS) clinical performance and thereby improve patient care.

Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients

The aim of this study is to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians and evaluate the effectiveness of the cardiac point-of-care ultrasound (POCUS) simulation-based training (CPST) and CPG implementation. By performing this study, the investigators hope to improve diagnostic processes and time-to-diuretic dosing for acute heart failure (AHF) patients.

Reduction of Low-value Prescribing Through Audit and Feedback

The objective is to estimate the effect attributable to a primary care pharmacist-led audit and feedback (AF) strategy compared to the currently used AF strategy as a management tool to evaluate healthcare performance focusing on processes and outcomes, for reducing the rate of patients over 65 years of age with potentially inappropriate prescribing (PIP) of benzodiazepines, proton pump inhibitors and opioids. A closed-cohort stepped-wedge cluster-randomised trial will be conducted in nine PC centres from Barakaldo-Sestao Integrated Health Organization, Basque Health Service (Osakidetza). All health centre clusters will start under the control condition, and after an initial study period of 4 months in the control phase, one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention, under which they will be exposed to an additional component of AF, namely, primary care pharmacist-led facilitation. Mixed-methods analysis will be performed, gathering quantitative data to assess the results of the implementations at health centre and clinician levels, and qualitative data to assess the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and explore the experience and satisfaction of patients regarding the healthcare received. This study will provide useful knowledge on the effect attributable to a more intensive AF strategy (facilitated AF) compared to standard procedures of AF reports, and of the characteristics of AF that are most effective.

Leveraging Telepsychology and Behavioral Economics to Increase Fidelity to CBT

The goal of this study is to develop and test a telehealth tool intended to support community mental health clinicians to deliver cognitive behavioral therapy (CBT). The main aims of the study are to: 1. Collaborate with clinicians and supervisors to design an accessible prototype to increase clinician use of CBT in community mental health settings through focus groups, interviews, and surveys. 2. Adapt the initial model through feedback from clinicians and their patients who will be asked to test the tool then complete interviews and surveys. 3. Test the model with clinicians and their patients who will be asked to use the tool for several weeks. 4. Evaluate the acceptability and feasibility of using the tool in a pilot trial through surveys and interviews.

Development of Implementation Toolkits

The purpose of the study is to conduct an intervention program aimed at increasing HPV self-sampling among women living with HIV in Ghana.

Implementing PrEP for Women Who Inject Drugs

Women who inject drugs are among the most vulnerable to acquiring HIV, but very few women who inject drugs are prescribed pre-exposure prophylaxis (PrEP) for HIV prevention largely due to barriers within our healthcare system. This research will consider the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP to women who inject drugs, thereby reducing new HIV infections in this population.

Deimplementing CXR After CVC (DRAUP) in the ICU

This study proposes adapting and testing an innovative, behavioral theory-driven deimplementation program called DRAUP in two intensive care units for proof of concept and support that the program can help providers and hospital organizations address context determinants of deimplementation. Study data will be used to optimize the intervention for a subsequent larger trials.

CommunityRx-Dementia + Peer Navigation (CRxDpeer)

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

Implementation Facilitation of Exercise is Medicine Greenville

A public health priority exists for the U.S. healthcare sector to integrate physical activity (PA) as a part of the patient care model. This research will provide valuable information on facilitating optimal implementation of a clinic-to-community model that identifies, refers, and enrolls physically inactive patients to community-based PA programs for the prevention and treatment of chronic diseases. Further, this work will provide evidence on the cost-effectiveness of integrating PA in healthcare systems as a population health management strategy.

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following: 1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity. 2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes. 3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.

Implementation Pilot of Preoperative CGA Before Major Surgery

The goal of this clinical trial is to test whether a new implementation package can help older adults prepare for major surgery. The main question it aims to answer is: Can the implementation package help give more people access to this resource? Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The results will be compared to a historic baseline.