Clinical Research Directory

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.

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.

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

The overall objective is to evaluate the effectiveness and implementation of the Corrie Lipids Program, a comprehensive digital health initiative designed to address critical gaps in lipid-lowering as a component of ASCVD treatment by delivering an intervention that combines a patient-facing smartphone app, clinician education and coaching, and seamless incorporation into clinical workflows. Researchers plan to assess this multicenter digital health initiative in approximately 1,000 adults with uncontrolled LDL-C and elevated ASCVD risk using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study will examine whether the program improves LDL-C goal attainment, app engagement, prescribing patterns, and LDL-C monitoring, while also identifying barriers and facilitators to implementation across sites.

Data2Action Oregon Project: Supporting Data-driven Decision-Making for Substance Use Services, Policy, and Overdose Prevention

Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use services and mitigate the growing opioid and methamphetamine epidemics in their state. Consistent with the HEAL Data2Action call for Innovation projects that drive action with data in real-world settings, this study will refine and test the impact of a novel implementation strategy to engage cross- sector decision makers and make data that they identify as relevant to their decisions available to them in easy- to-use products. The proposed study aims to not only address critical knowledge gaps regarding how and when data can inform impactful, transparent decision-making, but to provide decision makers with the data that they need to achieve community-wide substance use prevention and treatment goals, including the increased delivery of high-quality, evidence-informed, services and the prevention of overdoses.

Feasibility of Choose to Move Replacement Ready

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 goal of this observational study is to learn if the adapted program, Choose to Move Replacement Ready (CTM-RR), is feasible to deliver to people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. 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.

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.

Implementing Low-Barrier HCV Treatment in a Jail Setting

The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial. The study asks: * Can a simplified, low-barrier HCV treatment program work in a jail setting? * Do participants finish treatment and get cured using this approach? All participants will receive a 12-week course of the HCV medication sofosbuvir/velpatasvir (Epclusa). If they are released before completing treatment, they will take the remaining doses with them. Community Health Workers (CHWs) will help support participants after release, including reminding them to take medications and helping them get follow-up lab work. Researchers will measure: * Whether participants are cured of HCV * Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity) * Whether the program could be used in other jails or expanded in the future This study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.

Behavioral Economic & Staffing Strategies in the ICU

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.

Optimizing Implementation of the Intensive Diabetes Prevention Program

The goal of this clinical trial is to explore the effectiveness and implementation outcomes of the optimized Intensive Diabetes Prevention Program (IDPP) in District Health Centres. The main questions it aims to answer are: * Do the implementation strategies - patient engagement system, structured training, and reminder systems - work better than usual approaches in terms of acceptability, adoption, appropriateness, feasibility, sustainability, and implementation cost? * Do patient health outcomes - HbA1c levels, BMI, lipid profile, quality of life, perception of empowerment, and health service utilization - stay the same or get better when these improved strategies are used compared to usual approaches?

Enhancing Mental and Physical Health of Women Veterans

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

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.

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.

Behavioral Economics to Implement Nutrition Ranking in Food Pantries

The goal of this randomized controlled trial is to test whether using behavioral economic strategies to promote healthy food choices on a food bank's online ordering platform increases the use of the traffic light nutrition ranking system and increases healthier food selections by the food agencies (e.g., food pantries) who use the food bank.

Enhancing Mental and Physical Health of Women Veterans 3.0

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

The P-KIDs CARE Health Systems Intervention in Tanzania

The objective of the proposed research is to develop and pilot a locally-relevant, multicomponent intervention to streamline the triage process (e.g. patient assessment, stabilization, and disposition) for pediatric injury patients in Tanzania. This health systems intervention will work at the first level of medical contact (e.g., health center and district hospital), in order to facilitate timely disposition and referrals, and subsequently decrease time to definitive care. The proposed study has three aims: 1) With a mixed methods approach, describe the barriers to pediatric injury care at the first medical contact; 2) Iteratively develop the P-KIDs CARE intervention using a nominal group technique and conduct a pre-implementation assessment and refinement; 3) Pilot the P-KIDs CARE intervention and perform an implementation-focused formative evaluation. The proposed study focuses on pediatric injury patients and the family members and healthcare providers that care for them in Kilimanjaro, Tanzania. The investigators will recruit pediatric injury patients, family members, and healthcare providers from 2 health facilities in the Kilimanjaro Region.

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 at each step, some three centres 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.

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.

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.

Sustainability Via Active Garden Education Wellness Implementation Strategies in Early Care and Education

This project compares four SAGE implementation strategies to evaluate effectiveness in implementation, sustainability, cost, and child health outcomes. Using the CFIR and MOST frameworks, the investigators will analyze key components to identify the most efficient and scalable strategies. Data will come from ECE site audits, surveys, social network analysis, and child health assessments. Findings will inform sustainable, cost-effective approaches to improve early childhood nutrition and physical activity.

Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV

Ending the HIV epidemic for youth living with HIV will require implementation and optimization of evidence-based interventions that address barriers to treatment. The proposed implementation study will test a youth-led data-driven implementation strategy to scale-up an evidence-based Adolescent Transition Package (ATP) aimed at improving transition processes and post-transition clinical outcomes for youth living with HIV in Kenya. Clinics will be randomized to receive standard of care implementation through trainer of trainers or the youth-led data-driven implementation strategy alongside trainer of trainers. We will study whether the enhanced implementation strategy improves the number of youth who receive the ATP, the number of providers that initially chose to use the ATP, and the consistency with which the ATP is used over time. We will also evaluate the cost of the ATP and whether the ATP improves health outcomes among youth living with HIV, including viral suppression and retention in care. Healthcare workers at study sites will complete surveys, focus group discussions, interviews, and participate in continuous quality improvement processes. Youth will participate in surveys and focus groups, and have their routine medical records abstracted.

BrighT STAR LIBRA: Leveraging Implementation Science for Blood Culture Reduction Approaches

This study will compare two strategies that target distinct determinants of blood culture overuse in an exploratory, hybrid, pilot trial in 8 PICUs. It aims to determine if there is any association between specific strategies used to reduce blood culture overuse on unit-wide blood culture rates, patient safety, and concurrently explore aspects of the implementation process (acceptability, feasibility, appropriateness).