Clinical Research Directory

Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice

Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions. This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.

Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists

This study looks at whether using secure digital systems to share information between pediatric health care providers (during regular well-child visits) and social care providers (during regular visits with WIC nutritionists) can help mothers receive consistent guidance on responsive parenting to support healthy child growth and development. Responsive parenting means learning how to respond to a baby's needs in ways that support healthy eating, sleep, activity, and emotion regulation habits. The main questions this study aims to answer are: 1. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting to support healthy growth from birth to 24 months? 2. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting, improve responsive parenting practices and child diet quality? The investigators will compare the group that receives secure digital systems for sharing information on responsive parenting to a group that receives standard care (does not receive this) to see if secure digital systems for sharing information on responsive parenting work to support healthy child growth and development. The goal is to see if this approach can improve early health behaviors and reduce health disparities for families in rural, low-income communities.

Testing the CrOss Systems Technical Assistance for Retaining Staff (COSTARS) Model for Improving Staff Retention Among Child Welfare Workers and Peer Supporters, and Implementation of Evidence Based Interventions.

The goal of this study is to test whether the CrOss System Technical Assistance for Retaining Staff (COSTARS) supervision leadership institute can promote workforce stability and improved implementation outcomes within the Ohio START child welfare program. The main questions it aims to answer are: * Among supervisors, caseworkers, and family peer mentors, what is the effect of COSTARS on staff retention and perceptions of the work environment? * What is the effect of COSTARS on service timeliness, implementation fidelity, and parent outcomes within Ohio START? Researchers will compare public children services agencies implementing COSTARS to those implementing supervision practices as usual to see if there are differences between groups in the outcomes described above. Participating supervisors will: * Complete a 6-hour training workshop in the FOCUS model of supervision. * Participate in monthly group coaching sessions with other supervisors, for approximately one year. * Receive individualized feedback from coaches about their supervision performance.

FAmily Engagement Strategy for Coordinated Specialty Care

Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.

Canada-wide Implementation of a Virtual Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients and Their Partners

The goal of this observational study is to evaluate the effectiveness of SHAReClinic, a national, virtual Sexual Health and Rehabilitation eClinic designed to support prostate cancer patients and their partners. Specifically, this study aims to assess SHAReClinic's impact on improving sexual function, satisfaction, and relational intimacy after treatment. The primary objective is to evaluate SHAReClinic's effectiveness across participating sites and determine its role in supporting long-term sexual health and well-being. As part of usual care, newly enrolled SHAReClinic patients will receive guided education modules and access to sexual health counselling at key recovery milestones. SHAReClinic seeks to expand access to sexual health care for prostate cancer patients across Canada by providing evidence-based, virtual sexual rehabilitation. Findings from this study will inform best practices in survivorship care and contribute to the development of a national standard for oncology sexual health interventions.

Parks & Pediatrics Fit Together

The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.

Y of Central Maryland Head Start Asthma Implementation

Despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. Head Start (HS) serves over one million low income children in the US each year by focusing on early learning, physical health, and family engagement. HS is committed to implementing evidence based programs to promote overall child well-being, and is focused on addressing asthma symptoms due to the deleterious impact on school absences and child development. We have demonstrated the effectiveness of a multi-level staff and family education program (ABC Asthma) that significantly reduced asthma symptoms and courses of oral corticosteroids. However, these interventions are not successfully integrated within community organizations for long-term sustainability. It is unknown how to best scale up and implement these evidence based asthma interventions into low resource community organizations that serve children at risk. Implementation strategies are frequently developed atheoretically and may not be tailored to the setting. The overall purpose of this project is to inform best practices of implementation of an asthma education program by 1) systematically evaluating the use of intervention mapping to develop a tailored implementation strategy in partnership with Head Start stakeholders, 2) examining both staff and organizational level determinants associated with implementation of ABC Asthma, and 3) evaluating the success of tailored implementation strategies on implementation outcomes and school absences and other health outcomes. The YMCA of Central Maryland have enthusiastically agreed to implement the Maryland ABC HS Asthma within 40 sites in four communities: Baltimore City, Baltimore County, Anne Arundel County, and Prince George's County.

Cascading A Healthy Sleep Intervention In Vocational Education

Sleep is crucial for the mental, cognitive and physical health of adolescents. However, teenagers in 2024 sleep less and less and their sleep is of poorer quality. It is striking that adolescents who follow vocational education sleep even worse compared to peers who follow a technical or general education. It is therefore important to focus on this risk group of adolescents to reduce health differences. However, there are no previous intervention studies that focused on them. In previous research, a healthy sleep intervention was already developed, implemented and evaluated in a participatory manner. Within this research, the investigators want to focus on evaluating the process of implementation of this intervention among first and second year secondary school students (12 to 14 year olds) and teachers from vocational education. Based on the results of this process evaluation, the investigators want to deliver this intervention as a ready-made package to Flemish secondary schools.

Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients

MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible. The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients

Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord

The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD. The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed? Healthcare providers and patients are asked to use the module and share their experiences with it.

Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity

This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.

Standardizing Right Hemicolectomy for Colon Cancer

A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes. For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection. Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. Detailed objective assessment of the LRHC is currently not performed in clinical practice nor in surgical training. Quality assessment of LRHC has great potential to improve surgical training and furthermore, implementation of a standardized technique will ultimately lead to better quality of care for patients suffering from right-sided colon cancer. The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.