Clinical Research Directory

Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness

The purpose for this research project is to successfully achieve the primary systems intervention outcome, maintaining fidelity to the intervention model and time to rehospitalization. In the proposed research, the plan is to build the research infrastructure to ultimately test the effectiveness of CBIT on time to rehospitalization in a sample of rural Americans with SMI and determine the effective implementation strategies to bring the program to scale to address the significant unmet needs of this population. The proposed research will improve scientific knowledge and clinical and community practice by identifying the CBIT intervention's key components associated with enhancements in overall wellness and the mechanisms through which these improvements are attained. This may also better inform the practical and logistical design of future research for CBIT.

Postpartum Care in the NICU Multi-Site

Parents of infants admitted to the neonatal intensive care unit (NICU) face unique challenges in caring for their own health after giving birth. The demands of having a critically ill infant often make it difficult or impossible to attend postpartum care appointments, and research shows that NICU mothers are significantly more likely than other new mothers to develop postpartum depression and other health conditions, including hypertensive disorders of pregnancy. However, these conditions frequently go undetected and untreated because standard postpartum care systems are not designed to address the needs of NICU mothers, who often prioritize being present in the NICU over their own needs. The PeliCaN (Postpartum Care in the NICU) Multi-Site trial will test whether trained postpartum doulas supporting mothers directly in the NICU can help close postpartum care gaps. Study doulas will provide emotional support, help mothers monitor their blood pressure, screen for postpartum depression, assist with scheduling and attending postpartum care visits, and connect families to community resources while their infant is in the NICU and after discharge for up to 6 months. The study team will enroll approximately 756 mothers across 13 NICUs in the Metro-Philadelphia area. Participating NICUs will be randomly assigned to groups on a stepped-wedge schedule to begin offering the doula intervention. Mothers enrolled before their site begins the doula intervention will receive standard postpartum care and support; mothers enrolled after their site transitions to the intervention period will receive doula support. All participants will complete surveys at enrollment and at 6 months after birth and will have their medical records reviewed. The study's main goals are to determine whether having a doula in the NICU helps mothers to receive recommended comprehensive postpartum care within the first 12 weeks after birth and will assess whether doula support reduces symptoms of postpartum depression and increases maternal transition to primary adult care by 6 months postpartum. The study will also examine the experience of implementing doulas in the NICU across multiple hospital sites among intervention participants and NICU staff members.

Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities

The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.

Feasibility of the Implementation of the SPARKLe Nurse-led Integrated Transitional Care Model for Children With Complex Care Needs

Children with complex care needs often experience fragmented care during transitions from hospital to home, leading to unmet needs and increased burden on families. The SPARKLe project aims to address this gap through a nurse-led integrated transitional care model. This study evaluates the feasibility of implementing the SPARKLe model in a real-world hospital setting using a mixed-methods design, focusing on implementation outcomes including feasibility, acceptability, adoption, and fidelity.

Maternal Health Assessment in Pediatric Care

The major goal of this study is to develop and pilot M-HARP (Maternal Health Assessment and Referral Integrated into Pediatric Care). M-HARP will adapt a successful US-based health screening and referral protocol to fit the needs of new mothers at Clínica de Familia La Romana, Dominican Republic.

AI-based Predictive and Interventional System for Early Detection of Non-compliance Risks With Oral Therapies in Lymphoma Patients.

This research forms part of a continuous quality improvement initiative. It aims to assess patient compliance of oral therapies by artificial intelligence. It could overcome the limitations of current practices and enhance the responsiveness and accuracy of clinical interventions.

Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy

This multicenter pilot study evaluates the feasibility, implementation fidelity, and preliminary effects of the GAP-421 (Personalized Care Management) model for chronic pain management in primary care physiotherapy. The GAP model is a time-limited organizational modality that reconfigures schedules, resources, and professional roles during a defined 6-week window to organize care around the individual patient and their trajectory, formalizing coordination work that previously occurred informally. The study uses a convergent mixed-methods design across three primary care health centers in the Southeast Healthcare District (DASE) of the Community of Madrid, Spain. The quantitative component is a prospective multicenter pre-post case series with 3-month follow-up (n=66 patients, 22 per center). The qualitative component includes semi-structured interviews (n=12) and focus groups (3 groups, n=6 each). Integration occurs through Joint Display, Pillar Integration Process, and a 9-type legitimation framework. The primary outcome is patient-perceived care coordination measured on a 0-10 numerical scale (PREM). Secondary outcomes span five domains: patient-reported outcomes (EQ-5D-5L, Graded Chronic Pain Scale, pain intensity), professional outcomes (coordination burden, role clarity), system sustainability (avoidable re-consultations, emergency department use), implementation fidelity, and feasibility indicators. Results will generate feasibility parameters, intraclass correlation coefficient estimates, and process indicators essential for designing definitive cluster-randomized trials testing organizational interventions in primary care physiotherapy.

Leveraging mHealth to Enable and Adapt CHW Strategies to Improve TB/HIV Patient Outcomes in SA

mHealth solutions designed to support affordable human resources for health, such as community health workers (CHWs), offer the opportunity to reimagine a patient-centered, system-level solution that may radically change care models in low resource settings. The 'leap' of m-health is most potent and practical in settings where desktop-based infrastructure is lacking and hard-wired internet connectivity is unavailable. Investigators have demonstrated the feasibility of mHealth and human resource solutions in South Africa and shown marked improvements in screening, linkage and treatment initiation as well as supporting patient adherence through video DOT (vDOT) and early identification of treatment related toxicity. Investigators' strategies have evaluated solutions for individual cascade steps through TB and HIV smartphone and tablet-based m-health applications implemented by a CHW. This study combines these individual cascade step approaches into an innovative TB/HIV cascade intervention study entitled, "Leveraging mHealth to enable and adapt community health worker strategies to improve TB/HIV patient outcomes in South Africa (LEAP-TB-SA) Trial."

Improving Survivorship for Critically Ill Patients Aged 65 and Over

IMPROVE-65 is a randomised control trial designed specifically for people aged over 65 who have survived critical illness. It aims to support patients and general practitioners by providing timely, personalised information to help them work together to make informed goals and decisions about their care after hospital discharge. The aim of the study is to improve recovery and avoid preventable hospital readmissions.

Three-month Follow-up Analysis of Social Recommendations Issued by the Mobile Geriatric Team

This single-center, prospective, observational cohort study aims to evaluate the actual implementation rate of social recommendations formulated by the Mobile Geriatric Team at Saint-Étienne University Hospital three months after hospital discharge. These recommendations may include human assistance, technical aids, financial aid applications, legal protective measures, or referrals to appropriate care structures. A structured telephone interview at three months will assess the degree of implementation, explore associated barriers (administrative, cognitive, organizational, ...), and investigate any potential link with hospital readmissions or changes in patients' living situations.