Clinical Research Directory

AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)

This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

Empathy and Communication Training Program for Psychiatric Nurse Specialists in Saudi Arabia (ECTP)

This study tests whether a five-day Empathy and Communication Training Program (ECTP) helps psychiatric nurse specialists in Saudi Arabia engage better with their patients. Good relationships between nurses and patients are central to mental health care, but structured training in empathy and communication is limited in Saudi psychiatric hospitals. The ECTP is a face-to-face program of five two-hour sessions (10 hours in total). It covers empathy and communication, the work environment, language and cultural barriers, and emotional preparedness. Sessions use short lectures, role-play, case discussions and group reflection. The study took place at two psychiatric hospitals. Nurses at the Eradah Complex for Mental Health in Dammam took the ECTP. Nurses at the Eradah Hospital for Mental Health in Madinah attended their usual hospital training sessions instead. Participants were not randomly assigned. The hospital they worked in decided which group they joined. Nurses at both hospitals completed a 15-item questionnaire about therapeutic engagement before and after the training period. After the program, 15 nurses from the Dammam group were interviewed about how the training affected their work and what barriers remained. The study aims to find out whether nurses' self-reported therapeutic engagement improves after the ECTP compared with usual training, and to understand nurses' own experiences of the program.

The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now

In 2014, a team of parents, nurses, and physicians created Patient and Family Centered I-PASS (PFC I-PASS), a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. PFC I-PASS changed how doctors and nurses talk to patients and families on rounds when they're admitted to the hospital. (Rounds are when a team of doctors visit patients every morning to do a checkup and make a plan for the day.) Rounds used to happen in a way that left out patients and families. Doctors talked at, not with patients, used big words and medical talk, and left nurses out. PFC I-PASS changed rounds by including families and nurses, using simple non-medical words, and talking in an organized way so nothing is left out. When PFC I-PASS was put in place in 7 hospitals, patients had fewer adverse events and better hospital experience. But it didn't focus on how to talk with patients with language barriers. This project builds upon upon PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. This new intervention is known as PFC I-PASS+. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters on and after rounds and training doctors about communication and cultural humility. The study team will now conduct a stepped-wedge cluster randomized trial to compare the effectiveness of PFC I-PASS+ and PFC I-PASS to usual care at 8 hospitals.

A Communication Tool to Improve Communication in the ICU

The purpose of this study is to test the effectiveness of the Best Case/Worst Case-ICU communication tool on quality of communication, clinician moral distress, and ICU length of stay for older adults with serious traumatic injury. Investigators will follow an estimated 4500 patients aged 50 years and older who are in the ICU for 3 or more days and survey 1500 family members and up to 1600 clinicians from 8 sites nationwide.

The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer

Optimizing the Patient Experience Through Provider Coaching or Communication Intervention

Hypothesis: Clinicians who receive patient experience coaching or communication classes have improved patient satisfaction scores and improved clinician satisfaction.

Handoffs and Transitions in Critical Care - Understanding Scalability

The investigators will leverage implementation science and engineering to adapt, implement, and rigorously evaluate tailored postoperative handoff protocols and implementation strategies. In doing so, the investigators will develop a vital understanding of the factors needed for successful and sustained use of evidence-based interventions in acute care. This knowledge will inform approaches to bridge the evidence-to-practice gap that prevents effective interventions from realizing the promise of improved patient outcomes in acute care settings.

Effect of an AI Agent on Caregiver Communication Experience in the Pediatric Emergency Department

This single-center, single-blind, randomized controlled trial evaluates whether the use of a conversational large language model (LLM)-based AI agent, used by caregivers during the waiting period before physician consultation in a pediatric emergency department (ED), affects the caregiver-perceived effectiveness of clinical information delivery compared with standard care. The AI agent collects and summarizes the child's symptoms via voice before the consultation and does not participate in any diagnostic, prescribing, or treatment decisions. A total of 34 caregivers were enrolled at Samsung Medical Center.

Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers

To improve patient-centered outcomes for older patients with cancer considering or receiving chemotherapy and their caregivers. To do this, the project team will (a) establish the effectiveness of GA on communication about age-related concerns, patient and caregiver satisfaction with communication about age-related concerns, quality of life, and patient-reported side effects of chemotherapy; (b) evaluate the success of the implementation strategies on the adoption, reach, and fidelity of implementing the GA in community oncology practices; and (c) identify the resources needed to implement GA and the GA-guided recommendations in community oncology practices for older patients considering or receiving chemotherapy.

Communication Strategies to Increase HPV Vaccinations

This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. However, low HPV vaccination rates among adults remain a significant public health challenge. Although randomized controlled trials (RCTs) have demonstrated that interventions can increase vaccine uptake in children, few RCTs have been conducted among adults. To address this gap, a multidisciplinary investigative team with expertise in communication, medicine, nursing, and behavior-change intervention research will conduct a survey experiment and a cluster randomized controlled trial. First, a national sample of adults ages 18 to 45 who have not received the HPV vaccine or are unsure of their vaccination status will participate in a survey experiment to identify the most promising theory-based messages to strengthen HPV vaccine intentions. The two messages associated with the largest increases in vaccination intentions will then be selected for further testing. Next, 16 Penn Medicine primary care clinics will participate in a factorial cluster randomized controlled trial to test patient-level and clinic-level interventions designed to increase HPV vaccine uptake. Patient-level interventions will include theory-based text messages and a reminder-only message condition. The clinic-level intervention will provide healthcare providers with feedback on missed opportunities for HPV vaccination and a toolkit to support strong HPV vaccine recommendations. The study will evaluate whether these interventions increase receipt of the first HPV vaccine among eligible adult patients and whether combining patient-directed messages with the clinic-level intervention further increases HPV vaccination. HPV vaccination will be assessed using Penn Medicine electronic health records and, when needed, patient self-report.

AI-Driven Consent Simplification Study

The overarching goal of this pilot is to explore how generative artificial intelligence (genAI) can be used to improve the accessibility and understandability of informed consent materials in clinical research. The study will test the extent to which informed consent text can be improved by large language models (LLM; specifically, ChatGPT and NotebookLM) along with other AI tools (specifically, ElevenLabs) through qualitative and quantitative analyses. Simplifying such forms using genAI may facilitate better comprehension, ensuring truly informed consent. Improving informed consent form (ICF) comprehension can lead to more informed and willing participation in clinical studies. This improved understanding may result in higher enrollment rates, better subject retention, and more accurate data collection as individuals will have a clearer understanding of study procedures and risks. After reviewing the assigned consent information, participants will be asked a series of questions to capture their overall understanding. Then they will then be asked specific, multiple-choice questions about the content of the consent form.

The VIP3 (Very Old Intensive Care Patients) Study: Family Involvement in Treatment Decisions for Old ICU Patients

The demographics of the global population is changing with increasing numbers of elderly and co-morbid patients. As a result, more elderly patients will be admitted to the Intensive Care Unit (ICU), which will bring several ethical challenges. It is for this reason the investigators have chosen to focus on this historically neglected and important patient population. Little is known about how family meetings are implemented in ICUs in Europe and other parts of the world. However, these meetings contribute to building trust between the family and the ICU team. They are a crucial component for planning and conducting a time limited trials as they provide the opportunity for shared-decision making with the ICU team and with other stakeholders. The investigators plan to determine the current practice of communication between ICU staff and patients and their relatives. The investigators expect to find a substantial variation in approaches to family meetings. This information may then help design and further investigate targeted interventions enabling shared decision-making focused on family and patient values. The investigators research aim is to to investigate whether Family meetings are used in ICUs across Europe and other regions and, if so, how they are conducted and the influence on patient-centred outcome measures.

COVID-19 Resource Offers Among Rent and Utility Assistance Applicants in St. Louis

The purpose of this study is to evaluate health messaging strategies that help individuals with a high degree of housing-related needs engage in COVID-19 vaccination and testing behaviors. Findings from this research can help other communities determine how best to integrate social needs and COVID-19 prevention services. Participants' contact information will be shared with us by 211 with the participants' previously given consent. The study team will send via text message a link to a survey that includes a screen where they will provide informed consent. Those who provide consent will be randomly assigned to receive one of two surveys. The order of the offers is what varies across the surveys. Participants will be asked, along with other survey items, if they have been vaccinated against COVID-19. If they have not, they will be asked if they are interested in receiving help to receive a vaccine. Participants will also be asked if they are interested in receiving an at-home COVID self-test. If they say yes to assistance with vaccination, a vaccine navigator will call and assist them. If they say yes to receiving a COVID test, the study team will ship them a test that has been procured from the City of St. Louis Mayor's office. One month later participants will be sent a follow-up survey that asks about their experiences either with testing or with vaccination if applicable.

Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences

1 in 7 infants born in the United Kingdom will require treatment on a Neonatal unit to treat conditions, which vary in there level of severity. Treatments and interventions aimed at supporting the unwell neonate have associated risks and the evidence underpinning them can range from limited to substantial. There is a degree of uncertainty in Neonatology, which can be very stressful for parents and clinicians alike. Parents need to be supported by the clinical team in making many complicated clinical decisions, a skill that requires robust communication of risks, benefits and alternatives. In 2019 the British Association of Perinatal Medicine released a framework of care advocating Shared Decision Making (SDM) as the optimal process for making clinical decisions on neonatal units. This model builds upon the "informed decision" models by putting a greater emphasis on involving parents in key decisions regarding the treatment of their babies medical condition. Evidence has demonstrated that SDM can improve parental satisfaction and reduce anxiety and the likelihood of feeling regret. In order to support parents in the SDM process, clinicians need to be able to provide impartial information encompassing the proposed intervention, intended benefit, potential risks and alternatives. Whilst clinicians may have preconceptions on the information that they think should be provided, there is limited evidence in the literature of what are the most important concepts and themes that parents would expect to be conveyed during the SDM process. ShAPE is a qualitative study that aims to

Pictorial Support in Person-centred Care for Children (PicPecc)

Introduction: Person-centred care is based on the assumption that every person has resources that should be used in the care situation. In order for this to happen the patient has to be able to effectively communicate his/her symptoms. This protocol describes the analysis of a digital picture-based tool for communication support for children with cancer aged 5-17 years, who undergo high-dose methotrexate treatment. The advantage of a non-linguistic based platform, beside the expected clinical outcomes, is that it can be used in multiple national studies with minimal translation. Methods and analysis: Two studies will be conducted in a hybrid design, i.e., a crossover design will be used for the intervention (effects), and a mixed-methods design will be used for the process evaluation. Qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals as part of the process evaluation. The interviews will address the experiences of the intervention and frequency of use from the child's perspective. Interview transcripts will be analyzed qualitative descriptively. The digital communication tool will collect child self-reports of symptoms/emotions. The children will be monitored for biomarkers of stress and pain (neuropeptides, neurosteroids and peripheral steroids) in venous blood samples, in-app estimation levels for the children, drug consumption. Person-centeredness will be evaluated with the questionnaire Visual CARE Measure. Ethics: Ethical approval was obtained from the Swedish Ethical Review Authority (ref 2019-02392; 2020-02601).

Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations

Compared to the general population, individuals from underserved communities are more likely to receive low quality end-of-life care and unwanted, costly and burdensome treatments due in part to a lack of advance care planning (ACP; the process of discussing wishes for end-of-life care with loved ones/clinicians and documenting them in advance directives). This study will use existing, trusted, and respected social networks to evaluate two conversation-based tools intended to engage underserved individuals in discussions about end-of-life issue and motivate them to carry out ACP behaviors. Through this study, investigators will learn how best to engage underserved populations in ACP so as to: 1) increase the likelihood that patients from underserved communities will receive high-quality end-of-life care; 2) address health disparities related to end-of-life treatments; and 3) reduce unnecessary suffering for patients and their families.

Messages That Motivate: Communicating Alcohol-Related Breast Cancer Risk to Young Adult Women

This is an online cross-sectional experimental survey study examining two cancer communication questions: 1) What features of social media messages communicating the breast cancer risks from alcohol consumption will motivate young adult women to drink less? and 2) Do message features differ in their persuasive effects based on young adult women's alcohol consumption behavior?

Evaluating Food Messaging Campaigns for Young Adults

This study aims to determine whether online social media campaigns improve diet quality among young adults. Young adults will be exposed to one of three social media campaigns.

Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit

The purpose of this research study is to obtain insights and feedback from patients and parents about a new approach to support conversations about how cancer may affect one's future life and quality of life (i.e., prognostic communication). This study involves creating a personalized approach to discussing prognosis. Primary Objectives * To evaluate the feasibility of implementing the RIGHTimeCPV intervention among pediatric oncology patients, caregivers, and clinicians (referred to herein as "shareholders"). * To assess the acceptability of the intervention across the shareholder groups. Secondary Objectives * To explore the potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families and multidisciplinary clinicians. * To explore whether the practice of eliciting, sharing, and honoring individualized communication preferences is sustained by clinicians after participation in the RIGHTimeCPV intervention.

Young Adult Food Messaging Experiment

The primary objective of this study is to identify the food counter-marketing messages (i.e., messages that describe deceptive marketing tactics used by food companies) that are perceived as most effective among young adults.

Online Games to Help Canadian and U.S. Adults Identify COVID-19 and Vaccine Misinformation: Three Sequential Randomized Studies

COVID-19 misinformation contributed to vaccine hesitancy and preventable illness. This record covers three sequential randomized studies (conducted in Canada and the United States, November-December 2020) testing whether a brief online game helps adults identify COVID-19 and vaccine misinformation. In the game, participants judged whether statements about COVID-19 or COVID-19 vaccines were true or false and immediately received the correct answer with a brief evidence-based explanation, delivered in a game-like format with points, ranks, and feedback. Study 1 (Canada, n = 2,018) randomized participants to complete the knowledge assessment either before playing the game or immediately after playing it. Studies 2 (U.S., n = 822) and 3 (U.S., n = 797) compared the game against the identical corrective content presented as plain text, for general COVID-19 misinformation and vaccine-specific misinformation, respectively. The hypothesis was that gamified corrective information produces more accurate knowledge than non-gamified information. The primary outcome was accuracy in identifying true and false claims; vaccination intention was a secondary outcome.

An Online Game to Help Canadian Adults Identify COVID-19 Vaccine Misinformation With One-Month Follow-Up

COVID-19 vaccine misinformation contributed to vaccine hesitancy and preventable illness. This study tested whether a brief online game helps Canadian adults identify COVID-19 vaccine misinformation, and whether effects last one month. In the game, participants judged whether statements about COVID-19 vaccines were true or false and immediately received the correct answer with a brief evidence-based explanation, delivered in a game-like format with points, ranks, and feedback. Adults from a national non-probability online panel (n = 4,071) were randomized to the game, to the identical corrective content presented as a static blog post, or to a no-activity control. The game and blog groups were assessed immediately after the activity; all three groups were reassessed approximately one month later. The hypothesis was that gamified corrective information would produce more accurate knowledge than the same information presented as a static blog post and, at one month, than no activity. The primary outcome was accuracy in identifying true and false claims; vaccination intention, vaccine confidence, and self-reported vaccination were secondary outcomes. This is the fourth study in a research program whose first three trials are registered in a companion record.

Simulation on the Enhancement of Clinical Communication Competencies in Nursing Students

Background: Clinical communication is a core competency in nursing practice and is pivotal to the quality, safety, and person-centred delivery of care. Effective communication supports treatment adherence, reduces errors, enhances patient and family satisfaction, and contributes to nurses' professional wellbeing. Despite the acknowledged importance of these skills, nursing students frequently report difficulties communicating with confidence and assertiveness in clinical settings. Although simulation is widely regarded as an innovative educational approach, evidence regarding its specific impact on the development of clinical communication skills-and on students' self-perceived communication competence-during the early stages of nursing education remains limited. Methods: This protocol describes a parallel-group randomised controlled trial with 1:1 allocation, to be conducted at a private higher education institution in Portugal. First-year undergraduate nursing students enrolling for the first time in the Helping Relationship course unit will be eligible. The intervention group will participate in clinical simulation sessions, whereas the control group will receive conventional teaching comprising role-play, group discussion, and case analysis. Both groups will complete 10 contact hours delivered across three sessions over the semester. The primary outcomes will be: (a) clinical communication competence, assessed using the Interpersonal Communication Assessment Scale (ICAS), and (b) perceived self-efficacy, measured with the Self-Efficacy Questionnaire (SE-12), both administered pre- and post-intervention. Satisfaction with the educational experience will be assessed as a secondary outcome. Analyses will follow the intention-to-treat principle, complemented by a per-protocol analysis. Discussion: This study will help to clarify whether clinical simulation is superior to conventional teaching in fostering communication skills and students' self-perceived communication competence during the early stages of undergraduate nursing education. The findings may support the early integration of simulation within nursing curricula and inform the design of educational interventions that promote the development of professionals who are more competent and confident in clinical communication, with a direct impact on the quality and safety of care delivery.

Insights From Bereaved Parents and Oncologists

Investigators want to find better ways for doctors and families to talk about cancer and how uncertainty may affect a child's life.