Clinical Research Directory

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.

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.

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

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.

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.

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).

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?

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.

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.

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.

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.

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.

Role-play Video Demonstrations in Teaching Communication Skills

This study aims to evaluate the effectiveness of role-play video demonstrations in teaching Doctor-Team Communication skills to fifth-year medical students at Ain Shams University. The study compares students who learn through online courses supplemented with role-play videos with students who received the traditional online course. Outcomes include student satisfaction and academic performance. The findings may help improve communication skills training in undergraduate medical education.

Teen Driving Translation Study (NIH)

To translate our evidence-based, parent-engagement safe teen driving intervention to a high-risk, rural and urban teen drivers with a traffic violation, and to test the implementation, effectiveness, and cost-effectiveness of the proposed intervention.

IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention

This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic testing/counseling.

Multicenter HomeVENT: Home Values and Experiences Navigation Track

This is a multicenter study to test a decision-making support process for families and clinicians facing decisions about chronic home ventilation for a child. The investigators hypothesize that the intervention will increase family preparedness for decision-making and will improve clinician-family shared-decision making. Half of families will be assigned to "usual care" arm and half to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content. All families will be interviewed and surveyed at 1, 6 and 12 months after enrollment. Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed and surveyed at 1 month.

Seminar in Unwavering Empowering Presence Optimized for Rehabilitation Teams

The goal of this study to test the feasibility, acceptability, and potential impact of a serious illness communication skills training (CST) tailored to rehabilitation professionals to improve their comfort and confidence in navigating difficult conversations with patients and families. Primary Objectives: Aim 1: To assess feasibility and acceptability of a multidisciplinary co-designed interactive CST program for rehabilitation professionals who care for children with serious illness and their families. Aim 2: To characterize the potential impact of this CST intervention on pediatric rehabilitation professionals. Secondary Objective: Aim 3: To examine the perspectives of bereaved parent educators on participation in the implementation of communication training for rehabilitation professionals.

Anesthesia Counseling, Consent, & Professionalism

The anesthesia consent form has become a standard before surgery. However, verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion has not been addressed. This study will use preoperative discussions and postoperative patient questionnaires to examine the degree of awareness that the patients and the patients families have regarding what general anesthesia is, the responsibilities of the anesthesiologist, and the specifics of what the participants are agreeing to by signing the consent form.

Evaluation of the Efficiency of a Training Program Developed For Newly Graduate Nurses

Brief Summary: This research is a randomized, pre-test post-test control group, parallel group experimental study to evaluate the effectiveness of the language training program developed for newly graduated nurses. The study will be conducted with a total of 76 newly graduated nurses, 38 in the experimental group and 38 in the control group, at Etlik City Hospital Orthopedics-Neurology Hospital in Ankara. Participants will be informed about the study at the beginning of the study. Participants who agree to participate in the study and meet the eligibility criteria will be randomly assigned to groups by an independent statistician. The language training program will be applied to the experimental group, while no intervention will be made to the control group. The training program to be given to the experimental group will consist of a total of two days and four sessions (communication, speaking, patient safety, medical error), and each session will last 90 minutes. Data collection forms will be applied to the experimental and control groups before and after the training. Data collection forms include the descriptive characteristics form, working voice scale, effective communication skills scale, attitude scale in medical errors, and feedback about the language training program. Blinding of the raters will be applied to the participants to minimize bias. Data analysis will use statistical software that uses parametric tests for normally distributed data and nonparametric tests for non-normally distributed data.

Changing Talk Online Training (CHATO) National Trial

The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care.