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.

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.

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.

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.

Redesigning Surgical Care for Patients in Wisconsin

This study evaluates strategies to train surgeons to use Better Conversations, an evidence-based communication framework designed to improve informed consent by helping patients understand the goals of surgery, the downsides of treatment, and what to expect. Better Conversations supports deliberation, patient preparation, and alignment of decisions with patient goals, addressing known shortcomings in traditional informed consent. The purpose of this study is to compare two methods of surgeon training: (1) training delivered by an education specialist using audit and feedback, and (2) training supported by computerized automation that identifies elements of Better Conversations in de-identified transcripts of surgical consultations. The central question is whether the automated training program is non-inferior to the specialist-delivered program. Approximately 60 surgeons from two academic health systems will be randomized to one of these training approaches. Each surgeon will complete a didactic session, have outpatient surgical consultations audio-recorded for feedback, and complete assessment recordings after training. Patients of enrolled surgeons will complete surveys before and after their surgeon's training to evaluate patient-reported communication outcomes. Findings from this study will assess the effectiveness, feasibility, and acceptability of automated training and support the development of a larger pragmatic study to evaluate the broader effects of Better Conversations on patient outcomes.

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.

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.

Communication for Early Mobilisation of People Living With Dementia Following Surgery for Hip Fracture

This goal of this study is to identify ways that healthcare professionals communicate that are effective in helping a person living with dementia to stand or walk after surgery for a broken hip (hip fracture). We aim to identify 'what works' in successfully helping people with dementia to mobilise early, and share this in practice. The main question the research aims to answer is: What healthcare professional communication practices are effective in achieving early and continued mobilisation among people living with dementia following hip fracture surgery? We will use a research method called 'Conversation Analysis', to look at the fine detail of the language healthcare professionals use and responses to it. We will make video recordings of real-life ward care, when healthcare staff are trying to help a person with dementia get up early after hip fracture surgery. We will involve people with dementia in decisions to take part and get agreement from their families before we record anything. We have done this successfully in two previous studies. We will record up to 50 episodes of care on three trauma orthopaedic wards. We will identify specific, practical recommendations and 'teachable' approaches: ways of speaking, or sequences of requests or instructions. We will work with people with dementia, family carers, educators and clinicians to do this. We will use clips of videos in future communication training.

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.

A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)

The purpose of this study is to investigate a specific approach to patient care called a time-limited trial (TLT). This approach is sometimes used for people who develop critical illness and are cared for in an intensive care unit (ICU). A time-limited trial is a plan made together by medical teams, patients with critical illness (if they can take part), and their families or other important people helping to make their healthcare decisions. A time-limited trial starts with a discussion of the patient's goals and wishes. Then, a plan is made to use ICU treatments for a set period of time to give the patient the chance to recover. After this time, the patient's response to treatment will be reviewed to help guide what to do next. Medical teams consider this kind of plan when it is not clear if a patient can recover to a quality of life that is acceptable to them. With a time-limited trial, patients, families, and medical teams experience this uncertainty together. The main goal of this study is to find the best way to use TLTs for patients in the ICU who have trouble breathing and need mechanical ventilation to help them breathe. The hypothesis is that optimal time-limited trial delivery will reduce the time patients with acute respiratory failure spend in the ICU and will improve the intensive care unit experiences for their families and clinicians.

Timing of Physician Rounds for Antepartum Patients

This study will include patients admitted to the Antepartum service at Duke University Hospital, many of whom are managing high-risk pregnancies that require extended hospital stays and frequent physician interactions. Currently, two rounding methods are used interchangeably for patients who do not have pregnancy or delivery complications that would preclude participation in delayed daytime rounding. This randomized controlled trial will compare two rounding models: the standard model, in which patients receive two rounds (an early morning bedside encounter and a later team discussion), and the intervention model, which consolidates both rounds into a single, later-morning bedside encounter following the team's review of clinical data. The primary objective is to assess whether consolidating physician rounds into a single, later-morning encounter-referred to as discovery rounding-improves patient satisfaction with communication.

All Providers Better Communication Skills Program' (ABCs)

High quality, person-centered communication for those living with serious illness benefits patients, families and clinicians. Evidence shows that clinicians rarely engage patients in these, sometimes challenging, discussions. Current education programs to build health care provider competency in serious illness communication are often inconsistent in defined purpose and use of terms. This education also tends to be oriented to treatments, not a person or do not cover the full range of difficult conversations between diagnosis and delivery of end-of-life care. The ABCs program is an education intervention for health care providers that features a blended format of online modules and interactive virtual workshops, relevant to clinicians at all levels of training and practice. This study will examine the effectiveness of this training (over no training) for impacting provider competency and behavior change in serious illness communication. All participants in this study will receive the full ABCs training, but at different times. The overall intended impact of this program is to improve clinician confidence and satisfaction in having conversations with patients and families about serious illness. The ultimate goal of the ABCs program is to increase access to early palliative care by empowering more providers to initiate this care.

Parental Support Intervention in an Advanced Oncological Context

This prospective, two-arm randomized trial compares a psycho-educational program to a psycho-educational and experiential program for parents with advanced cancer. These two interventions aim to support parent-child communication about cancer, but we hypothesize that the combined intervention will be more effective for all studied communication variables.

Client Understanding, Expectations, and Intern Performance in Occupational Therapy

This study aims to investigate psychiatric clients' understanding of occupational therapy (OT), the reasonableness of their expectations regarding OT services, and OT interns' performance in Occupational Therapy Knowledge (OTK) health education and chief complaint/expectation interviews. The project includes developing assessment instruments for client OT knowledge, expectation reasonableness, and intern communication/education performance, followed by data collection in real clinical settings. Clients, clinical supervisors, and external experts will contribute ratings to evaluate instrument validity and reliability. The study will provide foundational evidence for improving OT health education, communication training, and clinical teaching practices.

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.

Effectiveness of Case-Based Educational Scenarios in the Metaverse on Interpersonal Communication Skills, Academic Engagement, and Mind-Wandering in University Nursing Students

This randomized controlled trial will evaluate the effect of case-based educational scenarios delivered in a metaverse environment on interpersonal communication skills, academic engagement, and mind-wandering among undergraduate nursing students. Fourth-level nursing students will be randomly assigned either to metaverse-based case scenarios integrated into their psychiatric nursing education or to usual teaching without metaverse exposure. Outcomes will be measured using validated scales for interpersonal communication, learning engagement, and mind-wandering before and after the intervention.

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.

Alcohol and Sexual Communication Among Couples in the Laboratory

Intimate Partner Sexual Violence (IPSV) is a significant and understudied public health problem among couples, yet little is known about factors that contribute to IPSV perpetration. This proposal aims to determine the acute effect of alcohol and sexual communication on IPSV. In this study, 240 couples who drink alcohol will be recruited from the Metro-Denver area. Upon arrival to the laboratory, a trained research assistant will check the participant's ID, verify that they adhered to the pre-session guidelines, administer a breath test to ensure a breath alcohol content (BrAC) of 0.00 and conduct a field sobriety test. They will also obtain informed consent for each member of the couple separately. Female participants will take a pregnancy test to ensure a negative result. All participants will complete measures to reverify eligibility criteria and be weighed to determine their correct alcohol dose. Partners will separately complete a baseline survey measuring demographic factors, alcohol use, sexual communication, and daily experiences. After completing the survey, participants will be assigned a beverage condition (alcohol or no-alcohol control) and couples will be randomly assigned to a communication condition (direct verbal or indirect verbal). Participants will be seated in a room separate from their partner, where they will drink an alcoholic or no-alcohol control beverage. Upon reaching a breath alcohol content (BrAC) of .07, or immediately after drinking in the No-Alcohol control condition, participants will complete a laboratory assessment of sexual violence. The main hypotheses are: (1) one's alcohol use will increase IPSV toward partners who are also drinking, (2) one's alcohol use will increase IPSV among partners who use indirect, relative to direct, communication, and (3) actor alcohol use will increase IPSV toward partners who are also drinking and use indirect, relative to direct, communication.

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.

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.

Avatar Contraception Communication Training

In order to support the desire of most adolescents to delay pregnancy (parenting) until their own adulthood, pediatricians must be comfortable and skilled in having reproductive health conversations with adolescents and the mothers of adolescents. Advocates for Youth (AFY), a national, youth-facing, well-established, non-profit, is known for innovative sexual and reproductive health programs. AFY successfully implemented a virtual simulation for schoolteachers to practice sex education scenarios by interacting with culturally diverse student avatars. We will partner with AFY to adapt their novel simulation-based approach to train medical residents in using SDM with youth and parent avatars. Our long-term goal is to build clinician confidence in SDM and actual skills via simulation training with dyadic avatars. We will also explore how evaluation of clinician communication skills varies from youth-, parent-, and clinician-viewpoints.

Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections

Background: Anxiety is highly prevalent before elective caesarean sections and can have a negative impact on anesthetic outcomes, postoperative pain and maternal mental health. The use of pharmacological premedication is controversial, and non-pharmacological alternatives are increasingly being explored. Therapeutic communication, based on empathy, positive language and the conscious avoidance of negative or anxiety-inducing suggestions, has shown promise in other surgical settings. However, its effectiveness in obstetrics remains to be explored. Methods This is a single-centre, prospective, observational, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training programme on therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study includes two groups of 130 patients each, one before the intervention and one after. Anxiety levels will be assessed using the French version of the State-Trait Anxiety Inventory score, and the primary outcome will be the difference in scores after caesarean section between the two groups. Secondary outcomes include the proportion of patients with high anxiety levels (STAI-State score \>45), as well as staff satisfaction, feeling of relevance, and indicators of the feasibility of implementing the training. The intervention consists of a short (less than 1 hour) training course using podcasts and flashcards, combined with distributing a lexicon that promotes hypnosis-based therapeutic communication (HBTC). Staff participation, perceived relevance and satisfaction will be assessed using structured questionnaires based on the Likert scale. Linear and logistic regression analyses will be used to adjust for confounding variables, including baseline anxiety, psychiatric history, and intraoperative complications. Discussion This is the first study to evaluate the impact of a dedicated HBTC training programme on patient anxiety and staff experience in an obstetric surgical setting. By integrating this approach into routine cesarean section care, our aim is to improve the patient experience and enhance communication practices within clinical teams. The results could inform clinical practices on non-pharmacological strategies in obstetric care.

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.

Communication With Mechanically Ventilated Intensive Care Patients

The overarching aim of this multicenter study is to develop a multimodule training intervention (COMMEC-ICU) for nurses working in ICUs, to increase nurses skills and knowledge and then improve communication for mechanically ventilated ICU patients. The intervention will be implemented at the included ICUs and evaluated both on nurses in the ICU and patients. Patients with delirium will also be included.