Clinical Research Directory

Effects of a Tactical Programme for Critical Thinking on Football-Specific Decision-Making in Under-9 Academy Players

This study evaluates whether embedding a Tactical Programme for Critical Thinking (TPCT) within routine academy football training improves football-specific decision-making and execution speed in under-9 male players. Participants will complete either TPCT-integrated training or standard academy training, and performance will be assessed before and after the intervention using the Stroop Task Football Test (STFT).

K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions

This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention.

Data2Action Oregon Project: Supporting Data-driven Decision-Making for Substance Use Services, Policy, and Overdose Prevention

Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use services and mitigate the growing opioid and methamphetamine epidemics in their state. Consistent with the HEAL Data2Action call for Innovation projects that drive action with data in real-world settings, this study will refine and test the impact of a novel implementation strategy to engage cross- sector decision makers and make data that they identify as relevant to their decisions available to them in easy- to-use products. The proposed study aims to not only address critical knowledge gaps regarding how and when data can inform impactful, transparent decision-making, but to provide decision makers with the data that they need to achieve community-wide substance use prevention and treatment goals, including the increased delivery of high-quality, evidence-informed, services and the prevention of overdoses.

Clinical Decision-Making During FEES: The Impact of Residue Amount and Location

In this study, the investigator aims to identify the threshold of food residue visualized in the throat during a FEES (fiberoptic endoscopic evaluation of swallowing) that speech-language pathologists allow before restricting a patient from eating. 60 speech-language pathologists will be required to participate, with half of them watching a pre-recorded video detailing current research about residue in the throat of pharynx. The group watching the video will then re-score their images. This investigates the impact of education on clinical decision-making. Finally, 8 clinicians will meet with the researcher individually to share their clinical decision-making rationale. With this information, the researcher hopes to identify a patient population who is at risk for diet restrictions in order to encourage speech-language pathologists to extend the swallow study and trial more compensatory strategies before restricting the patient's diet.

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.

Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children

Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support parents as they make decisions for their child and communicate with the health care team. The main questions this study aims to answer are: 1. Do parents who receive the BRIDGE intervention report being better prepared to make decisions for their child? 2. Do parents who receive the BRIDGE intervention report less regret about the decisions they made for their child? Participants will complete surveys at baseline and approximately 2 weeks, 6 months, and 12 months following enrollment. Some participants will also participate in interviews about their experiences.

Identifying the Neural Correlates of Mental Simulation in Multi-Step Planning

Planning is the ability to think ahead by considering possible future actions and their consequences. This research study aims to understand how the brain supports multi-step planning by testing whether people simulate promising future move sequences while deciding what to do next. Healthy adult volunteers will learn and play a strategy game called "Four-in-a-Row" (similar to Connect Four). Participants will complete two sessions on successive days: an online behavioral training/playing session and an in-person brain-recording session at New York University. During the brain-recording session, participants will view mid-game board positions and choose the best move while the study team records brain activity (using magnetoencephalography \[MEG\] or functional MRI \[fMRI\]) and eye movements. Data from the game and eye tracking will also be used to fit computational models of planning that help interpret the neural measurements.

Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome

The purpose of the study is to see if our education materials help people at risk for Lynch syndrome decide about seeking genetic services. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the an information letter or an information letter plus a booklet. Two follow-up surveys will be administered over the span of 6 months. Participants will also be invited to join an optional exit interview to provide feedback.

The Effect of Digital Games on Ethical Sensitivity and Decision Making in Nursing Students

The study was planned using a randomised controlled experimental design to determine the effectiveness of digital game-based teaching in the development of ethical sensitivity and ethical decision-making processes among nursing students.

The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers

The goal of this clinical trial is to learn if laughter yoga can improve both individual and organizational outcomes in nurse managers. The main questions it aims to answer are: * Does laughter yoga lower burnout and stress levels in nurse managers? * Does laughter yoga improve work-life quality and job performance? * Does laughter yoga help nurse managers make better decisions and solve problems more effectively? * Does laughter yoga lower compassion fatigue and support positive approaches to workplace conflict? Researchers will compare a laughter yoga group with a control group to see if there are meaningful differences. Participants will: * Join structured laughter yoga sessions for a defined period (weekly sessions). * Complete surveys before and after the program about stress, burnout, work-life quality, decision-making, problem solving, job performance, compassion fatigue, and conflict approaches. * Continue their usual work while attending sessions.

Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial

The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to reduce disparities in the allocation rate of advanced heart failure therapies, heart transplants and ventricular assist devices. This study proposes to implement evidence-based strategies that reduce unequal and unethical decision-making towards patients, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. Our rigorously designed trial will inform national guidelines for advanced heart failure therapy allocation, and data are likely to be generalizable to other organ replacement treatments and advanced chronic disease decision-making processes across populations.

Integrating Telehealth to Advance Lung Cancer Screening

The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are: 1. Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS? 2. Is the effectiveness of these telehealth strategies similar by race and sex? The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.

Interventions in Mathematics and Cognitive Skills

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making

This study aims to (i) assess the effects of combined tDCS and cognitive training on decision-making on a trained task (Iowa Gambling Task; IGT); and (ii) test generalization to a closely related cognitive domain, namely motor impulsivity. It is hypothesized that combined anodal tDCS and cognitive training will result in more advantageous decisions and better impulse control than combined sham tDCS and cognitive training.

Craving & Decision-Making

Craving is the strong desire for something, such as for substances in drug addiction and food or other activities in everyday life. Recent work suggests craving can influence how people make decisions and assign value to choice options available to them, yet the neural mechanisms underlying these interactions between craving and valuation remain unknown. To address this, this study uses cognitive decision-making tasks that measure how much individuals will pay (from a study endowment) to have everyday consumer items or snack foods when they crave something specific (opioids or a specific snack, respectively). First, the study will identify the neural mechanisms for how drug craving (craving for opioids) interacts with valuation for consumer items that have associations with drug use or not in people receiving treatment for opioid use disorder (OUD). This will be evaluated in the activity patterns and interactions among brain regions involved in craving and value assignment during decision-making. Then, the study will examine for parallel mechanisms for how food craving (craving for a specific snack) interacts with valuation for snack food items that have similar features to the craved snack or not in people receiving treatment for OUD and non-psychiatric community control participants.

3-Dimensional Evaluation of Body Perception

The goal of this observational study is to evaluate the changing body perception of amputees aged 18-65 years using prostheses through different personal perspectives of the right-left distinction. In addition, we aimed to examine the relationship between possible changes in body perception and visual spatial perception and neurocognitive performances. The main questions that this study aimed to answer are as follows: 1. Is there a difference between the amputee group and the control group in terms of parameters related to body perception? 2. Is there a difference between the amputee group and the control group in terms of neurocognitive skills? 3. Is there any difference between the amputee group and the control group in terms of visual spatial perception abilities? To examine whether changes in body perception in amputees affect neurocognitive performance, visuospatial perception and perspective perception and the relationship between them will be compared with a healthy control group. The assessments to be applied to both groups can be summarised as follows: * Demographic information such as age, gender, and education level will be recorded. * Mini-mental state test will be used to assess the cognitive level. * Edinburgh Handedness Scale will be used to determine the dominant side. * Right-left discrimination and personal perspective perception will be assessed using a desktop programme. * The clock drawing test and Benton line orientation test will be used to visual spatial perception. * A computer based program called The Central Nervous System (CNS) Vital Signs Neurocognitive Test Battery will be used to asesses neurocognitive abilities.

Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery

Emergency General Surgery (EGS) is an umbrella term which describes all patients presenting to hospital with an acute abdominal problem. Patients can have various conditions requiring emergency operations. EGS is one of the most common reasons for an emergency admission in the UK. EGS is often referred to as "high-risk" surgery. For those patients who do survive after their surgery, many struggle with frailty and new medical problems resulting in a reduction in their quality of life (QoL). The goal of this observational study is to explore QoL and decision-making in EGS through questionnaires and interviews with patients, families/supporters and consultants working in EGS. Workstream 1 will involve patients and families/supporters. Workstream 2 will involve consultants. The investigators are interested in patients who have either undergone EGS (EmLaps) or have needed but not undergone EGS (NoLaps). The investigators are interested in exploring participants (patients, families/supporters and consultants) experiences of this EmLap vs NoLap decision. The main questions the investigators want to answer are: * What is the long-term QOL of EmLap/NoLap patients and their family/supporters? * How do patients and their family/supporters describe their experience of decision-making in EGS? * What are consultant's experiences and views on decision-making in EGS? Workstream 1 participants (patients and family members/supporters) will complete questionnaires and take part in interviews at different time-points following their decision (1 month/3 months/ 9-12 months). Questionnaires and interviews will explore QoL and decision-making in EGS. Consultant participants will be asked to complete an online survey and/or take part in an individual interview. Both will explore decision-making in EGS.

Needs and Preferences of Patients With Head-neck Cutaneous SCC

The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. However, studies on the experiences and needs of patients with high-risk cutaneous squamous cell carcinomas in the head-neck region are lacking.

Impacts of the Indashyikirwa Program on Intimate Partner Violence in Syria

This study aims to evaluate the effectiveness of the Indashyikirwa program in enhancing women's empowerment and reducing Intimate Partner Violence (IPV) in conflict-affected communities in Northeast Syria. The intervention group will participate in the Indashyikirwa ("Agents of Change") program, which includes a comprehensive couples' training module and access to safe spaces. The control group will not receive the Indashyikirwa program. Both intervention and control groups are beneficieries of Small and Medium Enterprise (SME) support and Vocational Training (VT) to promote economic empowerment. The study employs a cluster-randomized controlled trial (cRCT) design. Out of 30 pre-identified villages, 15 villages were randomly assigned to receive the Indashyikirwa program and 15 villages will not receive the Indashyikirwa program. The villages were located within the same sub-districts to ensure a balanced geographic distribution of the intervention. Based on a power analysis with 80% power, at least 16 married couples from eligible SME and VT beneficiaries will be voluntarily enrolled in each village to receive the Indashyikirwa intervention. Similarly, 16 eligible SME and VT married couples from control villages will be enrolled using the same voluntary participation principle. To account for potential attrition, 20 couples per village will be initially enrolled, ensuring a robust sample size for analysis. This approach results in a total sample size of 600 couples (or 1,200 individual participants). The primary objective of this study is to assess the impact of Indashyikirwa program on key outcomes, including the reduction in IPV, transformation of gender norms, enhancement of women's empowerment, improvements in intra-household dynamics, economic benefits to the household. Data collection will involve structured surveys administered separately to both husbands and wives. Surveys will be conducted at four time points: baseline, 2 months post-intervention, 12 months post-intervention, and 24 months post-intervention.

Improved Prescribing for Older Nursing Home Patients

Research aim: To investigate the effect of training health care professionals in medication assessments on the medication use of nursing home residents with a limited life expectancy (\< 1.5-2 years). The core of the training is to tailor medication use to (palliative) treatment goals of nursing home residents. Design: A cluster randomized controlled trial on long term care wards in nursing homes, with the nursing home care organisations as unit of randomisation. The investigators intent to include 6 organisations and 450 nursing home patients. The research starts in september and lasts 1 year and 3 months. Eligible patients are nursing home patients of 65 years and older with a limited life expectancy (\< 1.5-2 year) of long term care wards. Intervention: The intervention includes a method in which healthcare professionals (medical practitioner, pharmacist and care worker) are trained to tailor medication to the (palliative) treatment goals of nursing home patients with a limited life expectancy. The training consists of 2 components: 1) medication assessment, and 2) advance care planning (ACP). In the intervention group, healthcare professionals receive the training in combination with supporting tools and educational materials, in the control group care continues as normal. The allocation ratio for control and intervention groups is 1:1. A process evaluation will take place simultaneously with the intervention study. Data collection takes place before the start of the intervention (T0), after 6 months (T1) and after 12 months (T2). Outcome measures: The primary outcome measure is potential under- and over-treatment with medication. The secondary outcome measure is experienced involvement in decision-making (measured with a short questionnaire based on the revised PATD (patients' attitude towards deprescribing)). Tertiary outcome measures are: quality of life, deaths, falls, hospital admissions/acute first aid referrals and pain. Discussion: The intervention is expected to result in a decrease in chronic and preventive medication prescriptions, an increase in medication for symptom treatment and more involvement (and satisfaction) of the nursing home resident in decision-making, without adverse effects.

Effects of Parents Included in Medical Round of Neonatal Intensive Care Unit

The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are: * How feasible the protocol of this study is to include parents in the medical round? * Does the Family Round promote the quality of family centered care in the NICU perceived by parents and healthcare staff? * Does the Family Round promote parent-infant bonding? * Does the Family Round reduce parents' anxiety? * Does the Family Round increase parents' satisfaction? * Does the Family Round improve staff's communication skills to integrate parents in the discussion of medical rounds? Participants will participate in the Family Round for two weeks, which is organized by healthcare staff following a protocol aiming to integrate parents into the discussion. They will be compared to the two-week period without the Family Round.

Strengthening Contraceptive Counseling Services: Research Protocol for a Multi-phase Complex Intervention in Pakistan and Nigeria

High-quality contraceptive counseling can strengthen global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of contraceptive counseling interventions for Pakistan and Nigeria designed to strengthen existing contraceptive services and determine its effectiveness in increasing clients' level of decision-making autonomy and meeting their contraceptive needs.